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Ethical issues for vaccines and immunization | Nature Reviews Immunology

Ethical issues for vaccines and immunization | Nature Reviews Immunology

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Ethical issues for vaccines and immunization

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Perspectives

Published: 01 April 2002

Science and society – vaccinesEthical issues for vaccines and immunization

Jeffrey B. Ulmer1 & Margaret A. Liu2 

Nature Reviews Immunology

volume 2, pages 291–296 (2002)Cite this article

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AbstractVaccination is the only type of medical intervention that has eliminated a disease successfully. However, both in countries with high immunization rates and in countries that are too impoverished to protect their citizens, many dilemmas and controversies surround immunization. This article describes some of the ethical issues involved, and presents some challenges and concepts for the global community.

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MainVaccines stand out as being among the most efficacious and cost-effective of global medical interventions1 (Box 1). Vaccines have saved millions of lives, prevented significant morbidity and suffering, and even eradicated a disease. This last accomplishment, the eradication of smallpox, highlights what can be achieved by vaccination. However, unfortunately, the inequalities in the distribution and use of vaccines are also striking. If vaccines can be deployed so successfully worldwide that a disease can be eliminated, why do millions of children still die each year from other vaccine-preventable diseases? From ethical and humanitarian perspectives, this should be unacceptable. However, despite the medical evidence of the benefits of vaccines, both immunization itself as a goal, as well as the actual efforts for global immunization, are often debated and criticized. So, the ethics of whether, and how, to vaccinate all of the world's population are much more complex than it would seem at first glance. Some of these issues will be examined and a call for action raised in this article.

Current state of immunization rates

At present, in industrialized countries such as the United States, infants routinely (∼80–95% coverage) receive vaccines against diphtheria, pertussis (whooping cough), tetanus, measles, mumps, rubella, polio, Haemophilus influenzae type b, hepatitis B, varicella, pneumococcus and, often, hepatitis A. The efficacy of these vaccines and the success of routine immunizations are such that in the United States, for example, the morbidity from previously routine childhood diseases has been reduced by 90–100% since the introduction of standard immunization2 (Table 1). In developed countries, the near disappearance of these diseases from normal childhood has removed much of the fear of the illnesses that they cause. The result is that the consequences of not vaccinating against these diseases are sometimes not fully appreciated by the public.Table 1 Reduction of the number of vaccine-preventable diseases in the USFull size tableIn developing countries, one in every four children born annually will not be vaccinated3. In many of the impoverished countries in which these children reside, the concomitant lack of health care, inadequate nutrition4, higher prevalence of disease, decreased hygiene and over-crowding conspire to increase the incidence of, as well as the morbidity and mortality from, both vaccine-preventable and other infectious diseases. Six children die every minute as a result of infectious diseases that could be prevented by existing vaccines, and for measles alone, nearly one million children die each year3. So, each day, 4,000–8,000 people3, mainly children, die from vaccine-preventable diseases (Table 2).Table 2 Global vaccine-preventable deaths through infant immunizationFull size tableVarious efforts to increase global immunization rates have protected many children successfully. For example, in 1974, before the Expanded Program on Immunization (EPI) was established, an estimated 8 million children died each year from measles5. Since then, the EPI has targeted six diseases: tuberculosis, measles, diphtheria, tetanus, pertussis and polio (Fig. 1). By 1980, the incidence of measles had been reduced by ∼50% (Fig. 2). In that year, the World Summit for Children set a goal of 80% coverage for these six basic immunizations to be achieved by 1990. Laudably, those efforts succeeded in raising global immunization rates from less than 10% to almost 80% in that decade6, with a concomitant reduction in disease burden (for example, see Fig. 2). But, a combination of complacency, competition for health-care resources with other diseases (such as HIV) and other factors, such as an inadequate and ageing health-care infrastructure, resulted in a subsequent plateau5 or decline in average immunization rates in the developing world6. This trend is worrying because of what it represents in terms of the commitment and sustainability of immunization programmes. Maintenance of a high level of coverage for immunization is crucial — unless a certain minimum percentage of the population is immune, the benefits of herd immunity (when sufficient people are immune such that a pathogen cannot easily persist and spread in a population) will not be achieved.Figure 1: Number of children's vaccines used routinely in developing and industrialized countries.As shown, the number of vaccines (y axis) that are given to children has risen steadily since 1985 in industrialized countries, but not in developing countries. DPT is a combination vaccine against three separate pathogens: diphtheria (D), pertussis (P) and tetanus (T). BCG is the Mycobacterium bovis bacillus Calmètte–Guerin vaccine against tuberculosis. The loss of life due to lack of infant immunization in developing countries is due to the smaller number of vaccines that are routinely used, as well as to lower immunization rates. Reproduced, with permission, from the World Health Organization6.Full size imageFigure 2: Measles global annual reported incidence and immunization coverage, 1980–2000.The global incidence of measles has declined as immunization coverage has increased. The level of immunization coverage plateaued in the 1990s, leaving a significant number of cases of measles still occurring each year. Reproduced, with permission, from the World Health Organization22.Full size image

Ethics of immunization and vaccines

The economic and human benefits of vaccination are clear for many vaccines. But, economic and political realities, along with philosophical questions, raise certain ethical issues concerning the use and distribution of vaccines7. What are the rights of individuals in deciding about vaccination versus the rights of, and risks to, society? Should different standards for the efficacy and safety of a particular vaccine be set for different populations for which the risk:benefit ratio might be different? How should priorities be set for different areas between and within countries? Which regulatory bodies have the right to make decisions at the individual or national level? Although few would argue against the responsibility of developed nations to help poorer countries and peoples to develop and use the necessary vaccines, what are the precise responsibilities of both developed and developing countries? Here, we examine several of these issues to highlight the complexities of the ethics of vaccine development and use.Whose choice is it? During the period when polio epidemics struck terror into the hearts of the population, the public clamoured for, supported the development of (for example, The March of Dimes in the United States, a national public compaign to raise donations to fund the research and development of polio vaccines) and welcomed a vaccine against polio. The live attenuated vaccine made possible a global mass-immunization campaign; on a single day of the various National Immunization Days, 83–147 million children were immunized8,6. Now, at a time when wild-type polio has been eliminated from the Western Hemisphere and nearly eradicated globally, the only cases of polio in the Western Hemisphere are caused by reversion mutants of the live-attenuated vaccine strain of the virus. For society as a whole, the total elimination of polio seems the obvious and correct path. But, as the probability of an individual being exposed to the virus decreases, and as the devastation of the historic polio epidemics fades in our memories, the rare cases of disease due to reversion of the vaccine itself become more prominent. The benefit of immunization for any given individual decreases (due to a lower probability of contracting the disease), whereas the perception of risk might increase9. So, what is best for the individual might be seen as potentially different from what will benefit society as a whole. However, it has only been through the participation of hundreds of millions of individuals in vaccination programmmes that unimmunized individuals have the luxury of an altered risk:benefit ratio. Interestingly, in 1980, the year that smallpox was officially declared to be eradicated, prominent individuals in the international health-planning community were critical of the smallpox campaign. They felt that the approach of 'top–down' (mandated and orchestrated by global bodies) programmes was wrong and contrary to more-localized, primary health care10,11. Even this pre-eminent example of the beneficial power of immunization was not without controversy.In the same manner, other vaccines have become victims of their own success. As diseases disappear from the general population after successful vaccination campaigns, the real risk of an individual contracting the disease decreases and the perception of the seriousness of the disease, even if contracted, is reduced. Concomitantly, concerns about the real or imagined adverse effects of the vaccines increase. As a result, individuals might disagree with government mandates for population-wide vaccination. For example, before the introduction of a vaccine against pertussis, there were approximately 2 million cases annually in the United States. In Great Britain, in the mid-1970s, some adverse reactions to the vaccine were widely publicized, and immunization rates declined from 80–90% to 30%. As a consequence, the population was vulnerable to two subsequent severe outbreaks of whooping cough, which resulted in more than 120,000 recorded instances of disease, hundreds of cases of serious complications and 28 deaths12. More recently, heightened fears of the perceived adverse effects of other vaccines (such as measles and hepatitis B), even if unproven, have had an impact on immunization rates and the incidence of disease6,13,14,15. A greater awareness of the consequences of failure to vaccinate, through better education, might be the best tool to combat this problem16.Poverty and priorities. In wealthier countries, the ethical issues that surround vaccination tend to focus on the rights of individuals versus government or society. In poorer countries, the fundamental issue is the lack of access to basic necessities for health, such as adequate nutrition, clean water, medicines or vaccines. Although poverty is clearly the main cause of these deficiencies, other factors contribute, such as the low priority given to health and preventive measures, the disenfranchisement and lack of political and economic power of the people most affected (children and women), corruption and regional warfare.In the year 2000, only 10% of global medical-research funds were directed towards the 90% of diseases that affect the world's poorest people6. It would seem obvious from the economic benefits that prevention of disease (and health in general) should be a priority for poor countries. It would seem equally obvious that helping to ensure such health should be a high priority for wealthy nations, even if simply to protect their own populations. Not only can newly emerging diseases spread rapidly across the globe, but pathogens eliminated from one population can be 're-imported' (or new strains introduced) by travellers or immigrants17.At present, only about 1% of contributions to overseas development are directed towards immunizations6. The hurdle is not simply the purchase price or availability of vaccines, but for many poor countries, there is a lack of infrastructure for health care in general, and vaccine delivery specifically. The needs are so great and so widespread, both geographically and technologically, that assigning priority is difficult. This prioritization is considered by some to be an ethical issue, but in reality, it might be simply that the pie is not sufficiently large, rather than that the pie should be sliced differently. The trade-off of protecting children now from disease versus an emphasis on the development of new vaccines to protect children in the future is not a debate that can be resolved even by Solomonic wisdom. Neither trade-off is ethically defensible, and the world should, instead, work constructively to increase the resources devoted to health, nutrition, prevention and specifically immunization, to make vaccines available to all people as required. But, how is this to be accomplished?'Trickle-down' or simultaneous introduction. A marked effort is required to introduce vaccines into all necessary areas of the globe in a more timely fashion. The average time lag between licensing of a new vaccine for industrialized countries and its use in less developed countries is 10–20 years6. There are many reasons for this, including the lack of manufacturing capability for vaccines that require new technology in their production, return on investment and the cost of manufacturing newer technology-based vaccines. For example, when the recombinant hepatitis B virus vaccine was first introduced, there was not sufficient capacity worldwide for its production. Moreover, the cost of manufacturing such a 'high-tech' vaccine put it beyond the reach of the existing purchasing programmes at the time. Although the technology that supports recombinant protein vaccines is now available worldwide, it took time and effort to develop that capacity, even in developed countries.

People are created equal, but different

The simultaneous introduction of vaccines into developed and developing countries is an important goal. However, this is easier said than done. In addition to the issues of availability and economics, it cannot be assumed that disease burden, strain prevalence, vaccine efficacy and effectiveness (how well a vaccine works in clinical trials and real-world settings, respectively), immunization schedules or risk:benefit ratio will be standard or will justify the use of a vaccine in all areas. Differences in genotype and health status of individuals could affect how their immune system responds to a given immune stimulus. Environmental influences on the immune system (for example, indigenous parasitic infections that affect the predominant cytokine-secretion profile of helper T cells, or bacterial infections that facilitate or hinder immunity against closely related pathogens) might affect the immunological outcome of a particular type of vaccine.Just as a vaccine that works in one population might not be as effective in another population, so might adverse effects of a vaccine be specific to one population. Hence, a vaccine company might be reluctant to simultaneously test a vaccine in two populations, for fear that an adverse effect in one population (due to genetic, nutritional or other health factors, or limitations of the infrastructure for vaccine delivery) would halt the development of a vaccine that could be both useful and commercially viable in another population. More importantly, the higher background rates of morbidity and mortality in certain developing countries might cause problems when presenting vaccines for licensure in more developed countries.A counter-example to illustrate why vaccines might need to be tested simultaneously in developed and developing countries is provided by a rotavirus vaccine. Rotavirus is a major cause of diarrhoea in infants. In the United States, 20 children die each year from rotavirus infection, and worldwide, the virus kills 600,000 children under the age of five annually18. In 1998, a new rotavirus vaccine was licensed in the United States. But by 1999, reports emerged from American clinics of the occurrence, after immunization, of a small number of cases of intestinal intussusception — a 'telescoping' of the small intestine that often requires emergency surgery18. The number of cases was small, and the aetiological link has been debated, but the vaccine was withdrawn from the market. Clinical trials that were testing the vaccine in developing countries were stopped. So, we do not yet know whether the vaccine would have been effective or caused side effects in children from developing countries, for whom the risk:benefit ratio might well be quite different. More than half a million children continue to die each year due to rotavirus infection (although it is hoped that other rotavirus vaccines that are under development will be approved for use). The issue of how to speed up vaccine deployment for developing countries and how to develop vaccines that specifically address the needs of those countries should not be oversimplified. Different vaccines (for example, for different virus strains) might be required to prevent the same disease in different parts of the world. The needs of people in developing countries must be specifically, rapidly and directly addressed to develop appropriate vaccines. To make this happen in a timely manner, more thought and effort is required at early stages of vaccine development. But, by whom and at whose expense?

A farewell to arms

In the face of the unacceptable and gaping inequalities in access to vaccines, the temptation has been to 'point the finger' at various countries or segments of society. A chief target for many of these denouncements has been large vaccine manufacturers, as well as the people and governments of their home countries. It has been easy to stir up indignation, although a thoughtful evaluation of the real contributions, roles and responsibilities of all parties has been more productive (Box 2). The cries for companies to lower the prices of their vaccines has reinforced the unwarranted notion that vaccines should be inexpensive — an idea that perpetuates the vicious cycle of the low valuation of health care, prevention and children's lives. Obviously, low cost might be an important means of increasing access to vaccines, but the fundamental problem is the low priority given to children, health and prevention.Most vaccines that are in use today were developed fully and are manufactured by industry, rather than the public sector. Commercial companies have responsibilities to their shareholders and are driven by profits. But, it is these profits that have enabled the companies to take the huge economic risks that are required for the long process of discovery, research and development of vaccines. If all economic incentive were removed, or made too small, even fewer companies would bother to make vaccines19, and, instead, would concentrate solely on therapeutic agents, because people will pay more for drugs that treat, rather than prevent, disease.So, companies should not be expected to be philanthropic, although they should be expected to be generous global citizens. Indeed, industry-driven scientific and technological advances have had an important impact on improving global health. Combination vaccines — whereby several vaccines can be given with a single injection — were developed in part for the market advantage that they would provide but have been an important tool for increasing global vaccination rates. In addition, industry and academia are both contributing to the continuing development of vaccines that do not require refrigeration or needles and can be given orally or nasally — a true 'farewell to arms'.In most walks of life, philanthropy usually comes as a consequence of success, and the same is true for medicines. So, the profit-driven priorities of vaccine companies are not unethical per se; rather, they are not driven primarily by ethical concerns, and the challenge is how to increase the efforts of industry that are directed at improving health on a global basis. The fact that only 1% of pharmaceuticals that reached the market-place between 1975 and 1997 were approved specifically for diseases of the developing world6 shows that, as a society, we need to re-evaluate our priorities and our paradigms, not that the economic model of financial incentive driving technical advances is wrong.

The challenge

We should challenge each economic sector, population and government to appropriately fulfil its responsibility to fellow humans or its own citizens; in other words, they should treat all of the world's children as their own, rather than denouncing particular groups as causing these inequities. Further support must be given rapidly to those whose efforts will result in vaccines that are better tailored for developing countries, both in terms of the disease focus and the development of technologies that will facilitate vaccine access and sustainability. New paradigms, including novel public–private partnerships (Box 2) and alliances that are designed to engage local governments and manufacturers at early stages of research and development, are required. In this way, each group can contribute what they do best to the common goals of improving access to existing vaccines, developing new vaccines and technologies for existing diseases (such as HIV and malaria), and ensuring that increases in immunization rates are sustainable. Perhaps most difficult of all will be to change the mindset of people all over the globe. We need to place a higher priority on health and disease prevention, and above all, to value the lives of all people, no matter where they live — even if they are impoverished and powerless.Box 1 | The economic benefits and cost-effectiveness of vaccinesThe statistics for the eradication of smallpox illustrate the benefits and economics of vaccines and disease eradication. The eradication of smallpox has probably saved 40 million lives over the past two decades6, at a cost of US $25 million per year during the eradication campaign. The equivalent of US $275 million is saved annually in terms of quarantine and treatment because of the eradication of smallpox3.The eradication of polio is also within reach. Between 1988 and 2000, coordinated public-health efforts, with a large contribution from Rotary International, have decreased the number of polio cases from approximately 350,000 to 3,500 per annum6. The potential future cost savings of polio eradication have been estimated at US $1.5 billion per year6, although the actual savings will probably be less than this owing to the need to continue immunization after eradication.The cost of immunizing a child with the six core vaccines that are recommended by the Expanded Program on Immunization (tuberculosis, measles, diphtheria, tetanus, pertussis and polio) is US $17 (Ref. 6). Of this amount, only a few dollars are for the cost of the vaccines, with the rest paying, for example, for personnel and transportation of the vaccine (including refrigeration).The benefits of vaccines are obvious in terms of the lives that are saved and the morbidity that is prevented or reduced, but the economic benefits extend beyond the benefits to the individuals that are protected. The economic benefits of immunization campaigns include savings in health-care costs for the treatment of illness and quarantine, the economic productivity of having a healthy workforce (or of not having parents removed from the workforce to care for an ill child) and coincident benefits that result from the immunization programme (such as an improved health-care infrastructure).Box 2 | Potential mechanisms to achieve equity in healthThe unequal access to existing vaccines and the relative lack of effort being applied to develop and produce vaccines for diseases that predominate in developing countries is part of the larger problem of extreme poverty in many nations. Although the roots and other manifestations of poverty must also be addressed, as Jorge Jiminez of the World Health Organization has said, “Health is seen more and more as preceeding development and not only as a consequence of wealth”20. Rather than relying on governments or international bodies as the sole means to address these problems, new models of public–private partnerships (PPPs) have arisen.The fundamental idea of a PPP is to bring together entities from both the public sector (government or intergovernmental agencies) and the private sector (for example, industries, such as vaccine companies) to address a particular need, with each partner undertaking specific activities on the basis of their particular expertise and capacity.Participation by industry might be in the form of donating a product, or applying research and development expertise to diseases (or types of health intervention) for which the market alone would not provide sufficient incentive. The motivation of the pharmaceutical industry might range from pure philanthropy (global citizenship and garnering goodwill) to economies of scale (if the product has a market elsewhere that will allow for higher prices to offset the lower prices in developing countries)21.Recent PPPs have been established to tackle the challenges of developing and producing vaccines for diseases such as HIV and malaria. The input of effort or intellectual property from a 'for-profit' company and the potential loss due to 'opportunity costs' (that is, the possible revenue from a highly recompensed product if the effort had been directed towards that product rather than a vaccine for a developing country) can be strong disincentives for companies to participate in PPPs. Another approach that might become increasingly useful is the provision of early access to new vaccines and technologies for developing countries by the transfer of technology from a pharmaceutical company in an industrialized country to a local manufacturer in a developing country. Key roles for governmental and intergovernmental agencies include the regulation of products, and testing and manufacturing processes, and the prevention of reflow of products produced for lower pricing in developing countries into countries in which companies anticipate higher pricing to recoup the costs of development and make profits for reinvestment in future products.

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Department of Vaccines and Biologicals. WHO Vaccine-Preventable Diseases: Monitoring System 2001 Global Summary (World Health Organization, Geneva, 2001) 〈http://www.who.int/vaccines-documents/GlobalSummary/GlobalSummary.pdf〉Download referencesAcknowledgementsWe would like to thank C. Wiley and, in particular, R. Ingrum for their assistance.Author informationAuthors and AffiliationsVaccines Research, Chiron Corporation, 4560 Horton Street, Emeryville, 94608, California, USAJeffrey B. UlmerTransgene, 11 rue de Molshelm, Strasbourg Cedex, 67082, FranceMargaret A. LiuAuthorsJeffrey B. UlmerView author publicationsYou can also search for this author in

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Internet Research Ethics (Stanford Encyclopedia of Philosophy)

Internet Research Ethics (Stanford Encyclopedia of Philosophy)

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Internet Research EthicsFirst published Fri Jun 22, 2012; substantive revision Tue Jan 12, 2021

There is little research that is not impacted in some way on or

through the Internet. The Internet, as a field, a tool, and a venue,

has specific and far-reaching ethical issues. Internet research ethics

is a subdiscipline that fits across many disciplines, ranging from

social sciences, arts and humanities, medical/biomedical, and natural

sciences. Extant ethical frameworks, including

consequentialism,

deontology,

virtue ethics,

and

feminist ethics,

have contributed to the ways in which ethical issues in Internet

research are considered and evaluated.

Conceptually and historically, Internet research ethics is most

related to computer and information ethics and includes such ethical

issues as participant knowledge and consent, data privacy, security,

anonymity and confidentiality, and integrity of data, intellectual

property issues, and community, disciplinary, and professional

standards or norms. Throughout the Internet’s evolution, there

has been continued debate whether there are new ethical dilemmas

emerging, or if the existing dilemmas are similar to dilemmas in other

research realms (Elgesem 2002; Walther 2002; Ess & AoIR 2002;

Marhkam & Buchanan 2012). These debates are similar to

philosophical debates in computer and information ethics. For example,

many years ago, James Moor (1985) asked “what is special about

computers” in order to understand what, if anything, is unique

ethically. Reminding us, however, that research itself must be guided

by ethical principles, regardless of technological intervention, van

Heerden et al. (2020) and Sloan et al. (2020) stress that the

“fundamental principles of conducting ethical social research

remain the same” (Ess & AoIR 2002; King 1996; Samuel and

Buchanan, 2020).

Yet, as the Internet has evolved into a more social and communicative

tool and venue, the ethical issues have shifted from purely

data-driven to more human-centered. “On-ground” or

face-to-face analogies, however, may not be applicable to online

research. For example, the concept of the public park has been used as

a site where researchers might observe others with little ethical

controversy, but online, the concepts of public versus private are

much more complex (SACHRP 2013). Thus, some scholars suggest that the

specificity of Internet research ethics calls for new regulatory

and/or professional and disciplinary guidance. For these reasons, the

concept of human subjects research policies and regulation, informs

this entry, which will continue discussions around ethical and

methodological complexity, including personal identifiability,

reputational risk and harm, notions of public space and public text,

ownership, and longevity of data as they relate to Internet research.

