The trusted source for
healthcare information and
By Melinda Young
The Office for Human Research Protections (OHRP) is making implementation of the revised Common Rule a little easier for IRBs with two exceptions to the single IRB review requirement.
IRBs can continue to use multiple IRBs, instead of a single IRB, in these cases:
• Cooperative research conducted by or supported by the U.S. Department of Health and Human Services, where the IRB initially approved the research before Jan. 20, 2020;
• Cooperative research conducted or supported by the National Institutes of Health (NIH) when the NIH single IRB policy does not apply and the research was approved by an IRB before Jan. 20, 2020, or when NIH excepted the research from its single IRB policy before Jan. 20, 2020.
Before OHRP’s announcement, some IRBs would have had to revisit some studies, entering into cooperative agreements after the fact. OHRP’s announcement clears up confusion over deadlines per the revised Common Rule.
“When OHRP released this new information, I was completely relieved,” says Alayna Nest, IRB coordinator at Oregon Public Health Division/Multnomah County Health Department IRB in Portland.
Nest realized in 2019 that some studies that were approved by a single IRB in 2019 would require a cooperative agreement under the revised Common Rule. This would have required the small IRB to backtrack and enter the cooperative agreements for those five to six studies. This was frustrating because it would have been easier to enter the agreements from the start if OHRP had made that intention clear, she explains.
“Why in the world would we backtrack a year when we could have done this from the get-go?” Nest asks. “If they were going to require us to go back to 2019 in the first place, they should have made it the same effective date as the rest of the regulations.”
The announced exceptions for research approved before Jan. 20, 2020, takes away that headache, she adds.
“OHRP’s announcement is very sensible,” she says. “Now, my concerns are gone.”
Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Jonathan Springston, Editorial Group Manager Leslie Coplin, and Physician Editor Lindsay McNair, MD, MPH, MSB, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Nurse Planner Kay Ball, PhD, RN, CNOR, CMLSO, FAAN, is a consultant for Ethicon USA and Mobile Instrument Service and Repair.