Recently, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) facilitated a didactic workshop session at the Public Responsibility in Medicine and Research (PRIM&R) Advancing Ethical Research Conference. This past Saturday, December 6, Bioethics Commission staff led the workshop IRB Primer: Incidental and Secondary Findings. The presentation provided an overview of the Commission’s recommendations regarding discoveries that lie outside the original aim of a test or procedure, and introduced educational materials to inform and support institutional review board (IRB) members, who often review protocols that include concerns about the ethical management of these findings.
Elizabeth Pike began with a brief introduction to the Bioethics Commission’s report Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts. She emphasized the Commission’s main message: The ethical management of incidental and secondary findings requires that practitioners in all contexts anticipate and communicate. Practitioners should anticipate the incidental and secondary findings that can arise from a particular test or procedure and communicate how those findings will be managed to a potential recipient. She also noted the role of IRBs in reviewing research, and provided an overview of definitional issues, including what makes findings “incidental” or “secondary,” as well as the types of tests and procedures that commonly produce these findings.
Misti Ault Anderson then discussed the role of researchers. She highlighted various options researchers have to facilitate the ethical management of incidental and secondary findings, including informed consent processes, access to additional expertise, and opportunities to obtain participant preferences and disclose findings in accordance with these wishes.
Finally, Karen Meagher presented on the ethical considerations pertinent to IRB members when evaluating protocols in which incidental and secondary findings can arise. This overview included relevant ethical principles, such as respect for persons and beneficence, that IRBs can apply when evaluating researchers’ plans for ethical management of incidental and secondary findings. By considering a variety of options, PRIM&R attendees were able to envision multiple ways in which researchers can meet their responsibilities to participants, including different ways to establish clear communication.
In the second part of the session, staff members facilitated small group activities including the analysis of hypothetical research case studies involving large-scale genetic sequencing, testing of biological specimens, and imaging. Small groups considered the case studies, and reported out to the larger group about how researchers might design ethical protocols regarding the management of incidental and secondary findings, generating a lively group discussion. One attendee noted how IRBs also benefit from planning ahead, as thinking through difficult decisions before they arise is preferable to reacting after an incidental or secondary finding has been discovered, when available options might be limited or the timing of decisions more urgent. Session attendees enriched discussion by sharing their own past experiences and insights gained from a wide variety of professional backgrounds in research ethics.
By prompting audience consideration of the ethical issues that arise when considering research that might produce incidental and secondary findings, staff members demonstrated how professionals can make use of Bioethics Commission educational resources in support of important ongoing work in research ethics.