Specifically, the emergence of the social web raises issues around

subject or participant recruitment practices, tiered informed consent

models, and protection of various expectations and forms of privacy in

an ever-increasing world of diffused and ubiquitous technologies.

Additional ethical concerns center on issues of anonymity and

confidentiality of data in spaces where researchers and their subjects

may not fully understand the terms and conditions of those venues or

tools, challenges to data integrity as research projects can be

outsourced or crowdsourced to online labor marketplaces, and

jurisdictional issues as more research is processed, stored, and

disseminated via cloud computing or in remote server locales,

presenting myriad legal complexities given jurisdictional differences

in data laws. Further, the dominance of big data research has

continued across research spaces, with the notions of

“real-world data” and pervasive computing readily accepted

and used in all disciplines. The ease of access and availability to

use big data sets in myriad ways has enabled AI (artificial

intelligence) and ML (machine learning) to grow as standard tools for

researchers.

As a result, researchers using the Internet as a tool for and/or a

space of research—and their research ethics boards (REBs), also

known as institutional review boards (IRBs) in the United States or

human research ethics committees (HRECs) in other countries such as

Australia—have been confronted with a series of new ethical

questions: What ethical obligations do researchers have to protect the

privacy of subjects engaging in activities in “public”

Internet spaces? What are such public spaces? Is there any reasonable

expectation of privacy in an era of pervasive and ubiquitous

surveillance and data tracking? How is confidentiality or anonymity

assured online? How is and should informed consent be obtained online?

How should research on minors be conducted, and how do you prove a

subject is not a minor? Is deception (pretending to be someone you are

not, withholding identifiable information, etc.) an acceptable online

norm or a harm? How is “harm” possible to someone existing

in an online space? How identifiable are individuals in large data

sets? Do human subjects protections apply to big data? As more

industry-sponsored research takes place, what ethical protections

exist outside of current regulatory structures? As laws, such as the

EU’s General Data Protection Regulation (GDPR 2016) are enacted,

what are the global implications for data privacy and individual

rights?

A growing number of scholars have explored these and related questions

(see, for example, Bromseth 2002; Bruckman 2006; Buchanan 2004;

Buchanan & Ess 2008; Johns, Chen & Hall 2003; Kitchin 2003,

2008; King 1996; Mann 2003; Markham & Baym 2008; McKee &

Porter 2009; Thorseth 2003; Ess 2016; Zimmer & Kinder-Kurlanda

(eds.) 2017; Samuel & Buchanan, 2020), scholarly associations have

drafted ethical guidelines for Internet research (Ess &

Association of Internet Researchers 2002; Markham, Buchanan, and AoIR

2012; franzke et al., 2020; Kraut et al. 2004), and non-profit

scholarly and scientific agencies such as AAAS (Frankel & Siang

1999) are confronting the myriad of ethical concerns that Internet

research poses to researchers and research ethics boards (REBs).

Given that over 50% of the world population uses the Internet, and

that 97% of the world population now lives within reach of a mobile

cellular signal and 93% within reach of a 3G (or higher) network

(International Telecommunications Union, 2019), continued exploration

of the ethical issues related to research in this heavily mediated

environment is critical.

1. Definitions

2. Human Subjects Research

3. History and Development of IRE as a Discipline

4. Key Ethical Issues in Internet Research

4.1 Privacy

4.2 Recruitment

4.3 Informed Consent

4.3.1 Minors and Consent

4.4 Cloud Computing and Research Ethics

4.5 Big Data Considerations

4.6 Internet Research and Industry Ethics

5. Research Ethics Boards Guidelines

Bibliography

Academic Tools

Other Internet Resources

Cited in Entry

Laws and Government Documents

Professional Standards

Journals, Forums, and Blogs

Other Resources

Related Entries

1. Definitions

The commonly accepted definition of Internet research ethics (IRE) has

been used by Buchanan and Ess (2008, 2009), Buchanan (2011), and Ess

& Association of Internet Researchers (AoIR) (2002):

IRE is defined as the analysis of ethical issues and

application of research ethics principles as they pertain to research

conducted on and in the Internet. Internet-based research, broadly

defined, is research which utilizes the Internet to collect

information through an online tool, such as an online survey; studies

about how people use the Internet, e.g., through collecting data

and/or examining activities in or on any online environments; and/or,

uses of online datasets, databases, or repositories.

These examples were broadened in 2013 by the United States

Secretary’s Advisory Committee to the Office for Human Research

Protections (SACHRP 2013), and included under the umbrella term

Internet Research:

Research studying information that is already available on or via

the Internet without direct interaction with human subjects

(harvesting, mining, profiling, scraping, observation or recording of

otherwise-existing data sets, chat room interactions, blogs, social

media postings, etc.)

Research that uses the Internet as a vehicle for recruiting or

interacting, directly or indirectly, with subjects (Self-testing

websites, survey tools, Amazon Mechanical Turk, etc.)

Research about the Internet itself and its effects (use patterns

or effects of social media, search engines, email, etc.; evolution of

privacy issues; information contagion; etc.)

Research about Internet users: what they do, and how the Internet

affects individuals and their behaviors Research that utilizes the

Internet as an interventional tool, for example, interventions that

influence subjects’ behavior

Others (emerging and cross-platform types of research and methods,

including m-research (mobile))

Recruitment in or through Internet locales or tools, for example

social media, push technologies

A critical distinction in the definition of Internet research ethics

is that between the Internet as a research tool versus a research

venue. The distinction between tool and venue plays out across

disciplinary and methodological orientations. As a tool, Internet

research is enabled by search engines, data aggregators, digital

archives, application programming interfaces (APIs), online survey

platforms, and crowdsourcing platforms. Internet-based research venues

include such spaces as conversation applications (instant messaging

and discussion forums, for example), online multiplayer games, blogs

and interactive websites, and social networking platforms.

Another way of conceptualizing the distinction between tool and venue

comes from Kitchin (2008), who has referred to a distinction in

Internet research using the concepts of “engaged web-based

research” versus “non-intrusive web-based

research:”

Non-intrusive analyses refer to techniques of data collection that do

not interrupt the naturally occurring state of the site or

cybercommunity, or interfere with premanufactured text. Conversely,

engaged analyses reach into the site or community and thus engage the

participants of the web source (2008: 15).

These two constructs provide researchers with a way of recognizing

when considering of human subject protections might need to occur.

McKee and Porter (2009), as well as Banks and Eble (2007) provide

guidance on the continuum of human-subjects research, noting a

distinction between person-based versus text-based. For example, McKee

and Porter provide a range of research variables (public/private,

topic sensitivity, degree of interaction, and subject vulnerability)

which are useful in determining where on the continuum of text-based

versus how person-based the research is, and whether or not subjects

would need to consent to the research (2009: 87–88).

While conceptually useful for determining human subjects

participation, the distinction between tool and venue or engaged

versus non-intrusive web-based research is increasingly blurring in

the face of social media and their third-party applications. Buchanan

(2016) has conceptualized three phases or stages of Internet research,

and the emergence of social media characterize the second phase, circa

2006–2014. The concept of social media entails

A group of Internet-based applications that build on the ideological

and technological foundations of Web 2.0, and that allow the creation

and exchange of user-generated content (Kaplan & Haenlein 2010:

61).

A “social network site” is a category of websites with

profiles, semi-persistent public commentary on the profile, and a

traversable publicly articulated social network displayed in relation

to the profile.

This collapse of tool and venue can be traced primarily to the

increasing use of third-party sites and applications such as Facebook,

Twitter, or any of the myriad online research tools where subject or

participant recruitment, data collection, data analysis, and data

dissemination can all occur in the same space. With these collapsing

boundaries, the terms of “inter-jurisdictional

coordination” (Gilbert 2009: 3) are inherently challenging;

Gilbert has specifically argued against the terms of use or end-user

license agreement stipulations in virtual worlds, noting that such

agreements are often “flawed”, as they rely on laws and

regulations from a specific locale and attempt to enforce them in a

non place-based environment. Nonetheless, researchers now make

frequent use of data aggregation tools, scraping data from user

profiles or transaction logs, harvesting data from Twitter streams, or

storing data on cloud servers such as Dropbox only after agreeing to

the terms of service that go along with those sites. The use of such

third party applications or tools changes fundamental aspects of

research, oftentimes displacing the researcher or research team as the

sole owner of their data. These unique characteristics implicate

concepts and practicalities of privacy, consent, ownership, and

jurisdictional boundaries.

A key moment that typified and called attention to many of these

concerns emerged with the 2014 Facebook Emotional Contagion study

(Booth, 2014). By virtue of agreeing to Facebook’s Terms of

Service, did users consent to participation in research activities?

Should there have been a debriefing after the experiment? How

thoroughly did a university research ethics board review the study?

Should industry-sponsored research undergo internal ethics review? In

response to the outcry of the Contagion study, Ok Cupid’s

Christian Rudder (2014

[OIR])

defended these sorts of experiments, noting

We noticed recently that people didn’t like it when Facebook

“experimented” with their news feed. Even the FTC is

getting involved. But guess what, everybody: if you use the Internet,

you’re the subject of hundreds of experiments at any given time,

on every site. That’s how websites work.

The phenomenon of the social web forces an ongoing negotiation between

researchers and their data sources, as seen in the Facebook contagion

study and the subsequent reaction to it. Moreover, with the growing

use and concentration of mobile devices, the notion of Internet

research is expanding with a movement away from a

“place-based” Internet to a dispersed reality. Data

collection from mobile devices has increased exponentially. For

example, mobile devices enable the use of synchronous data collection

and dissemination from non-place based environments. Researchers using

cloud-enabled applications can send and receive data to and from

participants synchronously. The impact of such research possibilities

for epidemiological research is staggering for its scientific

potential while demanding for the concurrent ethical challenges, as we

are seeing with mobile-based COVID-19 research (Drew et al., 2020) and

the sampling of subjects' current behaviors and experiences in

real-time (Hubach et al., forthcoming). As Internet research has grown

from a niche methodology into a nearly ubiquitous and often invisible

practice, the traditional concepts of human subjects research require

careful consideration.

2. Human Subjects Research

The practical, professional, and theoretical implications of human

subjects protections has been covered extensively in scholarly

literature, ranging from medical/biomedical to social sciences to

computing and technical disciplines (see Beauchamp & Childress

2008; Emanual et al. 2003; PRIM&R et al. 2021; Sieber 1992; Wright

2006). Relevant protections and regulations continue to receive much

attention in the face of research ethics violations (see, for example,

Skloot 2010, on Henrietta Lacks; the U.S. Government’s admission

and apology to the Guatemalan Government for STD testing in the 1940s

(BBC 2011); and Gaw & Burns 2011, on how lessons from the past

might inform current research ethics and conduct).

The history of human subjects protections (Sparks 2002 [see

Other Internet Resources aka OIR])

grew out of atrocities such as Nazi human experimentation during

World War II, which resulted in the Nuremberg Code (1947);

subsequently followed by the Declaration of Helsinki on Ethical

Principles for Medical Research Involving Human Subjects (World

Medical Association 1964/2008). Partially in response to the Tuskegee

syphilis experiment, an infamous clinical study conducted between 1932

and 1972 by the U.S. Public Health Service studying the natural

progression of untreated syphilis in rural African-American men in

Alabama under the guise of receiving free health care from the

government, the U.S. Department of Health and Human Services put forth

a set of basic regulations governing the protection of human subjects

(45 C.F.R. § 46) (see the links in the Other Internet Resources

section, under Laws and Government Documents). This was later followed

by the publication of the “Ethical Principles and Guidelines for

the Protection of Human Subjects of Research” by the National

Commission for the Protection of Human Subjects of Biomedical and

Behavioral Research, known as the Belmont Report (NCPHSBBR 1979). The

Belmont Report identifies three fundamental ethical principles for all

human subjects research: Respect for Persons, Beneficence, and

Justice.

To ensure consistency across federal agencies in the United States

context in human subjects protections, in 1991, the Federal Policy for

the Protection of Human Subjects, also known as the “Common

Rule” was codified; the Revised Common Rule was released in the

Federal Register on 19 January 2017, and went into effect 19 July

2018. Similar regulatory frameworks for the protection of human

subjects exist across the world, and include, for example, the

Canadian Tri-Council, the Australian Research Council, The European

Commission, The Research Council of Norway and its National Committee

for Research Ethics in the Social Sciences and Humanities (NESH 2006;

NESH 2019), and the U.K.’s NHS National Research Ethics Service

and the Research Ethics Framework (REF) of the ESRC (Economic and

Social Research Council) General Guidelines, and the Forum for Ethical

Review Committees in Asia and the Western Pacific (FERCAP).

In the United States, the various regulatory agencies who have signed

on to the Common Rule (45 C.F.R. 46 Subpart A) have not issued formal

guidance on Internet research (see the links in the Other Internet

Resources section, under Laws and Government Documents). The Preamble

to the Revised Rule referenced significant changes in the research

environment, recognizing a need to broaden the scope of the Rule.

However, substantial changes to the actual Rule in regards to Internet

research in its broadest context, were minimal.

For example, the Preamble states:

This final rule recognizes that in the past two decades a paradigm

shift has occurred in how research is conducted. Evolving

technologies—including imaging, mobile technologies, and the

growth in computing power—have changed the scale and nature of

information collected in many disciplines. Computer scientists,

engineers, and social scientists are developing techniques to

integrate different types of data so they can be combined, mined,

analyzed, and shared. The advent of sophisticated computer software

programs, the Internet, and mobile technology has created new areas of

research activity, particularly within the social and behavioral

sciences (Federal Register 2017 and HHS 2017).

Modest changes to the definition of human subjects included changing

“data” to “information” and

“biospecimens;” the definition now reads:

(e)

(1) Human subject means a living individual about

whom an investigator (whether professional or student) conducting

research:

(i) Obtains information or biospecimens through intervention or

interaction with the individual, and uses, studies, or analyzes the

information or biospecimens; or

(ii) Obtains, uses, studies, analyzes, or generates identifiable

private information or identifiable biospecimens.

(2) Intervention includes both physical

procedures by which information or biospecimens are gathered (e.g.,

venipuncture) and manipulations of the subject or the subject's

environment that are performed for research purposes.

(3) Interaction includes communication or

interpersonal contact between investigator and subject.

(4) Private information includes information

about behavior that occurs in a context in which an individual can

reasonably expect that no observation or recording is taking place,

and information that has been provided for specific purposes by an

individual and that the individual can reasonably expect will not be

made public (e.g., a medical record).

(5) Identifiable private information is private

information for which the identity of the subject is or may readily be

ascertained by the investigator or associated with the

information.

(6) An identifiable biospecimen is a biospecimen

for which the identity of the subject is or may readily be ascertained

by the investigator or associated with the biospecimen (45 C.F.R.

§ 46.102 (2018)).

However, the Revised Rule does have a provision that stands to be of

import in regards to Internet research; the Rule calls for

implementing departments or agencies to,

[(e)(7)]

(i) Upon consultation with appropriate experts (including experts

in data matching and re-identification), reexamine the meaning of

“identifiable private information”, as defined in

paragraph (e)(5) of this section, and “identifiable

biospecimen”, as defined in paragraph (e)(6) of this section.

This reexamination shall take place within 1 year and regularly

thereafter (at least every 4 years). This process will be conducted by

collaboration among the Federal departments and agencies implementing

this policy. If appropriate and permitted by law, such Federal

departments and agencies may alter the interpretation of these terms,

including through the use of guidance.

(ii) Upon consultation with appropriate experts, assess whether

there are analytic technologies or techniques that should be

considered by investigators to generate “identifiable private

information”, as defined in paragraph (e)(5) of this section, or

an “identifiable biospecimen”, as defined in paragraph

(e)(6) of this section. This assessment shall take place within 1 year

and regularly thereafter (at least every 4 years). This process will

be conducted by collaboration among the Federal departments and

agencies implementing this policy. Any such technologies or techniques

will be included on a list of technologies or techniques that produce

identifiable private information or identifiable biospecimens. This

list will be published in the Federal Register after notice and an

opportunity for public comment. The Secretary, HHS, shall maintain the

list on a publicly accessible Web site (45 C.F.R. § 46.102

(2018)).

As of this writing, there has not yet been a reexamination of the

concepts of “identifiable private information” or

“identifiable biospecimens”. However, as data analytics,

AI, and machine learning continue to expose ethical issues in human

subjects research, we expect to see engaged discussion at the federal

level and amongst research communities (PRIM&R 2021). Those

discussions may refer to previous conceptual work by Carpenter and

Dittrich (2012) and Aycock et al. (2012) that is concerned with risk

and identifiability. Secondary uses of identifiable, private data, for

example, may pose downstream harms, or unintentional risks, causing

reputational or informational harms. Reexaminations of

“identifiable private information” can not occur without

serious consideration of risk and “human harming

research”. Carpenter and Dittrich (2012) encourage

“Review boards should transition from an informed consent driven

review to a risk analysis review that addresses potential harms

stemming from research in which a researcher does not directly

interact with the at-risk individuals” (p. 4) as “[T]his

distance between researcher and affected individual indicates that a

paradigm shift is necessary in the research arena. We must transition

our idea of research protection from ‘human subjects

research’ to ‘human harming research’” (p.

14).[1]

Similarly, Aycock et al. (2012) assert that

Researchers and boards must balance presenting risks related to the

specific research with risks related to the technologies in use. With

computer security research, major issues around risk arise, for

society at large especially. The risk may not seem evident to an

individual but in the scope of security research, larger populations

may be vulnerable. There is a significant difficulty in quantifying

risks and benefits, in the traditional sense of research

ethics….An aggregation of surfing behaviors collected by a bot

presents greater distance between researcher and respondent than an

interview done in a virtual world between avatars. This distance leads

us to suggest that computer security research focus less concern

around human subjects research in the traditional sense and

more concern with human harming research (p. 3, italics

original).

These two conceptual notions are relevant for considering emergent

forms of identities or personally identifiable information (PII) such

as avatars, virtual beings, bots, textual and graphical information.

Within the Code of Federal Regulations (45 C.F.R. § 46.102(f)

2009): New forms of representations are considered human subjects if

PII about living individuals is obtained. PII can be obtained by

researchers through scraping data sources, profiles or avatars, or

other pieces of data made available by the platform. Fairfield agrees:

“An avatar, for example, does not merely represent a collection

of pixels—it represents the identity of the user” (2012:

701).

The multiple academic disciplines already long engaged in human

subjects research (medicine, sociology, anthropology, psychology,

communication) have established ethical guidelines intended to assist

researchers and those charged with ensuring that research on human

subjects follows both legal requirements and ethical practices. But

with research involving the Internet—where individuals

increasingly share personal information on platforms with porous and

shifting boundaries, where both the spread and aggregation of data

from disparate sources has become the norm, and where web-based

services, and their privacy policies and terms of service statements,

morph and evolve rapidly—the ethical frameworks and assumptions

traditionally used by researchers and REBs are frequently

challenged.

Research ethics boards themselves are increasingly challenged with the

unique ethical dimensions of internet-based research protocols. In a

2008 survey of U.S. IRBs, less than half of the ethical review boards

identified internet-based research was “an area of concern or

importance” at that time, and only 6% had guidelines or

checklists in place for reviewing internet-based research protocols

(Buchanan & Ess 2009). By 2015, 93% of IRBs surveyed acknowledged

that are ethical issues unique to research using “online

data”, yet only 55% said they felt their IRBs are well versed in

the technical aspects of online data collection, and only 57% agreed

that their IRB has the expertise to stay abreast of changes in online

technology. IRBs are now further challenged with the growth of big

data research (see

§4.5 below),

which increasingly relies on large datasets of personal information

generated via social media, digital devices, or other means often

hidden from users. A 2019 study of IRBs revealed only 25% felt

prepared to evaluate protocols relying on big data, and only 6% had

tools sufficient for considering this emerging area of internet

research (Zimmer & Chapman 2020). Further, after being presented

various hypothetical research scenarios utilizing big data and asked

how their IRB would likely review such a protocol, numerous viewpoints

different strongly in many cases. Consider the following scenario:

Researchers plan to scrape public comments from online newspaper pages

to predict election outcomes. They will aggregate their analysis to

determine public sentiment. The researchers don’t plan to inform

commenters, and they plan to collect potentially-identifiable user

names. Scraping comments violates the newspaper’s terms of

service.

18% of respondents indicated their IRB would view this as exempt, 21%

indicated expedited review, 33% suggested it would need full board

review, while 28% did not think this was even human subjects research

that would fall under their IRB’s purview (Zimmer & Chapman

2020). This points to potential gaps and inconsistencies in how IRBs

review the ethical implications of big data research protocols.

3. History and Development of IRE as a Discipline

An extensive body of literature has developed since the 1990s around

the use of the Internet for research (S. Jones 1999; Hunsinger,

Klastrup, & Allen (eds.) 2010; Consalvo & Ess (eds.) 2011;

Zimmer & Kinder-Kurlanda (eds.) 2017), with a growing emphasis on

the ethical dimensions of Internet research.

A flurry of Internet research, and explicit concern for the ethical

issues concurrently at play in it, began in the mid-1990s. In 1996,

Storm King recognized the growing use of the Internet as a venue for

research. His work explored the American Psychological

Association’s guidelines for human subjects research with

emergent forms of email, chat, listservs, and virtual communities.

With careful attention to risk and benefit to Internet subjects, King

offered a cautionary note:

When a field of study is new, the fine points of ethical

considerations involved are undefined. As the field matures and

results are compiled, researchers often review earlier studies and

become concerned because of the apparent disregard for the human

subjects involved (1996: 119).

The 1996 issue of Information Society dedicated to Internet

research is considered a watershed moment, and included much seminal

research still of impact and relevance today (Allen 1996; Boehlefeld

1996; Reid 1996).

Sherry Turkle’s 1997 Life on the Screen: Identity in the Age

of the Internet called direct attention to the human element of

online game environments. Moving squarely towards person-based versus

text-based research, Turkle pushed researchers to consider human

subjects implications of Internet research. Similarly, Markham’s

Life Online: Researching Real Experience in Virtual Space

(1998) highlighted the methodological complexities of online

ethnographic studies, as did Jacobson’s 1999 methodological

treatment of Internet research. The “field” of study

changed the dynamics of researcher-researched roles, identity, and

representation of participants from virtual spaces. Markham’s

work in qualitative online research has been influential across

disciplines, as research in nursing, psychology, and medicine has

found the potential of this paradigm for online research (Flicker et

al. 2004; Eysenbach & Till 2001; Seaboldt & Kupier 1997; Sharf

1997).

