HHS also faulted in GAO investigation
Questions raised after fake IRB registered
The General Accounting Office (GAO) report on the IRB system's vulnerabilities doesn't just criticize the individual IRBs targeted by the investigation.
It also faults the U.S. Department of Health and Human Services (HHS), which oversees the registration of IRBs and the issuance of federalwide assurances (FWAs), both of which investigators were able to obtain fraudulently for a fake IRB and fictitious medical device company.
In his report, Gregory Kutz, managing director of forensic audits and special investigations for the GAO in Washington, DC, described the process of registering the IRB through an online registration form, and then using that fake IRB on its application for a FWA for its medical device company. In neither case did HHS's Office for Human Research Protections (OHRP) verify the information in those applications.
"With an HHS-approved assurance, GAO's device company could have applied for federal funding for human subjects research," Kutz notes in the report.
Investigators created a Web site for their fake IRB and advertised in newspapers and online. They received one request from a real medical research company seeking to get approval to join an ongoing clinical trial.
"Since the transaction involved privately funded human subjects research and did not involve any FDA-regulated drugs or devices, GAO's bogus IRB could have authorized this testing to begin without needing to register with any federal agency," the report states.
In an interview, Kutz says the investigation revealed real vulnerabilities in the system for protecting human subjects.
"We wanted to see if anybody could set up a private IRB, and basically they could," he says. "And a federalwide assurance isn't an assurance of anything – it's just a self-certification process."
OHRP clarifies language
Marjorie Speers, PhD, executive director of the Association for the Accreditation of Human Research Protection Programs (AAHRPP), says the revelations in the report about HHS are of greater concern than the fact that one independent IRB approved a fraudulent protocol.
"Our protection system by both OHRP and the FDA is based on the fact that both regulatory agencies set the regulations and they're supposed to enforce the regulations," Speers says. "This operation shows that an IRB can register with OHRP and that registration doesn't have any meaning."
She notes that OHRP has issued clarifying language on its Web site stating that the fact that an IRB is registered doesn't mean that the IRB has the appropriate expertise to review a particular research study. In addition, it stated that issuance of an FWA doesn't mean that OHRP had determined that the institution complies with federal regulations.
"So if the federalwide assurance doesn't have any meaning, if the IRB registration doesn't have any meaning, then one has to ask how these federal agencies are ensuring the American public that research is conducted safely," Speers says.
OHRP Director Jerry Menikoff, MD, JD, says the current IRB registration system was created in response to a previous report by the Office of the Inspector General.
"Basically what that report said was it thought it would be useful to implement a very simple registration system, which would have a list of all the IRBs and you would have some basic contact information about them," Menikoff says.
"We do require that if an IRB is going to be used by one of the institutions under our jurisdiction, that we want them on this list," he says. "Being registered means just that – they've given us the required information."
He notes that FDA is setting up a similar registration to the one currently maintained by OHRP.
Menikoff says an FWA is akin to contractual agreement stating that an institution will abide by 45 CFR 46.
"So obtaining an FWA is a very significant thing, because that's how an institution has committed itself," he says. "It now is in a position that it has to do what those rules require in terms of protecting human subjects."
In the GAO report, HHS officials stated that OHRP does not have resources to verify the information on all of the applications it receives.
Menikoff says OHRP is part of a larger system of research protection, and that funding agencies such as the National Institutes of Health or the Centers for Disease Control and Prevention would be quite likely to catch a fraudulent investigator or organization.
"I suspect it would be a really, really difficult thing for some entity that's fictitious to actually end up going through all of the hoops in a very competitive process and getting federal funding," he says. "The GAO could have tried to create this entity and have it get funding from NIH, for example. And they didn't end up doing that, probably because they, too, recognized the fact that for a fictitious entity to get federal funding is not an easy thing."
He says in addition to releasing the clarifying language about FWAs and IRB registration, OHRP is working with Coast IRB, which is closing as a result of the sting, to ensure protection of human subjects in the Coast protocols that are being transferred to other IRBs.
Menikoff says it would be up to Congress to consider further policy changes to the current human subjects protection system.
Changing the system?
Trudo Lemmens, DCL, LLM, associate professor of law and medicine at the University of Toronto, has written extensively about human subjects protection. He says the GAO investigation has confirmed many of his fears about the vulnerabilities of the IRB system.
"In my view, you should have a system whereby a regulatory agency decides what IRBs can function for what kind of purpose," Lemmens says. "I would be in favor of a clear authority for particular IRBs in a particular region or for a particular kind of research."
While one alternative mentioned by Menikoff would be making the current voluntary IRB accreditation system mandatory, Speers worries that such a proposal could end up watering down accreditation standards in order to ensure that IRBs can achieve it.
"What I would like to see is voluntary accreditation with strong incentives," she says, noting there are some signs that is beginning to happen already. "For example, Pfizer has said it will only work with AAHRPP-accredited central IRBs in reviewing its research. And that it is encouraging investigative sites to become accredited."
She says having sponsors and even federal agencies give preference to accredited institutions is a better approach.
"That type of carrot rather than a stick is a much better way to drive institutions and companies to seek a higher standard," she says.
The General Accounting Office (GAO) report on the IRB system's vulnerabilities doesn't just criticize the individual IRBs targeted by the investigation.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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