Experts from different disciplines offer novel ideas for improving research oversight and protection of human subjects.

(2010). Ethical Rules for Human Subjects Research: A Case Where the “Is” Must Inform the “Ought”. The American Journal of Bioethics: Vol. 10, No. 6, pp. 14-15.

The experimental method is designed to secure the reliable attribution of causal relationships by means of controlled comparison across conditions. Doing so, however, depends upon the reduction of uncertainties and inconsistencies in the process of comparison; and this poses particularly significant challenges for the behavioral and social sciences because they work with human subjects, whose malleability and complexity often interact in unexpected ways with experimental manipulations, thus resulting in unpredictable behavior. Drawing on the Science and Technology Studies perspective (...) and one of our authors’ experiences in experimental work, this paper examines how experimental social scientists manage to establish objectivity and standardization in the face of vagaries arising from working with human subjects. In identifying experimental researchers’ solutions to this challenge, we draw on methodological discussions among applied social scientists as naturally occurring data, through which we show how some seemingly mundane practices play essential roles in extracting patterns out of otherwise unpredictable behaviors in the lab. Closely examining such strategies, we reveal the inherent instabilities in the experimental method when adopted in the social sciences and discuss their methodological implications. In conclusion, we make tentative suggestions for escaping the kinds of methodological impasses which we have identified. (shrink)

No consensus yet exists on how to handle incidental fnd-ings in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are fndings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as (...) imaging research. We conclude that researchers have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed. (shrink)

An engaging, compelling and disturbing confrontation with evil...a book that will be transformative in its call for individual and collective moral responsibility." - Michael A. Grodin, M.D., Professor and Director, Project on Medicine and the Holocaust, Elie Wiesel Center for Judaic Studies, Boston University Human Subjects Research after the Holocaust challenges you to confront the misguided medical ethics of the Third Reich personally, and to apply the lessons learned to contemporary human subjects research. While (...) it is comforting to believe that Nazi physicians, nurses, and bioscientists were either incompetent, mad, or few in number, they were, in fact, the best in the world at the time, and the vast majority participated in the government program of "applied biology." They were not coerced to behave as they did-they enthusiastically exploited widely accepted eugenic theories to design horrendous medical experiments, gas chambers and euthanasia programs, which ultimately led to mass murder in the concentration camps. Americans provided financial support for their research, modeled their medical education and research after the Germans, and continued to perform unethical human subjects research even after the Nuremberg Doctors' Trial. The German Medical Association apologized in 2012 for the behavior of its physicians during the Third Reich. By examining the medical crimes of human subjects researchers during the Third Reich, you will naturally examine your own behavior and that of your colleagues, and perhaps ask yourself "If the best physicians and bioscientists of the early 20th century could do evil while believing they were doing good, can I be certain that I will never do the same?" · Presents relatively unknown aspects of human subjects research during the Third Reich · Reveals surprising relationships between German and American human subjects research · Dispels myths about Nazi human subjects research · Compels introspection and self-examination by today's medical and research practitioners · Addresses contemporary bioethical issues affecting vulnerable populations · Brings together experts in the history of medicine during the Third Reich and thoughtful new voices. (shrink)

There is considerable confusion regarding the ethical appropriateness of using incentives in research with human subjects. Previous work on determining whether incentives are unethical considers them as a form of undue influence or coercive offer. We understand the ethical issue of undue influence as an issue, not of coercion, but of corruption of judgment. By doing so we find that, for the most part, the use of incentives to recruit and retain research subjects is innocuous. (...) But there are some instances where it is not. Specifically, incentives become problematic when conjoined with the following factors, singly or in combination with one another: where the subject is in a dependency relationship with the researcher, where the risks are particularly high, where the research is degrading, where the participant will only consent if the incentive is relatively large because the participant's aversion to the study is strong, and where the aversion is a principled one. The factors we have identified and the kinds of judgments they require differ substantially from those considered crucial in most previous discussions of the ethics of employing incentives in research with human subjects. (shrink)

