title: Considering Actionability at the Participant's Research Setting Level for Anticipatable Incidental Findings from Clinical Research.
abstract: Determining what constitutes an anticipatable incidental finding (IF) 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" (APRSL) 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.
authors.affiliation: Contractor, HJF-DAIDS, Clinical Research Implementation SME, Protection of Participants, Evaluation, and Policy Branch (ProPEP), OPCRO/DAIDS/NIAID/NIH/DHHS.
authors.forename: Alberto Betto
authors.initials: AB
authors.lastname: Ortiz-Osorno
authors.affiliation: Senior Nurse Consultant, ProPEP, OPCRO/DAIDS/NIAID/NIH/DHHS.
authors.forename: Linda A
authors.initials: LA
authors.lastname: Ehler
authors.affiliation: Branch Chief, ProPEP, OPCRO/DAIDS/NIAID/NIH/DHHS.
authors.forename: Judith
authors.initials: J
authors.lastname: Brooks
mesh_terms: D035843:Biomedical Research / Q000941:ethics*; D004991:Ethics, Institutional; D006801:Humans; D033162:Incidental Findings; D000070516:Intersectoral Collaboration; D035842:Research Subjects; D012935:Social Justice