PROFESSIONAL ISSUES

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. Additional information

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."

Beyond making physicians and others think twice before they agree to serve on an IRB, a successful suit against the Tulsa IRB members might also lead IRBs to be overly cautious in their approval of research.

"If you're too careful, you get to the point where you start turning down research because there might be some bad publicity if it goes wrong," explained Sanford Chodosh, MD, president of Public Responsibility in Medicine and Research in Boston.

But the role of these boards is not to protect investigators or institutions. "IRBs exist to protect human subjects," Dr. Chodosh said.

Named but not yet liable

Even though this case has raised considerable attention in research circles, some experts interviewed by AMNews said it was too early to determine its implications.

"There's always one case or another that's active somewhere, but nothing ever seems to come of it," said Robert J. Levine, MD, editor emeritus of IRB: A Review of Human Subjects Research. "There has never been a reported case of a successful lawsuit against an IRB member for doing an IRB member's job."

And naming everyone associated with a cause of action in a complaint is standard fare for plaintiff's attorneys. "It's a strategy that causes more people to be upset, and therefore encourages institutions to settle quicker," said Leonard H. Glantz, professor of health law at Boston University School of Public Health.

Currently, other obstacles, such as time IRBs spend on procedural matters, are more likely to make people reluctant to serve on IRBs than a lawsuit threat, said Norman Fost, MD, MPH, chair of the University of Wisconsin Hospital IRB in Madison. "In the last couple of years, people have questioned whether their time is being spent for an important purpose."

But the outcome of this case could have "enormous implications," said David Korn, MD, senior vice president for biomedical and health sciences research at the Assn. of American Medical Colleges.

"These decisions are often not black-and-white cases but rather require professional judgment," he said. "People who are going to do that in good faith, and spend time and energy on it, don't want to have their judgments challenged in lawsuits that charge them with reckless behavior and impose stiff penalties."

Staffing IRBs might become "absolutely impossible" given that it's a volunteer position, added Gary Chadwick, MPH, PharmD, executive director of the Research Subjects Review Board at the University of Rochester in New York.

"Why would I even want to risk the chance of being named in a lawsuit?" he asked. "With the amount of research done at any major research university or academic medical center, there will be people who have adverse events and there will be people who die. If the default is as soon as that happens the IRB gets sued, there will be no more IRBs and there will be no more research because you can't do research without IRBs."

Indemnified by the institution?

Gary Raskob, PhD, associate vice president for clinical research at the University of Oklahoma Health Sciences Center in Tulsa, would not comment on whether or not the institution's insurance policy covers the IRB members named in the Jan. 29 complaint.

That's among the first questions this lawsuit raises. "One of my board members came running down the hall with this when it was first on the wire and asked about our liability insurance," Dr. Chadwick said.

At Ohio State University, service on the IRB is clearly within the scope of responsibility for employees. "If IRB members perform their duties in good faith and in a reasonable manner, the risk of personal liability is negligible," said Todd G. Guttman, MD, associate counsel in the office of legal affairs.

Any exceptions to this, according to state law, would be actions that "were manifestly outside the scope of employment or official responsibilities" or those that were taken "with malicious purpose, in bad faith or in a wanton or reckless manner."

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ADDITIONAL INFORMATION: Case at a glance

Dawanna Robertson et al. v. J. Michael McGee, MD, et al.

Venue: U.S. District Court in Tulsa, Okla. Case No.: 01CV00G0H(M) At issue: Participants in a melanoma vaccine trial are suing individuals and institutions at the University of Oklahoma Health Sciences Center, Tulsa, for allegedly failing to ensure that federal regulations for human subject protections were followed. Potential impact: If IRB members are found personally liable, it might be difficult to recruit people to serve on voluntary research oversight committees. It could also make IRBs hesitant to approve promising but potentially controversial research.