In this paper, I discuss the ethical issues related to deception in human subject research in terms of honesty. First, I introduce the background and suggest the conception of honesty that understands it as involving respect for the right not to be deceived (RND). Next, I examine several ways to address the ethical issues of deceptive elements in the human subject research and show why they fail to adequately meet the demand of honesty. I focus on (...) how to make an honest research plan and examine after participation and before participation phases in turn. Then I conclude by suggesting possible strategies to minimizes dishonesty in human subject research. (shrink)

In the mid-1990s, the Internet rapidly changedfrom a venue used by a small number ofscientists to a popular phenomena affecting allaspects of life in industrialized nations. Scholars from diverse disciplines have taken aninterest in trying to understand the Internetand Internet users. However, as a variety ofresearchers have noted, guidelines for ethicalresearch on human subjects written before theInternet's growth can be difficult to extend toresearch on Internet users.In this paper, I focus on one ethicalissue: whether and to what extent (...) to disguisematerial collected online in publishedaccounts. While some people argue thatvulnerable human subjects must always be madeanonymous in publications for their ownprotection, others argue that Internet usersdeserve credit for their creative andintellectual work. Still others argue thatmuch material available online should betreated as ``published.'' To attempt to resolvethese issues, I first review my own experiencesof disguising material in research accountsfrom 1992 to 2002. Some of the thorniestissues emerge at the boundaries betweenresearch disciplines. Furthermore, manyhumanities disciplines have not historicallyviewed what they do as human subjects research. Next, I explore what it means to do humansubjects research in the humanities. Inspiredby issues raised by colleagues in thehumanities, I argue that the traditional notionof a ``human subject'' does not adequatelycharacterize Internet users. A useful alternatemental model is proposed: Internet users areamateur artists. The Internet can be seen as aplayground for amateur artists creatingsemi-published work. I argue that thisapproach helps make some ethical dilemmaseasier to reason about, because it highlightskey novel aspects of the situation,particularly with regard to disguisingmaterial. Finally, I conclude by proposing aset of practical guidelines regardingdisguising material gathered on the Internet inpublished accounts, on a continuum from nodisguise, light disguise, moderate disguise, toheavy disguise. (shrink)

Non-lethal weapons have become an increasingly important class of weapons. Creating these armaments requires examination of ethical issues in their research and development processes. Chief a...

Over the past 40 years, a complex review and oversight system has grown within the United States and internationally to regulate the conduct of human subjects research. This system developed in response to revelations of abuses of human subjects in experiments such as those conducted in the Nazi concentration camps, the Tuskegee Study of Untreated Syphilis in the Negro Male, the Willowbrook Hepatitis Studies, and the studies described by Beecher in his 1966 article in the (...) New England Journal of Medicine. The oversight system is based on a foundation, first implemented by the U.S. Public Health Service in 1966 and by the U.S. Food and Drug Administration in 1971, of prior review and approval of a written experimental protocol by an independent committee. The World Medical Association articulated the ethical centrality of independent review in its 1975 revision of the Declaration of Helsinki, and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research endorsed the requirement in its flagship Belmont Report. (shrink)

In order to increase understanding of the ethical implications of biomedical, behavioral and clinical research, the Fogarty International Center, part of the United States National Institutes of Health, established an International Research Ethics Education and Curriculum Development Award to support programs in low- and middle-income countries. To develop research ethics expertise in Jordan, the University of California San Diego fellowship program in collaboration with Jordan University of Science and Technology provides courses that enable participants to develop skills (...) in varied research ethics topics, including research with human subjects. The program provides a master’s level curriculum, including practicum experiences. In this article we describe a practicum project to modify an existing introduction to human subjects research for a US audience to be linguistically and culturally appropriate to Arabic-speaking-Islamic communities. We also highlight key differences that guided the conversion of an English version to one that is in Arabic. And finally, as Institutional Review Boards follow the ethical principles of the Belmont Report in evaluating and approving biomedical and behavioral human subjects research proposals, we provide observations on the conformity of the three ethical principles of the Belmont Report with Islam. (shrink)

