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Abstract:
Our system of protecting human subjects in medical research faces an unprecedented crisis. In addition to a few highly publicized scandals in which previously healthy individuals died during the course of clinical trials, a series of government investigations has documented significant deficiencies in the system's capacity to ensure compliance with federal regulations governing human subject protection. There is widespread consensus that any effective reform program must do something to improve the existing system of institutional review boards (IRBs), the committees within research institutions that decide which protocols can go forward and under what conditions. However, most of the current discussion about IRB reform has focused on questions about the basic structure of the IRB system, ignoring important process-oriented questions about how IRBs actually decide which protocols to accept, reject, or revise. To fill this gap, Professor Coleman takes a critical look at the process IRBs use to review research protocols, focusing specifically on risk assessment, one of the most important, and least understood, elements of protocol review. He argues that IRBs' current approach to risk assessment closely mirrors the deliberative process used by common-law juries, and that in both juries and IRBs this process suffers from considerable flaws. After examining the limitations of a jury approach to risk assessment determinations, Professor Coleman explains why our willingness to tolerate these limitations in the context of jury deliberations does not mean they also should be accepted in IRB review. He argues that, in place of the ill-fitting model of the common-law jury, IRBs should incorporate decision-making mechanisms used by judges and administrative agencies, including reasoning by analogy, written opinions, appellate review and precedent, and notice-and-comment rulemaking. He shows how adopting these strategies could improve the quality of IRB risk assessments, and examines the practical considerations such changes are likely to raise.

Human subject research, risk assessment, institutional review boards, juries, analogical reasoning

Abstract:
Clinical trials pose a fundamental conflict between physicians' commitment to protecting the medical best interests of current patients and the goal of producing scientific knowledge for the potential benefit of patients in the future. While this conflict has long been of interest to physicians and bioethicists, it has largely escaped the attention of legal scholars. That is likely to change, however, as a growing wave of litigation brought by individuals injured in clinical trials will force courts to determine the nature of researchers' legal obligations to subjects. In making these determinations, this Article argues, courts must recognize that medical research is fundamentally different from ordinary clinical treatment, in terms of both its underlying purposes and its methodology. In light of these differences, requiring researchers to adhere to the same therapeutic obligations as treating physicians, as some commentators have advocated, would be tantamount to a virtual prohibition of clinical trials, an outcome that courts should reject. At the same time, it would be a mistake to hold that researchers have no duty whatsoever to protect the medical best interests of individual subjects. This Article therefore develops an alternative framework for conceptualizing researchers' duties to subjects, using principles governing conflicts of interests in fiduciary relationships a starting point for analysis. These principles demonstrate that it is possible to protect vulnerable individuals in dependent relationships without absolutely precluding the pursuit of goals that potentially conflict with those individuals' overall welfare. Importantly, however, consent is generally insufficient to justify deviations from the pursuit of the best interests of the beneficiary in a fiduciary relationship; instead, the law imposes additional requirements to ensure that such deviations are objectively fair. After explaining why a similar approach makes sense in the context of clinical trials, this Article provides a specific framework for using those principles to resolve conflicts between the pursuit of scientific knowledge and subjects' medical needs.

Human subject, research, duty, fiduciary

Abstract:
In anticipation of pandemics and other mass disasters, several states have enacted little-known laws that authorize government officials to order health care professionals to work during declared public health emergencies, even when doing so would pose life-threatening risks. Health care professionals who violate these orders could face substantial penalties, ranging from license revocations to fines and imprisonment. The penalties would apply even to individuals whose jobs do not normally involve clinical responsibilities, as well as to health care professionals who are retired or taking time off from work to care for their families. This Article argues that these laws impose burdens that exceed the ethical commitments individuals make when they accept a professional license. In so doing, they compel health care professionals to engage in what is normally considered supererogatory behavior -- i.e., acts that are commendable if done voluntarily, but that go beyond what is expected.

