Investigators and institutional review boards should integrate plans about the appropriate disclosure of individual genetic results when designing research studies. The ethical principles of beneficence, respect, reciprocity, and justice provide justification for routinely offering certain results to research participants. We propose a result-evaluation approach that assesses the expected information and the context of the study in order to decide whether results should be offered. According to this approach, the analytic validity and the clinical utility of a specific result determine whether (...) it should be offered routinely. Different results may therefore require different decisions even within the same study. We argue that the threshold of clinical utility for disclosing a result in a research study should be lower than the threshold used for clinical use of the same result. The personal meaning of a result provides additional criteria for evaluation. Finally, the context of the study allows for a more nuanced analysis by addressing the investigators' capabilities for appropriate disclosure, participants' alternative access to the result, and their relationship with the investigators. This analysis shows that the same result may require different decisions in different contexts. (shrink)

Many research ethics guidelines now oblige researchers to offer research participants the results of research in which they participated. This practice is intended to uphold respect for persons and ensure that participants are not treated as mere means to an end. Yet some scholars have begun to question a generalised duty to disclose research results, highlighting the potential harms arising from disclosure and questioning the ethical justification for a duty to disclose, especially with respect to individual results. In support of (...) this view, we argue that current rationales for a duty of disclosure do not form an adequate basis for an ethical imperative. We review policy guidance and scholarly commentary regarding the duty to communicate the results of biomedical, epidemiological and genetic research to research participants and show that there is wide variation in opinion regarding what should be disclosed and under what circumstance. Moreover, we argue that there is fundamental confusion about the notion of “research results,” specifically regarding three core concepts: the distinction between aggregate and individual results, amongst different types of research, and across different degrees of result veracity. Even where policy guidance and scholarly commentary have been most forceful in support of an ethical imperative to disclose research results, ambiguity regarding what is to be disclosed confounds ethical action. (shrink)

The notion that it is useful to specify norms progressively in order to resolve doubts about what to do, which I developed initially in a 1990 article, has been only partly assimilated by the bioethics literature. The thought is not just that it is helpful to work with relatively specific norms. It is more than that: specification can replace deductive subsumption and balancing. Here I argue against two versions of reliance on balancing that are prominent in recent bioethical discussions. Without (...) meaning to address the substance or the overall merits of either view I criticize, I attack Gert, Culver and Clouser's implicit reliance on some overall dimension of balancing as a basis of resolving conflicts among norms and Beauchamp and Childress's residual acceptance of 'justified balancing'. The former authors' description of resolving conflicts depends upon a type of value commensurability that (as they otherwise seem to admit) does not obtain, while the latter authors' role for justified balancing would be better served by continued specification. (shrink)