Defining and Navigating Risk in Exempt Research Webinar

Tuesday, October 29, 2024 

1:00-2:30 PM ET

Overview

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 will address 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. 

After participating in this webinar, attendees will be able 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 

 

 

Contributors

David Comalli, PhD

David Comalli, PhD

IRB Director, Temple University

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Justin Snyder, PhD 

Justin Snyder, PhD 

HRP Education Coordinator, University of Pittsburgh  

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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.