[Carl Elliott, Useless Pharmaceutical Studies, Real Harm, New York Times, 29 July 2011.]
The main source of protection for research subjects is a patchwork system of ethics committees known as institutional review boards, or I.R.B.’s. These are small, federally empowered bodies that review research proposals before they are carried out, to ensure that the studies are ethically sound. But they don’t typically pass judgment on whether a study is being carried out merely to market a drug. Nor do most I.R.B.’s have the requisite expertise to do so. Even worse, many I.R.B.’s are now themselves for-profit businesses, paid directly by the sponsors of the studies they evaluate. If one I.R.B. gets a reputation for being too strict, a pharmaceutical company can simply go elsewhere for its review.
Last week, the federal government announced that it was overhauling its rules governing the protection of human subjects. But the new rules would not stop seeding trials. It is time to admit that I.R.B.’s are simply incapable of overseeing a global, multibillion-dollar corporate enterprise. They should be replaced with an oversight system that is financially and administratively independent of the research it oversees. The system must have the power to impose sanctions, and its responsibilities must extend to fraud, bribery and corruption.
See also, "Dreger Wants to Scrap IRBs" and "Stark Wants to Scrap IRBs." All of these scholars doubt the ability of local IRBs to police multinational corporations. And I think Elliott is right that the proposals in the ANPRM wouldn't fix that.