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Final revisions to the Federal Policy for the Protection of Human Subjects (a.k.a. the "Common Rule") were issued by the Department of Health and Human Services (HHS) on January 18, 2017. The majority of changes will go into effect on January 19, 2018.
Major Regulation Changes
- Continuing Review - No longer required for some minimal risk research, including studies where the only remaining activity is the analysis of identifiable data/biospecimens or activity to obtain follow-up clinical data.
- Exemptions - New categories and clarification of existing categories. Some exemptions may require "limited IRB review" (similar to an expedited review process), while others may qualify for "self-determination."
- Informed Consent - A new "Key Elements" section and a rearrangement of content is designed to facilitate a potential subject's decision to participate or not. A new option for broad consent may be available in certain situations.
- Single IRB-of-Record (sIRB) - IRB oversight for most federally-funded 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. See Other Regulatory Changes for information about the NIH sIRB policy implementation.
What to Expect
The new regulations do not impact studies approved prior to January 19, 2018.
For new studies, expect to see:
- eResearch & IRB application changes
- Informed consent template revisions
- HRPP Operation Manual updates
- U-M IRB standard operating procedure updates
- Minor IRB jurisdiction changes to facilitate workload changes
- A conservative approach as to when U-M will be the sIRB, with IRB consultation recommended prior to application submission
For existing studies, after the U-M implementation date the U-M IRBs may choose to apply the new rules to minimize burden for investigators.
The U-M Human Research Protections Program (HRPP), the four U-M IRB Offices, and ITS eResearch teams are working collectively to interpret the new Common Rule elements and update the University's policies, business processes, and eResearch systems to accommodate the changes while maintaining a high-level of subject protection. The working groups will present their proposed business process changes to U-M's IRB Council, the advisory/governing body for the HRPP, in July. Once approved, these teams will seek feedback from the research community and work on implementation plans so that U-M is prepared to follow the revised Common Rule by January 19, 2018.
Decisions Made to Date
Exemptions - U-M plans to pursue options for self-determination for some exemption categories. As this is a big change to current University practice, a post-approval audit period may be implemented to evaluate the effectiveness and limit potential risk. By adopting this optional element of the Common Rule, the HRPP believes that U-M can demonstrate administrative flexibility and be a leader among its peer institutuions.
sIRB - U-M IRBs will continue to assess its criteria for whether U-M will serve as the single IRB-of-Record or cede review to another institution or a commercial IRB.
What You Can Do
- Check this website periodically for new information. We will continue to add information through January 2018, as it becomes available.
- Look for educational sessions, such as IRBMED's seminar series, advertised here, in newsletters, on the HRPP and IRB websites.
The National Institutes of Health (NIH) is implementing a variation of the Single IRB-of-Record policy beginning January 25, 2018 (prior to the Common Rule implementation date). The NIH sIRB policy applies to:
- NIH-sponsored multi-site studies, where the same protocol is used at multiple sites
- Domestic research only