Two years ago, the Journal of Law, Medicine & Ethics published volume 28, number 4, devoted to a symposium entitled Human Subjects Research and the Role of Institutional Review Boards - Conflicts and Challenges. I had the good fortune to be asked to serve as editor of that issue. In her introduction to the symposium, the then editor-in-chief of the journal, Ellen Wright Clayton, observed that the country is currently undergoing a major reexamination of how biomedical (...) class='Hi'>research is conducted. While that reexamination has continued in the interim, some very recent events raise questions about the extent to which this will continue, at least in the short run, with equal vigor. The intervening years have witnessed a variety of new directions and events. The federal Office of Human Research Protections, directed by Dr. Greg Koski, who wrote a brief commentary for the last symposium,L has taken a new direction, strongly stressing the need for institutions and their institutional review boards ORBS) to engage in extensive educational and quality improvement efforts with both researchers and their own member. (shrink)

The use of brain imaging technology as a common tool of research has spawned concern and debate over how investigators should respond to incidental fndings discovered in the course of research. In this article, we argue that investigators have an obligation to respond to incidental fndings in view of their entering into a professional relationship with research participants in which they are granted privileged access to private information with potential relevance to participants' health. We discuss the scope (...) and limits of this professional obligation to respond to incidental fndings, bearing in mind that the relationship between investigators and research participants differs fundamentally from the doctor-patient relationship. (shrink)

In the United States, the Presidential Commission for the Study of Bioethical Issues has proposed deliberative democracy as an approach for dealing with ethical issues surrounding synthetic biology. Deliberative democracy might similarly help us as we update the regulation of human subjects research. This paper considers how the values that deliberative democratic engagement aims to realize can be realized in a human subjects research context. Deliberative democracy is characterized by an ongoing exchange of ideas (...) between participants, and an effort to justify decisions that bind participants by appeal to reasons that the participants can understand and share. Even when unanimous agreement is not reached, the active participation of everyone along with the requirement that reasons be made accessible enhances the legitimacy of the ultimate outcome. Importantly, deliberative democratic structures avoid strict hierarchies and place participants, as much as possible, in the position of equals. Human subjects research has some features that may make deliberative democratic principles seem initially unappealing. For one, there are asymmetries in knowledge between expert researchers conducting the research and participants in the research process. For another, statistical validity is made easiest by research paradigms that produce standardized, quantitative data, which can be difficult to achieve if research participants are given the power to deliberatively reshape the research design as it progresses. These and other problems have tended to produce a human subjects research process where subjects do not actively participate in shaping research, but rather consent to a predefined set of interventions designed by expert researchers and vetted by Institutional Review Boards (IRBs). In this paper, I suggest some ways in which human subjects research could do more to realize deliberative democratic values, and, in particular, how a revised Common Rule might help to realize these values. First, research participants could be treated not as passive subjects but instead involved in research design, ethical review, and the ongoing conduct and dissemination of research. Such participation might involve, for instance, including people who have served as research subjects on IRBs, or replacing IRB oversight for certain forms of research exempted from IRB oversight under a revised Common Rule with oversight by a body of community members or research subjects. It might also involve having the oversight of research that uses more participatory models be more participatory and less hierarchical in nature. I also raise questions about the exemption of research on public benefit programs from any research-level oversight and from consent requirements. While IRBs are likely not the correct overseers, there may be good reason to view such research with a critical eye, because of its potential for long-range impacts on the lives of participants. By giving research subjects a greater voice in research that aims at fine-tuning public benefit programs on which subjects rely, a deliberative oversight process has the potential to recast research participation as a form of active democratic participation and to address a “democratic deficit” in public health. Numerous proposals regarding health care have called for greater participation by laypeople and a more nonhierarchical approach to setting health priorities. Involving lay research subjects in the conduct of public benefits research and other forms of public health research may help to further these goals. (shrink)