Then, in 1999, the American Association for the Advancement of Science

(AAAS), with a contract from the U.S. Office for Protection from

Research Risks (now known as the Office for Human Research

Protections), convened a workshop, with the goal of assessing the

alignment of traditional research ethics concepts to Internet

research. The workshop acknowledged

The vast amount of social and behavioral information potentially

available on the Internet has made it a prime target for researchers

wishing to study the dynamics of human interactions and their

consequences in this virtual medium. Researchers can potentially

collect data from widely dispersed population sat relatively low cost

and in less time than similar efforts in the physical world. As a

result, there has been an increase in the number of Internet studies,

ranging from surveys to naturalistic observation (Frankel & Siang

1999: 1).

In the medical/biomedical contexts, Internet research has grown

rapidly. Also in 1999, Gunther Eysenbach wrote the first editorial to

the newly formed Journal of Medical Internet Research. There

were three driving forces behind the inception of this journal, and

Eysenbach called attention to the growing social and interpersonal

aspects of the Internet:

First, Internet protocols are used for clinical information and

communication. In the future, Internet technology will be the platform

for many telemedical applications. Second, the Internet revolutionizes

the gathering, access and dissemination of non-clinical information in

medicine: Bibliographic and factual databases are now world-wide

accessible via graphical user interfaces, epidemiological and public

health information can be gathered using the Internet, and

increasingly the Internet is used for interactive medical education

applications. Third, the Internet plays an important role for consumer

health education, health promotion and teleprevention. (As an aside,

it should be emphasized that “health education” on the

Internet goes beyond the traditional model of health education, where

a medical professional teaches the patient: On the Internet, much

“health education” is done

“consumer-to-consumer” by means of patient self support

groups organizing in cyberspace. These patient-to-patient interchanges

are becoming an important part of healthcare and are redefining the

traditional model of preventive medicine and health promotion).

With scholarly attention growing and with the 1999 AAAS report

(Frankel & Siang 1999) calling for action, other professional

associations took notice and began drafting statements or guidelines,

or addendum to their extant professional standards. For example, The

Board of Scientific Affairs (BSA) of the American Psychological

Association established an Advisory Group on Conducting Research on

the Internet in 2001; the American Counseling Association’s 2005

revision to its Code of Ethics; the Association of Internet

Researchers (AoIR) Ethics Working Group Guidelines, the National

Committee for Research Ethics in the Social Sciences and the

Humanities (NESH Norway), among others, have directed researchers and

review boards to the ethics of Internet research, with attention to

the most common areas of ethical concern (see

OIR

for links).

While many researchers focus on traditional research ethics

principles, conceptualizations of Internet research ethics depend on

disciplinary perspectives. Some disciplines, notably from the arts and

humanities, posit that Internet research is more about context and

representation than about “human subjects”, suggesting

there is no intent, and thus minimal or no harm, to engage in research

about actual persons. The debate has continued since the early 2000s.

White (2002) argued against extant regulations that favored or

privileged specific ideological, disciplinary and cultural

prerogatives, which limit the freedoms and creativity of arts and

humanities research. For example, she notes that the AAAS report

“confuses physical individuals with constructed materials and

human subjects with composite cultural works”, again calling

attention to the person versus text divide that has permeated Internet

research ethics debates. Another example of disciplinary differences

comes from the Oral History Association, which acknowledged the

growing use of the Internet as a site for research:

Simply put, oral history collects memories and personal commentaries

of historical significance through recorded interviews. An oral

history interview generally consists of a well-prepared interviewer

questioning an interviewee and recording their exchange in audio or

video format. Recordings of the interview are transcribed, summarized,

or indexed and then placed in a library or archives. These interviews

may be used for research or excerpted in a publication, radio or video

documentary, museum exhibition, dramatization or other form of public

presentation. Recordings, transcripts, catalogs, photographs and

related documentary materials can also be posted on the Internet

(Ritchie 2003: 19).

While the American Historical Association (A. Jones 2008) has argued

that such research be “explicitly exempted” from ethical

review board oversight, the use of the Internet could complicate such

a stance if such data became available in public settings or available

“downstream” with potential, unforeseeable risks to

reputation, economic standing, or psychological harm, should

identification occur.

Under the concept of text rather than human subjects, Internet

research rests on arguments of publication and copyright; consider the

venue of a blog, which does not meet the definition of human subject

as in 45 C.F.R. § 46.102f (2009), as interpreted by most ethical

review boards. A researcher need not obtain consent to use text from a

blog, as it is generally considered publicly available, textual,

published material. This argument of the “public park”

analogy that has been generally accepted by researchers is appropriate

for some Internet venues and tools, but not all: Context, intent,

sensitivity of data, and expectations of Internet participants were

identified in 2004 by Sveninngsson as crucial markers in Internet

research ethics considerations.

By the mid-2000s, with three major anthologies published, and a

growing literature base, there was ample scholarly literature

documenting IRE across disciplines and methodologies, and

subsequently, there was anecdotal data emerging from the review boards

evaluating such research. In search of empirical data regarding the

actual review board processes of Internet research from a human

subjects perspective, Buchanan and Ess surveyed over 700 United States

ethics review boards, and found that boards were primarily concerned

with privacy, data security and confidentiality, and ensuring

appropriate informed consent and recruitment procedures (Buchanan

& Ess 2009; Buchanan & Hvizdak 2009).

In 2008, the Canadian Tri-Council’s Social Sciences and

Humanities Research Ethics Special Working Committee: A Working

Committee of the Interagency Advisory Panel on Research Ethics was

convened (Blackstone et al. 2008); and in 2010, a meeting at the

Secretary’s Advisory Committee to the Office for Human Research

Protections highlighted Internet research (SACHRP 2010). Such

prominent professional organizations as the Public Responsibility in

Medicine and Research (PRIM&R) and the American Educational

Research Association (AERA) have begun featuring Internet research

ethics regularly at their conferences and related publications.

Recently, disciplines not traditionally involved in human subjects

research have begun their own explorations of IRE. For example,

researchers in computer security have actively examined the tenets of

research ethics in CS and ICT (Aycock et al. 2012; Dittrich, Bailey,

& Dietrich 2011; Carpenter & Dittrich 2012; Buchanan et al.

2011). Notably, the U.S. Federal Register requested comments on

“The Menlo Report” in December 2011, which calls for a

commitment by computer science researchers to the three principles of

respect for persons, beneficence, and justice, while also adding a

fourth principle on respect for law and public interest (Homeland

Security 2011). SIGCHI, an international society for professionals,

academics, and students interested in human-technology and

human-computer interaction (HCI), has increasingly focused on how IRE

applies to work in their domain (Frauenberger et al. 2017; Fiesler et

al. 2018).

4. Key Ethical Issues in Internet Research

4.1 Privacy

Principles of research ethics dictate that researchers must ensure

there are adequate provisions to protect the privacy of subjects and

to maintain the confidentiality of any data collected. A violation of

privacy or breach of confidentiality presents a risk of serious harm

to participants, ranging from the exposure of personal or sensitive

information, the divulgence of embarrassing or illegal conduct, or the

release of data otherwise protected under law.

Research ethics concerns around individual privacy is often expressed

in terms of the level of linkability of data to individuals, and the

potential harms from disclosure of information As Internet research

has grown in complexity and computational sophistication, ethics

concerns have focused on current and future uses of data, and the

potential downstream harms that could occur. Protecting research

participants’ privacy and confidentiality is typically achieved

through a combination of research tactics and practices, including

engaging in data collection under controlled or anonymous

environments, the scrubbing of data to remove personally identifiable

information (PII), or the use of access restrictions and related data

security methods. And, the specificity and characteristics of the data

will often dictate if there are regulatory considerations, in addition

to the methodological considerations around privacy and

confidentiality. For example, personally identifiable information

(PII) typically demands the most stringent protections. The National

Institutes of Health (NIH), for example, defines PII as:

any information about an individual maintained by an agency,

including, but not limited to, education, financial transactions,

medical history, and criminal or employment history and information

which can be used to distinguish or trace an individual’s

identity, such as their name, SSN, date and place of birth,

mother’s maiden name, biometric records, etc., including any

other personal information that is linked or linkable to an individual

(NIH 2010).

Typically, examples of identifying pieces of information have included

personal characteristics (such as date of birth, place of birth,

mother’s maiden name, gender, sexual orientation, and other

distinguishing features and biometrics information, such as height,

weight, physical appearance, fingerprints, DNA and retinal scans),

unique numbers or identifiers assigned to an individual (such as a

name, address, phone number, social security number, driver’s

license number, financial account numbers), and descriptions of

physical location (GIS/GPS log data, electronic bracelet monitoring

information).

The 2018 EU General Data Protection Regulation lays out the legal and

regulatory requirements for data use across the EU. Mondschein &

Monda (2018) provides a thorough discussion on the different types of

data that are considered in the GDPR: Personal data, such as names,

identification numbers, location data, and so on; Special categories

of personal data, such as race or ethic origin, political opinions, or

religious beliefs; Pseudonymous data, referring to data that has been

altered so the subject cannot be directly identified without having

further information; Anonymous data, information which does not relate

to an identifiable natural person or to personal data rendered

anonymous in such a manner that the data subject is not or no longer

identifiable. They also advise researchers to consider

data protection issues at an early stage of a research project is of

great importance specifically in the context of large-scale research

endeavours that make use of personal data (2018: 56).

Internet research introduces new complications to these longstanding

definitions and regulatory frameworks intended to protect subject

privacy. For example, researchers increasingly are able to collect

detailed data about individuals from sources such as Facebook,

Twitter, blogs or public email archives, and these rich data sets can

more easily be processed, compared, and combined with other data (and

datasets) available online. In numerous cases, both researchers and

members of the general public have been able to re-identify

individuals by analyzing and comparing such datasets, using

data-fields as benign as one’s zip code (Sweeny 2002), random

Web search queries (Barbaro & Zeller 2006), or movie ratings

(Narayanan & Shmatikov 2008) as the vital key for reidentification

of a presumed anonymous user. Prior to widespread Internet-based data

collection and processing, few would have considered one’s movie

ratings or zipcode as personally-identifiable. Yet, these cases reveal

that merely stripping traditional “identifiable”

information such as a subject’s name, address, or social

security number is no longer sufficient to ensure data remains

anonymous (Ohm 2010), and requires the reconsideration of what is

considered “personally identifiable information” (Schwartz

& Solove 2011). This points to the critical distinction between

data that is kept confidential versus data that is truly anonymous.

Increasingly, data are rarely completely anonymous, as researchers

have routinely demonstrated they can often reidentify individuals

hidden in “anonymized” datasets with ease (Ohm 2010). This

reality places new pressure on ensuring datasets are kept, at the

least, suitably confidential through both physical and computational

security measures. These measures may also include requirements to

store data in “clean rooms”, or in non-networked

environments in an effort to control data transmission.

Similarly, new types of data often collected in Internet research

might also be used to identify a subject within a previously-assumed

anonymous dataset. For example, Internet researchers might collect

Internet Protocol (IP) addresses when conducting online surveys or

analyzing transaction logs. An IP address is a unique identifier that

is assigned to every device connected to the Internet; in most cases,

individual computers are assigned a unique IP address, while in some

cases the address is assigned to a larger node or Internet gateway for

a collection of computers. Nearly all websites and Internet service

providers store activity logs that link activity with IP addresses, in

many cases, eventually to specific computers or users. Current U.S.

law does not hold IP addresses to be personally identifiable

information, while other countries and regulatory bodies do. For

example, the European Data Privacy Act at Article 29, holds that IP

addresses do constitute PII. Buchanan et al. (2011), note, however,

that under the U.S. Civil Rights Act, for the purposes of the HIPAA

Act,[2]

IP addresses are considered a form of PII (45 C.F.R. § 164.514

2002).[3]

There could potentially be a reconsideration by other federal

regulatory agencies over IP addresses as PII, and researchers and

boards will need to be attentive should such change occur.

A similar complication emerges when we consider the meaning of

“private information” within the context of Internet-based

research. U.S. federal regulations define “private

information” as:

[A]ny information about behavior that occurs in a context in which an

individual can reasonably expect that no observation or recording is

taking place, and information that has been provided for specific

purposes by an individual and that the individual can reasonably

expect will not be made public (for example, a medical record) (45

C.F.R. § 46.102(f) 2009).

This standard definition of “private information” has two

key components. First, private information is that which subjects

reasonably expect is not normally monitored or collected. Second,

private information is that which subjects reasonably expect is not

typically publicly available. Conversely, the definition also suggests

the opposite is true: if users cannot reasonably expect data

isn’t being observed or recorded, or they cannot expect data

isn’t publicly available, then the data does not rise to the

level of “private information” requiring particular

privacy protections. Researchers and REBs have routinely worked with

this definition of “private information” to ensure the

protection of individuals’ privacy.

These distinctions take on greater weight, however, when considering

the data environments and collection practices common with

Internet-based research. Researchers interested in collecting or

analyzing online actions of subjects—perhaps through the mining

of online server logs, the use of tracking cookies, or the scraping of

social media profiles and feeds—could argue that subjects do not

have a reasonable expectation that such online activities are not

routinely monitored since nearly all online transactions and

interactions are routinely logged by websites and service providers.

Thus, online data trails might not rise to the level of “private

information”. However, numerous studies have indicated that

average Internet users have incomplete understandings of how their

activities are routinely tracked, and the related privacy practices

and policies of the sites they visit (Hoofnagle & King 2008

[OIR];

Milne & Culnan 2004; Tsai et al. 2006). Hudson and Bruckman

(2005) conducted empirical research on users’ expectations and

understandings of privacy, finding that participants’

expectations of privacy within public chatrooms conflicted with what

was actually a very public online space. Rosenberg (2010) examined the

public/private distinction in the realm of virtual worlds, suggesting

researchers must determine what kind of social norms and relations

predominate an online space before making assumptions about the

“publicness” of information shared within. Thus, it

remains unclear whether Internet users truly understand if and when

their online activity is regularly monitored and tracked, and what

kind of reasonable expectations truly exist. This ambiguity creates

new challenges for researchers and REBs when trying to apply the

definition of “private information” to ensure subject

privacy is properly addressed (Zimmer 2010).

This complexity in addressing subject privacy in Internet research is

further compounded with the rise of social networking as a place for

the sharing of information, and a site for research. Users

increasingly share more and more personal information on platforms

like Facebook or Twitter. For researchers, social media platforms

provide a rich resource for study, and much of the content is

available to be viewed and downloaded with minimal effort. Since much

of the information posted to social media sites is publicly viewable,

it thus fails to meet the standard regulatory definition of

“private information”. Therefore, researchers attempting

to collect and analyze social media postings might not treat the data

as requiring any particular privacy considerations. Yet, social media

platforms represent a complex environment of social interaction where

users are often required to place friends, lovers, colleagues, and

minor acquaintances within the same singular category of

“friends”, where privacy policies and terms of service are

not fully understood (Madejski et al. 2011), and where the technical

infrastructures fail to truly support privacy projections (Bonneau

& Preibush 2010) and regularly change with little notice (Stone

2009

[OIR];

Zimmer 2009

[OIR]).

As a result, it is difficult to understand with any certainty what a

user’s intention was when posting an item onto a social media

platform (Acquisti & Gross 2006). The user may have intended the

post for a private group but failed to completely understand how to

adjust the privacy settings accordingly. Or, the information might

have previously been restricted to only certain friends, but a change

in the technical platform suddenly made the data more visible to

all.

Ohm (2010) warns that

the utility and privacy of data are linked, and so long as data is

useful, even in the slightest, then it is also potentially

reidentifiable (2010: 1751).

With the rapid growth of Internet-based research, Ohm’s concern

becomes even more dire. The traditional definitions and approaches to

understanding the nature of privacy, anonymity, and precisely what

kind of information deserves protection becomes strained, forcing

researchers and REBs to consider more nuanced theories of privacy

(Nissenbaum 2009) and approaches to respecting and projecting subject

privacy (Markham 2012; Zimmer 2010).

4.2 Recruitment

Depending on the type of Internet research being carried out,

recruitment of participants may be done in a number of ways. As with

any form of research, the study population or participants are

selected for specific purposes (i.e., an ethnographic study of a

particular group on online game players), or, can be selected from a

range of sampling techniques (i.e., a convenience sample gleaned from

the users of Amazon’s Mechanical Turk crowdsourcing

platform[4]).

In the U.S. context, a recruitment plan is considered part of the

informed consent process, and as such, any recruitment script or

posting must be reviewed and approved by an REB prior to posting or

beginning solicitation (if the project is human subjects research).

Further, the selection of participants must be impartial and unbiased,

and any risks and benefits must be justly distributed. This concept is

challenging to apply in Internet contexts, in which populations are

often self-selected and can be exclusive, depending on membership and

access status, as well as the common disparities of online access

based on economic and social variables. Researchers also face

recruitment challenges due to online subjects’ potential

anonymity, especially as it relates to the frequent use of pseudonyms

online, having multiple or alternative identities online, and the

general challenges of verifying a subject’s age and demographic

information. Moreover, basic ethical principles for approaching and

recruiting participants involve protecting their privacy and

confidentiality. Internet research can both maximize these

protections, as an individual may never be known beyond a screen name

or avatar existence; or, conversely, the use of IP addresses,

placement of cookies, availability and access to more information than

necessary for the research purposes, may minimize the protections of

privacy and confidentiality.

Much recruitment is taking place via social media; examples include

push technologies, a synchronous approach in which a text or tweet is

sent from a researcher to potential participants based on profile

data, platform activity, or geolocation. Other methods of pull

technologies recruitment include direct email, dedicated web pages,

YouTube videos, direct solicitation via “stickies” posted

on fora or web sites directing participants to a study site, or data

aggregation or scraping data for potential recruitment. Regardless of

the means used, researchers must follow the terms of the

site—from the specific norms and nuances governing a site or

locale to the legal issues in terms of service agreements. For

example, early pro-anorexia web sites (see Overbeke 2008) were often

treated as sensitive spaces deserving spcicial consideration, and

researchers were asked to respect the privacy of the participants and

not engage in research (Walstrom 2004). In the gaming context,

Reynolds and de Zwart (2010) ask:

Has the researcher disclosed the fact that he or she is engaged in

research and is observing/interacting with other players for the

purposes of gathering research data? How does the research project

impact upon the community and general game play? Is the research

project permitted under the Terms of Service?

Colvin and Lanigan (2005: 38) suggest researchers

Seek permission from Web site owners and group moderators before

posting recruitment announcements, Then, preface the recruitment

announcement with a statement that delineates the permission that has

been granted, including the contact person and date received. Identify

a concluding date (deadline) for the research study and make every

effort to remove recruitment postings, which often become embedded

within Web site postings.

Barratt and Lenton, among others, agree:

It is critical, therefore, to form partnerships with online community

moderators by not only asking their permission to post the request,

but eliciting their feedback and support as well (2010: 71).

Mendelson (2007) and Smith and Leigh (1997) note that recruitment

notices need to contain more information than the typical flyers or

advertisements used for newspaper advertisements. Mentioning the

approval of moderators is important for establishing authenticity, and

so is providing detailed information about the study and how to

contact both the researchers and the appropriate research ethics

board.

Given the array of techniques possible for recruitment, the concept of

“research spam” requires attention. The Council of

American Survey Research warns

Research Organizations should take steps to limit the number of survey

invitations sent to targeted respondents by email solicitations or

other methods over the Internet so as to avoid harassment and response

bias caused by the repeated recruitment and participation by a given

pool (or panel) of data subjects (CASRO 2011: I.B.3).

Ultimately, researchers using Internet recruitment measures must

ensure that potential participants are getting enough information in

both the recruitment materials and any subsequent consent documents.

Researchers must ensure that recruitment methods do not lead to an

individual being identified without their permission, and if such

identification is possible, are there significant risks involved?

4.3 Informed Consent

As the cornerstone of human subjects protections, informed consent

means that participants are voluntarily participating in the research

with adequate knowledge of relevant risks and benefits. Providing

informed consent typically includes the researcher explaining the

purpose of the research, the methods being used, the possible outcomes

of the research, as well as associated risks or harms that the

participants might face. The process involves providing the recipient

clear and understandable explanations of these issues in a concise

way, providing sufficient opportunity to consider them and enquire

about any aspect of the research prior to granting consent, and

ensuring the subject has not been coerced into participating. Gaining

consent in traditional research is typically done verbally or in

writing, either in a face-to-face meeting where the researcher reviews

the document, through telephone scripts, through mailed documents,

fax, or video, and can be obtained with the assistance of an advocate

in the case of vulnerable populations. Most importantly, informed

consent was built on the ideal of “process” and the

verification of understanding, and thus, requires an ongoing

communicative relationship between and among researchers and their

participants. The emergence of the Internet as both a tool and a venue

for research has introduced challenges to this traditional approach to

informed consent.

In most regulatory frameworks, there are instances when informed

consent might be waived, or the standard processes of obtaining

informed consent might be modified, if approved by a research ethics

board.[5]

Various forms of Internet research require different approaches to

the consent process. Some standards have emerged, depending on venue

(i.e., an online survey platform versus a private Facebook group).

However, researchers are encouraged to consider waiver of consent

and/or documentation, if appropriate, by using the flexibilities of

their extant regulations.

Where consent is required but documentation has been waived by an

ethical review board, a “portal” can be used to provide

consent information. For example, a researcher may send an email to

the participant with a link a separate portal or site information page

where information on the project is contained. The participant can

read the documentation and click on an “I agree”

submission. Rosser et al. (2010) recommend using a

“chunked” consent document, whereby individuals can read

specific sections, agree, and then continue onwards to completion of

the consent form, until reaching the study site.

In addition to portals, researchers will often make use of consent

cards or tokens; this alleviates concerns that unannounced researcher

presence is unacceptable, or, that a researcher’s presence is

intrusive to the natural flow and movement of a given locale. Hudson

and Bruckman (2004, 2005) highlighted the unique challenges in gaining

consent in chat rooms, while Lawson (2004) offers an array of consent

possibilities for synchronous computer-mediated communication. There

are different practical challenges in the consent process in Internet

research, given the fluidity and temporal nature of Internet

spaces.

