Testimony delivered at the hearing by the US Government Accountability Office (GAO) claimed that the IRB system is “vulnerable to unethical manipulation,” based on the results of undercover investigations by agency staff.
Given that the task of an IRB is to formally review and monitor clinical trials involving human subjects, the deficiencies in the system raise serious concerns about the rights and welfare of the research subjects under the current system, according to GAO’s Gregory Kutz.
He told the hearing that the GAO found it very easy to set up a fake IRB, register it with the US Health and Human Services (HHS) department, and get approval to test a fictitious medical device – called Adhesiabloc - on human subjects.
That approval was granted even though the device description deliberately matched examples of “significant risk” devices cited in Food and Drug Administration (FDA) guidance.
The GAO is also concerned by a shift in IRBs from academic institutions to private enterprises, said Kutz.
As setting up a bogus ‘HHS-approved’ IRB proved simple, the GAO then investigated whether it was able to get an actual IRB to approve a fictitious protocol for human subjects research, including false (and easily checked) claims that the device under test was FDA-approved.
While two IRBs rejected the protocol, the third approved it unanimously, “which raises concerns that ... IRBs may conduct protocol reviews without exercising due diligence, thereby exposing research volunteers to significant risk,” according to the GAO.
Astonishingly, there are already more than 6,000 IRBs registered with the HHS and the department receives around 300 new registrations every month, which have to be reviewed by just three employees.
The IRB that approved the protocol submitted in the GAO probe – Washington-based Coast – said it would institute “immediate and sweeping reforms” to prevent a “recurrence of the vulnerabilities ... brought to light in the investigation.”
The IRB sent a post-hearing statement to the Subcommittee listing 12 specific reforms, from background checks on every sponsor of a clinical trial to the hiring of an expert consultant to revamp its IRB reviews. Coast is also replacing the current chair of its IRB, it said.
The FDA told the hearing that in future it will require IRBs to register with the agency, and is also working on voluntary guidelines for companies and IRBs to follow. The new registration process, scheduled to start in July, will create a database of IRBs to make it easier for the FDA to inspect and communicate with them.