On January 25, 2018, new rules take effect for NIH-funded multi-site research studies. Non-exempt human subjects research studies that are conducted at more than one U.S. site and use the same protocol must use a single IRB. This applies to all competing grant applications: new, renewal, revision, or resubmission.
What does the new policy mean for OHSU researchers?
OHSU has already begun streamlining the multi-site review process, using IRB reliance systems to waive oversight to other IRBs. In these cases, OHSU will continue to perform compliance reviews, which include research training compliance, OHSU-specific ancillary reviews, and required consent language.
OHSU study teams will be required to submit and maintain current versions of some study documents, including protocol, consent, and drug information. They must meet OHSU ancillary review requirements and complete OHSU required research trainings and Conflict of Interest Disclosures. OHSU study teams will also be required to inform the OHSU IRB of any event that is determined by the central IRB to be an “unanticipated problem.”
Please email Research Integrity at firstname.lastname@example.org with any questions.