Beyond Regulations: Ethics in Human Subjects Research

Introduction: Relationships in Research

A New Paradigm

Nancy M. P. King, Gail E. Henderson, Jane Stein

In November 1995, a three-day conference held at the University of North Carolina at Chapel Hill examined cross-cultural controversies in the ethics of human subjects research.¹ That conference began this book. Although our initial goal was to address ethical problems arising in international health research, it quickly became clear to us that our focus of inquiry should be much broader, for two reasons. First, challenges to traditional moral principles have been sounded across a broad sweep of academic disciplines, echoing a wide variety of intellectual efforts to discern and define new ways of understanding moral issues through consideration of their complex social, cultural, and political contexts. Second, these same concerns about context have caused us to recognize that, in effect, all research is cross-cultural. All research involves both researchers and subjects, who always bring very different intellectual frameworks to a project. In addition, most if not all domestic research projects draw on groups of subjects representing a variety of cultures, however defined. Thus we determined to find new ways to consider and address ongoing moral problems in all human subjects research.

In this book we seek to make a case for the value of looking at research as a series of relationships, to say something new about the nature of the research enterprise itself, and to apply this approach to a reexamination of research ethics. The best way to understand this perspective is to read through the six cases and twelve commentaries in the volume.

Across a broad range of disciplines and types of human subjects research—in biomedicine, the social sciences, and the humanities—researchers, researchers in training, and their teachers, as well as those charged with evaluating and overseeing research, are increasingly struggling with questions about the ethics of relationships between researchers and their subjects, funders, institutions, and colleagues. All those who are—or should be—asking these questions are the audience for this book.

To adequately address the ethics of human subjects research, we must develop a shared set of ethical concepts, a common vocabulary, and a relationship-focused, richly contextual perspective. The first goal of this book is to contribute to this process through close examination of cases designed to elicit common issues and problems from a variety of research settings and scholarly perspectives.

Based on this goal, the book’s second objective is to develop a new, relationship-based paradigm for research ethics. Such a paradigm should enable scholars, researchers, and others involved in research design, evaluation, or approval to facilitate human subjects research that is sensitive and responsible as well as scientifically fruitful.

The book’s six cases were selected because they enable this audience to consider research as embodied in a set of relationships between researchers, subjects, communities, funders, institutions, and governments. Examining these relationships illuminates ethical dilemmas in a nuanced and realistic way, for all academic disciplines that engage in research with human subjects—including social science, public health, and clinical medicine. The relationships perspective is relevant to the broadest range of research questions and methods. The cases we include here feature a variety of methods and disciplines: ethnography, survey and interview methods, community-based research, longitudinal multi-method studies, and randomized controlled clinical trials. Most of the cases and commentators come from the University of North Carolina, but it should be obvious that this is not because UNC researchers and scholars are more ethical than anyone else. Instead, it is testimony to the pervasiveness of the issues that so many of them could be addressed in cases that were, for us, close to home. Similarly rich and provocative cases can surely be found in abundance at most research universities and elsewhere.

In the first case, an anthropologist proposes to do ethnographic research in a small Jewish community in Curaçao. In a break with traditional researcher-subject relations, community representatives require that the researcher sign a contract giving them complete veto power over any publications before they will give their approval to the research. What are the implications of such a contract? Does it undermine academic freedom? The second case is also about community, but in this case it is a community imagined by the National Institutes of Health and the Centers for Disease Control—persons at risk for HIV/AIDS. The goal appears to be for university research teams to pave the way for successful HIV vaccine trials by studying and gaining the cooperation of at-risk populations. In this case, African Americans in Durham, North Carolina, may not constitute a single self-identified community, and we therefore wonder who should or can speak for them.

In the third case, a nutrition economist accepted a large gift from the Nestlé company in the early 1980s to support an ambitious research plan for studying infant feeding practices in the Philippines. The influence of the funder—any funder—on both the research process and the reporting of results is at issue, as are the effects of the decision of a single researcher on the rights and interests of the larger research community.

In the fourth case, a research project studying illegal abortions in Argentina raises difficult logistical and ethical dilemmas. Because these investigators are not subject to the same institutional review requirements as exist in the United States, resolution of these dilemmas falls to them alone. Their justification for not informing potential subjects of the nature of the research is based upon a profound and ongoing sense of relationship with the women they are studying. But is this enough? The fifth case also discusses the dilemma of how to tell subjects about the risks of participation in a study—here a longitudinal investigation of the impact of child abuse. The added twist is the inherent conflict between the legal requirement to report abuse (thus protecting children) and the ethical obligation of a researcher to protect the confidentiality of all information provided by study subjects (both parents and children).

