: Ulysses contracts have faced paternalism objections since they first were proposed. Since the contracts are designed to override a present request from a legally competent patient in favor of a past request made by that patient, enforcement of these contracts was argued to be unjustifiable strong paternalism. Recent legal developments and new theories of practical reasoning suggest that the discussion of Ulysses contracts should be revived. This paper argues that with a proper understanding of the future-directed planning embodied in (...) Ulysses contracts, the charge of strong paternalism can be answered, and the enforcement of some Ulysses contracts may be justified under the rubric of weak paternalism. (shrink)

In this article, we develop a non-rights-based argument based on beneficence (i.e., the welfare of individuals and communities) and justice as the disposition to act justly to promote equity in health care resource allocation. To this end, we structured our analysis according to the following main sections. The first section examines the work of Amartya Sen and his equality of capabilities approach and outlines a framework of health care as a fundamental human need. In the subsequent section, we provide a (...) definition of health equity based on the moral imperative to guarantee that every individual ought to have the freedom to pursue health goals and well-being. In the later part of the article, we outline a non-right approach to health care based on three pillars: (1) human flourishing, (2) justice as a disposition not a process, and (3) solidarity. (shrink)

The American Journal of Bioethics, Volume 12, Issue 7, Page 53-54, July 2012.

This paper argues that it will be important for new genomic technologies to recognize the limits of traditional approaches to informed consent, so that other-regarding implications of genomic information can be properly contextualized and individual rights respected. Respect for individual autonomy will increasingly require dynamic consideration of the interrelated dimensions of individual and broader community interests, so that the interests of one do not undermine fundamental interests of the other. In this, protection of individual rights will be a complex interplay (...) between individual and community concerns. (shrink)

In this case, it is noted that while DNA testing and methylation are being studied as biomarkers for high-grade squamous intraepithelial lesions in the anal canal, their efficacy is no...

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)

How research studies should use social media to recruit research participants is a timely question. Importantly, the question is how, not if, studies should use...

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)

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” has raised legitimate concerns about the integrity of the IRB process. One author has described a multicenter trial as being withdrawn from consideration at one institution when rejection was imminent, in order to avoid informing other IRBs reviewing (...) the protocol of the study's rejection. This practice and IRB shopping seem at odds with the spirit, if not the “letter,” of the regulations. 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. (shrink)

Community and patient stakeholder partners serve in many roles. One particularly important role of community and patient organizations and representatives is to serve as gatekeepers; in this role, they monitor, and in some cases even determine, what research does and does not get conducted with their communities. Such gatekeeping can prevent “helicopter” research and community research fatigue. Gatekeeping can also aid in identifying and mitigating harms that might occur not only to individual participants but to third parties (who do not (...) provide consent for participation) or to the community as a whole. Although individual informed consent and independent review both aim to protect against research risks, in research with identifiable communities these protections may be insufficient to protect from other types of harms. Given the gaps in protection, the gatekeeping role of community research partners is an important supplement to informed consent and independent IRB review, but it also raises its own set of ethical challenges. Here, we discuss the limitations of informed consent and independent review in research with identifiable communities, the benefits of gatekeeping for protecting third parties and groups, types of gatekeepers, and issues in the selection of gatekeepers. (shrink)