Institutional Biosafety Committee (IBC)
Effective July 1, 2018 any study involving blood and serum must undergo a limited review by the IBC in addition to the IRB. Principal investigators using blood and serum will be required to submit documentation to the IBC regarding lab practices in addition to the IRB application. The IBC review will be utilized to ensure proper training and lab safety documentation is in place. Please note, the IBC review will not hold up the IRB review. The IBC protocol form can be found at: https://integrity.uncg.edu/institutional-biosafety-committee
Institutional Review Board (IRB)
Effective July 19, 2018, the Office of Human Research Protections (OHRP) implemented three burden-reducing provisions in the revised Common Rule.
UNCG will be implementing two of the three provisions:
- Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements; OHRP guidance can be accessed at https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/draft-guidance-scholarly-and-journalistic-activities-deemed-not-to-be-research/index.html
- Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements; OHRP guidance can be accessed at https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/draft-guidance-elimination-of-irb-review-of-research-applications-and-proposals/index.html
A new webpage provides Revised Common Rule Resources, including a set of commonly asked Q&As for quick reference. More resources are being developed and will be posted regularly: https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/index.html
Expansion of the NIH Definition of a Clinical Trial
The NIH has delayed enforcement of and has provided short-term flexibilities for some requirements affecting prospective basic science studies involving human participants. For more information see: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-212.html
