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PRIM&R Webinar

Defining and Navigating Risk in Exempt Research

Purchase Recording

Overview

Survey IRB websites, presentations on Exempt research, or review the preamble to the revised Common Rule, and it becomes apparent that Exempt research is often approached as no risk or the least risky human subject research. At the same time, the regulations are silent on risk and the Exemptions except for the determining if Limited Review is required for certain categories. Does this provide sufficient protection for subjects? How should IRB’s address the risks of Exempt research? What are the greatest allowable risks for an Exempt study, and how should IRB’s handle studies that exceed that threshold but otherwise meet an Exempt category? How might we improve subject protections by reviewing Exempt research from a perspective that is not restricted to traditional risk concerns? This webinar addresses these and related ethical questions with an emphasis on SBER. The webinar will provide a basic overview of Exemptions followed by an intermediate to advanced discussion of risk and the application of the Exemption categories.

Cost

Members: Free Nonmembers: $190
You Will Learn How To
  • List and describe the Exemption categories and prevailing wisdom on Exempt research
  • Analyze the ethical considerations associated with Exempt research and how IRB’s might approach those considerations
Audience
  • IRB administrators, members, staff and researchers

Credits Offered

CE Credit
Participants will receive a certificate of attendance that documents up to 1.5 continuing education credit hours for their attendance at this webinar. Certificates of attendance are useful for obtaining CE credits from professional associations. Each association's guidelines for accepting CE credit hours (in-person or virtual) may differ. Please consult the appropriate association representative for information on if, and how many, CE credits from this PRIM&R webinar may be used.
CIP Credit
Course participants who hold the Certified IRB Professional (CIP®) credential may apply 1.5 continuing education credits towards CIP® recertification credit for this PRIM&R webinar. Please refer to the CIP® recertification guidelines for additional information.

David Comalli, PhD

IRB Director, Temple University
David is the IRB Director at Temple University, where he has worked for the past 8 years, first as an IRB Coordinator and then as the Director. When training new staff to conduct Exempt reviews, he stresses that the IRB can require changes to the study (e.g., data security measures, ensuring protocols are in place in case a subject experiences a mental health crisis, etc.) to reduce the risk to no more than minimal risk. This philosophy allows flexibility in reviews that are not afforded by Expedited or Full Board reviews, while still helping protect human subjects. David has a background in Developmental Psychology, with a focus on the development of making motor decisions

Justin Snyder, PhD

HRP Education Coordinator, University of Pittsburgh
Justin is the HRP Education Coordinator at the University of Pittsburgh. Alongside organizing and conducting training for the research community, he trains all new staff, provides continuing education and guidance for existing staff, onboards IRB members, and directly supports HRP leadership in policy decisions. He has previously held positions in the HRP programs at Temple and Penn State. Prior to his career in human research protections, he served as Assistant Professor of Sociology at St. Francis University. There he conducted in-depth interviews with veterans suffering from PTSD, exploring the moral dimensions of combat trauma.