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New Educational Primers to Accompany Anticipate and Communicate

As part of its ongoing effort to support bioethics education, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has developed and posted to a new primer to inform institutional review boards (IRBs) and their members on the ethical management of incidental and secondary findings. The Bioethics Commission designed the IRB Primer to aid IRB members as they review research protocols, grapple with the issues related to incidental findings, and help researchers implement the Bioethics Commission’s recommendations in Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts.

Members of the Bioethics Commission discuss the main message of that report in a video recently posted to Bioethicsgov on YouTube:  in short, practitioners—across contexts—should anticipate potential incidental and secondary findings and make a plan for managing them.  In the research context, IRBs play a crucial role in ensuring that researchers have anticipated and planned for incidental findings.

The IRB Primer begins with a set of frequently asked questions, including: What are incidental and secondary findings? What are some tests and procedures that could give rise to incidental and secondary findings? These introductory questions will help IRB members assess whether the protocols they review might encounter issues related to incidental findings.

The primer also includes helpful tables, including the Bioethics Commission’s taxonomy of findings, and a table describing relevant ethical principles and their application to incidental and secondary findings.

The goal of the primer is to help IRBs evaluate whether researchers and institutions have fully prepared for incidental and secondary findings that might arise in their protocols, and whether they have taken relevant considerations into account. It describes a variety of factors that contribute to an ethical plan, including informed consent, expertise, participant preferences, and researcher responsibilities.

All Bioethics Commission educational materials are available for free download at  In the coming weeks, two additional sets of primers to accompany Anticipate and Communicate will be posted to one set to guide practitioners who might discover incidental findings, including clinicians, researchers, and DTC providers; and another set to guide potential recipients of incidental findings, including patients, research participants, and DTC consumers. The Bioethics Commission encourages feedback on the materials at


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