The human subjects researchmodel is increasingly invoked in discussions ofethics for Internet research. Here we seek toquestion the widespread application of thismodel, critiquing it through the two themes ofspace and textual form. Drawing on ourexperience of a previous piece ofresearch, we highlightthe implications of re-considering thetextuality of the Internet in addition to thespatial metaphors that are more commonlydeployed to describe Internet activity. Weargue that the use of spatial metaphors indescriptions of the Internet has shaped theadoption of the (...) human subjects research model.Whilst this model is appropriate in some areasof Internet research such as emailcommunication, we feel that researchers, whennavigating the complex terrain of Internetresearch ethics, need also to consider theInternet as cultural production of texts. (shrink)

This paper examines the role of equipoise in evaluating international research. It distinguishes two possible formulations of the equipoise requirement that license very different evaluations of international research proposals. The interpretation that adopts a narrow criterion of similarity between clinical contexts has played an important role in one recent controversy, but it suffers from a number of problems. An alternative interpretation that adopts a broader criterion of similarity does a better job of avoiding both exploitation of the brute (...) fact of social deprivation and the exploitation of needy populations for the benefit of more well-off populations. It also holds out the promise of reconciling the need to find interventions that can be employed in developing world contexts with the cluster of moral values that must constrain the way such research is carried out. (shrink)

Purpose Academic scholars have leveraged crowd work platforms such as Amazon Mechanical Turk for human subjects research for almost two decades. However, few scholars have reflected or questioned this mode of academic research. This paper aims to examine three fundamental problems of crowd work and elaborates on their lasting effects on impacting the validity and quality of human subjects research on crowd work. Design/methodology/approach` A critical analysis is conducted on the characteristics of crowd (...) work, and three fundamental problems of crowd work since its origin were identified, namely, the position of “Human-as-a-service,” the confusion of terminology and crowd work platforms’ abdication of responsibilities. Findings This paper explains that the three identified fundamental problems of crowd work render at least two lasting problems in crowd work-based research: first, the negligence of the teleological difference between crowd work and academic research; second, the ontological schism between scholars and institutional review boards (IRBs) in their ethical concerns and practices. Originality/value This paper critiques the foundation of crowd work-based research that has become growingly popular, extolled and taken for granted. Such a critique is deficient in literature and may seem a bit peculiar. However, we hold that it is time to take research ethics seriously in crowd work because we need to introspect and question ourselves as scholars: What is our motive or ethical stance in using crowd work for human subjects research? Is it for advancing scientific knowledge, promoting crowd workers’ welfare, or predominantly for benefiting ourselves from the fast, cheap and “good” data via crowd work? (shrink)

A collaborative team of environmental sociologists, community psychologists, religious studies scholars, environmental studies/science researchers and engineers has been working together to design and implement new training in research ethics, culture and community-based approaches for place-based communities and cultural groups. The training is designed for short and semester-long graduate courses at several universities in the northeastern US. The team received a 3 year grant from the US National Science Foundation’s Ethics Education in Science and Engineering in 2010. This manuscript details (...) the curriculum topics developed that incorporate ethical principles, particularly for group protections/benefits within the field practices of environmental/engineering researchers. (shrink)

Answering important public health questions often requires collection of sensitive information about individuals. For example, our understanding of how HIV is transmitted and how to prevent it only came about with people's willingness to share information about their sexual and drug-using behaviors. Given the scientific need for sensitive, personal information, researchers have a corresponding ethical and legal obligation to maintain the confidentiality of data they collect and typically promise in consent forms to restrict access to it and not to publish (...) identifying data.The interests of others, however, can threaten researchers' promises of confidentiality when legal demands are made to access research data. In some cases, the subject of the litigation is tightly connected to the research questions, and litigants' interest in the data is not surprising. Researchers conducting studies on tobacco or occupational or other chemical exposures, for example, are relatively frequent targets of subpoenas. (shrink)

