Common Rule Revisions
New Common Rule (IRB Regulations):
USA IRB Implementation
The Federal Policy for Protection of Human Research Subjects, also known as “The Common Rule”, codifies the processes for IRB review and approval of research with human subjects. Changes to the Common Rule will take effect on studies starting on or after January 21, 2019.
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Key Changes to New Common Rule
- The definition of “research” has been expanded to list activities that are specifically
deemed not to be research
- (e.g., oral history, journalism, public health surveillance, criminal justice or criminal investigative activities, and activities in support of intelligence, homeland security, defense, or other national security missions).
- Research Terms: New/Revised
- New Exemption Categories
- Single IRB (sIRB) Review
- NIH effective January 25, 2018
- HHS effective January 2020
- The reviewing IRB must be identified by funding agency or proposed by the lead institution
- Revisions to Informed Consent Criteria
- Broad consent geared toward repositories for which the primary purpose is secondary research use. This is not a requirement of the Common Rule. (USA IRB WILL NOT IMPLEMENT AT THIS TIME)
- Annual continuing review requests are no longer required in the following circumstances:
- Research eligible for exempt review
- Studies that have completed study interventions and are merely analyzing study data
What to Expect:
For new studies, expect to see:
- IRB application changes
- Informed consent template revisions
- IRB SOP updates and Exempt Research Guidance documents
USA IRB Implementation
Exemptions – There are now new categories and clarification of existing categories of research exemption. Some exemptions may require “limited IRB review” (similar to an expedited review process). SEE IRB REVIEW - EXEMPT RESEARCH
Informed Consent –
- Informed Consent Criteria & Revisions – SEE CHECKLIST
- Consent Template
- "Key Information” must be presented first with sufficient detail for subjects understanding of reasons to participate.
- For clinical trials supported by federal funding, one IRB approved consent form used to enroll participants must be posted on a publicly available website
- Continuing Review – No longer required* for:
- Most minimal risk research (i.e., expedited research studies)
- Exempt research requiring limited IRB review
- Research interventions completed and only remaining activity is the analysis of identifiable data/biospecimens or activity to obtain follow-up clinical data.
*The IRB can override this default and conduct continuing review, but must justify and document the reason
Office of Human Research Protections (OHRP):
Guidance on the new Common Rule
OHRP has also developed a series of VIDEOS to further explain the Common Rule changes
Published in the Federal Register on January 17th, the Delay of the Revisions to the Federal Policy for the Protection of Human Subjects delays the effective date and general compliance of the revised Common Rule to July 19, 2018.