In making this argument, the Article rejects commonly-made assertions about health care professionals' ethical obligations, including the claim that health care professionals assumed the risk of infection; that a social contract requires health care professionals to work despite potential health risks; and that individuals who have urgently-needed skills have an obligation to use them. It concludes that, while health care professionals can legitimately be sanctioned for violating voluntarily-assumed employment or contractual agreements, they should not be compelled to assume life-threatening risks based solely on their status as licensed professionals. In place of singling out health care professionals for punitive measures, the Article argues that policy-makers should institute mechanisms to promote volunteerism.

health care professionals, pandemic, ethical obligations, assumption of risk, social contract, licensing

Abstract:
Applying the concept of disability discrimination to decisions about medical treatment poses profound challenges for both civil rights law and bioethics. To the extent this challenge has been examined in the legal literature, the focus has largely been limited to the application of the Americans with Disabilities Act (ADA) to decisions about life-sustaining treatment. Yet, at the other end of life's continuum - decisions about the use of medical procedures to help individuals conceive a child (collectively known as "assisted reproductive technologies," or ARTs) - the legal implications of disability-related eligibility criteria remain largely unexplored. This is surprising, as some ART practitioners take a variety of disability-related factors into account in patient selection decisions. For example, some physicians refuse to provide ARTs to patients who are HIV-positive, to patients with other chronic medical conditions, or to patients with certain genetic diseases. The extent of disability-related denials of ARTs is impossible to determine, but it is undoubtedly significant. Indeed, until February 2002, the American Society for Reproductive Medicine expressly supported the exclusion of HIV-positive patients from ART programs.

Applying the ADA to denials of treatment by ART practitioners raises particularly challenging legal and ethical issues. On the one hand, the danger that physicians will inappropriately deny treatment to patients with disabilities is especially worrisome in the context of ARTs, given the widespread stigma associated with reproduction by individuals with disabilities. On the other hand, patients' disabilities may sometimes have potentially devastating implications for any child resulting from treatment, including the possibility that the child will be born with life-threatening or seriously debilitating impairments. Some physicians have strong ethical objections to helping patients become pregnant in the face of such risks.

This article develops a framework for applying the ADA to disability-based denials of ARTs that addresses these competing considerations. In recognizing risks to the future child as a potential defense to an ADA claim, it rejects the view of some commentators that such risks are relevant to reproductive decisions only if the child is likely to suffer so much that she would prefer not to exist. Instead, it proposes that, when patients' disabilities create significant risks to the future child, the question should be how the risks and benefits of the patient's requested treatment compare to those associated with other available reproductive and parenting options. This comparative analysis would be required only when the patient's disabilities create a significant risk that the child's health will fall below a minimum threshold; indirect risks to the child resulting from patients' disabilities would not be taken into account.

While the approach recommended in this article would permit physicians to deny ARTs to patients with disabilities in some circumstances, it also would invalidate many disability-based selection criteria currently in use.

disability, ADA, assisted reproductive technologies, in vitro fertilization, HIV, genetics

Abstract:
The amount of medical research with persons who lack decision-making capacity is rapidly increasing, but in most states it takes place without clear legal authority. In addition to creating significant liability risks for researchers and persons who provide consent on behalf of incapacitated subjects, the lack of explicit legal standards means that few, if any, safeguards exist to protect incapacitated persons' rights and welfare. Previous efforts to close the gap between clinical reality and legal requirements have failed in part because they have not provided a coherent or persuasive ethical justification for permitting this research. This Article seeks to fill that void by proposing a new way of thinking about the ethics of research with incapacitated persons, grounded in a long-term, systemic approach to risk-benefit assessment. This approach explains why it is ultimately in incapacitated persons' best interests to be governed by a policy that permits them to be enrolled in research without their personal authorization¿even if such a policy puts them at risk of participating in studies that, when viewed in isolation, may involve more burdens than benefits. Unlike other approaches, the framework developed here does not depend on false analogies between participating in research and receiving medical treatment, or dubious claims about family members' inherent authority or incapacitated persons' obligations to society. Because the proposed framework directly responds to the criticism that research with incapacitated persons is a form of exploitation, it may increase the likelihood that proposals to authorize this research will actually be adopted. It also has important implications for both how laws governing research with incapacitated persons should be structured, and the roles and responsibilities of surrogate decision makers.

medical research, human subjects, incapacity, surrogate consent

Abstract:
Countries are increasingly devoting significant resources to creating or strengthening research ethics committees (RECs) to review research involving human participants, but there has been insufficient attention to assessing whether these committees actually provide significant benefits to research participants or their communities. This article examines the obstacles RECs face in achieving their goals and the strengths and limitations of existing methods to assess RECs' effectiveness. It then proposes specific mechanisms for incorporating outcomes-oriented questions into the process of REC oversight.

research, health, medicine, ethics, developing countries, accreditation, quality assurance, outcomes assessment