Institutional review boards (IRBs), designed to serve as gatekeepers protecting patients from unethical human research practices, are under new scrutiny from federal regulators and ethicists.
Critics say studies with serious design flaws that could lead to unethical practices or participant harm continue to win approval because IRBs are too lax, have unqualified members, are riddled with institutional and personal conflicts of interest, and are overwhelmed by the volume of studies they must review.
Those involved with IRBs counter that while the system isn't perfect, the integrity of human research would be compromised without their involvement. They say IRBs have improved in terms of transparency and conflict disclosure.
Last month, the consumer advocacy group Public Citizen and the American Medical Student Association complained to HHS' Office for Human Research Protections (OHRP) about the ethical integrity of two ongoing studies analyzing the impact of longer-than-recommended work shifts for first-year medical residents on 30-day patient mortality rates. Public Citizen and the student association called the studies “highly unethical” for not seeking informed consent from the medical residents or the patients studied. The research design, they said, forced hundreds of residents across the country to work “dangerously long shifts,” placing them and their patients at risk of serious harm. HHS said the OHRP is reviewing the complaints.
The lead investigators on those two studies, from Northwestern University and the University of Pennsylvania, say their studies were evaluated and approved by IRBs at dozens of participating sites. They say there is no solid evidence about whether shorter resident hours are safer for patients, which is why the studies are needed.
“We just have never had prospective, randomized, high-level evidence to inform our decisionmaking,” said one of the study leads, Dr. Karl Bilimoria, vice chairman for quality in the surgery department at Northwestern's Feinberg School of Medicine. “That's why these trials are so important.”
In September, the OHRP and 15 other federal agencies proposed the first substantial revisions in nearly 25 years to the Common Rule, a set of regulations designed to protect medical research participants. The proposed revisions address major shifts in the medical research environment since the early 1990s, and would apply to all U.S. clinical trials, regardless of their funding source. Two provisions would directly affect IRBs.
But Dr. Robert Klitzman, director of the graduate bioethics program at Columbia University, said the proposed rules don't do enough to hold IRBs more accountable and don't address what he calls shortcomings in the qualifications and expertise of IRB members.