Sharing of IRB approvals raises questions, concerns
OHRP analyst comments on trend
As times change and evolve, so do IRBs and, ultimately, IRB guidelines and rules. Lately, the evolution of IRBs can be seen in the trend of an increasing number of multi-site studies.
Changes in how IRBs handle multi-site studies have been slower to evolve.
"Historically, the procedure was to have the study reviewed by the IRB for each site," says Glen Drew, MS, JD, health policy analyst for the Office for Human Research Protections (OHRP), Department of Health and Human Services in Rockville, MD.
"The regulations provide for cooperative research agreements where institutions recognize the review of the IRB at another institution and accept that review as being verification that human subject's protection requirements are being provided," Drew explains. "So the regulations have long provided for that, but it is often not utilized by institutions."
Many institutions have continued to want all research to be reviewed by their own IRB, Drew notes.
Yet, as the number of multi-site trials increases, the reliance on individual IRB review for each site is seen by many as an unnecessary burden, Drew says.
OHRP officials and other government officials are considering holding a public conference later this year to discuss the options and alternatives available to individual IRB review by all institutions involved in a multi-site study, Drew says.
In discussions that have already taken place, officials agree that it's desirable to encourage an increase in alternatives to individual IRB reviews, he adds.
"Many institutions are reluctant to give up the control they fell they exercise through their own IRB," Drew says. "I think one of the matters to be addressed in coming days, perhaps coming years, is how to relieve concerns the individual institutions might have."
For example, a chief concern involves liability in the event a problem occurs with the research, Drew says.
"If there's an adverse event or an unexpected outcome in the research, then institutions don't want to risk some level of liability for that outcome without having exercised the control of being involved in the review of the research," Drew says.
One solution to this concern is greater education and knowledge about cooperative arrangements now in place, he says.
For example, the Biomedical Research Alliance of New York is a group of academic institutions in the Northeast that has decided that an IRB review by any one of the involved institutions would be recognized and accepted by all of the other institutions, Drew explains.
"There are a couple of other consortia in operation," Drew says. "The National Cancer Institute has a pilot project that has grown over time and operates a central IRB for adult oncology research and for pediatric oncology research."
The arrangement permits local IRBs to rely entirely on the central IRB's review or to rely partially on the central IRB's review and retain their own local context and/or informed consent review, he says.
Gaining greater acceptance for central IRB review may occur when it's no longer a matter of institutional pride to favor one's own IRB's judgment over other IRBs' judgment, Drew suggests.
"Certainly there are possibilities for having test cases in which you have the same protocol reviewed by multiple IRBs and compare the conclusions they draw," Drew says.
"Some IRBs may find a protocol acceptable as written, while others would require modifications, and these requirements may be in full alignment or vary across the IRBs," he adds. "Seeing results of each other's work may give or prevent some confidence in the work of other IRBs."
Other confidence-building measures include inviting other IRB members to visit an IRB meeting as guests, he says.
Sponsors often see the model of a central IRB as desirable because it may prevent delays, Drew says.
"It reduces the overall delay because it eliminates the need to reconcile any differences between what different IRBs say," Drew says. "There's no need to send consent language back and forth between different IRBs."
The people most impacted by multiple IRB reviews are investigators who can't get their studies going and sponsors who want to move their investigational product more quickly to market, he adds.
OHRP has been trying to reduce and eliminate unnecessary burdens on the research enterprise, while maintaining protections for subjects, Drew says.
Some people in the research industry think OHRP frowns on the practice of central IRB review, but the truth is that such reviews are perfectly acceptable, Drew says.
"I think there's a need for increasing the awareness of the acceptability of such practices," he says. "Where they can increase efficiency without compromising protections, they are to be encouraged, and that's why we're working with other federal agencies to increase awareness that the practice is perfectly acceptable so long as protections are not compromised."