Friday, September 7, 2012

Can an IRB Ban a Researcher?

In July, the Sacramento Bee reported that the University of California, Davis, had ordered two doctors--J. Paul Muizelaar and Dr. Rudolph J. Schrot--"to halt all human research activity 'except as necessary to protect the safety and welfare of research participants.'" Schrot told the Bee that "To be banned from clinical research makes a career in academic medicine challenging, to say the least."

The Common Rule (45 CFR 46.113) empowers IRBs to "suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects," but it does not explicitly empower them to ban a researcher from all research.

Curious about this case, I submitted a public records request to the university and received a copy of the attachments to the letter sent by the university to the FDA, including--on page 134 of the PDF--a copy of the 14 October 2011 letter in which the UC Davis IRB office told the two doctors to "immediately cease and desist from any research activity in studies for which you serve as Principal Investigator or co-Principal Investigator" (emphasis in original) and to "cease participation on any human research activity" for which they were co-investigators. The letter did not limit itself to the research described in 45 CFR 46.113, nor did it offer citation to federal or university regulations giving it the authority to make these demands.

Perhaps I am unfamiliar with some federal or university regulation or guidance empowering an IRB to ban a researcher from all human subjects research. If so, the UC Davis IRB missed an opportunity to educate me. If no such regulation exists, the IRB may have exceeded its authority in imposing this penalty. What we need is a culture of legality in which IRBs explain their actions.

Meanwhile, the Bee reports that the federal government is investigating the case an one of possibly improper patient care, not research misconduct.


Anonymous said...

An institution doesn't need a regulation in order to demand that an employee cease an activity, not least one that threatens the integrity and funding of institution.

Zachary M. Schrag said...

Yes, it really does, if it's committed to academic freedom and the rule of law. And the IRB is not the institution. A committee is only empowered to carry out the duties granted to it by the institution's governing board.

Anonymous said...

Academic freedom to experiment on people with terminal illnesses with disregard of the IRB, FDA, and so on? With all freedoms come responsibilities. They blew it.

True, "the IRB is not the institution". But if you really think that the letter telling them to cease all research wasn't written without the knowledge and approval of the university's GC and senior leadership, I have bridge in Brooklyn I can offer you at a great price.

Zachary M. Schrag said...

The UC Davis leadership and GC couldn't control the police department. Why assume that the IRB chairs weren't going rogue as well?