The final case is about a 1996 federal regulatory exception to the informed consent requirement in emergency research for life-threatening illness or injury. The United States government determined that in this situation, the need for progress in research outweighs the imperative of informed consent, although some form of community consultation and public disclosure is required. While the issue of community is problematic for subjects in emergency rooms, equally difficult is the potential for conflict between the interests of the research community and their funding agencies, on the one hand, and on the other the potential subjects whose voices will not now be heard.

These cases portray complex dilemmas because research relationships are complex, contradictory, and always changing. All of them address issues not commonly encountered in traditional discussions of research ethics—issues such as power, control, and trust. But most importantly, each of these issues is real, current, and potentially troubling for researchers engaged in human subjects research in any field. The range of disciplines engaged in research with human subjects is broad, and this book is informed by the perspectives of internal medicine, pediatrics, psychiatry, surgery, preventive medicine, dentistry, nursing, epidemiology and public health, sociology, anthropology, ethics and philosophy, history, law, health policy, and health services research. Each of these disciplines, and numerous others, has its own history and tradition of reflection on the moral dilemmas presented by research with human subjects, and makes unique contributions to the continuing debate about them.

Three paths converged in shaping the concerns of this book. First are the continuing stories of error and abuse in American research with human subjects, despite a nearly thirty-year experience in applying detailed federal regulations to shape and govern the design and conduct of that research (Advisory Committee on Human Radiation Experiments 1995; Faden and Beauchamp 1986; Rothman 1991). Next come the arguments, played out on the international stage, that those American regulations—grounded in the principles of autonomy, beneficence, and justice—should not apply in all cultures. For example, cultures that define or value those principles differently, or that do not acknowledge them or acknowledge principle-based moral reasoning at all, must be accorded respect (Christakis 1992; Newton 1990). Finally comes the counterargument that the regulations are not enough, that by virtue of their roots in acontextual moral principles that originated in the European Enlightenment, they fail to answer, and may even be incapable of asking, some intractable ethical questions (Angell 1988; Barry 1988). The regulations address some of these questions—for example, how to design and carry out a good informed consent process—but do not answer them completely or well. Other questions, such as whether and how research direction should be influenced by funders or by subjects, simply fall outside the regulations’ purview altogether.

It thus seems to us that, although the term is overused, we might be in the middle of a paradigm shift. Ethics generally, and bioethics in particular, have recently been debating whether the invocation of principles is adequate for moral analysis of the complex and diverse questions that arise today (Arras and Steinbock 1995; Beauchamp and Childress 1994). A persuasive case can be made that principlism, by itself, is a moral perspective that is insufficiently flexible. A variety of new moral perspectives, including narrative ethics (Churchill 1997; Clouser and Hawkins 1996; Hunter 1991, 1995), feminist ethics (Kittay and Meyers 1987; Mahowald 1993; McCarrick and Darragh 1996; Tong 1993; Wolf 1996), revivals of virtue ethics (Macintyre 1984) and casuistry (Jonsen and Toulmin 1988), and a renewed attention to the meaning of culture, have begun to add richness and nuance to the portraits of moral problems, moving analysis away from a mathematized computation of moral answers toward a focus on mutuality.

These debates and critiques are flourishing in a broad range of academic disciplines engaged in research with human subjects. We have attempted to characterize the current discussion as shifting from a regulatory, principlist paradigm (based on rules derived from principle-based reasoning about moral problems in human subjects research) to a relationships paradigm. This new paradigm emphasizes relationships, interactions, power, responsibility, and contextual and historical considerations in examining moral issues.

New paradigms, however, do not just appear. They evolve out of older ones, and those who attempt to implement and justify them must struggle with what to keep from earlier systems and how to defend their rejection of the rest. This is never easy, but it is particularly challenging when it takes place across academic disciplines, each with its own history, tradition, and language. For this reason, we have grounded this book in case studies from a variety of fields that present a range of ethical issues. Underlying all of them, however, is this recognition: traditional ways of overseeing the ethics of research are insufficient to address issues faced by researchers who are concerned about their responsibilities to and relationships with those whom they study, their funding organizations, their professional peers, and the audiences for their research.

