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