If documentation of consent is required, some researchers have

utilized alternatives such as electronic signatures, which can range

from a simple electronic check box to acknowledge acceptance of the

terms to more robust means of validation using encrypted digital

signatures, although the validity of electronic signatures vary by

jurisdiction.

Regardless of venue, informed consent documents are undergoing changes

in the information provided to research participants. While the basic

elements of consent remain intact, researchers must now acknowledge

with less certainty specific aspects of their data longevity, risks to

privacy, confidentiality and anonymity (see

§4.1 Privacy, above),

and access to or ownership of data. Research participants must

understand that their terms of service or end user license agreement

consent is distinct from their consent to participate in research.

And, researchers must address and inform participants/subjects about

potential risk of data intrusion or misappropriation of data if

subsequently made public or available outside of the confines of the

original research. Statements should be revised to reflect such

realities as cloud storage (see

§4.4 below)

and data sharing.

For example, Aycock et al. (2012: 141) describe a continuum of

security and access statements used in informed consent documents:

“No others will have access to the data”

“Anonymous identifiers will be used during all data

collection and analysis and the link to the subject identifiers will

be stored in a secure manner”

“Data files that contain summaries of chart reviews and

surveys will only have study numbers but no data to identify the

subject. The key [linking] subject names and these study identifiers

will be kept in a locked file”

“Electronic data will be stored on a password protected and

secure computer that will be kept in a locked office. The software

‘File Vault’ will be used to protect all study data loaded

to portable laptops, flash drives or other storage media. This will

encode all data… using Advanced Encryption Standard with

128-bit keys (AES-128)”

This use of encryption in the last statement may be necessary in

research including sensitive data, such as medical, sexual, health,

financial, and so on. Barratt and Lenton (2010), in their research on

illicit drug use and online forum behaviors, also provide guidance

about use of secure transmission and encryption as part of the consent

process.

In addition to informing participants about potential risks and

employing technological protections, NIH-funded researchers whose work

includes projects with identifiable, sensitive information will

automatically be issued a Certificate of Confidentiality:

CoCs protect the privacy of research subjects by prohibiting

disclosure of identifiable, sensitive research information to anyone

not connected to the research except when the subject consents or in a

few other specific situations (NIH 2021

[OIR]).

However, these do not protect against release of data outside of the

U.S. Given the reality of Internet research itself, which inherently

spans borders, new models may be in order to ensure confidentiality of

data and protections of data. Models of informed consent for

traditional international research are fundamentally challenging due

to cultural specificity and norms (Annas 2009; Boga et al. 2011;

Krogstad et al. 2010); with Internet research, where researchers may

be unaware of the specific location of an individual, consent takes on

significantly higher demands. While current standards of practice show

that consent models stem from the jurisdiction of the researcher and

sponsoring research institution, complications arise in the face of

age verification, age of majority/consent, reporting of adverse

effects or complaints with the research process, and authentication of

identity. Various jurisdictional laws around privacy are relevant for

the consent process; a useful tool is Forrester’s Data Privacy

Heat Map, which relies on in-depth analyses of the data

privacy-related laws and cultures of countries around the world,

helping researchers design appropriate approaches to privacy and data

protection given the particular context (see

OIR).

In addition, as more federal agencies and funding bodies across the

globe encourage making research data publicly-available (i.e., NSF,

NIH, Wellcome Trust, Research Councils U.K.), the language used in

consent documents will change accordingly to represent this intended

longevity of data and opportunities for future, unanticipated use.

Given the ease with which Internet data can flow between and among

Internet venues, changes in the overall accessibility of data might

occur (early “private” newsgroup conversations were made

“publicly searchable” when Google bought DejaNews), and

reuse and access by others is increasingly possible with shared

datasets. Current data sharing mandates must be considered in the

consent process. Alignment between a data sharing policy and an

informed consent document is imperative. Both should include

provisions for appropriate protection of privacy, confidentiality,

security, and intellectual property.

There is general agreement in the U.S. that individual consent is not

necessary for researchers to use publicly available data, such as

public Twitter feeds. Recommendations were made by The National Human

Subjects Protection Advisory Committee (NHRPAC) in 2002 regarding

publicly available data sets (see

OIR).

Data use or data restriction agreements are commonly used and set the

parameters of use for researchers.

The U.K. Data Archive (2011

[OIR])

provides guidance on consent and data sharing:

When research involves obtaining data from people, researchers are

expected to maintain high ethical standards such as those recommended

by professional bodies, institutions and funding organisations, both

during research and when sharing data. Research data — even

sensitive and confidential data — can be shared ethically and

legally if researchers pay attention, from the beginning of research,

to three important aspects:

• when gaining informed consent, include provision for data

sharing

• where needed, protect people’s identities by anonymising

data

• consider controlling access to data These measures should be

considered jointly. The same measures form part of good research

practice and data management, even if data sharing is not envisioned.

Data collected from and about people may hold personal, sensitive or

confidential information. This does not mean that all data obtained by

research with participants are personal or confidential.

Data sharing made public headlines in 2016 when a Danish researcher

released a data set comprised of scraped data from nearly 70,000 users

of the OkCupid online dating site. The data set was highly

reidentifiable and included potentially sensitive information,

including usernames, age, gender, geographic location, what kind of

relationship (or sex) they’re interested in, personality traits,

and answers to thousands of profiling questions used by the site. The

researcher claimed the data were public and thus, such sharing and use

was unproblematic. Zimmer (2016) was among many privacy and ethics

scholars who critiqued this stance.

The Danish researchers did not seek any form of consent or debriefing

on the collection and use of the data, nor did they have any ethics

oversight. Many researchers and ethics boards are, however, attempting

to mitigate some of these ethical concerns by including blanket

statements in their consent processes, indicating such precautions for

research participants. For example,

I understand that online communications may be at greater risk for

hacking, intrusions, and other violations. Despite these

possibilities, I consent to participate.

A more specific example comes from the Canadian context when

researchers propose to use specific online survey tools hosted in the

United States; REBs commonly recommend the following type language for

use in informed consent documents:

Please note that the online survey is hosted by Company ABC which is a

web survey company located in the U.S.A. All responses to the survey

will be stored and accessed in the U.S.A. This company is subject to

U.S. Laws, in particular, to the U.S. Patriot Act/Domestic Security

Enhancement Act that allows authorities access to the records that

your responses to the questions will be stored and accessed in the

U.S.A. The security and private policy for Company ABC can be viewed

at

http://…/.[6]

Researchers are also encouraged to review the Terms of Use and Terms

of Service of the application that are being used, demonstrating its

details to the REB in the application and informing participants of

such details in the informed consent form or script. Researchers are

also encouraged to consider broader contextual factors of the data

source and research goals when weighing the possible violation of a

platform’s Terms of Service (Fiesler, Beard, & Keegan

2020).

4.3.1 Minors and Consent

Internet research poses particular challenges to age verification,

assent and consent procedures, and appropriate methodological

approaches with minors. Age of consent varies across countries,

states, communities, and locales of all sorts. For research conducted

or supported by U.S. federal agencies bound by the Common Rule,

children are

persons who have not attained the legal age for consent [18, in the

U.S.] to treatments or procedures involved in the research, under the

applicable law of the jurisdiction in which the research will be

conducted (45 C.F.R. § 46.402(a) 2009).

Goldfarb (2008) provides an exhaustive discussion of age of majority

across the U.S. states, with a special focus on clinical

research, noting children must be seven or older to assent to

participation (see 45 C.F.R. § 46 Subpart D 2009).

Spriggs (2010), from the Australian context, notes that while no

formal guidance exists on Internet research and minors under the

National Statement, she advises:

Parental consent may be needed when information is potentially

identifiable. Identifiable information makes risks to individuals

higher and may mean that the safety net of parental consent is

preferable.

There is also a need to consider whether seeking parental consent

would make things worse e.g., by putting a young person from a

dysfunctional home at risk or result in disclosure to the researcher

of additional identifying information about the identity and location

of the young person. Parental consent may be “contrary to the

best interests” of the child or young person when it offers no

protection or makes matters worse (2010: 30).

To assist with the consent process, age verification measures can be

used. These can range from more technical software applications to

less formal knowledge checks embedded in an information sheet or

consent document. Multiple confirmation points (asking for age, later

asking for year of birth, etc.) are practical measures for

researchers. Depending on the types of data, sensitivity of data, use

of data, researchers and boards will carefully construct the

appropriate options for consent, including waiver of consent, waiver

of documentation, and/or waiver of parental consent.

4.4 Cloud Computing and Research Ethics

Recent developments in cloud computing platforms have led to unique

opportunities—and ethical challenges—for researchers.

Cloud computing describes the deployment of computing resources via

the Internet, providing on-demand, flexible, and scalable computing

from remote locations. Examples include web-based email and

calendaring services provided by Google or Yahoo, online productivity

platforms like Google Docs or Microsoft Office 365, online file

storage and sharing platforms like Dropbox or Box.net, and large-scale

application development and data processing platforms such as Google

Apps, Facebook Developers Platform, and Amazon Web Services.

Alongside businesses and consumers, researchers have begun utilizing

cloud computing platforms and services to assist in various tasks,

including subject recruitment, data collection and storage,

large-scale data processing, as well as communication and

collaboration (Allan 2011

[OIR];

X. Chen et al. 2010

[OIR]);

Simmhan et al. 2008; Simmhan et al. 2009).

As reliance on cloud computing increases among researchers, so do the

ethical implications. Among the greatest concerns is ensuring data

privacy and security with cloud-based services. For researchers

sharing datasets online for collaborative processing and analysis,

steps must be taken to ensure only authorized personnel have access to

the online data that might contain PII, but also that suitable

encryption is used for data transfer and storage, and that the cloud

service provider maintains sufficient security to prevent breaches.

Further, once research data is uploaded to a third-party cloud

provider, attention must be paid to the terms of service for the

contracted provider to determine what level of access to the data, if

any, might be allowed to advertisers, law enforcement, or other

external agents.

Alongside the privacy and security concerns, researchers also have an

ethical duty of data stewardship which is further complicated when

research data is placed in the cloud for storage or processing. Cloud

providers might utilize data centers spread across the globe, meaning

research data might be located outside the United States, and its

legal jurisdictions. Terms of service might grant cloud providers a

license to access and use research data for purposes not initially

intended or approved of by the subjects involved. Stewardship may

require the prompt and complete destruction of research data, a

measure complicated if a cloud provider has distributed and backed-up

the data across multiple locations.

A more unique application of cloud computing for research involves the

crowdsourcing of data analysis and processing functions, that is,

leveraging the thousands of users of various online products and

services to complete research related tasks remotely. Examples include

using a distributed network of video game players to assist in solving

protein folding problems (Markoff 2010), and leveraging Amazon’s

Mechanical Turk crowdsourcing marketplace platform to assist with

large scale data processing and coding functions that cannot be

automated (Conley & Tosti-Kharas 2014; J. Chen et al. 2011). Using

cloud-based platforms can raise various critical ethical and

methodological issues.

First, new concerns over data privacy and security emerge when

research tasks are widely distributed across a global network of

users. Researchers must take great care in ensuring research data

containing personal or sensitive information isn’t accessible by

outsourced labor, or that none of the users providing crowdsourced

labor are able to aggregate and store their own copy of the research

dataset. Second, crowdsourcing presents ethical concerns over trust

and validity of the research process itself. Rather than a local team

of research assistants usually under a principal investigator’s

supervision and control, crowdsourcing tends to be distributed beyond

the direct management or control of the researcher, providing less

opportunity to ensure sufficient training for the required tasks.

Thus, researchers will need to create additional means of verifying

data results to confirm tasks are completed properly and

correctly.

Two additional ethical concerns with crowdsourcing involve labor

management and authorship. Mechanical Turk users were not originally

intended to be research subjects, first and foremost. However,

researchers using Mechanical Turks must ensure that the laborers on

the other end of the cloud-based relationship are not being exploited,

that they are legally eligible to be working for hire, and that the

incentives provided are real, meaningful, and appropriate (Scholz

2008; Williams 2010

[OIR).

Finally, at the end of a successful research project utilizing

crowdsourcing, a researcher may be confronted with the ethical

challenge of how to properly acknowledge the contributions made by

(typically anonymous) laborers. Ethical research requires the fair and

accurate description of authorship. Disciplines vary as to how to

report relative contributions made by collaborators and research

assistants, and this dilemma increases when crowdsourcing is used to

assist with the research project.

4.5 Big Data Considerations

Algorithmic processing is a corollary of big data research, and

newfound ethical considerations have emerged. From “algorithmic

harms” to “predictive analytics”, the power of

today’s algorithms exceeds long-standing privacy beliefs and

norms. Specifically, the National Science and Technology Council

note:

“Analytical algorithms” as algorithms for prioritizing,

classifying, filtering, and predicting. Their use can create privacy

issues when the information used by algorithms is inappropriate or

inaccurate, when incorrect decisions occur, when there is no

reasonable means of redress, when an individual’s autonomy is

directly related to algorithmic scoring, or when the use of predictive

algorithms chills desirable behavior or encourages other privacy

harms. (NSTC 2016: 18).

While the concept of big data is not new, and the term has been in

technical discourses since the 1990s, public awareness and response to

big data research is much more recent. Following the rise of social

media-based research, Buchanan (2016) has delineated the emergence of

“big data”-based research from 2012 to the present, with

no signs of an endpoint.

Big data research is challenging for research ethics boards, often

presenting what the computer ethicist James Moor would call

“conceptual muddles”: the inability to properly

conceptualize the ethical values and dilemmas at play in a new

technological context. Subject privacy, for example, is typically

protected within the context of research ethics through a combination

of various tactics and practices, including engaging in data

collection under controlled or anonymous environments, limiting the

personal information gathered, scrubbing data to remove or obscure

personally identifiable information, and using access restrictions and

related data security methods to prevent unauthorized access and use

of the research data itself. The nature and understanding of privacy

become muddled, however, in the context of big data research, and as a

result, ensuring it is respected and protected in this new domain

becomes challenging.

For example, the determination of what constitutes “private

information”—and thus triggering particular privacy

concerns—becomes difficult within the context of big data

research. Distinctions within the regulatory definition of

“private information”—namely, that it only applies

to information which subjects reasonably expect is not normally

monitored or collected and not normally publicly

available—become less clearly applicable when considering the

data environments and collection practices that typify big data

research, such as the wholesale scraping of Facebook news feed content

or public OKCupid accounts.

When considered through the lens of the regulatory definition of

“private information”, social media postings are often

considered public, especially when users take no visible, affirmative

steps to restrict access. As a result, big data researchers might

conclude subjects are not deserving of particular privacy

consideration. Yet, the social media platforms frequently used for big

data research purposes represent a complex environment of

socio-technical interactions, where users often fail to understand

fully how their social activities might be regularly monitored,

harvested, and shared with third parties, where privacy policies and

terms of service are not fully understood and change frequently, and

where the technical infrastructures and interfaces are designed to

make restricting information flows and protecting one’s privacy

difficult.

As noted

in §4.1 above

it becomes difficult to confirm a user’s intention when sharing

information on a social media platform, and whether users recognize

that providing information in a social environment also opens it up

for widespread harvesting and use by researchers. This uncertainty in

the intent and expectations of users of social media and

internet-based platforms—often fueled by the design of the

platforms themselves—create numerous conceptual muddles in our

ability to properly alleviate potential privacy concerns in big data

research.

The conceptual gaps that exist regarding privacy and the definition of

personally identifiable information in the context of big data

research inevitably lead to similar gaps regarding when informed

consent is necessary. Researchers mining Facebook profile information

or public Twitter streams, for example, typically argue that no

specific consent is necessary due to the fact the information was

publicly available. It remains unknown whether users truly understood

the technical conditions under which they made information visible on

these social media platforms or if they foresaw their data being

harvested for research purposes, rather than just appearing onscreen

for fleeting glimpses by their friends and followers (Fiesler &

Proferes, 2018). In the case of the Facebook emotional contagion

experiment (Kramer, Guillory, & Hancock 2014), the lack of

obtaining consent was initially rationalized through the notion that

the research appeared to have been carried out under Facebook’s

extensive terms of service, whose data use policy, while more than

9,000 words long, does make passing mention to “research”.

It was later revealed, however, that the data use policy in effect

when the experiment was conducted never mentioned

“research” at all (Hill 2014).

Additional ethical concerns have arisen surrounding the large scale

data collection practices connected to machine learning and the

development of artificial intelligence. For example, negative public

attention have surrounded algorithms designed to infer sexual

orientation from photographs and facial recognition algorithms trained

on videos of transgender people. In both cases, ethical concerns have

been raised about both the purpose of these algorithms and the fact

that the data that trained them (dating profile photos and YouTube

videos, respectively) was “public” but collected from

potentially vulnerable populations without consent (Metcalf 2017;

Keyes 2019). While those building AI systems cannot always control the

conditions under which the data they utilize is collected, their

increased use of big datasets captured from social media or related

sources raises a number of concerns beyond what typically is

considered part of the growing focus on AI ethics: fairness,

accountability and transparency in AI can only be fully possible when

data collection is achieved in a fair, ethical, and just manner (Stahl

& Wright 2018; Kerry 2020).

4.6 Internet Research and Industry Ethics

The Facebook emotional contagion experiment, discussed above, is just

one example in a larger trend of big data research conducted outside

of traditional university-based research ethics oversight mechanisms.

Nearly all online companies and platforms analyze data and test

theories that often rely on data from individual users. Industry-based

data research, once limited to marketing-oriented “A/B

testing” of benign changes in interface designs or corporate

communication messages, now encompasses information about how users

behave online, what they click and read, how they move, eat, and

sleep, the content they consume online, and even how they move about

their homes. Such research produces inferences about

individuals’ tastes and preferences, social relations,

communications, movements, and work habits. It implies pervasive

testing of products and services that are an integral part of intimate

daily life, ranging from connected home products to social networks to

smart cars. Except in cases where they are partnering with academic

institutions, companies typically do not put internal research

activities through a formal ethical review process, since results are

typically never shared publicly and the perceived impact on users is

minimal.

The growth of industry-based big data research, however, presents new

risks to individuals’ privacy, on the one hand, and to

organizations’ legal compliance, reputation, and brand, on the

other hand. When organizations process personal data outside of their

original context, individuals may in some cases greatly benefit, but

in other cases may be surprised, outraged, or even harmed. Soliciting

consent from affected individuals can be impractical: Organizations

might collect data indirectly or based on identifiers that do not

directly match individuals’ contact details. Moreover, by

definition, some non-contextual uses—including the retention of

data for longer than envisaged for purposes of a newly emergent

use—may be unforeseen at the time of collection. As Crawford and

Schultz (2014) note,

how does one give notice and get consent for innumerable and perhaps

even yet-to-be-determined queries that one might run that create

“personal data”? (2014: 108)

With corporations developing vast “living laboratories”

for big data research, research ethics has become a critical component

of the design and oversight of these activities. For example, in

response to the controversy surrounding the emotional contagion

experiment, Facebook developed an internal ethical review process

that, according to its facilitators,

leverages the company’s organizational structure, creating

multiple training opportunities and research review checkpoints in the

existing organizational flow (Jackman & Kanerva 2016: 444).

While such efforts are important and laudable, they remain open for

improvement. Hoffmann (2016), for example, has criticized Facebook for

launching

an ethics review process that innovates on process but tells us little

about the ethical values informing their product development.

Further, in their study of employees doing the work of ethics inside

of numerous Silicon Valley companies, Metcalf and colleagues found

considerable tension between trying to resolve thorny ethical dilemmas

that emerge within an organization’s data practices and the

broader business model and corporate logic that dominates internal

decision-making (Metcalf, Moss, & boyd 2019).

5. Research Ethics Boards Guidelines

While many researchers and review boards across the world work without

formal guidance, many research ethics boards have developed guidelines

for Internet research. While many such guidelines exist, the following

provides examples for researchers preparing for an REB review, or for

boards developing their own policies.

Bard College (New York) Guidelines for Internet Research

Loyola University Chicago Policy for Online Survey Research Involving Human Participants

Penn State Guidelines for Computer- and Internet-Based Research Involving Human Participants

U.K. Data Archive Further Resources

University of California-Berkeley Data Security and Human Research Data Risk Assessment Matrix (pdf)

University of Connecticut Guidance for Computer and Internet-Based Research Involving Human Participants

Additional resources are found in

Other Internet Resources

below.

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Related Entries

ethics, biomedical: clinical research |

ethics: deontological |

informed consent |

privacy

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Ethical issues in stem cell research and therapy | Stem Cell Research & Therapy | Full Text

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Ethical issues in stem cell research and therapy

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Published: 07 July 2014

Ethical issues in stem cell research and therapy

Nancy MP King1 & Jacob Perrin2 

Stem Cell Research & Therapy

volume 5, Article number: 85 (2014)

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AbstractRapid progress in biotechnology has introduced a host of pressing ethical and policy issues pertaining to stem cell research. In this review, we provide an overview of the most significant issues with which the stem cell research community should be familiar. We draw on a sample of the bioethics and scientific literatures to address issues that are specific to stem cell research and therapy, as well as issues that are important for stem cell research and therapy but also for translational research in related fields, and issues that apply to all clinical research and therapy. Although debate about the moral status of the embryo in human embryonic stem cell research continues to have relevance, the discovery of other highly multipotent stem cell types and alternative methods of isolating and creating highly multipotent stem cells has raised new questions and concerns. Induced pluripotent stem cells hold great promise, but care is needed to ensure their safety in translational clinical trials, despite the temptation to move quickly from bench to bedside. A variety of highly multipotent stem cells - such as mesenchymal stem/stromal cells and stem cells derived from amniotic fluid, umbilical cord blood, adipose tissue, or urine - present the opportunity for widespread biobanking and increased access. With these increased opportunities, however, come pressing policy issues of consent, control, and justice. The imperatives to minimize risks of harm, obtain informed consent, reduce the likelihood of the therapeutic misconception, and facilitate sound translation from bench to bedside are not unique to stem cell research; their application to stem cell research and therapy nonetheless merits particular attention. Because stem cell research is both scientifically promising and ethically challenging, both the application of existing ethical frameworks and careful consideration of new ethical implications are necessary as this broad and diverse field moves forward.