A Brief History: Images and Ethics of Human Subjects Research

Problem Cases

The ethics of human subjects research has enjoyed a resurgence of public attention in recent years. Most recently, this attention has been fueled by the President s Advisory Committee on Human Radiation Experiments, which began its work in 1994 and issued its Final Report in 1995. The Advisory Committee, which examined radiation research that took place during the Cold War era, concluded that lapses in protection of the rights, interests, and safety of human subjects are distressingly common even today, despite the elaborate federal regulatory process for the review and approval of human subjects research (Advisory Committee on Human Radiation Experiments 1995).

Research with human subjects has a long tradition in many fields besides bio-medicine, including social science, public health, epidemiology, and even the humanities. Concerns about the ethics of research with human subjects could be said to predate the existence of modern medical and scientific research, but certainly go back as far as Claude Bernard and other physician-researchers of the nineteenth century.²

Public interest and attention has generally been associated with problem cases and the governmental actions they engender. For example, the passage in 1906 of the Pure Food and Drugs Act, and in 1938 of the Food, Drug, and Cosmetic Act, came in response to concerns about quackery and the patent medicine industry. Similarly, the Drug Amendments of 1962, which laid the groundwork for close governmental control over the testing and approval of new drugs, were passed as a result of the Thalidomide tragedy.³ Not surprisingly, most problem cases have concerned medical and scientific research that has caused harm to subjects. However, in a number of cases, violations of subjects’ rights—for example, their privacy, or their right to choose to participate in research without coercion or deception—have also attracted public concern.

Although the twenty-year period following World War II appears to be a time during which research ethics was discovered, it is better understood as a period during which the concerns occasionally voiced throughout the first half of the century, by a wide range of professionals and scholars, and even by the courts, finally took form. At the end of World War II, there were virtually no noteworthy formal guidelines or codes governing research with human subjects. But . . . over twenty guidelines and codes, designed to protect subjects, [were] passed between 1948 and 1968 by major organizations (Faden and Beauchamp 1986, 186, footnote omitted). The increased attention to control of human subjects research was largely spurred by the Nuremberg trial of Nazi physicians, whose deadly research epitomized the horrors of the Nazi regime and resulted in the influential Nuremberg Code of research ethics (see Appendix A). New concerns about research ethics, however, were surely also influenced by profound and ongoing changes in American society, including attention to civil rights and individual freedoms, the development of formal professional organizations, and the growth of research, industry, and the university (Faden and Beauchamp 1986; Rothman 1991).

A handful of highly publicized instances of obviously unethical research helped command attention to the issues. The most notorious cases included three medical research projects—the U.S. Public Health Service’s Tuskegee syphilis study, the Jewish Chronic Disease Hospital case, and the Willowbrook study—and two psychology research projects—the Zimbardo prison experiment and Stanley Milgram’s obedience study. All posed risks of serious physical or psychological harm to subjects, including failure to treat serious disease in subjects, exposing subjects to the risk of disease, placing subjects in distressing situations, and putting subjects at risk of shame or embarrassment. All also involved, at best, flawed or incomplete consent processes, or at worst, deception of subjects.

In the Tuskegee syphilis study, poorly educated black men from the rural South were enrolled in a U.S. Public Health Service study to examine the progression of untreated syphilis. The subjects were not told that they were participants in research, and were deliberately deceived about the nature of the interventions they received. Worst of all, available treatments—including highly effective antibiotics—were kept from them. When this study came to public attention, it had been going on for some forty years, and revelations about it caused an uproar (Brandt 1978; Faden and Beauchamp 1986, 165–67; Jones 1992).

The Jewish Chronic Disease Hospital case and the Willowbrook study both made use of decisionally incapable institutionalized patients for studies unrelated to the conditions resulting in their institutionalization and incapacity. The Jewish Chronic Disease Hospital case involved elderly subjects, some of whom were incompetent, who were given injections of live cancer cells without their knowledge or consent. The researchers claimed to be convinced that the injections could not cause cancer, and that examining how long it took for a debilitated subject s immune system to reject the foreign cells would be important information in the war against cancer. However, the researchers had bypassed the hospital’s research review committee, had failed to consult the subjects’ physicians, and had determined that informing the subjects would only alarm them (Faden and Beauchamp 1986, 161-62). At Willowbrook, an institution for mentally disabled children, researchers sought to develop a hepatitis vaccine by studying children whom they had deliberately infected with the virus. Although this research was questioned on a variety of ethical grounds, it continued for several decades (Faden and Beauchamp 1986, 163–64).

