Return of Individual Research Results:
the NASEM Report and the Role of the IRB

Return of Individual Research Results

the NASEM Report and the Role of the IRB

Online

Whether and how to return individual research results to subjects has been an ongoing area of uncertainty and controversy for investigators and research institutions. Often, experimental results are not validated, and disclosure could lead to harmful decisions on the part of the subject. Nevertheless, many subjects want and expect to receive their personal results after being involved in clinical research1. Further, the return of results is emerging as an important strategy to improve transparency and engagement with research subjects. Regulatory frameworks are beginning to acknowledge this: the revised Common Rule, for example, mandates that consent forms contain “a statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions.”2 However, many ethical and regulatory challenges remain.

On July 10, 2018, the National Academies of Science, Engineering, and Medicine (NASEM) released a report, "Return of Individual-Specific Research Results to Participants: Guidance for a New Research Paradigm", offering recommendations for “a process-oriented approach to returning individual research results that considers the value to the research subject, the risks and feasibility of return, and the quality of the research laboratory”3. During this webinar, two members of the NASEM committee will:

  • Summarize the NASEM report’s recommendations, with particular attention to potential implications for IRBs, including recommendations for IRBs to consider in their review of protocols that involve human biospecimens, plans for the return of results, plans for community engagement, and laboratory quality
  • Discuss the regulatory and legal challenges and tensions surrounding return of results with respect to HIPAA, CLIA, FDA regulations, and the revised Common Rule, and provide some considerations for IRBs within existing regulatory frameworks

What will I learn?

After attending this webinar, you will be able to:

  • Summarize the primary recommendations of the NASEM report on return of individual research results, including potential implications for IRBs
  • Identify some IRB strategies around return of individual research results

Who should attend?

This webinar will be beneficial for IRB professionals and members.


1 The National Academies of Sciences, Engineering, and Medicine. (2018). Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Retrieved from: https://www.nap.edu/catalog/25094/returning-individual-research-results-to-participants-guidance-for-a-new

2 Federal Policy for the Protection of Human Subjects, 45 CFR § 46.116(c)(8)

3 The National Academies of Sciences, Engineering, and Medicine. (2018). Returning Individual Research Results to Participants: Guidance for a New Research Paradigm (Report Highlights). Retrieved from: https://www.nap.edu/resource/25094/07102018_Return_of_Results_highlights.pdf

Continuing Education

Webinar participants holding the Certified IRB Professional (CIP®) credential may apply 1 continuing education credit towards CIP recertification.

Speakers

Amy McGuire, JD, PhD

Amy McGuire, JD, PhD

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Jeffrey Botkin, MD, MPH

Jeffrey Botkin, MD, MPH

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Additional Resources

 

A collection of relevant background reading, further reading, links, templates, checklists, and/or charts accompany each PRIM&R webinar. Groups that register for webinars receive a discussion guide containing thought-provoking questions and facilitation tips that may help in using the webinar as an educational tool for IRBs.

Background Reading:

National Academies of Science, Engineering, and Medicine. (2018). Consensus Study Report Highlights: Returning Individual Research Results to Participants: Guidance for a New Research Paradigm.

From the Director: Taking a look at the National Academies’ report on returning individual research results to participants
Blog post by Elisa A. Hurley, PhD, in Ampersand
September 11, 2018

Fees

If you are not yet a PRIM&R member, we encourage you to join today, and take advantage of your very first membership benefit immediately: a discounted registration fee to this webinar.

Member $95
Nonmember $135
Member $225
Nonmember $300