The overlap and differences between the parallel regulatory systems for research create ample room for confusion and missteps, as discussed by Barbara Bierer and Mark Barnes in their report in this supplement. In practice, beyond the inherent differences in the two systems of regulations themselves, there are many issues that further complicate the application of these regulations. These include the variation in size of the institutions receiving PHS funding, the increased prevalence of multisite research, the allocation of (...) class='Hi'>research conduct and oversight to external organizations, and the variability in assignment of human subject protection roles between the IRB and the institution. (shrink)

International health-related research on human subjects entails unique ethical responsibilities and difficulties. Often, these difficulties are augmented by the lack of a local ethical review infrastructure. In a recent cross-national study conducted by us, three critical components of ethical regulation were identified—external oversight, local oversight and subject involvement—and integrated into the study design. These three concepts are outlined and established as an important aspect of ensuring ethical coherence in the local context, particularly when reviews by the local (...) institutional review boards cannot practically be obtained. The three levels of ethical oversight identified are suggested to be the framework within which future field studies on human subjects are developed and a standard for maintaining ethical rigorousness in research on humans. (shrink)

Nanomedicine is yielding new and improved treatments and diagnostics for a range of diseases and disorders. Nanomedicine applications incorporate materials and components with nanoscale dimensions where novel physiochemical properties emerge as a result of size-dependent phenomena and high surface-to-mass ratio. Nanotherapeutics and in vivo nanodiagnostics are a subset of nanomedicine products that enter the human body. These include drugs, biological products, implantable medical devices, and combination products that are designed to function in the body in ways unachievable at larger (...) scales. Nanotherapeutics andin vivonanodiagnostics incorporate materials that are engineered at the nanoscale to express novel properties that are medicinally useful. These nanomedicine applications can also contain nanomaterials that are biologically active, producing interactions that depend on biological triggers. Examples include nanoscale formulations of insoluble drugs to improve bioavailability and pharmacokinetics, drugs encapsulated in hollow nanoparticles with the ability to target and cross cellular and tissue membranes and to release their payload at a specific time or location, imaging agents that demonstrate novel optical properties to aid in locating micrometastases, and antimicrobial and drug-eluting components or coatings of implantable medical devices such as stents. (shrink)

This paper is, in part, a response to the model of university-based human subjects ethics review described by Bryn Williams-Jones and Soren Holm in Research Ethics Review [1] and the current ethical review process at the University of Ulster [2]. In this paper the two predominant systems of ethical review within UK universities are described. It is argued that each of these systems has significant deficiencies. Having suggested why these two models are less than ideal, a “third (...) way’ of ethical review is proposed that encapsulates the strengths of these two models while avoiding the weaknesses. (shrink)

Although most researchers are familiar with the application of the Common Rule in research, fewer are aware of specific requirements and restrictions for conducting human subjects research when employees of the US Department of Defense (DoD) will be participants. Because of the additional regulations concerning DoD employees as participants, federal regulations and research policies require researchers to submit their human subjects research proposals through a DoD review process to ensure compliance with DoD (...) research policies, regardless of a non-DoD IRB’s approval. These research policies recognize the vulnerability of military subjects within a hierarchical organization to potential coercion and abuse during research studies. This article describes some of the unique requirements to conduct human subjects research within the DoD (in which the participants are military or civilian). The article concludes with steps researchers can follow to facilitate the DoD review process for research, and timely research within the DoD. (shrink)

