Considering Actionability at the Participant's Research Setting Level for Anticipatable Incidental Findings from Clinical Research

Wolf et al. define an incidental finding (IF) as “... a finding concerning an individual research participant that has potential health or reproductive importance and is discovered in the course of conducting research but is beyond the aims of the study...” Wolf et al. also propose that researchers “... should consider what kinds of IFs the protocol may produce and how rapidly the identification and evaluation process needs to proceed to provide timely information to the research participant and avoid harm.” Recently, the U.S. Presidential Commission for the Study of Bioethical Issues considered the matter of IFs. In the Commission's December 2013 report on this topic, “Anticipate and Communicate–Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts,” the panel further defines two categories of IFs, anticipatable and un-anticipatable, as well as introduces the concept of secondary findings. The commission recommends that researchers should develop plans to manage anticipatable IFs, and should consider to actively look for secondary findings.