GOVERNMENT & POLICY
ETHICAL REVIEW GAO finds that ethics review boards for clinical trials are VULNERABLE TO FRAUD, abuse to ensure that research involving human subjects is carried out ethically, a recent investigation by the Government Accountability Office (GAO) ironically found that the system for reviewing the ethics of clinical trials is vulnerable to unethical manipulation. Under federal law, all clinical research including human testing must first be approved by an institutional review board (IRB)—a panel of at least five experts, including one scientist and one nonscientist, that reviews the study for purposes of protecting the rights and welfare of human subjects. The Department of Health & Human Services’ (HHS) Office for Human Research Protections (OHRP) and the Food & Drug Administration oversee various aspects of the IRB system. Historically, IRBs were located at academic institutions or hospitals where clinical trials are conducted. But today, hundreds of private, for-profit IRBs have entered the marketplace. These so-called independent IRBs typically provide services to private pharmaceutical companies or device makers that conduct or sponsor clinical trials. Because of concerns about the quality of some IRBs, the Oversight & Investigations Subcommittee of the House Energy & Commerce Committee asked GAO to conduct an undercover operation to test the IRB review process. Details of the investigation came to light during a hearing of the subcommittee in late March. GAO concluded that the IRB system is vulnerable to manipulation by companies or individuals who intend to abuse the system or to commit fraud. As described at the hearing by Gregory D. Kutz, managing director of GAO’s Forensic Audits & Special Investigations Unit, GAO investigators submitted a bogus research study involving a fictitious medical device to three independent IRBs for review. One of them, Coast IRB of Colorado Springs, Colo., said the device was “probably very safe” and gave the green light to test the device on human subjects. The
other two IRBs did not approve the study, citing safety concerns about the device. Coast Chief Executive Officer and President Daniel S. Dueber defended his company at the hearing, saying that Coast was a victim of what it deemed as an extensive fraud perpetrated by GAO. He emphasized that Coast changed its standard operating procedures after it had been “hoodwinked” by the federal government. FDA EVALUATED the information pro-
vided by GAO and immediately took action against Coast. In mid-April, Coast voluntarily agreed to stop reviewing new trials that involve FDA-regulated products, and subsequently the company provided FDA with a corrective action plan. But experts are concerned that Coast is just one of many IRBs that fail to perform robust reviews of clinical trials before approving them. The GAO investigation revealed that anyone could create an IRB and register it with HHS regardless of their credentials. As part of the investigation, GAO created a fictitious IRB using clever names such as April Phuls, at phony locations such as Phulovit FREE TICKET Coast, In a continuing effort to the IRB at the center establish oversight on trials Lane, Chetesville, Ariz. It then regof a GAO sting, went istered the fictitious IRB with HHS that do not involve FDAas far as sending a via an online registration form, regulated products and are coupon offering a Kutz noted. HHS did not question not funded with federal free IRB review so the application and issued the pho- researchers could dollars, Rep. Diana DeGette “coast through your ny IRB a registration number. (D-Colo.) has introduced next study.” When lawmakers asked why a bill, the Protection for OHRP did not question the blaParticipants in Research tantly phony registration, Jerry A. Act (H.R. 1715), in each of Menikoff, director of OHRP, replied that the past three Congresses. The bill would the system wasn’t designed to catch fake reform federal regulation and oversight data. He emphasized that registration in of research on humans, making federal the OHRP database does not mean that an regulations applicable to all research that IRB is endorsed by the federal government. involves human subjects regardless of the However, the perception in the marketfunding source. place is that registration with OHRP gives Some observers are hopeful that this credibility to an IRB, Kutz noted. will be the year that the legislation passes. Joanne R. Less, director of FDA’s Good “Reforms are way overdue,” Shamoo says. Clinical Practice Program, defended FDA’s As the GAO sting revealed, he notes, “the role in protecting the safety and rights of system is completely broken.”—BRITT human participants in clinical trials that ERICKSON GAO
ALTHOUGH SAFEGUARDS are in place
involve FDA-regulated products. She emphasized that GAO’s faux trial would not have started because trials that involve FDA-regulated products such as a drug or medical device need approval from both an IRB and FDA before they can begin. But only about 25% of the 25 million humans enrolled in clinical trials each year are treated with an FDA-regulated product, says Adil E. Shamoo, a biochemist and bioethicist at the University of Maryland School of Medicine and cofounder of the advocacy group Citizens for Responsible Care & Research. Safeguards are also in place for trials involving human subjects that are funded by the federal government. Such trials must be carried out in compliance with ethical principles and OHRP regulations. About 40–45% of all human subjects are enrolled in clinical trials that are funded by the federal government, Shamoo tells C&EN.
WWW.CEN-ONLINE.ORG
43
MAY 4, 2009
