Writing in the New York Times about a series of scandals at the University of Minnesota, bioethicist Carl Elliott calls for the IRB system to be abandoned and replaced with “a full-blown regulatory system.” This is essentially the same argument he made in the New York Times in 2011, when the ANPRM was issued.
[Carl Elliott, “The University of Minnesota’s Medical Research Mess,” New York Times, May 26, 2015.]
Elliott terms medical research “a global, multibillion-dollar business enterprise, powered by the pharmaceutical and medical-device industries,” with the resources to give researchers “powerful financial incentives to do unethical things.” (Since scholars in the social sciences and the humanities don’t receive powerful financial incentives to do anything, I trust Elliott does not wish to include us in his regulatory proposal.)
With so much money at stake in drug research, research subjects need a full-blown regulatory system. I.R.B.s should be replaced with oversight bodies that are fully independent — both financially and institutionally — of the research they are overseeing. These bodies must have the staffing and the authority to monitor research on the ground. And they must have the power to punish researchers who break the rules and institutions that cover up wrongdoing.
He analogizes to other industries:
In what other potentially dangerous industry do we rely on an honor code to keep people safe? Imagine if inspectors never actually set foot in meatpacking plants or coal mines, but gave approvals based entirely on paperwork filled out by the owners.
I realize Elliott’s question is rhetorical, but Carl Schneider’s new book, The Censor’s Hand, gives one answer:
Doctors must daily use unproved treatments, and patients often face choices much more numerous and dangerous than most research subjects. Doctors cause over 50,000 unnecessary deaths annually—incalculably more than research misconduct in all its history. Yet doctors are regulated by licenses and tort liability, not a Treatment Review Board.
Is Elliott proposing full-blown regulation for that multi-trillion-dollar industry?