NPRM Webinar Series: NPRM Proposals to Reduce IRB Administrative Burden
Lynn Smith, Madeleine Williams, Thomas Bechert
In our first webinar, we provided a high-level overview of each of the Common Rule's major proposed changes.
Our second webinar covered proposed changes specific to research with biospecimens and private identifiable information in additional depth.
This third webinar in our series focuses primarily on the proposed Common Rule changes aimed at reducing the administrative burdens on IRBs and IRB staff as well as investigators and study teams.
These areas include the newly-proposed “exclusion” categories, revised exemption categories, modified IRB review and operations processes, and informed consent content and documentation changes.
During the webinar, our speakers:
- Re-visit the relevant proposals
- Discuss specific research scenarios
- Highlight the differences between how those scenarios are addressed under the current rule and how they would be addressed under the proposed rule