2014 Webinar: Ethical Management of Incidental and Secondary Findings

View the webinar archive.

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

Audience

This intermediate-level webinar was of interest to IRB chairs, members, administrators, and staff.

Faculty

Elizabeth PikeElizabeth Pike, JD, LLM, is a senior policy and research analyst with the Bioethics Commission, and was staff lead on the Commission’s report Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts. Elizabeth is an alumni of Swarthmore College and Georgetown University Law Center, and received an LLM in global health law. Elizabeth spent three years in private practice and worked as a legal researcher for the International Criminal Tribunal for Rwanda. Most recently, Elizabeth worked as a post-doctoral fellow in the NIH Department of Bioethics where she focused on compensation for research-related injuries and incidental findings in genetic research. Her work on these topics has been presented at national conferences and has been published in the Georgetown Law Journal, the Nebraska Law Review, the American Journal of Law and Medicine, and the Journal of Medical Ethics.

Nicolle StrandNicolle K. Strand, JD, M.Bioethics, is a research analyst with the Bioethics Commission. She received her BA in bioethics from Wellesley College, and her JD and Masters in Bioethics from the University of Pennsylvania, where she was an editor of the Journal of Constitutional Law and the director of the Reproductive Rights Law Project. She has interned at the US Food and Drug Administration, the Framingham Heart Study, and the New York City Legal Aid Health Law Unit. She was a law clerk at Penn’s Office of General Counsel, where she worked on interpreting state health regulations and modifying hospital policies and procedures. She has published in the area of informed consent for genetic research, and incidental findings in genetic research. Nicolle has contributed to several of the Bioethics Commission’s reports, including Privacy and Progress in Whole Genome Sequencing, and Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings. Her work has been presented at several national conferences.

Certificates of Attendance

Certificates of attendance for the Anticipate and Communicate for IRBs: Ethical Management of Incidental and Secondary Findings webinar were made available at the conclusion of the webinar. To access the certificate, you must first complete the online evaluation. Such certificates are useful for obtaining continuing education (CE) credits (not Continuing Medical Education credits) from professional associations. Note that guidelines concerning CE credits may differ, and you should consult the appropriate professional association representative for further guidance.

CE Credit for Certified IRB Professional (CIP®) Recertification
Webinar participants holding the CIP credential who wish to apply credits from Anticipate and Communicate for IRBs: Ethical Management of Incidental and Secondary Findings toward CIP recertification may submit the Certificate of Attendance they received upon completing the online evaluation as documentation of their participation. Participation in this 90-minute webinar counts as 1.5 CE credit hours. 

For recertification by CE, CIPs must complete 30 documented hours of continuing education. At least 15 of the 30 hours must either carry credits issued by a recognized accrediting body or have received advanced recognition from the Council for Certification of IRB Professionals (CCIP). Credits from PRIM&R webinars have received such advance recognition, and may be counted towards these 15 hours.

Additional information about CIP recertification can be found here.