Many see the single IRB requirement in the revised Common Rule as a necessary sword to sever the Gordian knot of regulatory overlap and unnecessary delay of multisite review. Suzanne M. Rivera, PhD, is not one of them.

The single IRB requirement, to quote a phrase from Rivera’s recent analysis of the situation, “is a solution looking for a problem.”1 Rivera is a bioethics professor and vice president for research at Case Western Reserve University in Cleveland.

“The existing regulations already permitted institutions to collaborate and defer to one another for IRB review,” she tells IRB Advisor. “It wasn’t necessary to change the regulations to require that because we already had the freedom under the old version of the Common Rule to do that.”

For example, many academic medical centers rely on the National Cancer Institute central IRB for oncology research protocols. Similarly, many institutions collaborate with independent IRBs, Rivera says. Others have interreliability agreements with one another, which in Cleveland means research hospitals and universities can rely on each other’s IRBs when needed to reduce redundancy and increase efficiency, Rivera says.

“The new version of the Common Rule that requires a single IRB for multisite studies, I feel, is going a step too far,” she says. “It does not allow the discretion of the participating institutions to decide when a single IRB is appropriate and helpful versus when it is not. By requiring it in all cases for multisite studies, I fear there could be some unintended consequences.”

These consequences, in Rivera’s view, fall somewhat disproportionately on those already abiding to ethical imperatives, an argument somewhat similar to the old “forgotten man” theory in social science where the compliant pays for reforms necessary to rein in the violator.

For example, if a researcher commits some ethical breach, rather than single out the individual, the default position has been to penalize the larger group with new requirements.

“We should address bad actors by holding them accountable for violating the rules, rather than making the rules more rigorous across the board,” she says. “I think the vast majority of researchers do follow the rules and uphold important ethical principles in the conduct of their research. But I worry when a few people, either by mistake or deliberately, violate the rules that there tends to be a reaction to make it harder to do research for everyone. I think that is counterproductive.”

SACHRP previously recommended that the Common Rule outline penalties for rogue investigators and educate the public about the importance of human research.

“I thought those ideas were really important and valuable,” Rivera says. “One of the ideas was an effort to educate the public, including patients and client populations, about the importance of the research. The other [recommendation] was penalties for investigators who, in an unauthorized fashion, try to reidentify specimens or data that had been deidentified. But neither of those suggestions made it into the proposed final rule.”

REFERENCE

1. Rivera SM. Reasonable research oversight: A work in progress. IRB: Ethics & Human Research 2017;39(6):15-19.