As someone who has served on a hospital IRB for a number of years and greatly respected the work of the committee, I was surprised to learn that "commercial boards" are rapidly replacing the volunteer IRBs in hospitals and now dominate the clinical trial process (see: In clinical trials, for-profit review boards are taking over for hospitals. Should they?). Here are some of the details from the article:
Institutional review boards [IRBs] — which review all research that involves human participants — have undergone a quiet revolution in recent years, with many drug companies strongly encouraging researchers to use commercial boards [such as WIRB-Copernicus Group], considered by many more efficient than their nonprofit counterparts. Commercial IRBs now oversee an estimated 70 percent of US clinical trials for drugs and medical devices. The industry has also consolidated, with larger IRBs buying smaller ones, and even private equity firms coming along and buying the companies....But even if the tide has already turned, the debate over commercial review boards ....continues to swirl. The debate could also intensify. Late last month, the National Institutes of Health announced that US-funded trials that are carried out at multiple research centers must begin using a single IRB, with few exemptions possible. Because few universities or hospitals have the capacity to review study protocols and track adverse events for far-flung institutions, the new rule is expected to be a windfall for commercial IRBs.
The modern history of science is littered with studies in which participants were harmed because researchers failed to take necessary precautions.....But some experts say the risks [of harm in clinical trials] are far greater with commercial review boards, which often have harder-to-spot conflicts of interest and a profit motive. The Food and Drug Administration reported twice as many violations and problems with commercial IRBs as with nonprofit boards from 2008 to 2014, according to preliminary findings in a recent study,....Mark Schreiner, a medical school professor and vice chairman of the IRB at Children’s Hospital of Philadelphia, said he is uncomfortable outsourcing the evaluation of pediatric trials to commercial review boards.“IRBs are hired by the sponsor,” Schreiner said. “They are paid by them. And so if they turn down the study, then I think they’re unlikely to get repeat business.
Here's a brief definition of the work of an IRB (see: Institutional review board):
A committee used in [connection with medical] research in the United States that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans. They often conduct some form of risk-benefit analysis in an attempt to determine whether or not research should be done. The purpose of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study.
My own view about all of this is that it's a major step backward and another step in the "industrialization" of healthcare and medical research (see: The Significance and Relevance of the "Industrialization" of Healthcare). Here's a quote from this previous note about the prerequisites of industrialization: (1) an increasing division of labor, (2) standardization of roles and tasks, (3) the rise of a managerial superstructure, and the (4) degradation (or de-skilling) of work. IRBs are tasked primarily with the protection of the rights of research subjects enrolled in clinical trials. As described perhaps too delicately in the quote above, commercial review boards may be subject to hard-to-spot conflicts of interest and their profit motive. Put more bluntly, there is the serious risk of a compelling financial relationship between the pharmaceutical companies and the commercial IRBs with the research subjects caught in the middle and in peril. The dominant goal of pharmaceutical companies is to successfully complete drug trials, obtain FDA approval, and bring their products to market. Unlike volunteer hospital IRBs, concern for subjects is not their primary concern.
It came as no surprise to me that, according to the article, the NIH is now requiring that a single IRB oversee trials carried out in multiple centers. Also, as noted above, such a rule plays into the hands of the commercial IRBs. Multi-center trials are common for studies for which it is difficult to enroll sufficient subjects from a single hospital. This decision by the NIH makes perfect sense in terms of administrate simplicity for the it given that academic centers have each evolved some of their own IRB rules and bureaucracy. The rule will surely streamline then process of managing and completing multi-center trials. Unfortunately, administrative simplicity will be achieved by creating a duopoly consisting of commercial IRBs and drug companies with the health and well-being of research subjects at risk.