As part of our commitment to continuous quality improvement, we offer educational webinars for accredited and non-accredited organizations. These are offered free of charge to our clients.
November 2019 Webinar
Exercising the Exemptions:
Understanding and Applying Exemptions
Under the New Common Rule
Ms. Laura Odwazny, JD, MA, Senior Attorney with the Office of the General Counsel at HHS, and adviser to OHRP
Dr. John Baumann, PhD, Associate Vice President for Research Compliance, Indiana University
Tuesday, November 12, 2019 1:00 PM - 2:30 PM ET
The revised Common Rule led to significant changes in HRPP infrastructure, policies, and processes. It significantly enlarged the scope of human subjects research that may qualify for exemption. Existing exemptions were expanded, new exemptions were added and limited IRB review was introduced, leading institutions to think about re-structuring their processes for confirming that proposed studies met the criteria for an exemption.
In this session, the speakers will provide both expert commentary and lessons learned from the experience of implementing the new regulations for exempt research. This webinar will provide participants with an understanding, description, and examples of the application of the new exemptions, including but not limited to:
- Determining the applicability and application of limited IRB review;
- Determining the applicability and application of the review of studies involving ‘benign behavioral interventions’;
- Understanding the application of the change to secondary rather than retrospective research;
- A greater understanding of the new exemptions involving broad consent and the collection, storage, maintenance and use of identifiable biospecimen and private information