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.