Two staff members of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) will lead the October 2014 webinar for Public Responsibility in Medicine and Research (PRIM&R). Elizabeth Pike, J.D., L.L.M., Senior Policy and Research Analyst, and Nicolle K. Strand, J.D., M. Bioethics, Research Analyst, will present “Anticipate and Communicate for IRBs: Ethical Management of Incidental and Secondary Findings” on Tuesday, October 7, 2014 from 1-2:30 p.m. The webinar will focus on helping IRB members and staff interpret the Bioethics Commission’s December 2013 report Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts. The webinar is free and open to both PRIM&R members and nonmembers; those wishing to attend the webinar are encouraged to register early online on the PRIM&R website.
The Bioethics Commission has defined incidental findings as discoveries that lie outside the original aim of a test or procedure; secondary findings are also not the primary target of the testing but, unlike incidental findings, they are actively sought. Anticipate and Communicate contains specific recommendations for the clinical, research, and direct-to-consumer settings as well as broader recommendations for the management of incidental and secondary findings to help anticipate and communicate unanticipated findings from research.
Pike will open the webinar with a summary of the 2013 report’s analysis and recommendations, focusing specifically on the research context. She will highlight the practical, ethical, and legal challenges to managing incidental and secondary findings in research and will discuss the role IRBs can play in implementing the Bioethics Commission’s recommendations.
In addition to the report, the Bioethics Commission has also released a number of educational materials for practitioners as well as recipients on incidental and secondary findings, and Strand will describe how IRBs can use the educational materials. Specifically, Strand will demonstrate how to use the Bioethics Commission’s IRB primer to conduct training sessions for IRB members to help prepare them as they assess plans on the management of these findings. In addition, Strand will describe a piece designed for research participants from the Bioethics Commission’s “Conversation Series”—a one-page description of incidental findings that might arise in research and how to prepare for them—and will demonstrate how researchers could use this additional resource as a part of the consent process.
Pike and Strand look forward to a robust question and answer session following the presentations.
All educational materials produced by the Bioethics Commission are available for free at http://bioethics.gov/education.