Friday, July 29, 2011

Elliott Wants to Scrap IRBs

Carl Elliott, author of White Coat, Black Hat: Adventures on the Dark Side of Medicine, calls IRBs "incapable" and wants them replaced.

[Carl Elliott, Useless Pharmaceutical Studies, Real Harm, New York Times, 29 July 2011.]

He writes,

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.

1 comment:

Anonymous said...

As a former IRB employee, I will say studies that make money for the company will get approved, even if those studies are questionable. It's not really about the "rights of human subjects" as it is more about how much money can be made from the drug companies. I was totally shocked at the level of corruption that took place at this IRB. High employee turnover, lack of quality training, unqualified people in power who are making decisions, record sabotage...the list goes on. I did not want to be part of this atmosphere once I really saw the truth. I would NEVER trust being a subject in a study now. I agree with Elliott.