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

Wednesday, October 3, 2018 | 1:00-2:00 PM ET

View the webinar recording:


Overview

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.

Continuing Education

CIP Credit labelWebinar participants holding the Certified IRB Professional (CIP®) credential may apply 1 continuing education credit towards CIP recertification. Learn More »

Speakers

Jeff-BotkinJeffrey Botkin, MD, MPH is a professor of pediatrics at the University of Utah and an adjunct professor of human genetics. He is past chief of the Division of Medical Ethics and Humanities in the Department of Internal Medicine. He obtained his BA from Princeton University, MD from the University of Pittsburgh, and MPH from Johns Hopkins. Dr. Botkin is the Associate Vice President for Research Integrity at the University of Utah with oversight responsibilities for the IRB, conflict of interest, responsible conduct of research, biosafety, and research ethics education. His research and publications are focused on the ethical, legal, and social implications of genetic technology with a particular emphasis on research ethics, genetic testing for cancer susceptibility, newborn screening, and prenatal diagnosis. Dr. Botkin formerly was chair of the Committee on Bioethics for the American Academy of Pediatrics and a former member of the Secretary’s Advisory Committee on Human Research Protections. Dr. Botkin is currently a member of the Secretary’s Advisory Committee on Heritable Diseases in Newborns and Children. He chairs the National Institute of Health (NIH)’s Embryonic Stem Cell Working Group and is a member of the FDA’s Pediatric Ethics Advisory Committee. Dr. Botkin is an elected fellow of the Hastings Center.

Amy-McGuireAmy McGuire, JD, PhD is the Leon Jaworski Professor of Biomedical Ethics and director of the Center for Medical Ethics and Health Policy at Baylor College of Medicine. She received her BA in psychology from the University of Pennsylvania, summa cum laude, her JD from the University of Houston, summa cum laude, and her PhD, with distinction, from the Institute for Medical Humanities at University of Texas Medical Branch. Her research focuses on the clinical integration of emerging technologies, with a particular focus on ethical and policy issues in human genetics and genomic research. Dr. McGuire served as a member of the National Advisory Council for Human Genome Research from 2011-2015. She is currently on the program committee for the Greenwall Foundation Faculty Scholars Program in Bioethics and is president of the Association of Bioethics Program Directors. Her research is funded by the NIH.

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.

Individual rates
Member $95
Nonmember $135
Group rates
Member $225
Nonmember $300

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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