Stanley Milgram’s obedience research used deception to examine the willingness of subjects to obey the commands of an authority figure. Subjects were told that they were participating in an experiment to determine whether aversive conditioning improved learning and memory. Each was instructed to administer electric shocks of increasing severity to a false subject, a confederate working in concert with the experimenter who gave wrong answers in a word association test. The false subject did not in fact receive any shocks, but screamed as if in pain, begged to be released, and otherwise simulated great injury. Subjects who objected to continuing to give the shocks were repeatedly told to continue for the advancement of science. Extreme distress usually accompanied obedience, but complete debriefing and reconciliation with the unharmed false subject followed the completion of each subject’s participation. Milgram’s research, in which sixty percent of subjects obeyed the authority figure all the way to the most severe shock, arguably produced important results, but critics maintained that the price was far too high (Faden and Beauchamp 1986, 174–77).

The Zimbardo prison experiment used no deception, but was criticized, as was Milgram’s research, for underestimating the likelihood and severity of psychological harm to subjects. Zimbardo set up a mock prison using volunteer college student subjects to assume the roles of prisoners and guards. The problem was how well it worked; student guards brutalized student prisoners, and these results raised questions about how well researchers must anticipate possible outcomes and describe them to potential subjects (Faden and Beauchamp 1986, 178–79).

Of the well-known cases from this period, only the Wichita Jury Study and Laud Humphreys’s tearoom trade research, which were conducted without subjects’ consent, were condemned solely because they violated the rights and interests of subjects without posing risks of harm to them. In the Wichita study, researchers secretly recorded and examined the deliberations of six juries. The jurors never knew that they were research subjects or that their deliberations were recorded, and this breach of the privacy and confidentiality of the jury process was bitterly controversial in both law and academia (Faden and Beauchamp 1986, 173–75). Humphreys observed the behavior of homosexuals in public restrooms without their consent, and in some instances surreptitiously determined their identities and later interviewed them under false pretenses. Again, it was argued that his results were important—they cast doubt on many stereotypes about homosexuality—but that the invasions of privacy and confidentiality of the unwitting subjects simply could not be outweighed by any benefits from the research (Faden and Beauchamp 1986, 177–78).

These problem cases focused attention on the development and refinement of rules, policies, and guidelines, resulting in some significant advances in public consciousness about and professional regulation of human subjects research. The effectiveness of such regulation depends, however, on its being understood as the vehicle for the application of principles to particular circumstances. And in the latter part of the twentieth century, this principlist paradigm of moral reasoning has been challenged.

Moral Principles

All of the codes, guidelines, and even discussion of problem cases that emerged from the latter half of the twentieth century found their underpinnings in the moral philosophy of the European Enlightenment. The enunciation of principles and rules, and the use of logic and even of mathematical calculation to determine moral behavior, profoundly influenced the development of research ethics, just as it influenced Western intellectual history in general (Beauchamp and Childress 1994; Maclntyre 1984). The current system of federal regulation of research with human subjects is exemplified by the principlist paradigm in the Belmont Report, a document produced in 1978 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to ground and justify the federal regulations. The Belmont Report sets forth the three moral principles of respect for persons, beneficence, and justice as the basis for the protection of human subjects, applies those principles to human subjects research, and deduces from them a set of requirements for research with human subjects (National Commission 1978).

Respect for persons, the first principle, includes both respect for the choices of autonomous persons and protection of the rights, needs, and interests of persons who lack the capacity to decide for themselves or have constraints upon their freedom of choice. This principle requires that the autonomy of subjects and potential subjects be supported in the informed consent process, and that subjects and potential subjects who may lack autonomy, such as children, persons with mental disabilities, or the institutionalized, be protected from exploitation. Thus, for example, autonomous persons need more than information. They may need information conveyed at a level appropriate to their education or in their native language. In addition, persons whose decisionmaking capacity is questionable or limited may be precluded from taking part in some potentially risky research, must have legally authorized decisionmakers to act on their behalf, and may be asked to provide assent to participation after information has been provided at a level appropriate to their understanding. Finally, persons who are incarcerated or dependent upon the state may need additional protection against the risk of undue influence in the consent process.

Beneficence, a familiar and well-understood principle, has tended to dominate discussion of research ethics. Like autonomy, it has two aspects: beneficence, or the duty to do good, and nonmaleficence, or the duty to refrain from causing or increasing harm. Thus, beneficence broadly understood includes both the familiar do no harm and the obligation to maximize the possibility of benefits and minimize the risks of harm. Beneficence in the research context governs both the design and conduct of research, including not only immediate risks and benefits to subjects, but consideration of whether the research is worth doing in light of long-term expected results and their societal implications.

