I am writing to provide you with information about changes coming soon in how human subjects research is regulated and how the university is preparing for these changes. The U.S. Department of Health and Human Services and 15 federal agencies issued a final rule revising the Federal Policy for the Protection of Human Subjects (the “Common Rule”) that safeguards individuals who participate in research.
Our office is working to prepare researchers for the implementation of these regulations. Most provisions will go into effect January 19, 2018.
The new regulations apply only to new studies approved or determined exempt after January 19, 2018.
Studies either approved or determined to be exempt before January 19, 2018, must continue to comply with the pre-2018 rule.
Key changes in the revised Common Rule include:
- Revisions and additions to the exempt review categories and the addition of a limited IRB review process for some exempt research
- Changes to continuing review requirements, including elimination of continuing review for many studies that pose minimal risk to participants
- Changes to the informed consent process and form, including a new requirement for presenting key information and a new requirement for clinical trials to post the informed consent form on a public website
- Additional provisions for handling, storage and maintenance of identifiable information and biospecimens
- Requirements for single-IRB oversight starting in 2020 for most collaborative research projects. Note: NIH has separate single-IRB requirements for multi-center studies which go into effect in late January 2018.
Research Compliance Services (RCS), in collaboration with members of the Institutional Review Board, is working diligently to prepare our institution for these new regulations. I encourage you to check out our new Common Rule web page. This page provides: - The latest information about the 2018 Common Rule implementation
- Specific information for existing studies about continued compliance obligations under the pre-2018 regulations and opportunities related to the revised Common Rule
- Registration for an RCS general information session. These sessions will be held on:
- Monday, January 8 from 1 p.m. to 2:30 p.m. or
- Thursday, January 11 from 10 a.m. to 11:30 a.m.
Like other universities, we are awaiting additional federal guidance on the implementation of these revised regulations. Once the agency issues guidance, UO may need to make additional changes to our processes and templates. I encourage you to stay tuned to our Common Rule web page for updates and new information. If you have an existing project, you can learn more about next steps on our Existing and Ongoing Research page. If you have additional questions, please contact Research Compliance Services at researchcompliance@uoregon.edu or (541) 346-2510.
