Clinical trial patients sue IRB members

Suit could hinder medical research if individual institutional review board members are found liable.

By Vida Foubister, AMNews staff. Feb. 26, 2001.

Participants in a cancer clinical trial that was suspended last year after an audit found inadequate protections for human subjects filed a lawsuit Jan. 29 alleging that their constitutional right to be treated with dignity had been violated.

The complaint names all members of the now-disbanded institutional review board at the Tulsa campus of the University of Oklahoma Health Sciences Center individually as defendants -- a strategy believed to be without precedent.

"Federal regulatory agents made specific reference to the inadequate job of supervision that the IRB did," said Alan Milstein, the plaintiff's attorney, in explaining why the IRB members are fair game.

The Office for Human Research Protections found that "the IRB failed to conduct substantive and meaningful continuing review," said a June 29, 2000, letter suspending all federally funded research at the university.

Further, the informed consent documents approved by the Tulsa IRB failed to describe the risks of the trial and overstated its foreseeable benefits. "[S]ubjects were unlikely to benefit ... given that this was a phase I study of a vaccine never before administered to human subjects," OHRP concluded.

This leap from naming the IRB as a defendant, which has been done before, to naming its members individually is "significant," said Ernest Prentice, PhD, associate vice chancellor for regulatory compliance and co-chair of the IRB at the University of Nebraska Medical Center in Omaha.

"If an IRB does its job, if they follow the federal regulations, if they document compliance and if a patient suffers an unfortunate adverse event, even though they may be named in a complaint, I expect it will be dismissed," he added. "If they don't and they were irresponsible, it could certainly add strength to a plaintiff's complaint." [...]