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Common Rule Revisions: The Saga Continues
Citation:
Nelson, D. Common Rule Revisions: The Saga Continues. Three I's & Biosecurity Conference, Chapel Hill, NC, March 15, 2018.
Impact/Purpose:
The “Three I’s and Biosecurity” is an annual conference jointly sponsored by the Massachusetts Society for Medical Research (MSMR), the FBI Weapons of Mass Destruction Directorate (FBI), and the North Carolina Association for Biomedical Research (NCABR). The “three I’s” refers to oversight functions involved in research, including Institutional Review Boards (IRB), Institutional Animal Care and Use Committees (IACUC), and Institutional Biosafety Committees (IBC). Conference attendees include research scientists, university administrators and compliance officers involved in these oversight functions. The conference provides updates and insights on compliance-related processes, and the regulations I will be describing are one important component of that. Attendees will leave with an improved understanding of the Common Rule regulations, to aid in their respective workplaces.
Description:
The Common Rule regulations that govern human subjects research were revised in 2017, after a 6-year rulemaking process. Changes were made in many areas, including informed consent, continuing review, exemptions and multi-site research, with an effective date of January 2018 (currently delayed). This session will review the major changes and provide an update on current status.