IntroductionAs every reader of this journal knows, ‘stem cell research’ is a category of enormous breadth and complexity. Current and potential therapeutic applications for stem cells are numerous. Stem cell researchers may be engaged in many different endeavors, including but not limited to seeking new sources of highly multipotent stem cells and methods of perpetuating them; creating induced pluripotent stem cell (iPSC) lines to study genetic disorders or explore pharmacogenomics; conducting animal or early-phase human studies of experimental stem cell interventions; or working with stem cells and biomaterials to develop organoids and other products for use in regenerative medicine, to name only a few possibilities.In this review of selected major ethical issues in stem cell research and therapy, we briefly describe and discuss the most significant ethical implications of this wide-ranging and fast-moving field. Our discussion addresses research oversight in the historical context of human embryonic stem cell (hESC) research; clinical translation and uncertainty; the profound tension between the desire for clinical progress and the need for scientific caution; and issues of consent, control, commercialization, and justice arising from stem cell banking, disease modeling, and drug discovery. We seek to make stem cell scientists more aware of the need for clarity of discussion and to improve professional and public understanding of the ethical and policy issues affecting this important but early research. A review this brief is necessarily general; our hope is that researchers can use this discussion as a starting point for more in-depth identification and analysis of issues pertinent to specific translational research projects [1–3].Stem cell research: oversight and clinical translationThe basic system of regulation and review of research involving humans and animals as subjects [4, 5] is familiar to investigators. Recently, however, the term ‘translational’ has come to describe a line of research inquiry intended to stretch from bench to bedside and beyond. This has helped to emphasize that thinking about ethical issues should begin at the earliest stages of preclinical research. Ethics in both research and clinical settings is most effective when it is preventive.In this respect, stem cell research is not unique; stem cell researchers should ask themselves the same questions about the trajectory of their translational research as would any other biomedical researcher [6]. Oversight of cell-based interventions does, however, include additional features that, while adding complexity to the regulatory process, also make it easier to take a long view, by requiring attention to the use of stem cells at all research stages. Increasing pressures for the rapid clinical translation and commercialization of stem cell products underscore the value of this long view [7–14].The ethical issues that all researchers face during clinical translation begin with the need to ask a meaningful question, the answer to which has both scientific and social value and can be reached by the study as designed when properly conducted [6, 15]. The risks of harm and the potential benefits to society from the development of generalizable knowledge (and, sometimes, potential direct benefit to patient-subjects) must be weighed and balanced at each stage of the research. Sound justification is necessary to support moving from the laboratory into animal studies, and from animals into human subjects, as well as through relevant phases of research with humans [15–18]. Minimizing the risks of harm, selecting and recruiting appropriate patient-subjects, facilitating informed decision making through the consent form and process, and avoiding the ‘therapeutic misconception’, whereby unduly high expectations affect all interested parties to a clinical trial, are all significant research ethics considerations, especially in first-in-human and other early-phase studies [19–26]. To many researchers, these considerations are simply requirements of sound and responsible study design, as exemplified, for example, in US Food and Drug Administration (FDA) guidance documents and investigational new drug requirements [27]. It should come as no surprise, however, that research design and research ethics are closely intertwined [1, 6, 15].Stem cell research may give rise to heightened concern in several of these areas. One such concern is clarity of language. The term ‘stem cell’ by itself is broad and non-specific enough to be confusing; it can refer to hESCs, to iPSCs, to other types of multipotent and highly multipotent stem cells (including but not limited to stem cells derived from amniotic fluid, umbilical cord blood, adipose tissue, or urine), or to determined or adult stem cells like hematopoietic stem cells (HSCs), which have long been used in standard therapies. Patients, science reporters, and the public, on hearing the term ‘stem cell’, may thus find it difficult to distinguish between experimental stem cell interventions and proven stem cell therapies of long standing, such as treatments involving autologous or allogeneic HSC transplantation. The commercial availability worldwide of unproven ‘stem cell therapies’ that have not been studied in translational research adds to this confusion [12, 14, 24–26, 28, 29].Human embryonic stem cells and embryonic stem cell research oversight committeesHopes that the ethical controversy surrounding hESCs would become irrelevant when new sources of highly multipotent stem cells became available have proven somewhat premature. hESCs remain scientifically promising and continue to have important uses, even as research with iPSCs and other highly multipotent stem cells gains momentum [30–32]. A brief discussion thus seems warranted.The first hESC line was derived in 1998, ushering in one of the most public, spirited, and intractable debates in research ethics: the moral status of the embryo from which hESCs are derived. To harvest hESCs, it is first necessary to destroy the 5-day-old preimplantation embryo. Opponents of hESC research argue that because the embryo is capable of developing into a human being, it has significant moral standing; therefore, its destruction is unethical. Some proponents of hESC research deny that the embryo has any moral status; others grant it limited moral status but argue that the value of this limited status is far outweighed by the potential benefits that can result from hESC research [24, 33].The ethical implications of hESC research in the US have been reflected in federal funding policy and in research oversight. In 2003, the National Academy of Sciences (NAS) established a committee to develop guidelines for institutions and investigators conducting hESC research [9]. The NAS Guidelines for Human Embryonic Stem Cell Research, most recently amended in 2010 [34], comprehensively address permissible and impermissible categories of hESC research and recommend the establishment of embryonic stem cell research oversight committees (ESCROs) to assist in research review. They also incorporate National Institutes of Health guidelines promulgated after a 2009 federal funding expansion, recommend oversight of research with human pluripotent stem cells, and address questions of consent from all donors of biomaterials, creation and use of embryos for research purposes, and animal-human chimeras.Many research institutions have created ESCROs or ‘SCROs’ to review hESC and iPSC research; others rely on their institutional review boards or their animal care and use committees or both. As stem cell research diversifies, its ethical oversight also becomes more diverse, and questions have been raised regarding the ongoing need for specialized committees like ESCROs and SCROs [9, 10]. The NAS Guidelines are nonetheless likely to continue providing guidance for a variety of oversight bodies reviewing stem cell research [9, 10, 32].Induced pluripotent stem cells on the translational pathwayControversy about the derivation and use of hESCs led investigators to seek less ethically fraught but maximally useful types of stem cells [31]. The history of iPSCs is one of seeking efficient ways to induce pluripotency that minimize the risk of teratoma development [35]. Although the rapidly developing science has reduced risks of harm and has increased the efficiency of pluripotent cell line creation to some extent, safety and efficacy concerns remain [36]. Indeed, the most recent advance in inducing pluripotency - stimulus-triggered acquisition of pluripotency, or STAP [37] - was widely heralded [38] but has since been called into question [39]. Obokata and colleagues [37] presented data suggesting that subjecting somatic cells to various stresses could quickly and safely produce iPSCs, but their results have not proven reproducible.In research with iPSCs as well as with other types of stem cells, it is essential that preclinical studies in animal models and other media be sufficient to justify the progression to clinical trials. Toxicity and the risk of tumorigenicity must be assessed for all stem cell-based products, especially when genetically modified, in order to minimize the risks of harm as far as feasible before moving to humans [11, 12, 16, 17, 26, 40].Concern about the research use of animals - especially non-human primates - in preclinical research, including iPSC research, is growing and must be addressed; at the same time, researchers are increasingly aware that good animal models are often unavailable or inadequate to predict effects in humans. Thus, considerable uncertainty continues to surround first-in-human trials and other early-phase studies using stem cells, even as the rapid pace and apparently improving safety of iPSC creation tempt the field to move rapidly into clinical research and even therapeutic applications [5, 25, 41].Clinical trials: uncertainty and human subjectsClinical trials of iPSCs and other highly pluripotent stem cell interventions generally enroll patients as subjects at all trial stages, as using healthy volunteers may raise safety concerns or compromise the value of the data. All clinical trials must, of course, be carefully designed, rigorously justified, and properly conducted in order to protect the rights, interests, and welfare of trial subjects and contribute to generalizable knowledge [11, 12, 15–17, 25, 26, 35, 40]. Stem cell researchers can and should benefit from the lessons learned by gene transfer researchers: rapid transition to clinical applications without sufficient understanding of the mechanisms of effect is both inefficient and unwise [11, 12, 25, 42].The Geron trial provides just one instructive example. In late January 2009, the FDA approved the first clinical trial of an hESC-based experimental intervention for spinal cord injury. The product, oligodendrocyte progenitor cells (OPCs), is thought to remyelinate spinal cord axons. The trial was to enroll a small number of patient-subjects with recent serious spinal cord lesions. It was placed on hold once by the FDA to ensure the purity and safety of the OPCs and ultimately was halted by the sponsor, Geron Corporation (Menlo Park, CA, USA), for reasons of cost, after only four patient-subjects had received the intervention.Both the trial’s design and its ultimate discontinuation were controversial. Its design caused controversy because the subjects were enrolled very soon after a serious injury, making understanding and consent challenging in this first-in-human trial and in addition making it potentially difficult to distinguish between spontaneous recovery of function and remyelination attributable to the intervention. Patients with older lesions, though very probably in a better position to make decisions about trial participation, have scar tissue that makes remyelination unlikely or impossible. The sponsor’s premature discontinuation of the trial was problematic because data insufficiency renders worthless not only its own investment but also those made by patient-subjects and investigators. The outcome had the potential to discourage pioneering stem cell research in the future [25, 43, 44]. Nonetheless, identifying the optimal time for post-injury intervention, both to maximize the potential for assessing effects on remyelination and to promote an optimal decision-making process by patient-subjects, is of ongoing concern to spinal cord injury researchers studying cell-based interventions [45]. More recently, discussions of ethical and design issues in particular stem cell trials (for example, macular degeneration [2] and cardiovascular disease [3]) highlight the difficult balance between the imperatives of caution and progress for first-in-human trials in high-profile areas like stem cell intervention research.Disclosure and discussion of uncertainty with potential subjects in stem cell trials are essential in order to reduce the incidence of therapeutic misconception, whereby research subjects and also investigators and oversight bodies view research as a treatment modality or significantly overestimate the likelihood of direct benefit or both [19–22, 41]. This information transparency also helps protect the integrity of the research process and the safety of patients in the face of increasing global availability of unapproved and unproven stem cell ‘treatments’ [11, 12, 16, 24–26].Many types of multipotent and highly multipotent stem cells have been identified as potentially suitable for clinical applications. Some of the most significant challenges faced in clinical application include how quickly to move forward in the face of great promise, great uncertainty, and great clinical need; how to regard research with investigational interventions that are difficult to standardize and impossible to undo; and how to define and describe these uncertainties in the consent process. A growing number of prestigious academics from both science and bioethics are calling attention to these challenges [2, 24, 26, 42].One prominent scientist commentator compares the current state of stem cell research with the histories of HSC transplantation and gene transfer research, citing several principles: risks of harm should be commensurate with the severity of the condition under study, preclinical animal models remain critically important, and gaining insight into therapeutic mechanisms is essential to the success of a line of clinical research. He advocates ‘a conservative approach to clinical translation of stem cell therapies’ at present, not because of risks of harm, ‘but rather because our understanding of the mechanisms by which stem cells might prove useful, and in which diseases, remains primitive’ [25]. Similarly, in an international survey of stem cell scientists and scholars of ethical issues in stem cell research, a prolific bioethics research group has identified increasing concerns arising from pressures for clinical translation, commercialization, and oversight of new stem cell technologies [14].Highly multipotent stem cells: biobanking, disease modeling, and drug discoverySome applications of stem cell research, such as disease modeling, drug discovery and testing, cell line banking, and commercialization of stem cell therapies, also give rise to ethical considerations specific to the field [11, 12, 14, 16, 24–26, 28, 29]. iPSCs and other highly multipotent stem cells have many additional important uses outside the typical clinical research trajectory. The creation and use of disease-specific iPSC lines, both alone and in combination with regenerative medicine products (for example, to produce ex vivo organoids), are essential components of disease modeling and drug discovery. ‘Body-on-a-chip’ types of three-dimensional organoid arrays hold great promise for improving drug development, disease modeling, and pharmacogenomic research, by lowering costs, speeding results, and increasing the safety and potential efficacy signaling of first-in-human trials, and considerable research is under way [46]. That promise is as yet unrealized, but questions of consent and control arise even at the bench. Because iPSC lines are derived from the somatic cells of identifiable individuals, disclosing to those individuals the planned and envisioned uses of iPSCs derived from the cells they have donated and obtaining consent from them are critical for the creation and sharing of cell line research libraries and the future uses of biomaterials derived from previously donated biospecimens [24, 26, 47–50].As potentially therapeutic applications proliferate for different highly multipotent stem cell types and as technical barriers to the collection and perpetuation of cell lines continue to fall, proposed research and treatment uses abound for both autologous and allogeneic stem cells. In particular, the development of public and other broadly accessible biobanking models for stem cells derived from umbilical cord blood, amniotic fluid and placental tissue, urine, and adipose tissue holds promise for easy collection of good allograft matches for a large percentage of the population but also requires attention to ethical and policy issues [26, 51].Justice in stem cell research and treatmentJustice is a necessary but neglected consideration in all scientific research. Like many novel biotechnologies, gene- and cell-based and regenerative medicine interventions and products can be extraordinarily costly and time- and labor-intensive to develop and use. Justice thus requires attention to the costs of developing stem cell therapies and making them available, with the goal of reducing unfair disparities in access. Cost is a standard distributive justice concern. Less commonly discussed is the effect of research funding decisions on health disparities - both priority-setting within research and priority between research funding and funding for medical care, public health, and other public goods [19–21].Justice considerations are addressed in stem cell research and therapy in several ways. The first is biobanking policy and practice. The rationale for public stem cell banking is to provide a resource for transplantation of blood-forming HSCs to virtually anyone. Ideally, large-scale banking efforts could store enough different lines of broadly multipotent and pluripotent stem cells, suitable for use in regenerative medicine applications, to provide good matches for nearly the entire population of the US. Comprehensive systems for the collection, storage, and use of stem cells of different types are, however, still in the early stages of technological and policy development. Scientific, practical, and ethical challenges include ensuring broad availability of matches for those in need, determining access for both research and therapy, refining consent forms and processes, and protecting confidentiality in labeling and information linkage [11, 12, 16, 26, 51, 52]. Thus, large-scale biobanking of stem cell lines holds the potential to greatly increase access to stem cell therapies and reduce costs, but because available allogeneic matches may not be perfect, balancing the harms and benefits of biobanking remains critical.The second justice-promoting feature of stem cell research and therapy has some similarities. Attempts to standardize and streamline production are more prevalent in stem cell-related research than elsewhere - especially in development of cell-based products and in regenerative medicine. In other new technologies like gene transfer, standardization, the development of platform technologies, and attempts at large-scale, cost-reducing production are in their infancy. This production perspective is an important step in reducing time, labor, and costs and thus increasing access, but it could also have interesting ethical implications. Autologous or individually ‘compounded’ cell-based interventions will certainly be more costly and less readily available - and will take more time to produce - than allogeneic and other ‘mass-produced’ cell-based interventions, which may provide a less-than-perfect match or fit for a given patient. Such differences could have efficacy implications that must be monitored and balanced against cost savings and access gains [51].A final justice consideration that is heightened in the stem cell context is the simple reality that important work dedicated to improving the health of the public takes place in a market system with its attendant pressures of competition and commercialization. The attempt to ensure that hope does not become hype and that hype does not become fraud is a matter of justice. Thus, sound practice in clinical translation, careful discussion in the media, and even seeking balance between scientific transparency and data-sharing and the intellectual property interests of industry all have important justice implications [13, 16, 24–29, 42, 53]. As research funding shrinks and competitive pressures grow, it may become increasingly difficult to move deliberately toward clinical translation and to allocate research resources wisely. This is especially likely as more is learned about how to reduce the risks of harm from the creation and use of iPSCs and as the costs of careful progress continue to increase. The fewer resources we have, the more important it is to allocate funds to maximize the likelihood of knowledge development in areas of greatest promise and clinical need [14, 21].Individual researchers may at first regard justice considerations as somewhat removed from their daily work at bench or bedside. The goals of advancing knowledge and, ultimately, improving human health are nonetheless social goals, not merely scientific goals. Researchers make vital contributions to societal views about the value of - and best directions for - scientific progress. For this reason alone, it is worthwhile for researchers to keep in mind the population-level applications of stem cell research as well as the effects of stem cell therapy on individual health.Summary and conclusionsAs our discussion has shown, many of the ethical and policy issues that are most significant for stem cell research and therapy are similar to those arising in other novel biotechnologies. Consideration of these issues in both scientific and bioethics literatures addresses many common themes: the minimization of risks of harm; the importance of information disclosure and informed consent; the potential for overpromising, overexpectations, and the therapeutic misconception; and the pressure from disease constituencies and commercial entities to move quickly into the clinic, too often at the expense of understanding basic mechanisms. In the realm of clinical translation, trial-specific examinations of ethical issues continue to provide important guidance, not only with regard to the trials specifically considered but also as models for investigators starting down new translational pathways.Although the creation and use of hESCs have long been the unique focus of stem cell ethics, more current controversies include the creation, for research use, of human embryos, human-animal chimeras, and gametes. Yet these marquee controversies are, in the long run, less important for the field as a whole than are more mundane, justice-oriented concerns like the creation and use of stem cell banks for research and therapy, facilitation of ‘off-the-shelf’ stem cell applications that could be less costly though perhaps less than perfect, and questions of consent, provenance, and policy. Finally, moving forward with the right blend of creativity and caution is essential, in the interest of both science and patients. In all areas of stem cell research and therapy, nuanced consideration and discussion of the best translational pathways, as viewed by ethics as well as science, will play a vital role in balancing hope and hype now and in the future, as the field continues its rapid progress.

AbbreviationsESCRO:

embryonic stem cell research oversight (committee)

FDA:

US Food and Drug Administration

hESC:

human embryonic stem cell

HSC:

hematopoietic stem cell

iPSC:

induced pluripotent stem cell

NAS:

National Academy of Sciences

OPC:

oligodendrocyte progenitor cell

SCRO:

stem cell research oversight (committee).

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Download referencesAuthor informationAuthors and AffiliationsDepartment of Social Sciences and Health Policy, Wake Forest School of Medicine, Medical Center Blvd, Winston-Salem, NC, 27157, USANancy MP KingCenter for Bioethics, Health, and Society, Wake Forest University, 1834 Wake Forest Rd, Winston-Salem, NC, 27106, USAJacob PerrinAuthorsNancy MP KingView author publicationsYou can also search for this author in

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Public health: ethical issues. | International Journal of Epidemiology | Oxford Academic

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Public health: ethical issues.

Public health: ethical issues.London:  Nuffield Council on Bioethics,  2007, pp.  191, £10, ISBN978 1 904384 17 5.

Ishani Kar-Purkayastha

Ishani Kar-Purkayastha

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International Journal of Epidemiology, Volume 38, Issue 4, August 2009, Pages 1166–1167, https://doi.org/10.1093/ije/dyn150

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Ethical discourse in medicine has been geared towards the typical clinical scenario of the individual patient encounter with the healthcare system. Over the years, as biotechnology made dramatic advances, the bioethical debates too, evolved to focus on the implications of research and technological innovation.1 In more recent years, public health has enjoyed a renaissance and as a result, its accompanying ethical dilemmas have been brought into the bioethical spotlight. The latest offering from the Nuffield Council on Bioethics, Public health: ethical issues, is therefore very timely and makes a substantial contribution to the emergent field of population level ethics.Broadly, the text is divided into two sections. In the first section, the authors explain the nature of public health and set the scene by summarizing some of the key perspectives that can be applied when considering ethical questions in public health. For example, importance of freedom from coercion, importance of minimizing harm to others, importance of protecting vulnerable populations, etc. In the second section, the authors contextualize these perspectives by situating them within four different scenarios or cases: infectious diseases; obesity; alcohol and tobacco and water fluoridation.In the first three chapters, after providing a comprehensive introduction to public health, the authors go on to articulate in greater detail the added complexities inherent to ethical decision making at the population level, including: the need to balance the conflicting interests of the individual with the community; implementation of preventive measures; redressing health inequalities and importantly the role of the state as the arbitrator of these actions. Borrowing from political theory, they outline a spectrum of ‘state-citizen’ relationships, ranging from libertarian to liberal through to collectivist and, although the discussion is far from exhaustive, the authors distil out for the reader the beliefs that lie at the hub of each of these schools of thought. Then, choosing the liberal state as a prototype of Western government, the authors propose an ethical framework that would be in keeping with the ideologies of such a state. However, this initial framework, outlined in chapter 2 under the heading ‘an initial liberal framework’, is then modified to both enable and entrust the state to undertake a more active role in ensuring health for its citizens. The authors go on to propose a modified liberal framework that would encompasses these added expectations and call this the ‘stewardship model’.Unlike the set of four principles that form the framework for clinical ethics (i.e. respect for autonomy, beneficence, non-maleficence and justice), the ‘stewardship model’ is presented as a set of guidelines addressing goals and constraints for public health programmes. This approach to ethical frameworks is not unprecedented in public health.2 It may be argued that because of the varied (and sometimes competing) interests of the individual, society and the state, guidelines that are developed to greater specification are more useful to public health than a code with a set of overarching principles.What is surprisingly lacking in this scene-setting is the lack of overt reference to the juxtaposition of the two key ethical theories (i.e. deontological and utilitarian) that inform public health debates. Although the authors discuss utilitarianism, they do not at any point contrast its principles with those of duty-based ethics.In chapter 3, the authors go on to introduce the ‘intervention ladder’—a tool for determining how interventionist a public health policy is. The higher the rung, the more intrusive the policy and, therefore, the stronger the justification needs to be for implementing it. Importantly, both here and elsewhere the authors emphasize that taking no action also entails an active decision and (depending on the situation) will require justification.In the subsequent chapters, we are presented with case studies that have been selected by the authors as areas within public health to which many of these debates are relevant. At the beginning of each chapter, the authors provide specific background information on the topic in question, laying out the pertinent facts, so that subsequent discussion is easily accessible to people who have no background in public health, medicine or ethics. For example, the authors’ explanation of vaccination, what it entails, pros and cons would be easily comprehensible to a non-specialist reader and provides the backdrop within which to situate the ethical issues that arise.For each topic the authors go on to talk about specific aspects of population level ethics that are of particular salience, incorporating into the discussion comments received as part of the consultative process. At the end of each chapter, the authors provide recommendations that would, by their reasoning, be appropriate to include in the policy-making process.The insight into the application of public health ethics that the authors have provided is very informative and will be useful to policy makers, public health practitioners and members of the public. However, despite investing a significant amount of space in developing the ‘stewardship model’, the authors did not consistently use this as a centrepiece around which to expand the case-based discussion. In certain chapters, such as chapter 7 on water fluoridation, the arguments are explicitly structured along the lines of the considerations of the ‘stewardship model’. In other chapters, the authors have chosen to formulate the discussion around the circumstances of the case itself. The rationale behind this inconsistency was not obvious.Finally, of particular interest to epidemiologists will be the authors’ decision to include availability of evidence as a policy rather than ethical issue. As one of the key methodologies available to public health, epidemiology is entrusted with providing much of the evidence base on which public health policy should be premised. Other authors2 have included the need for good evidence as an integral component of an ethical framework for public health.Overall, the authors have provided an informative report, with a usable ethical framework and case-based discussion that will make a valuable contribution to the ongoing discourse in public health ethics. References

1Callahan D,  Jennings B. Ethics and public health: forging a strong relationship, Am J Public Health, 2002, vol. 92 (pg. 169-76)Google ScholarCrossrefSearch ADS PubMedWorldCat 2Kass NE. An ethics framework for public health, Public Health Matters, 2001, vol. 91 (pg. 1776-82)Google ScholarOpenURL Placeholder TextWorldCat 

Published by Oxford University Press on behalf of the International Epidemiological Association © The Author 2008; all rights reserved.

