Clinical research with adults who are unable to provide informed consent has the potential to improve understanding and care of a number of devastating conditions. This research also has the potential to exploit some of society's most vulnerable members. Recently, a number of task forces and individual writers have proposed guidelines to ensure that such research is both possible and ethical. Yet, there is widespread disagreement over which safeguards should be adopted. In the present paper, I consider to what extent (...) these disagreements can be resolved by appeal to a general account of the interests of subjects who are unable to consent and the conditions that must be satisfied for research enrollment to constitute exploitation of their inability to make their own decisions. (shrink)

Clinical research with adults who are unable to provide informed consent has the potential to improve understanding and care of a number of devasting conditions. This research also has the potential to exploit some of society's most vulnerable members. Recently, a number of task forces and individual writers have proposed guidelines to ensure that such research is both possible and ethical. Yet, there is widespread disagreement over which safeguards should be adopted. In the present paper, I consider to what extent (...) these disagreements can be resolved by appeal to a general account of the interests of subjects who are unable to consent and the conditions that must be satisfied for research enrollment to constitute exploitation of their inability to make their own decisions. (shrink)

The philosophical literature would have us believe that the conservative view on abortion is based on the claim that the fetus is a person from the time of conception. Given the widespread acceptance of this analysis, it comes as something of a surprise to learn that it conflicts with a number of major arguments offered in support of the conservative view. I argue, in the present paper, that a careful examination of these inconsistencies establishes that the personhood analysis is mistaken: (...) the conservative view is based on the natural process of fetal development, not the personhood of the fetus. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:When Should “Riskier” Subjects Be Excluded from Research Participation?*Dave Wendler** (bio)AbstractThe exclusion of potential subjects based on increased risks is a common practice in human subjects research. However, there are no guidelines to ensure that this practice is conducted in a systematic and fair way. This gap in the literature and regulations is addressed by a specific account of a “condition on inclusion risks” (CIR), a condition under which (...) potential subjects should be excluded from research on the basis of increased risks. This account provides a general framework for assessing standard exclusions as well as more controversial ones such as the exclusion of pregnant women and women of childbearing potential from certain types of research.The exclusion of potential subjects on the basis of increased risks is a common and, in most instances, noncontroversial practice in human subjects research. Investigators routinely exclude potential subjects with reduced kidney function, bleeding disorders, and allergies to the drugs under investigation. Surprisingly, this use of exclusion criteria takes place in the absence of any explicit guidelines. In the present paper, I attempt to fill this gap in the literature and regulations by offering a specific account of the conditions under which potential subjects should be excluded from research on the basis of increased risk. This account serves two purposes.First, subjects who are excluded on the basis of increased risk are prevented from making their own enrollment decisions. Therefore, it is important to ensure, in spite of the broad range of potential subjects and the varied reasons for excluding them, that potential subjects are excluded in [End Page 307] a systematic and fair way. Second, certain instances of subject exclusion, most notably the exclusion of pregnant women and women of childbearing potential, raise more difficult issues. By providing a general framework for assessing the exclusion of potential subjects based on increased risks, the present analysis covers these cases as well and, thus, offers a solution to one of the thornier ethical dilemmas facing investigators and IRBs today.Briefly, I argue that standard exclusion practices suggest that whenever two groups of potential research subjects offer the same opportunity for scientific and individual benefit, but different levels of risk, the group that would introduce greater risks should be excluded. With this framework in place, I consider potential subjects, such as men and women of child-parenting potential, whose research participation introduces increased risks to third parties. I argue that the present approach is justified, not because it reduces harms to specific individuals, but because it reduces aggregate harms. Therefore, it should be applied to all riskier potential subjects regardless of who faces the risks in question. After defending this approach, I consider several objections.First, I argue that the present approach is not paternalistic; the exclusions it calls for are not justified by what is thought to be in the best interests of the individuals excluded. Rather, the argument is that these exclusions minimize the aggregate harm of human subjects research. In addition, the present approach does not violate the obligation of researchers to respect subject autonomy because it does not reduce the number of potential subjects who are given the opportunity to enroll in a particular protocol. Finally, the exclusions are consistent with reasonable side constraints on attaining the goals of research.“Riskier” SubjectsWhen it comes to evaluating risks, most guidelines on human subjects research stipulate simply that the risks entailed must be reasonable given the potential for benefit. The Australian National Health and Medical Research Council’s guidelines, for instance, require only that “the investigator... must be satisfied that the possible advantage to be gained from the work justifies any discomfort or risk involved” (ANMRC 1992, Clause 3). To determine whether the risks of a protocol are justified, one sums the risks of the various procedures in the protocol, whatever those procedures may be, and compares the result to the procedures’ potential for benefit. This evaluation of risks assumes that the aggregate risks of a [End Page 308] given protocol are fixed and thus will not help to determine whether and when the risks of particular protocols should be reduced by excluding riskier subjects. The United States Department of Health... (shrink)

Volume 20, Issue 10, October 2020, Page 94-96.