BackgroundCountries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of human research participants.DiscussionResearch ethics committees face numerous obstacles to achieving their goal of improving research participant protection. These include the inherently amorphous nature of ethics review, the tendency of regulatory systems to encourage a focus on form over substance, financial and resource constraints, and conflicts of interest. Auditing and accreditation programs (...) can improve the quality of ethics review by encouraging the development of standardized policies and procedures, promoting a common base of knowledge, and enhancing the status of research ethics committees within their own institutions. However, these mechanisms focus largely on questions of structure and process and are therefore incapable of answering many critical questions about ethics committees' actual impact on research practices.The first step in determining whether research ethics committees are achieving their intended function is to identify what prospective research participants and their communities hope to get out of the ethics review process. Answers to this question can help guide the development of effective outcomes assessment measures. It is also important to determine whether research ethics committees' guidance to investigators is actually being followed. Finally, the information developed through outcomes assessment must be disseminated to key decision-makers and incorporated into practice. This article offers concrete suggestions for achieving these goals.ConclusionOutcomes assessment of research ethics committees should address the following questions: First, does research ethics committee review improve participants' understanding of the risks and potential benefits of studies? Second, does the process affect prospective participants' decisions about whether to participate in research? Third, does it change participants' subjective experiences in studies or their attitudes about research? Fourth, does it reduce the riskiness of research? Fifth, does it result in more research responsive to the local community's self-identified needs? Sixth, is research ethics committees' guidance to researchers actually being followed? (shrink)

This article examines and critiques the use of the term “vulnerability” in U.S. and international regulations and guidelines on research ethics. After concluding that the term is currently used in multiple, often inconsistent, senses, it calls on regulators to differentiate between three distinct types of vulnerability: “consent-based vulnerability,”“risk-based vulnerability,” and “justice-based vulnerability.”.

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)

Developing countries face numerous barriers to conducting effective and efficient ethics reviews of international collaborative research. In addition to potentially overlooking important scientific and ethical considerations, inadequate or insufficiently trained ethics committees may insist on unwarranted changes to protocols that can impair a study's scientific or ethical validity. Moreover, poorly functioning review systems can impose substantial delays on the commencement of research, which needlessly undermine the development of new interventions for urgent medical needs. In response to these concerns, the Drugs (...) for Neglected Diseases Initiative, an independent nonprofit organization founded by a coalition of public sector and international organizations, developed a mechanism to facilitate more effective and efficient host country ethics review for a study of the use of fexinidazole for the treatment of late stage African Trypanosomiasis. The project involved the implementation of a novel ‘pre-review’ process of ethical oversight, conducted by an ad hoc committee of ethics committee representatives from African and European countries, in collaboration with internationally recognized scientific experts. This article examines the process and outcomes of this collaborative process. (shrink)

In “Should We Impose Quotas? Evaluating the ‘Disparate Impact’ Argument Against Legalization of Assisted Suicide,” Ronald Lindsay argues that it should make no difference to the debate over legalizing assisted suicide whether the risks associated with legalization would fall disproportionately on the poor, people with disabilities, racial minorities, or any other especially vulnerable social group. Even assuming such an inequitable distribution of risks would occur, he maintains, attempting to avoid such an outcome is not a good reason to deny assisted (...) suicide to “competent persons who truly voluntarily choose it.”Those of us who worry that legalization will differentially burden already disadvantaged segments of society have generally taken it for granted that the possibility of such disparities raises significant public policy concerns. By insisting on an explanation of this assumption — and, in so doing, making explicit the tension between autonomy and equality that underlies the assisted suicide debate — Lindsay has significantly advanced the ongoing conversation. While I disagree with his analysis, I commend him for a thoughtful, provocative, and important contribution to the literature. (shrink)

In “Should We Impose Quotas? Evaluating the ‘Disparate Impact’ Argument Against Legalization of Assisted Suicide,” Ronald Lindsay argues that it should make no difference to the debate over legalizing assisted suicide whether the risks associated with legalization would fall disproportionately on the poor, people with disabilities, racial minorities, or any other especially vulnerable social group. Even assuming such an inequitable distribution of risks would occur, he maintains, attempting to avoid such an outcome is not a good reason to deny assisted (...) suicide to “competent persons who truly voluntarily choose it.”Those of us who worry that legalization will differentially burden already disadvantaged segments of society have generally taken it for granted that the possibility of such disparities raises significant public policy concerns. By insisting on an explanation of this assumption — and, in so doing, making explicit the tension between autonomy and equality that underlies the assisted suicide debate — Lindsay has significantly advanced the ongoing conversation. While I disagree with his analysis, I commend him for a thoughtful, provocative, and important contribution to the literature. (shrink)

