In December 2013, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) released its report titled Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts. The report outlines the types of findings that can arise from tests and procedures in several biomedical contexts, and makes 17 recommendations regarding the ethical and professional management of these findings.

Building on the work of that report, in April 2014, the Bioethics Commission released a primer for institutional review boards (IRBs) designed to aid IRB members as they review research protocols, grapple with the issues related to incidental and secondary findings, and help researchers understand how they might implement the Bioethics Commission’s recommendations.

This webinar focused on the Bioethics Commission’s recommendations for ethically managing the incidental and secondary findings that arise in research. Bioethics Commission staff members demonstrated how IRB staff can conduct a training session for their members and for researchers using the IRB primer and:

• Answered frequently asked questions about incidental and secondary findings, when they are likely to arise, and how researchers should plan for their ethical management
• Described arguments in favor of returning—and not returning—results
• Highlighted four basic ethical principles that apply to the management of incidental and secondary findings
• Explained relevant considerations for crafting an ethical plan for management of incidental and secondary findings
• Demonstrated how IRB members can use a list of considerations that is included in the primer to evaluate research protocols