Deception, cheating, and loopholes within the IRB approval process have received significant attention in the past several years. Surveys of clinical researchers indicate common deception ranging from omitting information to outright lying, and controversy surrounding the FDA's decision not to ban “IRB shopping” (the practice of submitting protocols to multiple IRBs until one is found that will approve the protocol) has raised legitimate concerns about the integrity of the IRB process. While at first blush these practices seem to cast aspersions (...) on the integrity of clinical researchers, the moral issues raised go deeper than the ethics of cheating. To the extent that these practices are common, or represent an IRB system that places unreasonable burdens on those seeking IRB approval, we should consider whether non-compliance reflects problems of normative legitimacy for the IRB system itself. (shrink)
Numerous grounds have been offered for the view that healthcare workers have a duty to treat, including expressed consent, implied consent, special training, reciprocity (also called the social contract view), and professional oaths and codes. Quite often, however, these grounds are simply asserted without being adequately defended or without the defenses being critically evaluated. This essay aims to help remedy that problem by providing a critical examination of the strengths and weaknesses of each of these five grounds for asserting that (...) healthcare workers have a duty to treat, especially as that duty would arise in the context of an infectious disease pandemic. Ultimately, it argues that none of the defenses is currently sufficient to ground the kind of duty that would be needed in a pandemic. It concludes by sketching some practical recommendations in that regard. (shrink)
In clinical mental health research with children, both child and parent are essential members of the research team. The 3 R's of parent/child team membership are respect, rapport, and recognition. Respect and recognition include fair reimbursement for time, expense, and inconvenience, but the most important compensation for many families is the appreciation of the other team members for their sacrifice and cooperation. Reimbursement, although honoring the principles of justice and respect for persons, raises difficult issues about appropriate amount, particularly in (...) research involving children. The 3 R's are supported by the investigator 5 A's: attitude, adaptability, availability, attachment, and appreciation. Although the principles seem clear in the abstract, implementation encounters many practical problems. Perhaps the most difficult of these is determining the appropriate amount of compensation that avoids undue inducement but not at the expense of the 3 R's and 5 A's. (shrink)
Post-9/11, concern about bioterrorism has transformed public health from unappreciated to a central component of national security. Within the War on Terror, bioterrorism preparedness has taken a back seat only to direct military action in terms of funding. Domestically, homelessness, joblessness, crime, education, and race relations are just a few of a litany of pressing issues requiring government attention. Even within the biomedical sciences and healthcare, issues surrounding the fact that more than 40 million Americans lack health insurance, the rising (...) cost of prescription medications, and the use of government funds for research using embryonic stem cells remain unresolved. Should we prioritize a hypothetical threat (bioterrorism), or existing conditions that have implications for identifiable individuals? Even more fundamentally, should we prioritize research aimed at defense from bioterrorism (or even terrorism in general) when there are so many pressing social problems that affect the U.S. population? (shrink)
Journalists seldom consider the layers of those affected by their actions; third parties such as families, children, and even people unlucky enough to be in the wrong place at the wrong time. This article argues for consideration of the broader group, considering a range of options available for doing their duty to inform the public while also minimizing harm to others. Journalists might compare themselves with other professions that have similar roles, such as anthropologists, on such issues as confidentiality and (...) disclosure. A broader lesson is the value of applying different views, theoretical frameworks, and starting points to the ethical issues in any profession. (shrink)
: In June 2002, the Advisory Committee on Immunization Practices (ACIP) approved draft recommendations concerning preparation for potential biological terror attacks that utilize the smallpox virus. ACIP recommends against both mandatory and voluntary vaccination of the general public. The present paper examines the moral and political considerations both for and against each of the general public vaccination options considered by the ACIP in the context of the state's authority over vaccination for the purposes of protecting public health. Although it is (...) clear that compulsory mass vaccination is not justified at this time, the issues surrounding voluntary vaccination are more complex. Should smallpox vaccination prior to an outbreak be made available to the general public? The paper concludes that the vaccine should not be made available at this time. This conclusion, however, is based upon contingent features of current circumstances, which would change once an outbreak occurred. In the event of a terror-related outbreak of smallpox, the general public's access to voluntary vaccination would become justified, even in areas beyond where the outbreak has occurred. (shrink)
Issues concerning patients' rights are at the center of bioethics, but the political basis for these rights has rarely been examined. In Bioethics in a Liberal Society: The Political Framework of Bioethics Decision Making , Thomas May offers a compelling analysis of how the political context of liberal constitutional democracy shapes the rights and obligations of both patients and health care professionals. May focuses on how a key feature of liberal society -- namely, an individual's right to make independent decisions (...) -- has an impact on the most important relational facets of health care, such as patients' autonomy and professionals' rights of conscience. Although a liberal political framework protects individual judgments, May asserts that this right is based on the assumption of an individual's competency to make sound decisions. May uses case studies to examine society's approach to medical decision making when, for reasons ranging from age to severe mental disorder, a person lacks sufficient competency to make independent and fully informed choices. To protect the autonomy of these vulnerable patients, May emphasizes the need for health care ethics committees and ethics consultants to help guide the decision-making process in clinical settings. Bioethics in a Liberal Society is essential reading for all those interested in understanding how bioethics is practiced within our society. (shrink)
The multidisciplinary nature of bioethics can result in narrow sub-specialists within the field, whose work reflects the issues and concerns most relevant to their home discipline. This can result in work which is insensitive to the important ways in which particular areas of bioethics are interrelated, and which (while viable in the context of the sub-specialty) is not viable in a broader context. The narrow focus of many healthcare ethics committees on issues directly related to clinical patient care can exacerbate (...) this problem. Increasingly, issues in the clinical care of patients cannot be separated from issues in research, organizational ethics, and public policy. I argue that these problems call for a need to identify core areas for bioethics education. This is especially true for education of hospital ethics committees, which incresingly face complex cases involving concerns that fall outside traditional patient care issues. I then consider nine areas examined in detail in A Companion to Bioethics edited by Helga Kuhse and Peter Singer, as potential candidates for core areas of bioethics education. At the same time, I evaluate the range of issues examined in each area of the book, in the context of the books ability to provide an introduction to each area. (shrink)
This paper argues for the importance of the political context of a society for bioethics. In particular, I argue that in a liberal constitutional society, such as the one we find ourselves in, no particular moral perspective is granted a privileged position. Rather, individuals are allowed to live their lives according to values they adopt for themselves, and the rights granted to protect this ability “trump” social consensus, and place boundaries on the social application of personal moral beliefs and values.