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Ethical issues, dilemmas and controversies in 'cosmetic' or aesthetic dentistry. A personal opinion | British Dental Journal

Ethical issues, dilemmas and controversies in 'cosmetic' or aesthetic dentistry. A personal opinion | British Dental Journal

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nature

british dental journal

opinion

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Ethical issues, dilemmas and controversies in 'cosmetic' or aesthetic dentistry. A personal opinion

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Opinion

Published: 27 April 2012

Ethical issues, dilemmas and controversies in 'cosmetic' or aesthetic dentistry. A personal opinion

M. Kelleher1,2 

British Dental Journal

volume 212, pages 365–367 (2012)Cite this article

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EthicsLawTherapeutics

Key Points

Helps to resolve some ethical and moral dilemmas in the appropriate delivery of 'cosmetic' or aesthetic dentistry.

Provides an understanding of how to lower biological and legal risks when considering 'cosmetic' dentistry.

Emphasises a cost effective, lower risk, minimally destructive approach which is both ethically sound and usually produces a win/win outcome for most patients and their dentists alike.

AbstractStephen Hancocks' elegant editorial of 11 December 2011 raises interesting questions which deserve discussion. Most experienced dentists would agree that the less that is done to teeth for cosmetic reasons, the lesser are the risks of disappointment, failure of expectation, or threat of litigation. Yet there is an increasing number of cases where aesthetics are the primary concern for dentists and patients alike and some patients are consenting to treatment without being properly informed of the destructive nature of the procedures to their sound tooth tissue and structures to achieve the desired 'cosmetic' outcome. This raises ethical issues, as much of this overtreatment is unnecessarily destructive and goes against the healing and caring principles of the dental profession.

IntroductionMany of us who have lectured and written about solving dental aesthetic problems by various means, usually involving minimally destructive (though not minimally interventive) dentistry, have been emphasising similar points to those raised in Stephen Hancocks' editorial of 11 December 20111 for many years.Bleaching on its own or in conjunction with resin composite direct bonding, or where appropriate, orthodontic alignment, have been promoted by many speakers and writers including myself as being biologically sensible methods of overcoming most dental aesthetic problems.2 Viewed from an ethical perspective, one attraction of this approach is that the desirable aesthetic improvements for patients can be enormous and are readily achieved without destroying their own sound tooth tissue, structural strength, or dental pulpal health as unintended consequences of this elective treatment. These usually predictable procedures help to solve many aesthetic problems and ethically one should actively seek to avoid inflicting inadvertent collateral structural or other biologic damage in the process of improving patients' dental appearance.'Permanent' veneersSadly, some seriously destructive veneer approaches are cause for considerable ethical concern. In discussing ethics and supposedly 'cosmetic' dentistry it seems prudent to draw attention to the lack of permanence of porcelain veneers, with one study in the UK showing that only 53% of porcelain veneers were present without re-intervention after 10 years.3This does not sound much like a 'permanent veneer' to me and yet that seductively attractive term is used by many dentists. It has been shown that up to 30% of sound dental tissue can be removed in the preparation for extended porcelain veneers.4 This elective destructive treatment is done mainly for cosmetic reasons. Worryingly, the very same paper stated that between 62% and 73% of sound anterior tooth structure is destroyed during the preparation for all ceramic full coverage crowns.4 These preparations are neither benign, nor reversible interventions.In my opinion, it is unethical for some dentists to neglect to tell patients these relevant facts and figures in advance of any elective preparations for 'cosmetic' restorations. It is ethically flawed to pass them off as merely minor changes to their teeth that will seem insignificant at the end of treatment when the patient is rewarded with a 'Hollywood' or supposedly 'perfect' smile.In order to give their properly informed consent, patients really do need to know these relevant figures at the planning stage given the scale of the proposed elective destruction of their existing sound tooth structure and the possible consequential pulpal problems in the long term.Curiously, in all the records of negligence claims that I have examined that have been instigated by dissatisfied patients against their dentists in relation to unsatisfactory cosmetic outcomes, I have never seen a record in the dentist's notes stating that the patient was actually given figures in advance of treatment for the longevity of 'permanent veneers' or the amount of tooth structure that would be destroyed in the preparation for such approaches. Furthermore, I have not seen it entered in the dental notes in such cases that, on receiving this important written information, the patient subsequently agreed to have up to two-thirds of their sound tooth tissue removed purely for cosmetic reasons or so that the adjacent, but at the time mainly intact, teeth, would match the ones that really did require significant treatment. Consequently, many of these cases have had to be settled by the indemnifying organisations, often at vast expense, on the basis of breach of duty or the patient's 'lack of consent'. All the patient has to prove is that they are either unhappy with the outcome of the cosmetic appearance, the instability of the 'rapid orthodontic' result, the fact that they were misled or never adequately informed of the possible negative aspects of the treatment nor told about other viable options before undergoing this elective treatment. Many would regard these sorts of complex problems as involving moral or ethical issues as much as legal ones.Smile design damageIt is a matter of grave concern, therefore, that articles in some populist dental journals exhibit cases of significant amounts of apparent over-prescription and dental destruction being undertaken on adjacent or uninvolved teeth. Presumably this extra treatment involving variable amounts of dental damage is incorporated into the 'ideal smile design', in order that eventually the repaired teeth will match one another or conform to a particular fundamentalist formula. Sadly, they often do indeed 'match', but arguably in an unnatural, false tooth, de-personalised, monochromatic way.5 However, just imagine in terms of the ethical implications of over-prescription if one had to have a terminally arthritic knee replaced and the friendly orthopaedic surgeon kindly offered to also replace your other asymptomatic knee at the same time just 'so they matched'. Would you be tempted? No? Really?Could there possibly be some worrying ethical issues involved if such a wonderful offer conveniently doubled the fee for doing so? Yet somewhat bizarrely, judging on the basis of recently published cases in some (mainly non-peer reviewed) journals, that sort of approach now seems to be endemic in supposedly 'cosmetic' dentistry. Innocent adjacent or opposite teeth, or sometimes an entire group of teeth, seem to get reduced to a pile of dental dust in minutes just so that the resulting repaired teeth can 'match' or meet patient demands.5Unfortunately in some of these articles the ethical principles of 'firstly do no harm' or 'extreme remedies should be reserved for extreme diseases' seem to have been either blissfully ignored or conveniently forgotten.It was very much to the credit of the current organising committee of the British Academy of Cosmetic Dentistry (BACD) that they now appear to me to have had a significant change in their thinking or emphasis. This might be based on a better understanding of the longer term biological consequences of significant 'cosmetic' interventions and an increasing desire to avoid causing collateral damage. Whatever the reasons, many within the BACD appear to have now departed significantly from the 'all big white teeth and have a nice day' multiple porcelain veneer treatment philosophy as promulgated for many years by some destructive American 'gurus'.6 In doing so, it would appear that some at least have drifted back to the centre ground and away from the more 'extreme makeover' or fundamentalist 'cosmetic smile design' concepts. I suspect that many of the BACD's more reflective dentists were already there, or had always remained there, but some others may now also find themselves much more in the middle ground that most of us have been occupying for many years.Based on those reassurances, I was happy to accept their invitation to speak, along with Trevor Burke, at the recent meeting of the BACD in London to which Stephen Hancocks' editorial referred. One session was delivered by myself and Trevor Burke on a minimally destructive approach to tooth wear involving pragmatic aesthetics – a topic that we had both addressed a year previously at the Dental Update day in London and separately on many previous occasions both nationally and internationally.I would, therefore, challenge Stephen Hancocks' statement that seemed to me to imply that all the 'hecklers' were at the far end of the cosmetic spectrum shouting 'thou shalt not touch an enamel prism under any circumstances'.1It is quite possible to be critical of the more fundamentalist extreme makeover over-treatments without necessarily being extreme in one's own views. For instance, in politics it is possible to be critical of the extreme right (for which one could read 'extremely destructive makeovers') or the extreme left ('do nothing because the state says it is only cosmetic'), while still maintaining a much more centrist ('it all depends') position oneself.Generally speaking when discussing ethics and aesthetics/cosmetics, much depends on the severity of the aesthetic problems and the patients in whom those problems occur. For many years now there has been mounting evidence to support quite a number of procedures that can be undertaken with appropriate training to improve patient's dental appearance without having to resort to doing destructive dentistry.6 It is the unnecessary destruction of sound tooth tissue that is one of the main targets in my arguments about ethics and 'cosmetic' dentistry.It is certainly not the case that one does not want to help improve the appearance of some unfortunate people's teeth. However, ethically one does not want to cause massively inappropriate long-term, collateral biologic damage in the process of trying to help them.2,7 As in most aspects of dentistry, there is a balance to be struck between doing 'aesthetic good' and avoiding doing long-term biologic harm. However, that does not mean that there are no worries about the current fashion for using rapid action 'orthodontic gizmos' to move teeth to unstable positions and then trying to keep them there in the long term. Unstable tooth positions are exactly that, regardless of the promises made for supposedly 'permanent retention'. Removal of the retainers risks relapse.In Stephen Hancocks' editorial there is an allusion to the daughter test as being 'wheeled out' and some fancy footwork being used in trying to out-moralise others.1 I found this to be a curious mixture of metaphors.The actual title of the daughter test8 is probably relatively unimportant. This sort of test has probably existed in some form, perhaps described in different words, during many sensible ethical or moral discussions about supposedly 'cosmetic' (but in reality destructive) interventions or when trying to avoid invoking the 'law of unintended consequences'.To me and many others who do have a daughter (for which you can read any close family member that one is trying to mind for the rest of their life), it just happens to be a convenient way of thinking about the available supposedly cosmetic, but actually irreversibly damaging, options. At its core this test is articulated in order to try to help avoid doing more destructive procedures than are appropriate, especially when much less destructive, predictable, scientifically proven approaches would produce a more than acceptable result for most reasonable patients, but without doing long-term serious damage to their precious teeth as needless collateral damage.This test, whatever one may want to call it, is offered merely as some possible help in a very grey and contentious area.However, sadly I have to agree with the Editor-in-Chief that there are some high profile or commercially driven, unscrupulous members of the dental profession and that these individuals also exist in many different countries with different cultures and value systems. Moreover, there are also dentists who are largely unsympathetic to people's very real or perceived aesthetic problems.In reality none of us is a paragon of virtue.Published materialIn this context, however, I would like to point out that there are some fairly questionable dental editors around who readily accept dubiously aggressive 'cosmetic' or advertorial articles, some involving experimental or unproven materials or techniques.Some editors publish these glossy, superficial, 'cosmetic' (but usually destructive or orthodontically unstable) articles, apparently without any qualms or any real evidence of their long-term efficacy. Little responsible thought seems to be given by them as to what the effects of such publications might be on some younger or more impressionable dentists, who as a consequence of reading these nicely photographed, but often ethically flawed, articles, might be tempted to carry out wholesale dental destruction simply because the patient asked them 'to improve their smiles'.A tentative, but very understandable request from a patient does not readily translate into 'please butcher my other sound teeth in order to achieve this quickly' nor indeed to 'what I really want is some fashion driven instant dental gratification involving a swift front of mouth mutilectomy, please'. Unfortunately, discreet advertorial case reports illustrating nicely photographed short-term or 'bought pseudo-research' cases in some publications may have the effect of apparently legitimising destructive techniques including the utilisation of dubious or unproven materials to replace previously sound tooth tissue.9ConclusionsMost experienced ethical dentists are attuned to their own patient's reasonable aesthetic desires and aspirations. Many have invested in further appropriate training and are more than capable, willing and able to help with improving patient's dental appearance by using sensible, biologically sound, minimally destructive, ethical means if allowed to do so.In essence, solving aesthetic problems ethically requires very detailed individual discussions and careful evaluation of the various options available (including the ones that other disciplines or skills could possibly provide) coupled with appropriate training and skills before there can be any real hope of achieving appropriate solutions to those problems.In passing, it should be pointed out that cosmetic dentistry is regarded by many as just one aspect of decent restorative dentistry. Among its many objectives, restorative dentistry has always been about eliminating or minimising dental disease and improving or maintaining function, but also, where appropriate, to make things look both nicer and healthier. However, in seeking to do so, the 'risk to reward ratio' must be considered and enough time must be taken to ethically weigh up the real potential aesthetic benefits against the many risks involved. These risks include the structural or long-term biologic damage or stability, that might be involved in delivering any such changes in vulnerable patients.This critical balance is what needs to be kept uppermost in one's mind when discussing ethics and 'cosmetic' dentistry.

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Download referencesAuthor informationAuthors and AffiliationsConsultant and Specialist in Restorative Dentistry and Prosthodontics, King's College London Dental Institute at Guy's, King's College, M. KelleherSt Thomas' Hospitals, M. KelleherAuthorsM. KelleherView author publicationsYou can also search for this author in

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Rights and permissionsReprints and permissionsAbout this articleCite this articleKelleher, M. Ethical issues, dilemmas and controversies in 'cosmetic' or aesthetic dentistry. A personal opinion.

Br Dent J 212, 365–367 (2012). https://doi.org/10.1038/sj.bdj.2012.317Download citationPublished: 27 April 2012Issue Date: 28 April 2012DOI: https://doi.org/10.1038/sj.bdj.2012.317Share this articleAnyone you share the following link with will be able to read this content:Get shareable linkSorry, a shareable link is not currently available for this article.Copy to clipboard

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The New Economy: Ethical Issues | Journal of Business Ethics

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Journal of Business Ethics

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The New Economy: Ethical Issues

Published: April 2003

Volume 44, pages 3–22, (2003)

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Antonio Argandoña1 

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AbstractThe new economy is a technological revolution involving the information and communication technologies and which affects almost all aspects of the economy, business, and our personal lives. The problems it raises for businesses are not radically new, and even less so from an ethical viewpoint. However, they deserve particular attention, especially now, in the first years of the 21st century, when we are feeling the full impact of the changes brought about by this technological revolution. In this article, I will try to draw a "map" of the main, positive and negative ethical challenges raised by the new economy, concentrating on its three basic features: (1) a knowledge- and information-based technological change, (2) which is taking place in real time on a planetary scale (globalization), and (3) which entails a new, flexible, network-based business organization.

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Download referencesAuthor informationAuthors and AffiliationsIESE Business School, University of Navarra, Av. Pearson, 21, 08034, Barcelona, SpainAntonio ArgandoñaAuthorsAntonio ArgandoñaView author publicationsYou can also search for this author in

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Journal of Business Ethics 44, 3–22 (2003). https://doi.org/10.1023/A:1023226105869Download citationIssue Date: April 2003DOI: https://doi.org/10.1023/A:1023226105869Share this articleAnyone you share the following link with will be able to read this content:Get shareable linkSorry, a shareable link is not currently available for this article.Copy to clipboard

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Environmental Health Research Involving Human Subjects: Ethical Issues - PMC

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Environ Health Insights. 2008; 2: 27–34. Published online 2008 Jul 14. doi: 10.4137/EHI.S892PMCID: PMC2855191NIHMSID: NIHMS143850PMID: 20401332Environmental Health Research Involving Human Subjects: Ethical IssuesDavid B. ResnikAuthor information Copyright and License information PMC DisclaimerBioethicist National Institute of Environmental Health Sciences, National Institutes of Health, Research Triangle Park, NCCorrespondence: David B. Resnik, JD., Ph.D., Bioethicist, National Institutes of Health, Mail Drop NH 06, Box 12233, Research Triangle Park, NC, 27709. Tel: 919 541 5658; Fax: 919 541 3845; Email: vog.hin.shein@dkinserCopyright © the author(s), publisher and licensee Libertas Academica Ltd.This article is an open-access article distributed under the terms and conditions of the Creative Commons Attribution license (http://creativecommons.org/licenses/by/3.0/).AbstractThis article reviews some of the ethical issues that arise in environmental health research with human subjects, such as minimizing risks to subjects, balancing benefits and risks in research, intentional exposure studies with human subjects, protecting third parties in research, informing subjects about environmental hazards, communicating health information to subjects, and protecting privacy and confidentiality.IntroductionSince the U.S. adopted regulations governing research with human subjects in the 1970s, most of the ethical debates about research with human subjects have focused on questions relating to clinical research, such as management of risks, using placebos in control groups, randomization, informed consent, reporting adverse events, recruitment of subjects, and research on vulnerable populations. Most of the infamous or controversial cases discussed in the literature on human experimentation—the Nazi Experiments, the Tuskegee Syphilis Study, the Department of Energy’s secret human radiation experiments, and HIV research in developing nations—have been about medical research conducted in a clinical setting (Coleman et al. 2005; Emanuel et al. 2008; Levine 1988). In the last five years, however, ethical issues in environmental health research with human subjects have drawn greater attention (Resnik et al. 2005; Resnik and Zeldin, 2008; Resnik and Wing, 2007; Resnik, 2008; Resnik, 2006; Institute of Medicine, 2005; National Research Council, 2004; Sharp, 2003). Most of the ethical issues that occur in environmental health research are similar to those that arise in clinical research, but since there are important scientific, social, and political differences between environmental health research and clinical research, these familiar issues appear under a new light. This article will review some of the more challenging ethical issues in environmental health research.Environmental Health Research with Human SubjectsTo understand some of the ethical issues in environmental health research with human subjects, it is important to distinguish between different research methods used by investigators, since these methods generate different ethical questions and problems. Environmental health research methods involving human subjects can be classified as either observational or experimental. Observational studies gather information about human subjects in their natural environment, whereas experiments gather information on human subjects under controlled conditions. Some of the designs commonly used in observational research include case-control studies, cohort studies, field studies, and cross-sectional studies. These study designs are commonly used in epidemiological and medical research. In a retrospective case-control study, investigators collect information on the environmental exposures of a group of people with a disease or condition (cases) over a period of time and a group of people similar to the cases but who do not have the disease or condition in question. In a prospective cohort study, investigators follow one group of people (the cohort) who have a particular characteristic (such as an environmental exposure) for a long period of time (10 years or more). Investigators also follow a comparison group of people (the control group) who do not have the characteristic. Field studies are similar to prospective cohort studies, except the observational period is much shorter: a field study may involve observation of subjects over a period involving days, weeks, or months. In a cross-sectional study, investigators make observations of a population at a single point in time. In all of these methods, investigators attempt to determine whether observed differences between the groups (e.g. cases vs. controls or cohort vs. control) are due to differences in environmental exposures (Gertsman, 2003).Experimental research with human subjects includes intentional exposure studies and interventional studies in a particular environment, such as a home, workplace, hospital, or school. Intentional exposure studies expose human subjects to a safe dosage of an environmental agent, such as ozone, dust, or allergens, under controlled conditions, such as a laboratory.2 Intentional exposure studies can help investigators to obtain a better understanding of causal pathways from exposure to disease (National Research Council, 2004). Interventional studies expose a group of subject (the experimental group) to an environmental health intervention (such as lead abatement or educational materials). Interventional studies usually also include a control group that is not exposed to the intervention. The control group may be exposed to a different intervention or none at all (Institute of Medicine, 2005).Basic Requirements for Ethical ResearchOver the last three decades, ethicists, researchers, and scholars have come to recognize some basic requirements for ethical research with human subjects (see Shamoo and Resnik, 2008; Emanuel et al. 2000 for further discussion):

