NCQA: Standards for VA IRB accreditation finalized
Debut doesn’t come without IRB concerns
In the ongoing race to develop accreditation standards for IRBs, the National Committee for Quality Assurance (NCQA) in Washington, DC, has reached the finish line. On Aug. 16, the NCQA published its final standards for the Veterans Affairs (VA) Human Research Protection Accreditation Program standards (VAHRPAP). The new standards have elicited both praise and concern among the IRB and research communities.
"I believe the final set of standards developed by the VA and NCQA is an excellent beginning in the VA’s efforts to standardize and improve the IRB process," says John D. Burke, MA, RPh, chairman of the human studies subcommittee at the VA Medical Center in Louisville, KY. "It is obvious that we who are responsible for ensuring protection of human subjects in research are expected to be very diligent and proactive in our efforts to ensure this protection," Burke says. "Therefore, I am concerned that we will require more resources and support than we have previously had."
Burke’s sentiments are seconded by Steve Belknap, MD, assistant professor of clinical pharmacology and medicine at the University of Illinois College of Medicine in Peoria. "I think the NCQA accreditation program that was developed for the VA has a lot of value," Belknap says. "My concern is that very likely many IRBs will be unable to meet the standards set by the VA Human Research Protection Accreditation Program," he says.
VA standards could be guidelines for all IRBs
Whether or not VA IRBs agree with the new standards, they will need to be prepared for surveys immediately. The first surveyors were dispatched in September, says Sandra Sanford, RN, MSN, CCRC, CIP, director of Human Research Protection Accreditation Program for NCQA. (See "Major changes to the final VA standards explained," in this issue.)
The Louisville VA Medical Center should have no difficulty meeting the new accreditation standards, provided that a few areas are addressed and several documents are created or revised, Burke says. "I can’t honestly say I’m looking forward to this review, but I don’t fear it either."
Burke says the only difficulty he anticipates is in providing continuing education for the IRB and researchers. "While I have been a member of both of our research committees for a number of years, membership does change frequently on the committees," Burke explains. "Often, committee members are just beginning to fully comprehend the responsibilities of the IRB when they have to rotate off the committee."
It’s also possible that the new standards will lead to some smaller VA medical centers closing their IRBs, but this should not result in those institutions stopping their research, Burke says. The smaller VAs might resort to using the IRB of a university affiliate or the IRB of a larger VA.
One of the chief concerns private IRBs and researchers might have is that the VA standards will be used as a basis for a national standard for all IRBs, Belknap says. If that occurs, one of the likely effects would be that many marginal IRBs would stop functioning, and their function would be turned over to national IRBs that might not encourage input from local communities, Belknap adds.
For example, IRBs need to know the competence and experience of people conducting research, and some of the information IRBs need to assess competence is derived from personal contact with the researcher. Smaller, community-based IRBs typically do not rely entirely on a researcher’s curriculum vitae (CV), Belknap explains. "So if you had a national IRB they wouldn’t know that investigator personally and might make a judgment based only on the researcher’s CV," he adds. Smaller IRBs also have the flexibility of speaking directly with researchers to discuss the protocol, and this way the IRB can resolve many minor research issues without having to delay the project due to paperwork changes, Belknap says.
Sanford says that it isn’t NCQA’s intent to create IRB standards that mirror the VA human research accreditation standards. "There are clearly pieces that are pertinent only to the VA," Sanford says. "We fully recognize that these standards are not immediately transferable or generalized to the outside world." NCQA now is engaged in a process to develop a potential business plan and feasibility study to determine whether the organization will develop non-VA IRB standards, Sanford adds.
Burke says that the NCQA VAHRPAP standards are an excellent beginning for standards to be developed for IRBs in the private sector. "Very minor parts of the VAHRPAP differ from IRB requirements currently applied in many universities or private IRBs," Burke notes. Also, it will be easier for other organizations to develop new IRB standards because the VA standards can serve as a set of guidelines, Burke says.
Everyone involved in human research would like to prevent problems, Burke adds. "We need to suppress the very large egos of individuals and institutions and admit that we have sometimes become careless and arrogant in our conduct of research," Burke says. "We are dealing with human beings and they deserve our respect, our vigilance, and our concern when we ask them to submit to research."
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