Preventing exploitation in human subjects research requires a benchmark of fairness against which to judge the distribution of the benefits and burdens of a trial. This paper proposes the ideal market and its fair market price as a criterion of fairness. The ideal market approach is not new to discussions about exploitation, so this paper reviews Wertheimer's inchoate presentation of the ideal market as a principle of fairness, attempt of Emanuel and colleagues to apply the ideal market (...) to human subjects research, and Ballantyne's criticisms of both the ideal market and the resulting benchmark of fairness. It argues that the criticism of this particular benchmark is on point, but the rejection of the ideal market is mistaken. After presenting a complete account of the ideal market, this paper proposes a new method for applying the ideal market to human subjects research and illustrates the proposal by considering a sample case. (shrink)

Federal policies on human subjects research have performed a near‐about face. In the 1970s, policies were motivated chiefly by a belief that subjects needed protection from the harms and risks of research. Now the driving concern is that patients, and the populations they represent, need access to the benefits of research.

Federal policies on human subjects research have undergone a progressive transformation. In the early decades of the twentieth century, federal policies largely relied on the discretion of investigators to decide when and how to conduct research. This approach gradually gave way to policies that augmented investigator discretion with externally imposed protections. We may now be entering an era of even more stringent external protections. Whether the new policies effectively absolve investigators of personal responsibility for conducting ethical (...) research, and whether it is wise to do so, remains to be seen. (shrink)

Here I inquire into the status of the rules promulgated in the canonical pronouncements on human subjects research, such as the Declaration of Helsinki and the Belmont Report. The question is whether they are ethical rules or rules of policy. An ethical rule is supposed to accurately reflect the ethical fact (the fact that the action the rule prescribes is ethically obligatory), whereas rules of policy are implemented to achieve a goal. We should be skeptical, I argue, (...) that the actions prescribed by the rules are ethically obligatory, and consequently we should focus our attention on how to craft the rules so as to promote the legitimate goals of human subjects research. Unfortunately, this cannot be done without evidence about the likely effects of various candidate policies—evidence we currently lack. Therefore, we should take the rules as mere starting points, subject to revision as the evidence comes in. (shrink)

Technology has outpaced the capacity of researchers performing research on human participants to interpret all data generated and handle those data responsibly. This poses a critical challenge to existing rules governing human subjects research. The technologies used in research to generate images, scans, and data can now produce so much information that there is significant potential for incidental findings, findings generated in the course of research but beyond the aims of the study. Neuroimaging (...) scans may visualize the entire brain and even the entire head; computed tomography colonography research may visualize the entire torso, from the base of the lungs to the pubis; genetics studies may reveal “extra” and sometimes unwanted information about the family, such as misattributed paternity and undisclosed adoption; and genomic microarray research increasingly involves whole-genome analysis revealing an individual’s complete genotype, with enormous potential for uncovering unexpected information about an individual’s genetics and risks of developing future conditions. (shrink)

Human subjects research is an annual $10 billion dollar global activity. In May 2012, Harvard Law School hosted a conference on human subjects research . The conference critically examined HSR relative to the proposed American regulatory framework for federally funded research. The conference did not question the need for human subjects research. Rather, it discussed the need to balance the protection of human subjects from possible research risks (...) while not hindering research—an epic, ongoing debate regarding the balance between paternalism and autonomy. This book draws on the analysis and insights of 33 experts in the field of HSR. The authors critically analyse the epic balance in five parts:‘The Regulation of Risk’, ‘The Protection of Vulnerable Populations’, ‘Re-defining the Participant-Researcher Relationship and the Role of IRBs’, ‘Specimens, Data and Privacy’, and ‘Paradigm Shifts in Research Ethics’. Within each part, the authors sketch out their preferr .. (shrink)

What are the Differences between Public Health Practice and Research? This perplexing question constantly arises in the planning and performance of public health activities involving the acquisition and use of identifiable health information. Public health agencies collect and analyze significant identifiable health data from health care providers, insurers, other agencies, or individuals to perform an array of public health activities. These activities include surveillance, epidemiological investigations, and evaluation and monitoring. Few debate that these essential public health activities, often specifically (...) authorized by law, are classifiable as public health practice.Other public health activities in which identifiable health data are acquired or used, however, can resemble, include, or constitute human subjects research. “Human subjects research” is legally defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” that involves living human subjects. (shrink)