The question of legalizing physician-assisted suicide has become a serious public debate. Growing interest in assisted suicide reflects a public increasingly fearful of the process of dying, particularly the prospect of dying a painful, protracted, or undignified death. PAS has been proposed as a compassionate response to unrelievable suffering, designed to give terminally or incurably ill individuals direct control over the timing, manner, and circumstances of their death. Although the American Medical Association remains firmly opposed to legalizing PAS, many physicians (...) have begun to express support for the practice, and some have acknowledged that they have helped patients commit suicide despite the existing legal ban.As support for PAS grows, it becomes increasingly likely that the practice will be legalized in at least some states in the not-too-distant future. In 1994, Oregon voters approved a referendum legalizing PAS for competent, terminally ill patients; a federal court injunction preventing the referendum from going into effect is currently on appeal, and it is widely expected that the injunction will be lifted. (shrink)

The question of legalizing physician-assisted suicide has become a serious public debate. Growing interest in assisted suicide reflects a public increasingly fearful of the process of dying, particularly the prospect of dying a painful, protracted, or undignified death. PAS has been proposed as a compassionate response to unrelievable suffering, designed to give terminally or incurably ill individuals direct control over the timing, manner, and circumstances of their death. Although the American Medical Association remains firmly opposed to legalizing PAS, many physicians (...) have begun to express support for the practice, and some have acknowledged that they have helped patients commit suicide despite the existing legal ban.As support for PAS grows, it becomes increasingly likely that the practice will be legalized in at least some states in the not-too-distant future. In 1994, Oregon voters approved a referendum legalizing PAS for competent, terminally ill patients; a federal court injunction preventing the referendum from going into effect is currently on appeal, and it is widely expected that the injunction will be lifted. (shrink)

Under the Common Rule, federally-supported activities involving human participants are presumptively required to undergo prospective ethics review if they are “designed to develop or contribute to generalizable knowledge.” However, the “generalizable knowledge” standard is inherently ambiguous; moreover, it is both over- and under-inclusive of the type of activities that warrant prospective ethical oversight. Rather than conditioning prospective ethics review on an ethically irrelevant criterion like the generalizable knowledge standard, this article proposes that prior ethics review should be required when some (...) individuals are exposed to greater-than-minimal risks for the potential benefit of others, at least when the activity in question is conducted or supported by federal agencies. Under such an approach, the fact that an activity constitutes research would be neither necessary nor sufficient to trigger prospective ethical oversight. (shrink)

In recent years, the government, advocacy organizations, the press, and the public have pressured universities, academic medical centers, and physicianinvestigators to do more to ensure that their financial interests and relationships do not conflict with their duties to conduct high-quality research and protect the safety and welfare of clinical trial participants. A number of factors underlie the increased focus. First, private sector funding of clinical research has grown both in absolute terms and as a proportion of overall funding. In 2008, (...) the pharmaceutical, medical device, and biotechnology industries’ domestic research and development expenditures constituted approximately 60.9% of funding for biomedical research in the United States; the next largest funder, the National Institutes of Health, funded 27.9%. Private industry spent $58.6 billion on research in 2007, up from $40 billion in 2003, an increase of 25% after adjusting for inflation. (shrink)

Among the many explanations for antibiotic overprescription, some doctors cite the risk of malpractice liability if they deny a patient's request for an antibiotic and the patient's condition worsens. In this paper, I examine the merits of this concern—i.e., whether physicians could, in fact, face malpractice liability for refusing to prescribe an antibiotic when, from a public health perspective, the use of the antibiotic would be considered inappropriate. I conclude that the potential for liability cannot be dismissed entirely, but the (...) risk is remote—even in cases where there is a chance that the antibiotic might have benefited the patient. (shrink)

On November 8, 1994, Oregon became the first state in the nation to legalize assisted suicide. Passage of Proposition 16 was a milestone in the campaign to make assisted suicide a legal option. The culmination of years of effort, the Oregon vote followed on the heels of failed referenda in California and Washington, and other unsuccessful attempts to enact state laws guaranteeing the right to suicide assistance. Indeed, in 1993, four states passed laws strengthening or clarifying their ban against assisted (...) suicide. No doubt, Proposition 16 is likely to renew the effort to legalize assisted suicide at the state level.The battle over assisted suicide is also unfolding in the courts. Litigation challenging Proposition 16 on the grounds that it violates the equal protection clause is ongoing in Oregon. More significantly, three cases, two in federal courts and one in Michigan state court, have been brought to establish assisted suicide as a constitutionally protected right. (shrink)

In response to the increasing number of mentally ill people experiencing homelessness, some policy‐makers have called for the expanded use of involuntary commitment, even for individuals who are not engaging in behaviors that are immediately life‐threatening. Yet there is no evidence that involuntary commitment offers long‐term benefits, and significant reasons to believe that expanding the practice will cause harm. In addition, these proposals ignore research showing that most people with mental illness have the capacity to make medical decisions for themselves. (...) Rather than expanding the use of involuntary commitment, policy‐makers should support approaches proven to decrease the prevalence of homelessness, such as supportive housing. In addition, states should reevaluate their commitment standards for persons who pose no risk of harm to others. One promising approach is Northern Ireland's Mental Health Capacity Act of 2016, which establishes a uniform standard for imposing nonconsensual health care interventions, without any distinction between mental illnesses and other conditions in which capacity might be compromised. (shrink)