Determining what constitutes an anticipatable incidental finding from clinical research and defining whether, and when, this IF should be returned to the participant have been topics of discussion in the field of human subject protections for the last 10 years. It has been debated that implementing a comprehensive IF-approach that addresses both the responsibility of researchers to return IFs and the expectation of participants to receive them can be logistically challenging. IFs have been debated at different levels, such as the (...) ethical reasoning for considering their disclosure or the need for planning for them during the development of the research study. Some authors have discussed the methods for re-contacting participants for disclosing IFs, as well as the relevance of considering the clinical importance of the IFs. Similarly, other authors have debated about when IFs should be disclosed to participants. However, no author has addressed how the “actionability” of the IFs should be considered, evaluated, or characterized at the participant's research setting level. This paper defines the concept of “Actionability at the Participant's Research Setting Level” for anticipatable IFs from clinical research, discusses some related ethical concepts to justify the APRSL concept, proposes a strategy to incorporate APRSL into the planning and management of IFs, and suggests a strategy for integrating APRSL at each local research setting. (shrink)

It has been debated for quite some time among bioethicists and others whether or not the distinction between therapy and research in healthcare can and should be maintained. This paper tries to clarify what the disagreement is about, and argues that the distinction can be maintained in most, if not all, situations. However, even if it can be maintained, it does not necessarily follow that it should. It is argued here that there are good reasons to maintain the distinction both (...) for the sake of protecting research interests and the sake of patient safety. In addition, recognizing the distinction provides a barrier against unreasonable prioritization between patients. However, there may be situations, such as innovative last-resort treatment, in which regulatory requirements from both therapy and research should be considered. (shrink)

A current trend in bioethics considers genetic information as family property. This paper uses a logical approach to critically examine Matthew Liao’s proposal on the familial nature of genetic information as grounds for the duty to share it with relatives and for breach of confidentiality by the geneticist. The authors expand on the topic by examining the relationship between the arguments of probability and the familial nature of genetic information, as well as the concept of harm in the context of (...) genetic risk. Lastly, they examine the concept of harm in relation to the type of situations w the potential recipient of the information is not the person directly affected by the risk. (shrink)