Scientific validity: research should well-designed and executed; the use of human subjects must be necessary to answer scientific questions.Social value: research should be expected to produce benefits for society.Risk minimization: risks to human subjects should be minimized.Benefit/risk justification: the expected benefits of the study to the subjects or society must outweigh the potential risks to the subjects.Informed consent: research subjects (or their representatives) should give their informed consent to participate in research.Protection of confidentiality and privacy: the confidentiality and privacy of subjects should be protected to the extent allowable by law.Equitable subject selection: the selection of subjects must be equitable; there must be a sound scientific or moral justification for including subjects in research or excluding them from research.Protection of vulnerable subjects: vulnerable subjects, such as children, prisoners, or mentally disabled adults, should be protected from harm or exploitation in research.Data and safety monitoring: research should be monitored to protect subjects from harm and ensure the integrity of the data.Independent review: an independent committee, such as an institutional review board (IRB), should review and oversee research.These ethical requirements are embodied in various legal rules and policies, including the U.S. federal research regulations (e.g. 45 C.F.R. 46 and 21 C F.R. 50, 56), the Nuremberg Code, the World Medical Association’s Declaration of Helsinki, and the Good Clinical Practice Guidelines (Coleman et al. 2005). These ethical requirements apply to all types of research, including environmental health research. This review will discuss several issues relating to the application of these requirements to environmental health research.Benefits and RisksOne of the important ethical differences between observational and experimental studies in environmental health research is that observational studies usually impose fewer risks on research subjects than experimental ones, because observational studies collect data on people in their natural environment (Resnik and Wing, 2007). Observational studies usually impose risks on subjects that are not greater than the risks subjects would ordinarily encounter in daily life, which are defined as “minimal risks” under the federal research regulations (see 45 C.F.R. 46.102(i)). For example, a prospective cohort study of farm workers that asks subjects to complete a questionnaire and health survey every five years and provide 5 ml of blood for genetic analysis would impose few risks beyond the risk of loss of confidentiality, which could be minimized by taking protective measures, such as securing data and controlling access to it. A field study of pesticide applicators that measures pesticide residue on the subjects before and after the workday and also measures pesticide metabolites excreted in the urine would also impose few risks beyond the risk of the loss on confidentiality. Although the subjects would be exposed to pesticides at work, this exposure would have occurred even if they did not participate in the study, thus, it is not a risk imposed by the study. The study adds only the risks of collecting a urine sample and pesticide residue, completing surveys and questionnaires, and potential loss of confidentiality.Experimental studies may impose risks on research subjects that are more than minimal. For example, the Human Studies Division of the Environmental Protection Agency (EPA) has an exposure laboratory for conducting studies on the effects of air pollution on the human respiratory system. Subjects in different experiments are exposed to ozone, automobile emissions, or other pollutants under controlled conditions. Scientists measure the subjects’ responses to these exposures, and monitor the subjects’ medical condition (EPA, 2008). Some experiments that expose subjects to pollutants involve a bronchoscopy to examine the airway and collect a small piece lung tissue for analysis (Arjomandi et al. 2005). A bronchoscopy is a medical procedure in which a physician inserts a tube (known as bronchoscope) into a patient’s airways through the nose or mouth. The patient is usually sedated. The risks of a bronchoscopy include bronchial spasms, difficulty breathing, bleeding, cardiac arrhythmias, infections, hoarseness, and a 0.1% to 0.01% chance of death, depending on the patient and the procedure (WebMD, 2008; Rose and Knox, 2007).Imposing more than minimal risks on research subjects who are not expected to receive any medical benefits from the research can be ethically controversial. Since the subjects will receive little or no benefits from their participation, the research can be justified only if it is expected to yield important benefits for society, such as the development of new medical treatments.1 For example, Phase I trials of new drugs on healthy subjects usually involve risks that are more than minimal but offer the participants no benefits. The risks of any particular Phase I trial depend on the type of drug being tested, but there is often a small but very real chance of death, permanent injury, or disability. These studies can be ethically justified, according to most commentators, because they are a necessary step in the development of new drugs to treat diseases (Shamoo and Resnik, 2006).More than minimal risk environmental health research experiments, such as the exposure studies mentioned above, do not usually benefit society by paving the way for new medical treatments. Nevertheless, one might argue that these studies can be justified if they are expected to yield important biomedical knowledge that will help to promote and protect public health and they are not expected to cause permanent harm to the participants (Resnik, 2006). For example, exposing human subjects to ozone may help researchers better understand how ozone impairs lung function, which could lead to changes in preventative health recommendations or air pollution regulations. To justify these experiments, it is essential for investigators to take precautions necessary to minimize risks to the subjects, such as using inclusion/exclusion criteria to disqualify potential subjects who have an increased risk for developing health problems when participating in lung function studies, careful monitoring of subjects during the testing period, follow-up with subjects after the testing period, using a data and safety monitoring committee to oversee the research, and implementing effective procedures for reporting adverse events (Resnik, 2006).If experiments that expose research subjects to ozone can be ethically justified, what about experiments that expose subjects to pesticides? Some private companies have conducted pesticide experiments on human subjects, exposing people to minute amounts of chemicals that can be toxic or deadly in larger doses. Some commentators have argued that these experiments are unethical, because they do not offer society any important benefits. Companies designed these experiments in order to generate data to convince regulatory agencies to weaken pesticide registration rules (Environmental Working Group, 1998; Goldman and Links, 2004). Others argue that even if these particular experiments were not justified, some pesticide experiments could be justified if they are expected yield important public health benefits (such as stricter pesticide regulations) and they satisfy stringent scientific and ethical standards (Resnik and Portier, 2005; National Research Council, 2004). The ethical issues concerning pesticide testing on human subjects have not been resolved, and this remains a controversial topic in environmental health research.In the fall of 2004 a field study designed and funded by the EPA and Centers for Disease Control and Surveillance (CDC), with financial support from the American Chemistry Council (ACC), named the Children’s Environmental Exposure Study (CHEERS), became ensnared in the controversy concerning pesticide experiments on human subjects (Resnik and Wing, 2007). The aim of the study was to observe children’s exposures to pesticides and other chemicals in the home. Families with high pesticide use were invited to participate in the study, which also would include a control group of families with low pesticide use. The investigators planned to monitor pesticide exposures during a series of 30 visits to the home over a two-year period. The protocol called for investigators to take surface wipe samples from around the home and urine samples from the children. They would also ask parents to record their children’s activities with a video camera and to keep records of pesticide use in the home. Parents were not required to start using pesticides to be in study, and they could remain in the study even if they decided to stop using pesticides. The investigators planned to warn parents about unsafe uses of pesticides and dangerous pesticide levels detected in the home or the children. Parents would receive a free video camera and $970 if they completed all of the study activities. The three IRBs that reviewed the study classified it as minimal risk (Resnik and Wing, 2007).The study was initiated in the fall of 2004. Critics charged that CHEERS was an intentional exposure study that treated children like guinea pigs. They argued that the investigators were planning to conduct a controlled experiment in which parents would be asked to expose their young children to pesticides in return for a considerable sum of money. Critics also claimed that the study targeted low-income groups and that support from the ACC constituted an unacceptable conflict of interest (Organic Consumers Association, 2005). EPA officials and investigators were planning to revise the study to deal with these criticisms, but they were unable to convince politicians and the public that the study should go forward. Bowing to political pressure, the EPA cancelled the study in the spring of 2005 (Resnik and Wing, 2007). One of the important lessons from the demise of CHEERS is that environmental health researchers who are conducting observational studies should take steps to avoid creating the perception that their work intentionally exposes people to environmental agents, such as pesticides. The protocol and the informed consent document should be designed to clearly communicate to all parties that the research is observational, not experimental. Participants should not be asked to change their environmental exposures in order to be in the study or required to not change their exposures in order to remain in the study (Resnik and Wing, 2007).Issues pertaining to benefits and risks have also arisen in research on environmental health interventions, such as studies of lead abatement or mold remediation (Resnik, 2008; Institute of Medicine, 2005). In a study that has received considerable attention due to a lawsuit related to the research, investigators from the Kennedy Krieger Institute at Johns Hopkins University conducted a controlled trial on the effects of different types of lead abatement on houses with lead paint located in Baltimore, NY. Twenty-five low-income families with young children were enrolled in the study. They were randomly assigned to one of three experimental groups or two control groups. The experimental groups included families living in homes that received different degrees of lead abatement, but less than the full amount of abatement, while the control groups included families living in lead-free homes or homes that had received the full amount of lead abatement. The goal of the study was to determine whether less than the full amount of lead abatement is an effective method of preventing health hazards related to lead exposure in the home. Many people living in homes with lead paint (or their landlords) could not afford the thousands of dollars required for full abatement (Grimes v. Kenney Krieger Institute, 2001).One of the issues in the Kennedy Krieger study was whether it was ethical to not offer full lead abatement to all of the families living in homes with lead paint, since full lead abatement was the standard procedure for minimizing the health hazards of lead paint (Institute of Medicine, 2005). Some critics of the study argued that denying full lead abatement to subjects in the experimental groups was analogous to denying an effective treatment to patients in a clinical trial of a new medication (Spriggs, 2004). There is a consensus among medical ethicists that patients with a serious medical condition should not be denied and effective treatment when one is available, because clinical investigators have an ethical duty to provide their patients/subjects with the standard of care (London, 2000). Defenders of the lead abatement study responded to this charge by claiming that the study was different from a clinical trial, because the investigators were not physicians and the subjects were not their patients. Hence, the investigators did not have an obligation to provide all of the subjects with full lead abatement; they only had an obligation to avoid exploiting the subjects. The study was not exploitative because it benefitted the subjects, who received some lead abatement. The study also benefitted the community (Buchan and Miller, 2006). These are complex issues that bear further investigation and analysis. Although environmental health investigators are usually not physicians with a duty to promote their health of their patients/subjects, they should take steps to ensure that research subjects are not harmed and the benefits and burdens of research are distributed fairly (Resnik, 2008).It is also important to note that some environmental health studies impose risks on people who are not directly involved in research, i.e. third parties. For example, an environmental health invention in the home may impose risks on people who are not research subjects, such as occupants of the home, or a study of agricultural workers may impose risks on farmers who employ the workers (Resnik and Sharp, 2006). Addressing risks to third parties in research is ethically controversial, because most regulations and guidelines do not address risks to third parties. The federal research regulations, for example, only mention obligations to minimize risks to research subjects (Resnik and Sharp, 2006). Since human research regulations do not mention risks to third parties, some writers have questioned whether researchers and IRBs should address these risks at all. Others have argued that there is an ethical obligation to address third party risks based on the notion that researchers should avoid causing harm. Hence, researchers and IRBs should address risks to third parties, when these risks can be identified and prevented (Resnik and Sharp, 2006).Sharing Information with SubjectsInformed consent requirements in environmental health research are very similar to those in clinical research. Investigators must inform subjects about the goals, methods and procedures used in research; benefits, risks, alternatives, confidentiality protections; the right to withdraw from research; and whom to contact for more information. Consent forms should be written in language that is understandable to the subject, and consent discussions should also take place under circumstances that minimize the potential for coercion or undue influence. Consent should be documented, except in circumstances that involve procedures in which consent is not normally documented or the main risk of the research is loss confidentiality and the consent document is the only information linking the subject to the research (Department of Health and Human Services, 2005).One of the consent issues unique to environmental health research is informing subjects (or their families) about the risks present in their environment. When researchers collect data on hazards in the home or work environment, they have an obligation to inform subjects about those risks, because subjects need to know about these risks to make an informed choice (Institute of Medicine, 2005; Resnik and Zeldin, 2008). For example, investigators in the CHEERS study had planned to inform parents about dangerous pesticide exposures and unsafe pesticide practices. One of the allegations made by the plaintiffs in the Kennedy Krieger lawsuit was that the investigators did not inform the parents about dangerous lead levels in their children in a timely fashion (Grimes v. Kennedy Krieger Institute, 2001). Although clinical researchers inform subjects about study-related risks, they usually do not inform subjects about risks present in the subjects’ environment.Investigators may be reluctant to inform subjects about environmental risks because the subjects may decide to not enroll in the study, drop out of the study, or take steps that would affect the data. For example, consider a study of pesticide use in the home. If a family participating in the study is informed about the risks of pesticide use, they may decide to stop using pesticides rather than enroll in a study of pesticide use, or they may decide to drop out of the study, or they may decide to decrease their use of pesticides. Although investigators should be prepared to deal with the decisions that subjects may make when they receive information, they should not withhold information from subjects or potential subjects to control their behavior. Investigators should design their research to compensate for subjects’ decisions in response to the information they receive. For example, investigators could ensure that enrollment is high enough to compensate for potential withdrawals, and that data is collected and analyzed in a way that changes in the subject’s behavior will not significantly affect the results. Investigators should also be prepared to counsel subjects about risks that are discovered in the environment and to make referrals, so that subjects can take steps to reduce these risks (Institute of Medicine, 2004).During an inspection of a home, worksite, or other environmental setting, investigators may become aware of hazards that are not directly related to the study but are discovered while conducting the study, also known as incidental findings (Illes et al. 2008). For example, while inspecting a house for mold, an investigator may also detect unstable stairs in the basement, wasp nests in the attic, or other problems that could pose a risk to the occupants. Researchers must decide whether to disclose these incidental findings to the occupants of the home. An argument for disclosure is that researchers have an ethical obligation to protect research subjects (and third parties) from harm, including harm that is incidental to the research study. If an investigator smells a gas leak in the basement during a mold inspection, it would be callous and irresponsible not to inform the occupants of the home about the leak. An argument against disclosure is that investigators may not have the knowledge or expertise to assess or discuss findings that are unrelated to their research. Additionally, subjects also do not expect to receive reports of such findings. Most environmental health researchers are not trained as electricians, plumbers, or home inspectors. One suggested solution to the dilemma concerning incidental findings is to disclose only those findings that a reasonable person would disclose under the circumstances, rather than the findings that an expert would disclose (Resnik and Zeldin, 2008).Other types of information that investigators may consider sharing with research subjects include the results of tests conducted as part of the study, such as blood tests or genetic tests. The main reason to share these results with subjects is that they may contain information they can use to protect their health. For example, a parent would want to know if her child has elevated lead levels in her bloodstream, because she could use that information to decide whether her child should see a physician or whether she should take steps to reduce the child’s exposure to lead. Likewise, a family would want to know if their house contains an abnormally high amount of mold, because they could use that information to reduce mold levels.The argument against sharing results from test conducted for research purposes is that they may be useless to the subjects or even uninformative. For example, researchers who are conducting a study to determine whether there are genetic variants that increase susceptibility to the adverse effects of mercury exposure may not know whether the information about genetic variants will be useful to subjects in making medical decisions. The data may be useful in discovering associations between genes and diseases or generating hypotheses, but not useful in making medical decisions. Subjects who learn about these test results find the information to be useless or even confusing. According to some authors, the results of tests conducted for research purposes should be returned to subjects only if the tests are reliable and accurate, and the information is likely to useful to subjects in making medical decisions (Renegar et al. 2006).Privacy and ConfidentialityMost of the confidentiality and privacy issues in environmental health research with human subjects are similar to those that arise in clinical research. For example, environmental health researchers should restrict access to data, store data in a secure place using secure methods, and remove information from the data that identifies individuals prior to publication. Investigators may remove all personal identifiers from the data if this information is not needed for research purposes. Investigators should also inform subjects about the measures that will be taken to protect their privacy and confidentiality (Shamoo and Resnik, 2008).Some confidentiality and privacy issues are unique to environmental health research. When environmental health researchers conduct field studies in homes, businesses, or other venues, they may gain access to private information that is not part of the study (Institute of Medicine, 2005). For example, investigators conducting a study of allergen reduction in the home may find out about drug or alcohol use, sexual activity, health or psychological problems, and so on. Investigators should protect the privacy of their subjects and keep this information in confidence, unless they discover evidence of abuse of a child or vulnerable adult. Investigators should also inform subjects about their obligation to report evidence of the abuse of a child or vulnerable adult during the consent process (Resnik and Zeldin, 2008). In general, investigators should use discretion and good judgment when collecting data in the home, to avoid unnecessary disclosures of private information.ConclusionThis review has highlighted some of the ethical issues that arise in environmental health research with human subjects. There are of course some important issues that this review has not covered in depth, including conflicts of interest, payments to subjects, consulting with communities, and research with vulnerable populations.3 As one can see from this brief survey, the ethical issues that arise in environmental health research with human subjects are similar to those that arise in clinical research, but there are some situations unique to environmental health research that create dilemmas rarely encountered by clinical researchers. Many of these novel ethical dilemmas occur when investigators collect data or conduct interventions in the home environment or intentionally expose human subjects to dangerous environmental agents, such as pesticides. It is likely that other novel issues will emerge in environmental health research. Environmental scientists—and ethicists—should prepare to deal with them as they arise.AcknowledgmentsThis research was supported by the intramural program of the National Institute of Health Science, National Institutes of Health. It does not represent the views of the National Institute of Health Science or the National Institutes of Health.Footnotes1.Although subjects usually receive some payment for risk research that does not provide any medical benefits, most government agencies do not consider money to be a benefit. See Shamoo and Resnik (2006).2.A “safe” dosage would be one that is not expected to cause any permanent harm to the research subject. Some substances that are harmful in larger doses, such as ozone, may cause little harm in very small doses. Some substances may cause permanent harm even in small doses. For example, known carcinogens, such as benzene and asbestos can cause permanent damage at very small exposures. It makes no difference whether the unsafe expose might occur in normal life. For example, a construction worker might inhale asbestos dust when helping to demolish an old building, but this would not justify intentionally exposing a human subject to inhaled asbestos. For further discussion, see Resnik (2006), National Research Council (2004).3.For further discussion of conflicts of interest in biomedical research and research with vulnerable populations, see Shamoo and Resnik (2008); for discussion of payments to subjects, see Grady (2005); for discussion of community consultation in research, see Weijer and Emanuel (2000).ReferencesArjomandi M, Schmidlin I, Girling P, Boylen K, Ferrando R, Balmes J. 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[PubMed] [Google Scholar]Articles from Environmental Health Insights are provided here courtesy of SAGE Publications

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Triage in public health emergencies: ethical issues | Internal and Emergency Medicine

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Triage in public health emergencies: ethical issues

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Published: 19 February 2010

Volume 5, pages 137–144, (2010)

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Triage in public health emergencies: ethical issues

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Carlo Petrini1 

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AbstractGeneral concepts about medical disasters, public health and triage are outlined. Triage is described in the context of public health emergencies and disaster settings, and the main ethical values at stake in triage are discussed. Possible conflicts between competing values are outlined. Special attention is given to possible conflicts between the protection of individual interests (typical of clinical ethics), and the pursuit of collective interests (typical of public health and triage). Hippocratic ethics is compared to utilitarian ethics and to perspectives that emphasize the principle of justice. Three ethical attitudes are suggested that may contribute to a resolution of competing values: protection of human dignity, precaution and, especially, solidarity. Personalism promotes the collective good by safeguarding and giving value to the well-being of each individual. A personalistic perspective is suggested as a way to deepen the concept of solidarity as a pillar both of clinical and public health ethics.

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BackgroundThis paper examines the importance of discerning the ethics at play in deliberative processes associated with public health approaches to emergencies and disasters, and offers a possible ethical approach that may reconcile putative tensions between individualistic bioethics and utilitarianism in the application of triage.Society is vulnerable to medical disasters and public health emergencies caused by a variety of events such as pandemic disease, war and disasters (natural and man-made). The American College of Emergency Physicians (ACEP) defines medical disasters as situations in which the ‘destructive effects of natural or man-made forces overwhelm the ability of a given area or community to meet the demand for health care’ [1]. A public health emergency exists when an event (whether earthquake, rapid population migration and displacement, pandemic disease or others) overwhelms routine community capabilities to address them.In disasters settings, routine medical services are typically inadequate, and global experience has shown the need for systematic planning [2]. National and local communities have engaged with planning by: first, identifying procedures for rapidly handling medical emergencies; second, identifying protocols to support multiagency and multidisciplinary cooperation (since many organizations and different kinds of practitioners are invariably involved in the response effort, including, for instance, medical personnel, fire fighters and civilian volunteers); and third, identifying mechanisms for allocating limited resources to support medical care, such as drugs and medical supplies. Health emergencies thus defined require priority setting, rationing and triage.Triage, an established process of medical sorting, is useful both in ordinary and in catastrophic situations. In ordinary situations, triage involves making decisions about the order in which patients will be treated based on the urgency of patients’ needs. ‘In the last few years, the emergency department (ED) has faced a continuous increase in visits in part due to its excessive use for non-urgent problems’ [3]. During catastrophic events, triage may require making decisions that some patients will not receive treatment at all. ‘Triage, clinical assessment and discharge are identified as critical moments during an emergency care process’ [4]; indeed, effective triage is crucial in disaster settings when the volume of patients far exceeds the availability of human and material resources. Yet, although there has been increasingly urgent discussion of the ethics of triage in some of the medical disaster and ethics literature, there is as yet little agreement on an appropriate framework for such an ethics. While triage is typically supported by utilitarian principles—that decisions must benefit the greatest number of potential survivors—there is some acknowledgement of the potential for conflict for clinicians whose practice is underpinned by the individualist focus of conventional bioethics, and for whom attention to the common good may have the effect of overriding individual liberty and rights [2, 5].In part, this potential for conflict arises because the practice and ethical basis of triage has been largely shaped in the context of resource allocation in hospital settings [6], which are, in contrast to emergency and disaster settings, afforded the relative luxury of time. Clinicians who undertake triage in hospital settings—usually, though not exclusively, emergency physicians—have evolved an ethical framework to guide their practice. In such settings, the interests of individual patients remain paramount, but it is unclear how clinicians working in public health emergencies can apply triage in ways that address both the individual interests of patients and the common good embedded in the public health ethos that underpins disaster planning [7]. Indeed, in the disaster or public health emergency setting, time is at a premium: physicians have to rapidly make decisions about whom to treat and which resources to use in treatment. Consequently, their decisions are not necessarily made in the interests of individual patients, as required by the Hippocratic oath, but are instead made in the interests of a ‘common good’. This phenomenon raises important questions about the ethical framework of emergency response and disaster plans and the potential tension between the individualistic basis of bioethics and the utilitarian ethos of triage in these settings.DiscussionBiomedicine, public health practice and ethicsThe practice of biomedicine attempts to balance medical care of the individual with the individual’s autonomy; it takes place in a unique relationship between an individual and a physician; and there is a degree of congruence between clinical and ethical practice, since clinical bioethics is based on a deontological heritage derived from many centuries of Hippocratic-oath based medicine [8]. Indeed, from its beginnings in the early 1970s, traditional bioethics has produced substantial results in a relatively short period [9].In contrast, public health practice focuses on the health of the community in general, and has been largely shaped by utilitarian ethical principles [10], which have, at times, been at odds with the liberal rights of the individual. It is characterized by ‘collective action for sustained population-wide health improvement’ [11, 12] and its ethical focus is the ‘public good’ rather than on individuals. Moreover, historically, public health, especially in Europe, has been, at times, closely aligned with the objectives of the state, and has lacked a clear, widely held framework for its practice, and therefore its ethics [13, 14].Further, while the practice and ethics of biomedicine requires, by and large, the voluntary participation of the individual, public health operates along a continuum from noncoercive voluntary participation (e.g. antismoking campaigns) to more coercive interventions, such as those that promote lifestyle choices or in some way limit personal freedoms (e.g. quarantine). Disaster scenarios that precipitate public health emergencies are likely to incur interventions at the coercive end of this continuum; to limit the capacity of clinicians to make decisions about care in terms of the best interests of individual patients; and to limit the capacity of individuals to make choices about the care they receive. Indeed, policy for public health emergencies falls under the purview of public health officials rather than individual clinicians [15]. Moreover, not only has public health ethics matured more slowly than, and is quite distinct from, traditional bioethics [14], but, at the level of practice there may be conflict between clinical ethics and public health ethics, since ‘those involved in the practice of public health embrace a set of values that are often, not to say always, in conflict with the autonomy-centred values of those who take an individualistic (…) stance’ [16].The ethics of disaster planningIn public health emergency and medical disaster settings, ‘the personal choices and preferences of some will be overridden by a greater concern for the well being of a whole population’ [17]. Similarly, the ethical framework of disaster planning emphasizes the public good, and its objectives include: protecting life and health, respecting human rights, promoting social justice and building civic capacity so that communities can be resilient in their response and recovery [15]. Planning and preparedness are typically developed by the state (e.g. in the US, the Federal Emergency Management Association), and involves elaborating specific processes and procedures that coordinate the responses of various agencies and tell individual responders (e.g. physicians) what they must do. Planning, therefore, can be viewed as somewhat paternalistic, and it is this ethical strain that is embodied in the practice of triage, and that most stands in potential conflict with biomedical ethics that support clinical decisions in the best interests of individual patients.Clinical decision-making in disaster settings presents unique challenges to practitioners attending to victims. In Wynia’s view [18] for instance, healthcare providers are faced with three challenges: rationing (who gets care and what kind of care do they get), restrictions (e.g. isolation) and responsibilities. These challenges are thrown into sharp relief in the practice of triage.TriageTriage, which has been extensively studied in many countries [19], is an essential component of public health responses to mass disasters involving large numbers of casualties. The word ‘triage’ comes from the French ‘trier’, which means ‘to sort’ and originated as a method to evaluate and categorize the wounded in battle [20]. Originally, the practice of triage in military contexts was based on need rather than rank, and thus contains within it the seeds of an egalitarian ethics. While the term has negative connotations associated with using scarce resources ‘where they do the most good’ [21], it is, nonetheless a common method used by practitioners (often using science as the basis for decision-making, not ethics) to balance available resources with patient need.In disaster settings that incur mass casualties, triage is key, and needs to happen rapidly, objectively, accurately and optimally, to ensure the greatest good for the greatest number. Yet, discussions of the ethical basis of triage tend to use the allocation of resources in hospital settings as their reference point—settings in which clinicians also practice medicine with respect to the needs of individual patients. Therefore, a utilitarian approach may not be a fully adequate framework for planning and executing disaster responses [6] because the history and practice of triage also incurs an egalitarian ethics that focuses on assisting those in greatest need: that is, on the needs of particular individuals.The values at stakeWynia notes that while it cannot be denied that public health shows a markedly utilitarian component [18], reducing public health ethics to mere utilitarianism would be an oversimplification. He argues:

‘According to the oversimplified view, public health ethics is based entirely on a particular type of consequentialism: let us call it, ‘health utilitarianism’. That is, the proper goal of all public-health efforts is to advance the health of as many people as much as possible. Correct actions in public health can thus be determined by calculating the net health benefits to be gained by an action. If true, this would imply that individual rights can be a matter of public-health ethics only insofar as they affect health outcomes’ [18].

