Changes to the Common Rule
Major Regulation Changes:
- Continuing Review – The changes to the Common Rule allow for the elimination of continuing review for expedited studies, however, UNCG will continue to require continuing review annually for all studies. This is due to the fact that UNC-Chapel Hill is continuing to require annual review per AAHRPP recommendations. Because UNCG uses the UNC Chapel Hill online IRB system, IRBIS, we must follow the same protocol. The elimination of continuing review will be re-evaluated at the end of 2019.
- Exemptions – New categories and clarification of existing categories. UNCG will continue to require IRB review of studies qualifying for exemption.
- For guidance regarding the new exempt categories see: UNCG Guidance Document for Exempt Research 2018 Common Rule Changes
- For guidance specific to the new Exempt Category 3 – Benign Behavioral Interventions, please see: UNCG Guidance on Benign Interventions
- Informed Consent – A “Key Elements” section is designed to facilitate a potential subject’s decision to participate or not. Other revisions to the consent template, such as future use of data, have been made as well. The revised UNCG template will go into effect on January 1, 2019. This template can be found at: https://integrity.uncg.edu/institutional-review-board/ – under “IRB Consent Form Templates”. Both the Adult consent form template and the Parental Consent for a Minor template have been revised.
- Single IRB-of-Record (sIRB) – IRB oversight for collaborative research projects located in the U.S. will be required to use a single IRB (commercial, academic, or hospital-based) starting January 20, 2020.
What to Expect:
The new regulations do not impact studies approved prior to the proposed implementation date of January 21, 2019.
For new studies, expect to see:
- IRBIS & IRB application changes
- Informed consent template revisions
- IRB Standard Operating Procedure (SOP) updates
- Minor IRB process changes to facilitate workload changes
- In regard to the Single IRB-of-Record, please consult with the IRB office prior to committing the UNCG IRB as serving as the IRB of record.
Decisions made to date:
- Continuing Review (also known as Annual Renewal) -UNCG will continue to require continuing review annually as long as the study continues to enroll participants. Once enrollment has closed, annual renewal will no longer be required. The data analysis only no renewal policy is only for new study submissions submitted after January 21, 2019.
- sIRB – The UNCG IRB will continue to assess its criteria for whether UNCG will serve as the single IRB-of-Record or cede IRB review to another institution .
- Broad Consent – UNCG will not implement the new regulatory “Broad Consent” option as an informed consent process at this time. The new exemption categories 7 & 8, which rely on Broad Consent, also will not be implemented.
- Non-federally funded studies – UNCG IRB will take a “flexible” approach to the new regulations for studies that are not federally funded.
Other Recent Regulatory Changes:
NIH Single IRB (sIRB) Policy
The National Institutes of Health (NIH) has implemented a variation of the Single IRB-of-Record policy. This policy went into effect January 25, 2018. The NIH sIRB policy applies to:
- NIH-sponsored multi-site studies, where the same protocol is used at multiple sites
- Domestic research only
NIH Definition of Clinical Trial
The NIH has issued several other policies and guidance designed to “enhance the accountability and transparency of clinical research”:
- Revised clinical trial definition (1/25/2015)
- Requires Good Clinical Practice Training (1/18/2017)
- ClinicalTrials.gov registration and reporting of results (1/18/2017)
- Use of the new Human Subjects and Clinical Trial form (part of the NIH funding application package, Forms-E) (1/25/2018)
NIH’s definition of a clinical trial is broad, encompassing a wide range of activity which now may include behavioral studies (e.g., studies that manipulate an independent variable to observe a hypothesized modification of a behavioral process). For more information regarding the NIH definition of “clinical trial” click here.