Traditionally, medical research has been done at academic institutions with high levels of scrutiny and control over the entire process. Key to the system has been the Institutional Review Board (IRB) which has ensured that all aspects of the human subject testing process give participants notice of dangers and are performed in a way to minimize psychological and physical dangers where they cannot
In recent years, however, private IRBs have come into existence. If you participate in studies in the future, perhaps you would like to know how they operate.
For example, in 2002, a 47-year-old man died after his heart stopped beating while participating in an experimental trial of antipsychotic medication at a Texas research center. Before his death, the man spent 22 days suffering from fever, severe diarrhea, a rapid heartbeat, and kidney failure while under the care of researchers. The warning label for the experimental medication listed some of these serious side-effects and other signs of heart failure, but the IRB failed to ensure the risks were communicated to participants at the outset of the trial.
During the clinical trial, the lead researcher continually delegated control of the clinical trial to a man who was unlicensed to practice medicine in the United States. In its follow-up investigation after the death, the FDA noted that the IRB repeatedly violated regulations governing the proper conduct of clinical trials and did not adequately supervise the clinical trial.
Given that millions of Americans take part in clinical studies testing the safety and efficacy of experimental drugs and medical devices each year, it is important that strict oversight of the process be guaranteed.
GAO’s recent study on the IRB process tested how the system is functioning.
GAO investigators created fictitious companies, used counterfeit documents, and invented a fictitious medical device to investigate three key aspects of the IRB system. . . .
GAO created a Web site for a bogus IRB and advertised the bogus IRB’s services in newspapers and online. A real medical research company contacted the bogus IRB to get approval to join ongoing human trials involving invasive surgery — even though GAO’s investigators had no medical expertise whatsoever. 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.
Obtaining an HHS-approved assurance. GAO also registered its bogus IRB with HHS, and used this registration to apply for an HHS-approved assurance for GAO’s fictitious medical device company. An assurance is a statement by researchers to HHS that their human subjects research will follow ethical principles and federal regulations, which is required before researchers can receive federal funding for the research. On its assurance application, GAO designated its bogus IRB as the IRB that would review the research covered by the assurance.
Even though the entire process was done online or by fax — without any human interaction — HHS approved the assurance for GAO’s fictitious device company. With an HHS-approved assurance, GAO’s device company could have applied for federal funding for human subjects research.
GAO succeeded in getting approval from an actual IRB to test a fictitious medical device on human subjects. GAO’s fictitious device had fake specifications and matched several examples of “significant risk” devices from FDA guidance.
The IRB did not verify the information submitted by GAO, which included false information that FDA had already cleared GAO’s device for marketing. Although records from this IRB indicated that it believed GAO’s bogus device was “probably very safe,” two other IRBs that rejected GAO’s protocol cited safety concerns with GAO’s device. No human interaction with these IRBs was necessary as the entire process was done through e-mail or fax. GAO’s bogus IRB mentioned above also could have approved the fictitious protocol, which shows the potential for unethical manipulation in the IRB system.
At least two of the IRBs GAO dealt with did their jobs and found that the bogus protocols were junk and very unsafe. The third IRB readily approved it for testing on human subjects.
After submitting the protocols, we obtained meeting minutes for IRB 1 that showed its board members thought our bogus protocol was “probably very safe” and voted unanimously to approve it. However, in follow-up calls to the two other IRBs, an employee of IRB 2 said the protocol was “awful” and called it “junk.” A board member of IRB 3 said it was the “riskiest thing I’ve ever seen on this board” and indicated that IRB 3’s board voted unanimously to reject the protocol. If we had been a real medical device company, we could have used the IRB approval we received to test our device on human subjects even though our research staff had falsified credentials and no research experience.
However, even the two IRBs that rejected the study were hardly models for protecting those who participate in medical studies.
None of the three IRBs questioned us about the authenticity of our bogus CV and counterfeit medical license. As mentioned above, we fabricated these documents by using information found online and with commercially available hardware, software, and materials. Our bogus CV contained information on our fictitious researcher’s human subjects research background, which we created by using phony drug and device names and with information that we accessed on the Internet. Our counterfeit medical license contained a bogus license number with a similar format to real license numbers used by the state we claimed our license was from.
The study is Human Subjects Research: Undercover Tests Show the Institutional Review Board System Is Vulnerable to Unethical Manipulation GAO-09-448T, March 26, 2009