Justice is the least well understood and most neglected of the ethical principles presented in the Belmont Report. Justice is a principle designed to eliminate biases against groups of people; it is the principle that draws our focus from individuals to groups. However, justice can be interpreted in different ways (Mastroianni et al. 1994). The Belmont Report considers justice as a fair distribution of burdens and benefits among cultural, social, sexual, racial, and ethnic groups. As with each of the principles, what this means must be determined in the context of each specific research project, and this is of course no simple task.

The Belmont Report’s consideration of justice focuses principally on subject selection issues. However, in much of the literature and discussion related to changing research paradigms, justice has begun to appear as a stronger, more active principle—one that is related to past, present, and future distributions of power. This evolution reflects the view that research is part of a comprehensive system that unfairly distributes power and its perquisites, and that it is incumbent on researchers to compensate for both the past sins of research and the state of the world. Thus, many researchers—including feminist researchers, new paradigm researchers, and participatory action researchers—include the empowerment of research subjects as an ethical imperative (Stein 1997). This addition has resulted in an active dialogue on the need to recast such traditional research constructs as objectivity, bias, reliability, and validity. It has led researchers to question their own positions of privilege and their relationships with powerful others, such as funders, policymakers, and their academic community, causing them to rethink what research they are willing to do and to pay much closer attention to how they ought to do it.

Domestic and International Research: Do the Regulations Apply?

Policy: The Regulations

Current United States regulations governing research with human subjects, known as the federal Common Rule, evolved over the past twenty-five years. The process began with a 1971 governmental Guide (Public Health Service 1971), which was transformed into regulations in 1974.⁴ Substantially revised regulations followed in 1981 (Department of Health and Human Services 1981), along with a second Commission,⁵ which produced even more impressive and influential writings (Advisory Committee on Human Radiation Experiments 1995; Faden and Beauchamp 1986). The consolidation of all federal regulations governing human subjects research into the Common Rule (see Appendix B) followed in 1991.

Briefly, the Common Rule, which applies to all human subjects research conducted under the auspices of institutions receiving federal funding, defines research as a systematic investigation . . . designed to develop or contribute to generalizable knowledge. It describes the research that is subject to the regulations and requires the establishment of Institutional Review Boards (IRB) to review and approve proposed research. In addition, the Common Rule establishes the conditions of that approval, which include extensive informed consent requirements, a requirement that risks to subjects be minimized and that risks be reasonable in relation to anticipated benefits, protection of privacy and confidentiality where possible, equitable selection of subjects, and appropriate protections for special populations of subjects.

From the beginning of this expanded regulatory attention to research ethics, concern and controversy existed over the appropriateness of including behavioral research under the aegis of federal oversight. Social scientists in particular were dismayed, even indignant, to find that their work would be reviewed alongside clinical trials and other research posing physical risks to subjects, and would be subjected to the same standards of informed consent, which they viewed as inconveniences at best, and at worst as impediments that could render some research impossible to conduct.⁶

Although the Belmont Report featured respect for persons as the primary principle underpinning ethical research, beneficence continued to seem more significant to researchers. Much of the controversy surrounding the regulation of behavioral research stemmed from this view that protecting subjects from physical harm is more important than protecting them from wrongs, such as deception, failure to provide adequate information, breaches of privacy and confidentiality, or undue influence—that is, that violating the principle of beneficence is worse than violating the principle of respect for persons.

Some of the research ethics literature during this twenty-five-year period has attempted to draw discipline-based distinctions between types of research and link those research categories to different priorities and concerns regarding ethics in human subjects research. It has been argued, for example, that biomedical research, because it is more likely to involve physical interventions, is more likely to cause or risk harm to subjects, and that social science research, because it is more likely to be limited to information-gathering, is more likely to cause or risk wrongs to subjects—that is, violations of their rights and interests, including breaches of privacy and confidentiality and failure to protect their autonomy (Beauchamp et al. 1982; Wax and Cassell 1981).

