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Liability, federal rules dissuade use of alternative and central reviews; OHRP eyes national conference.(IRBs)
WASHINGTON -- IRBs are not using alternative review methods in great number--such as central IRBs--because of liability concerns and recommendations by attorneys at their institutions not to pass off responsibility to a central body if research is being conducted at that institution.
To combat such concerns, the Office for Human Research Protections (OHRP) held a workshop with the American Assn. of Medical Colleges and American Society of Clinical Oncologists last month, and will likely hold another conference on the topic. The goal is to devise recommendations to Department of Health and Human Services Secretary's Advisory Committee on Human Research Protections (SACHRP).
At the conclusion of the two-day meeting here, participants said it was important to invite a variety of people from institutions to talk with one another about ways to move toward alternative review, which is seen as a major means of offloading work from overburdened IRBs.
Participants agreed it was important to get in-house counsel for IRBs and institutions talking with one another, IRB chairs to talk to one another, and even university and hospital administrators to talk to each other.
OHRP Director Bernard Schwetz, Ph.D., said in an interview that revising regulations or legislation was not a viable solution. Several speakers said the common rule should be revised so there is less emphasis on "community IRBs" now that clinical trials are so large and require in many cases a for-profit IRB to oversee them. However, guidance could be in the office that has an "old guidance" on centralized review, but FDA issued one just last year.
But speakers said it has been difficult getting local boards to pass off their reviews to central IRBs.
For example, National Cancer Institute (NCI) has been using a central IRB for its cooperative research consortiums. About 72% of institutions participate in the central IRB review process, NCI officials said.
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