Therefore, in accepting utilitarianism as the premise for the ethics of disaster triage, one implicitly accepts the potential for conflict in practice. The ethical basis and practice of triage provokes conflicts in values between public health and clinical bioethics [22] precisely because of the tension between the rights of individuals and the need to protect the common good.In practice, the potential for conflict arises because in a public health emergency, clinicians used to subscribing to an ethical framework that privileges individual autonomy and the doctor–patient relationship are required to operate under a different ethical framework that seeks to minimize morbidity and mortality amongst the population as a whole. Thus, clinicians cannot in such an emergency make decisions about the care of patients that take into account only the needs of any particular patient. These need to be weighed in comparison to competing patient needs, and in that sense, triage, informed by a utilitarian public health ethics can be understood to stand in conflict with the Hippocratic oath, since triage effectively redefines the clinician’s scope of practice, and requires a restriction of healthcare in the interests of the common good.Thus, for some commentators, the practice of disaster triage compromises human rights [23], which are framed ostensibly as the rights of individuals. For others, the practice of disaster triage—at the very least—undercuts the ethical premise of the Hippocratic oath, which states that the physician shall practice medicine for benefit of patients according to the physician’s ability and judgement, and to not bring harm to patients. Within the framework of the Hippocratic oath, a physician cannot abandon the patient under his or her care to attend to the greater needs of another [24]. Yet, as we have seen, the practice of disaster triage prevents the application of a strictly Hippocratic ethics [2, 25], and so in emergency situations, a physician has to choose between two possible options [26]:

Attending to those victims for whom they can do the most good (utilitarian principle)

Attending to those with the greatest need (principle of justice or egalitarianism).

Disaster triage, as currently framed, requires health care professionals to disregard the concept of giving everyone a fair and equal opportunity to receive medical treatment [27]. Instead, triage privileges the likelihood of survival. Therefore, emergency triage provides neither equal shares of care nor equal opportunity [28]. In contrast, the ethics of triage need to account for both community and the individual, since, as Wynia adds: ‘attention to fundamental human rights is critical to good community health, as well as individual health’ [18]. Whether an emergency plan is ethically acceptable or not depends both on its substantive content (what it tells people to do and what its consequences are), and on the deliberative process used to approve it [29]. The deliberative process underpinning triage in public health emergencies is informed by utilitarian principles, yet, there is an alternative approach based on a tradition of European bioethics that takes a broader perspective and emphasizes solidarity.There is an ethical strain in both European and North-American bioethics that emphasizes dignity rather than autonomy, precaution and [30, 31], most of all, solidarity: when people in Europe are interviewed about the values they consider fundamental for the design of the health and social care systems, they often refer to solidarity [32].The concept of dignity of humankind describes the evolving understanding of those basic individual rights that no government or person should ever be permitted to limit [33–36].The ‘precautionary principle’ was first introduced in controversies about the environment [37], but it is also applicable to human health [38]. Precaution is an action principle [39] whereby in the absence of certainties (such as the availability of resources or the likelihood of survival) public authorities are committed, without waiting for the progress of knowledge, to taking temporary and flexible measures to face potential health or environmental risks, in respect of which the scientific data available are insufficient, uncertain or contradictory [40–42]. Within the parameters of this principle, triage could be reframed as an action that is necessary to address public health risks and that stems from the pursuit of solidarity.‘Solidarity exists amongst a group of people when they are committed to abiding by the outcome of some process of collective decision-making, or to promoting the wellbeing of other members of the group, perhaps at significant cost to themselves’ [43]. The principle for human solidarity asks special attention for patients in serious conditions. Solidarity is a decisive value for triage. Therefore, it deserves a specific discussion.SolidarityIn his wide-ranging historical analysis of the concept of solidarity, the German philosopher Bayerz [44] has indicated that its core meaning is the perception of mutual obligations between the members of a community.In the domain of health and social care, solidarity is first and foremost understood as a moral value and a social attitude regarding those in need of support.The concept of solidarity is deeply rooted in human experience and thought, and can be understood in different ways.In the liberal model, the most important principles are the right to personal freedom and private property. Liberals emphasize the distinction between justice and charity: meeting the medical needs of the diseased is a matter of charity, not justice [45, 46].Fundamental to the egalitarian model, on the contrary, is the notion of equality of human beings, and the creation of possibilities for people to become as much equal to others as possible, including as regards health. According to this model, there is a positive obligation to reduce differences in individual health: central in this model is the determination of who is the worst-off. Therefore, assessment of the severity of the conditions is a central issue [47].In the utilitarian model, utility is a central concept. It includes different notions, such as good health, well-being, pleasure, satisfaction, happiness, and, in general, being able to achieve one’s goal in life. Determination of the effectiveness and cost-effectiveness of a medical intervention is a key element in the utilitarian justice model, not the assessment of the disease burden itself. It is therefore especially concerned with the determination of ‘appropriate care’ [48].According to the communitarian model, justice in the distribution of health care is not determined by the individual or by the individual medical need, but by what a community considers as necessary care. This is in turn determined by the values and the standards chosen by each community, and can be different for different communities [49].Personalism considers the individual to be the core value, and tries to achieve the common good by promoting and enhancing the good of the individual. The main values proposed by personalism include respect for life, (public health actions are aimed at protecting and promoting human life and health), sociality and solidarity (social solidarity means and involves a commitment to bridge the gap between the different sectors of society and to integrate them into a community) and responsibility (the responsibility to prevent and protect against avoidable diseases, the duty not to create irresponsible burdens for the society, and responsibility for people in need) [50, 51].Solidarity emphasizes a sense of togetherness that implies a commitment to provide priority to the most disadvantaged: one of the most significant disadvantages of all collective decision-making is that decisions are usually about categories, so that the patient’s individual condition is not adequately taken in.There are some significant ethical misgivings to the use of collective, utilitarian and contractual models in disaster triage. As stated by Steinberg [52] ‘The utilitarian system significantly interferes with equality, and primarily undermines those who are in greatest need of health care services’. The utilitarian theory, by concentrating on societal good, may place a burden of unacceptable sacrifice on individuals or subpopulations [53]. That said, it is probably fair to state that the libertarian theories of justice, as rigidly constructed, do not furnish adequate answers to mass casualty triage. Although patient autonomy is a guiding principle of biomedical ethics, it is unrealistic to believe that a free-market system of resource allocation, based in large part on ability to pay, has any role in resource allocation during a disaster.The initial concept of modern triage, as developed on the battlefield by the Baron Dominique Jean Larrey (the surgeon in Napoleon’s army who devised a method to evaluate and categorize the wounded in battle and to evaluate those requiring the most urgent medical attention [20]) was one of need, regardless of rank, and therefore an egalitarian concept. Arguing a strong egalitarian approach, it follows that it would be better not to treat any victim rather than to treat victims unequally; this would not appear to be an ethically tenable viewpoint. However, Larrey’s approach, based on need rather than rank, heralded the maximum egalitarian principles posited by Rawls [54].During recent decades, a ‘technical’ approach has become increasingly influential in health care priority setting. However, non-technical considerations cannot be avoided. A model based on need, where the sickest are treated first and with the most resources, might, in fact, be fairer and improve societal outcome: solidarity can therefore be expressed by being altruistic, sympathetic, universally benevolent and just [55]. Where altruism is a general moral principle underlying selfless ‘good deeds’ that help others, being sympathetic is regarded as an attitude that leads everyone to feel kind with respect to others, and share in their joy and suffering. Because, in this view, solidarity springs from common elements of human experience, it is spontaneous, mutual and not externally (i.e. politically, sociologically) controlled. Solidarity is seen as being selfless, open and generous towards other people, putting their best interests before our own, without expecting anything in return. Therefore, solidarity cannot be seen within an exclusively utilitarian or an exclusively liberal framework [55].A few examples are probably useful to show how the principle of human solidarity can be applied when disease burdens are weighed and compared.Triage is necessary, for example, in the event of a massive disease outbreak. In these circumstances it is possible that hospitals and the health care system will lack the capacity to provide care for everyone who needs it. When there are not enough drugs, beds or other resources to provide for everyone in need, then a different—and more severe—kind of triage than that usually employed in the hospital emergency department (ED) will be required. While standard ED triage involves making decisions about the order in which patients will be treated based on the urgency of patients’ needs, in a catastrophic situation that could result from a bioterrorist attack, triage may require making decisions that some patients will not receive treatment at all [56]: ordinary triage classifies the patients so that all will receive optimal care, while mass casualty triage treats the patients according to the salvage value when the injured overwhelm available medical facilities and not all can be treated.In these strictly utilitarian conditions some categories of individual may be neglected.However, also more ordinary situations raise problems.Let us suppose, for example, that during a fall season, a man with no chronic medical condition requests an influenza immunization, as he does every year, and that, because of a trouble in the major vaccine manufacturing plant, there is a shortage of vaccines. The physician explains to the man that only patients at high risks are eligible for vaccination. Let us suppose also that the man responds that every year he is told that he should get vaccination, that even with the shot he usually gets a severe influenza, and that he is worried that he may die. In this case, the patient requests an intervention recommended by every standard guideline. What principles should drive the physician’s decision?Let us hypothesize a different situation: a bus accident has occurred, all passengers are severely hurt, and some might die if not helped immediately. Only one ambulance with one doctor is available. The doctor recognizes his brother amongst the more severely hurt. Amongst the passengers there is also a nurse who could help, but she is also hurt. In these dramatic conditions it is necessary to set priorities. If you were the physician, would you treat your brother, or those who are at higher risk of death, or the nurse?A large part of public health ethics is guided by a strictly utilitarian ethic promoting the maximization of benefits. This is the reason why a vaccination is not given to the person concerned about the potential consequences of the flu in the first case, and why the nurse is the first to be treated in the second case. This also corresponds to the indications found in many triage guidelines for emergency situations. For example NATO differentiates between ordinary and extraordinary triage: ‘Ordinary triage classifies the wounded so all will receive optimum care, while mass casualty triage treats the injured according to salvage value when the injured overwhelm available medical facilities and not all can be treated’ [57].Hippocratic ethics is instead of little help under these circumstances because it is better suited for the relationship between a physician and a single patient than for public health issues.Of course, the decision to not vaccinate in the first case and to treat the nurse first in the second case is in accord not only with the principle of utility but also with the principle of solidarity. However, solidarity calls upon the healthcare worker to intimately examine his or her deontology, responsibilities, and values. By no means does this intend to accuse utilitarianism of ignoring deontology, but it certainly involves a very powerful risk of reducing assessments to cold, mathematical calculations. Solidarity, however, can be understood in different ways. According to Pasini and Reichlin, for example, ‘Though solidarity (…) can be conceptualized in different ways, we suggest that it can be referred mainly in two different, if related, aspects of human community:

(i)

it can be understood as a concern for the worst off, or the disposition to care for the weakest members of the community; this would not necessarily involve compassion, or any feeling of inward participation in their suffering, but rather a concern for their predicament aimed at the protection of their dignity;

(ii)

it can also be conceived of as a consciousness of sharing a system of values, or a way of life; this involves caring for others as part of caring for the common good of the community in which one has been socialized and educated as an individual’ [58].

It would therefore be imprudent to suggest that the principle of solidarity offers a single, clear-cut response (particularly in the vaccination case, insofar as a doctor privileging a relative after the accident could easily be accused of violating the principle of justice). The aim here is to point out that the principle of solidarity involves many different potential values at stake, making it necessary to avoid generalizations and to make assessments on a case-by-case basis: ‘no matter how much we plan, the next disaster always seems to take us by surprise, to introduce a new twist, and to pervert our responses because of overwhelming novel and different political agendas’ [59].It would be clearly presumptuous to resolve in this discussion every ethical issue connected to these problems, and especially, the very personal conflicts for the doctors.However, solidarity can furnish a few elements useful in decision making.The first element is attentiveness: it is essential to be open to the needs of others.The second is responsibility: care requires that one feels responsible, according to the professional deontology.The third is competence: in order to give care, one has to be competent.A statement on the tableau in front of the Professor Schweitzer Hospital in Lambarene (Gaboon) may help guide the decision making in difficult choices: ‘Que le respect de la vie soit le principe élémentaire de l’éthique et de la vraie humanité’ (‘Respect for life must be the ethical principle and the truth of humanity’).ConclusionSolidarity is broadly expressed in Western thought [60], from Terence’s concept of ‘humanitas’, to Vergilius’s concept of ‘pietas’, Seneca’s concept of ‘simpatia’, the notion of ‘charitas’ in Christianity [61] and in philosophy, personalism. Personalism emphasizes absolute respect for life (the principle of inviolability); subsidiarity and the ‘minimum’ mandatory principle; justice and non-discrimination; and responsibility [62]. However, just as dignity and precaution are not an exclusive trait of any one philosophy, solidarity can be found in a variety of cultures, and therefore provides a cross-cultural way of thinking about the ethics of public health preparedness and the practice of triage.A possible transposition of the general principles into the specific context of triage might be:

Intervention must be necessary and effective.

Intervention should be the least restrictive alternative.

There should be procedural due process that offers the right to appeal.

Benefits and burdens of intervention should be fairly distributed.

Public health officials should make decision in an open and accountable manner (transparency).

Nonetheless, the complex ethical and social values invoked when triage is advocated should be examined before such measures are implemented. Personalism, by regarding the person as a fundamental value, promotes the collective good by safeguarding and giving value to the well-being of each individual. Consequently, in the context of disaster triage, personalism potentially offers an ethical bridge between the needs of the individual and those of the common good and a framework for elaborating the practice of triage.

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Download referencesConflict of interestNone.Author informationAuthors and AffiliationsIstituto Superiore di Sanità (National Institute of Health), Bioethics Unit, Office of the President, Via Giano della Bella 34, 00162, Rome, ItalyCarlo PetriniAuthorsCarlo PetriniView author publicationsYou can also search for this author in

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Intern Emerg Med 5, 137–144 (2010). https://doi.org/10.1007/s11739-010-0362-0Download citationReceived: 30 November 2009Accepted: 21 January 2010Published: 19 February 2010Issue Date: April 2010DOI: https://doi.org/10.1007/s11739-010-0362-0Share this articleAnyone you share the following link with will be able to read this content:Get shareable linkSorry, a shareable link is not currently available for this article.Copy to clipboard

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Embryo Donation: Ethical Issues

Stephanie O. Corley J.D.2 & Jessica Wilen Berg J.D., M.P.H.3 

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First Online: 01 January 2013

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AbstractThis chapter explores the novel ethical and legal questions resulting from the ability to cryopreserve embryos for future use. Individuals or couples may discard the embryos, donate the embryos to another couple for reproduction, donate the embryos to research, or freeze the embryos indefinitely. Occasionally, couples cannot agree and may face legal battles regarding embryo disposition or parentage. In other cases, clinic negligence results in embryo destruction, loss, mix-up, or misuse. We discuss these issues, as well as the growing concern over access to the technology, long-term storage, and the impact on future-born children, including commercialization and the creation of designer babies.KeywordsARTembryoadoptioncommercializationdesigner childrenparentageresearch

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Stephanie O. Corley J.D. .Editor informationEditors and AffiliationsUniversity Hospitals of Cleveland Case Western Reserve University, Director of Fertility Services and In Vitro Fertilization, Cleveland, Ohio, USAJames M. Goldfarb Rights and permissionsReprints and permissionsCopyright information© 2014 Springer Science+Business Media New YorkAbout this chapterCite this chapterCorley, S.O., Berg, J.W. (2014). Embryo Donation: Ethical Issues.

In: Goldfarb, J. (eds) Third-Party Reproduction. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-7169-1_12Download citation.RIS.ENW.BIBDOI: https://doi.org/10.1007/978-1-4614-7169-1_12Published: 13 June 2013

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Gene Therapy: Ethical Issues | Theoretical Medicine and Bioethics

Gene Therapy: Ethical Issues | Theoretical Medicine and Bioethics

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Theoretical Medicine and Bioethics

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Gene Therapy: Ethical Issues

Published: January 2003

Volume 24, pages 31–58, (2003)

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Isaac Rabino1,2 

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AbstractTo discern the ethical issues involved incurrent gene therapy research, to explore theproblems inherent in possible future genetherapies, and to encourage debate within thescientific community about ethical questionsrelevant to both, we surveyed American Societyof Human Genetics scientists who engage inhuman genetics research. This study of theopinions of U.S. scientific experts about theethical issues discussed in the literature ongene therapy contributes systematic data on theattitudes of those working in the field as wellas elaborative comments. Our survey finds thatrespondents are highly supportive of thepotential use of somatic cell gene therapy tocure serious diseases in adults and children aswell as prospective offspring. A clearmajority, however, believe that using suchgenetic techniques for enhancement purposes isunacceptable. Delineating the line betweendisease/disorder and improvement/enhancementposes a problem not easily resolved and oneconducive to the growth of slippery-slopeapprehensions. The majority of respondents alsoadvocate germ-line therapy, in theory at least,and under similar restrictions, but theyrecognize the roadblock that the existence ofunanticipated negative consequences currentlypresents. Another complex matter involvestrying to determine appropriate reasons forchoosing target diseases for research, forwhich the dichotomy between rare single-geneand common multifactorial diseases reveals anongoing dilemma.

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Download referencesAuthor informationAuthors and AffiliationsBiological and Health Sciences, Empire State College, State University of New York, 225 Varick Street, New York, NY, 10014-4382, USAIsaac Rabino41 Ellard Ave., Great Neck, NY, 11024, USAIsaac RabinoAuthorsIsaac RabinoView author publicationsYou can also search for this author in

PubMed Google ScholarRights and permissionsReprints and permissionsAbout this articleCite this articleRabino, I. Gene Therapy: Ethical Issues.

Theor Med Bioeth 24, 31–58 (2003). https://doi.org/10.1023/A:1022967623162Download citationIssue Date: January 2003DOI: https://doi.org/10.1023/A:1022967623162Share this articleAnyone you share the following link with will be able to read this content:Get shareable linkSorry, a shareable link is not currently available for this article.Copy to clipboard

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Agro-Biodiversity Conservation in Europe: Ethical Issues | Journal of Agricultural and Environmental Ethics

Agro-Biodiversity Conservation in Europe: Ethical Issues | Journal of Agricultural and Environmental Ethics

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Agro-Biodiversity Conservation in Europe: Ethical Issues

Published: January 2005

Volume 18, pages 3–25, (2005)

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Valeria Negri1 

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AbstractWhile it is commonly acknowledged that the ecosystemic, and the inter- and intra-specific diversity of “natural” life is under threat of being irremediably lost, there is much less awareness that the diversity in agro-ecosystems is also under threat. This paper is focused on the biodiverse agro-ecosystems generated by landraces (LRs), i.e., farmer-developed populations of cultivated species that show among- and within-population diversity and are linked to traditional cultures. The aim of this work is to arouse concern about their loss, to explain how they can be conserved, and to discuss values that support maintaining and/or restoring on-farm agro-biodiversity. Although agriculture has relied on biodiverse agro-ecosystems for millennia, most of them have disappeared or are disappearing due to profound transformations in the socio-economic context. This is discussed with particular reference to the European situation. The positive values of LRs and LR systems that support their conservation are discussed along with possible objections. The conservation of LRs and LR systems can be well justified on ethical grounds. In particular, the complex intertwining of the biological and cultural contexts of LR systems, which continuously creates new adaptive responses to the changing socio-economic and eco-physical processes, is a value that strongly motivates conservation, particularly when the needs of future generations are considered.

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Valeria Negri.Rights and permissionsReprints and permissionsAbout this articleCite this articleNegri, V. Agro-Biodiversity Conservation in Europe: Ethical Issues.

J Agric Environ Ethics 18, 3–25 (2005). https://doi.org/10.1007/s10806-004-3084-3Download citationAccepted: 03 June 2004Issue Date: January 2005DOI: https://doi.org/10.1007/s10806-004-3084-3Share this articleAnyone you share the following link with will be able to read this content:Get shareable linkSorry, a shareable link is not currently available for this article.Copy to clipboard

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Keywordsbiodiversitycomplexityethicslandraceson-farm conservationsustainability

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