Ethics regulation for human-subject research has been established for about 20 years in Brazil. However, compliance with this regulation is controversial for non-biomedical sciences, particularly for human and social sciences, the source of a recent debate at the National Commission for Research Ethics. We hypothesized that for these fields, formal requirements for compliance with HSR regulation in graduate programs, responsible for the greatest share of Brazilian science, would be small in number. We analyzed institutional documents from (...) 171 graduate programs at six prestigious Brazilian universities in São Paulo and Rio de Janeiro, the states that fund most of the science conducted in Brazil. Among these programs, 149 were in HSS. The results suggest that non-compliance with standard regulation seems to be the rule in most of these programs. The data may reflect not only a resistance from scientists in these fields to comply with standard regulations for ethics in HSR but also a disciplinary tradition that seems prevalent when it comes to research ethics in HSR. However, recent encounters between Brazilian biomedical and non-biomedical scientists for debates over ethics in HSR point to a changing culture in the approach to research ethics in the country. (shrink)

The concept of vulnerability has long played a central role in discussions of research ethics. In addition to its rhetorical use, vulnerability has become a term of art in U.S. and international research regulations and guidelines, many of which contain specific provisions applicable to research with vulnerable subjects. Yet, despite the frequency with which the term vulnerability is used, little consensus exists on what it actually means in the context of human subject protection or, more (...) importantly, on how a finding of vulnerability should affect the process of research ethics review.The Common Rule, the centerpiece of the U.S. human subject protection regulations, uses the word vulnerable three times. First, it provides that institutional review boards that regularly review research involving a vulnerable category of subjects should consider including one or more individuals who are knowledgeable about and experienced in working with these subjects. (shrink)

At a White House ceremony in October 1995, the Advisory Committee on Human Radiation Experiments presented its Final Report to President Bill Clinton. The 925-page report and the over 2,000 pages of supplemental volumes summarized eighteen months of investigative research, debate, and deliberation on historical and contemporary issues in human subjects research. The Advisory Committee's efforts were aided by unprecedented support from the highest levels of the executive branch, including the heads of eight cabinet-level agencies (...) and their departments' resources. The presidentially appointed committee and its staff delved into long-forgotten Cold Warera government archives, listened to hours of public testimony, interviewed key players in the development of medical therapies and nuclear weapons, and studied ethical issues arising in today's research.In this article we focus on a critical, but narrowly defined, part of the Advisory Committee's Final Report: remedying harms or wrongs to subjects of human radiation experiments conducted or sponsored by the U.S. government between 1944 and 1974. (shrink)

Ethics regulation for human-subject research (HSR) has been established for about 20 years in Brazil. However, compliance with this regulation is controversial for non-biomedical sciences, particularly for human and social sciences (HSS), the source of a recent debate at the National Commission for Research Ethics. We hypothesized that for these fields, formal requirements for compliance with HSR regulation in graduate programs, responsible for the greatest share of Brazilian science, would be small in number. We analyzed institutional (...) documents (collected from June 2014 to May 2015) from 171 graduate programs at six prestigious Brazilian universities in São Paulo and Rio de Janeiro, the states that fund most of the science conducted in Brazil. Among these programs, 149 were in HSS. The results suggest that non-compliance with standard regulation seems to be the rule in most of these programs. The data may reflect not only a resistance from scientists in these fields to comply with standard regulations for ethics in HSR but also a disciplinary tradition that seems prevalent when it comes to research ethics in HSR. However, recent encounters between Brazilian biomedical and non-biomedical scientists for debates over ethics in HSR point to a changing culture in the approach to research ethics in the country. (shrink)