Indeed, behavioral and social science researchers recognized early in the development of the regulations that some of their research designs, including ethnography, participant observation, and other longitudinal and interactive strategies, not only did not fit cleanly into the scheme of federal research regulation but also presented dilemmas of moral relationship that fell outside the regulatory paradigm’s reach. There is a considerable literature of discussion and critique of research within the social sciences that has many rich insights to offer to consideration of the relationships paradigm (Fine 1993; Homan 1992).⁷

In our view, however, distinguishing between biomedical and social science research represents no more than the crudest cut at the issues of concern to most researchers, and misrepresents the importance of evaluating the potential harms, wrongs, benefits, and burdens of all proposed research. Although some research does indeed fit these disciplinary stereotypes, much does not. Moreover, the prevalence of this disciplinary stereotyping has tended to obscure the existence of cross-disciplinary concerns that depend more on the particulars of the research than on how it is labeled. A few illustrations clarify this point.

How should biomedical researchers think about the long-term relationships they develop with chronically ill patient-subjects, except by looking to the long-term relationships developed between nonbiomedical researchers and the populations with whom they do fieldwork? By contrast, is a research project that involves data collection by anonymous questionnaire very different from a project that collects anonymous tissue samples if the focus of both is, say, genetic risk or HIV infection? And how should questions of consent and confidentiality in cross-cultural research be addressed, if not by the sharing of experiences and perspectives among researchers of a variety of disciplines who have faced such issues, both internationally and at home? Focusing on the relationships involved in all human subjects research serves not only as a means of addressing the characteristics of research that give rise to particular ethical concerns, but also as a means of beginning to structure meaningful analysis and successful solutions.

CIOMS Guidelines

Recent challenges to the traditional Western philosophical perspective on ethics have been articulated in the research context in two ways. Attacks on principlism are intended to dethrone the traditional triumvirate of bioethics principles—autonomy, beneficence, and justice—that underlies the regulation of research. Western moral imperialism, with its emphasis on individualism, is denounced as holding researchers in developing countries to irrelevant and impossible-to-meet standards. This position both highlights the communitarian ethics of non-Western traditions and seeks to promote the conduct of human subjects research in developing countries outside the standards represented by the principle-based research regulatory paradigm.

The principlist underpinnings of Western moral theory have had such pervasive influence that even international research guidelines have conformed to that model. This includes two recent and influential sets of guidelines for epidemiological research (1991, see Appendix C) and biomedical research (1993, see Appendix D) produced by the Council for International Organizations of Medical Sciences (CIOMS). These two sets of CIOMS guidelines adopt the approach and organization of the Belmont Report and of the Common Rule, but they also address key points and issues in light of local conditions. Both these sets of guidelines are the result of many iterations and revisions, as their authors have attempted to respond to various critiques.

Throughout these efforts, the guidelines have continued to reflect the basic premises of principlist ethics (Bankowski and Levine 1992; Ringheim 1995). Both sets of guidelines set up individual informed consent as a priority. This has been challenged by those who argue that the Western focus on individualism is being unfairly applied to cultures that are more communal or family-focused in their decisionmaking practices (Christakis 1992; Newton 1990). It has been applauded by others, however, who argue that when emphasis on individual consent is reduced, it permits the exploitation of women and encourages undue reliance on community leaders who are not necessarily endowed with authority by community members (Ijsselmuiden and Faden 1992).

The guidelines for biomedical research specifically address research involving subjects in underdeveloped countries, the equitable distribution of burdens and benefits of research, and the obligations of sponsoring and host countries in international research collaborations. Guidelines addressing the first two issues focus on preventing the exploitation of subjects and communities of subjects; the guideline on the third issue requires research to first meet the standards of the sponsoring country and then the standards of the host country. The guidelines for epidemiological research consider the acceptability of community agreement where collective decisionmaking is customary, and also address concerns including selective disclosure of information to prospective subjects, undue influence and undue inducements to participation, respect for social mores, cultural sensitivity, and conflict of interest.

The requirement that research meet the standards of the sponsoring country first and then the host country has drawn both praise and criticism—praise because it prevents the exploitation of host countries, criticism because it prioritizes the standards of the sponsoring (usually developed Western) country. This prioritization can lead to excessive attention to regulatory details like signature requirements for informed consent (often a barrier to research in countries with low literacy or with political circumstances that make signing one’s name seem very risky), as well as to the tendency to take less seriously the review by the host country’s IRB (But our IRB has already approved this!). The CIOMS attempt to take account of the needs and circumstances of the developing world thus can appear to be an effort to apply a superior (Western) model to inferior settings.

A Paradigm Shift: Are the Regulations Enough?

The current wave of public interest in research ethics parallels a related but distinct set of ongoing concerns shared by researchers, scholars, and students worldwide: that the conceptual and regulatory framework for attention to ethics in research with human subjects is insufficiently rich and nuanced to