Changes to the Common Rule and Implementation at UNC Charlotte
Revisions to the federal regulations for the protection of human subjects in research (45 CFR 46) took effect in January 2019.
The following highlight some of the significant changes.
- Certain activities are no longer considered research and therefore will not require Institutional Review Board (IRB) review.
- Most scholarly and journalistic activities that focus directly on specific individuals.
- Public health surveillance activities conducted by a public health authority.
- Criminal justice and criminal investigation activities.
- Agency-authorized activities in support of intelligence, defense, and homeland security.
- The revised Common Rule adds new and expanded Exemption categories.
- Investigators may propose Exemption eligibility; however, Exemption determinations will continue to be made by the Office of Research Protection and Integrity (ORPI) and IRB.
- Some Exemption categories will require Limited Review.
- Continuing review (renewal) will no longer be required for most studies (Exempt and Expedited studies) that do not undergo full IRB review.
- Informed consent documents must now include concise key information to facilitate participant comprehension. This will include organizing consent information to present the key information first.
- Single IRB review is required for cooperative/multi-site research. This change aligns with the National Institutes of Health (NIH) single IRB policy.
The following highlight some of the impacts.
- The Common Rule changes will impact new studies submitted on/after January 21, 2019.
- Studies (approved prior to January 21, 2019) will continue to follow the current pre-2018 regulations unless otherwise noted on the continuing review approval letter. The old rule (pre-2018) will still be implemented for studies that have external funding with limited exceptions (e.g., study is now in the data-analysis stage).