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The primary means of protecting research subjects are ethics committees known as institutional review boards.
The idea was that to protect the welfare of research subjects, all studies would be reviewed in advance by an ethics committee independent of the researchers conducting the study, whose scientific zeal might lead them to shortcomings safety. Traditionally, IRBs have been volunteer committees made up of scientists and clinicians working in the hospitals and medical schools where the studies they review are being carried out.
Today, however, the ethics review of more than half of all new drug submissions to the Food and Drug Administration is handled by a single for-profit IRB, Western Institutional Review Board in Olympia, Wash.
How did we get here? When IRBs were established a generation ago, medical research was conducted mainly by individual investigators working in medical schools who were funded by the federal government and who had little financial stake in their studies. These days, medical research is a massive, multinational corporate enterprise. Rather than contracting with academic researchers to test new drugs, the pharmaceutical industry has found it cheaper and more efficient to conduct studies in physicians' offices, industry laboratories, and private testing sites like SFBC's in Miami. As recently as 1994, 63 percent of clinical trials were taking place in academic settings. Ten years later, that figure had shrunk to 26 percent. Along with private-sector clinical research has come private IRBs, which market themselves by promising fast and industry-friendly service.
But the private IRBSshave a direct financial interest in keeping their drug-company clients happy. If one for-profit IRB rejects a study as unethical, the pharmaceutical company sponsoring the study can simply send it somewhere else. Free-marketeers argue that there's a countervailing pressure that should make drug companies welcome strict policing from the IRBs - the possibility that a strict ethics review on the front end could head off a lawsuit on the back end. But in reality, the incentives don't pan out that way. Lawsuits, while on the rise, are still relatively rare. For the companies bankrolling the clinical trials, litigation is a quite-manageable cost of doing business.
Surprisingly, for-profit IRBs have drawn little criticism from bioethicists. Instead, some university and government scientists are increasing their influence.
IRBs were never intended to be formal regulatory bodies. They were supposed to provide a kind of professional self-regulation, in which scientists were advised by their colleagues.
That mission might have made sense 30 years ago. Today, however, the prevalence of private-sector drug research and the push to commercialize every facet of medical research makes the original model hopelessly outdated. Research subjects need a watchdog to protect them, and not one that is owned by the pharmaceutical industry. If IRBs cannot do the job, then we need to replace them with something that can.
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