The Federal Policy for the Protection of Human Research Subjects, also known as the Common Rule, has been revised for the first time since 1991. The policy changes—which include several new requirements for researchers and IRBs—go into effect on January 21, 2019. This revision of the Common Rule has been adopted by the U.S. Department of Health and Human Services (HHS) and 15 other Federal Departments and Agencies.
What studies are affected?
- New studies that are federally funded or federally conducted will fall under the new rule.
- New = First-time submissions that have not received IRB approval as of January 21, 2019
- Federally funded = Receiving funds directly from a federal funding agency (not indirectly)
- Federally conducted = Study takes place at a federal site, e.g. the VA Medical Center or a National Laboratory
What studies are not affected?
- Studies that are not federally funded or federally conducted
- Studies that have been approved by the IRB before January 21, 2019 (regardless of funding source)
What are the main changes?
Review the Town Hall Presentation (see Resources, below) for a detailed summary of the changes most likely to impact UCSF researchers.
In brief, the main changes include:
- Continuing Review – Some new, minimal risk studies will no longer require annual review.
- Informed Consent – Several new standard statements are required in the consent form. New consent form templates are available on the IRB website here.
- Exemptions – Several exempt categories have been broadened, and one new category has been added: Benign behavioral interventions. The IRB application form and website guidance has been updated accordingly.
The guidance throughout the UCSF IRB website has been updated. Additionally, the following resources are available:
- Common Rule FAQ’s
- Town Hall Presentation slides and video, “The New Common Rule” by Laurie Herraiz, HRPP Director. Please note: the slides have been updated with new information about when you should and should not “convert” to the new IRB Application Form.
- Decision Tool: Does this Study Qualify as Exempt 1, 2, 3, or 4?
- CITI Program's Revised Common Rule Course
- CITI Program’s Final Rule Resources. This page offers a comprehensive overview of the revised regulations, but please note that UCSF may implement some of the changes differently than described by CITI.