IRB members face individual lawsuits

Boards may want to insure members

IRBs now have a new legal worry — the recent emergence of lawsuits aimed squarely at individual IRB members, rather than just at the institution or the IRB as a whole.

So far, there have been only a few cases that have received national attention. But that’s been enough for IRBs to go to their lawyers looking for advice — and to their insurers to make sure that individual members are covered.

The possibility that they could be personally sued if a research subject is injured has come as a shock to many IRB members, says Patricia Bass, JD, associate general counsel for Boston Medical Center.

"They probably thought of it previously as an innocuous activity, like being on a church board, that nothing really could happen to them," Bass says. "But when you really look at it, people who are on church boards can find themselves sued. From a pure lawyer’s standpoint, it’s not that different."

So far, the most well-known example of naming individual IRB members in a suit came in 2001 when participants in a cancer vaccine study at the University of Oklahoma Health Sciences Center in Tulsa (OUHSC) sued the lead investigator, university officials, and each member of the OUHSC-Tulsa IRB board, alleging violations of human subject protections.

Although officials at the university declined comment on the suit or its resolution, Alan Milstein, JD, a Pennsauken, NJ, attorney who represents the plaintiffs in the case, says the university settled the part of the suit that pertained to the IRB members.

Milstein says he included the members in the lawsuit because federal regulators had specifically faulted the IRB with failure to conduct its operations in accordance with regulations.

The Tulsa IRB has since disbanded.

Milstein has represented plaintiffs in a number of high-profile lawsuits over clinical research, including one filed by the family of Jesse Gelsinger, who died in 1999 in a gene therapy experiment at the University of Pennsylvania. He says that he infrequently names individual IRB members, in perhaps 10%-20% of the lawsuits he handles.

"You can’t simply sue an IRB member because they diligently did their job but perhaps came up with the wrong decision, based on hindsight," Milstein says.

"If you have a study in which clearly the design of the study was such that the risks outweighed the benefits, and it’s apparent that the IRB didn’t give the study the review it should have done before approving it, that’s one thing," he says. "When there’s absolutely no oversight once the study goes on — a lack of reporting, a lack of follow-up on why there is no reporting, then those are the other kinds of things that would bring the IRB into play."

Potential members wary

The repercussions of the Tulsa case are beginning to be felt at IRBs across the country. John Isidor, JD, chief executive officer of Schulman Associates, an independent IRB in Cincinnati, said he’s had one potential IRB member decline because of concern about liability.

"I did have one person that I contacted to either be a consultant or to be an alternate board member," he says. "He had discussed it with his counsel, and he declined because of liability concerns."

Although IRB members rarely have the kind of assets that plaintiffs in lawsuits are seeking, their inclusion in a suit can have a powerful effect, says Isidor, himself a former trial lawyer.

"Believe me, the members can exert pressure on the entity to settle because they’re prestigious people, and they’re unhappy," he says. "Plus, it creates a lot of negative publicity for the university."

Isidor notes that a member anxious to be released from a suit might be inclined to cooperate with the plaintiff. He says that while the IRB community is sensitive to the threat of lawsuits against members, concern would become much greater if any case were to result in individual judgments against IRB members.

"There have been a few cases that got a lot of publicity, but ultimately, they’ve settled out," Isidor says. "It hasn’t gone to the mat, so to speak.

"If there is a widespread recognition of the liability of these members and then subsequently it goes to judgment, or there are repeated lawsuits in which IRB members are named individually, then I think it would be very, very detrimental."

Kendra Dimond, JD, and Mary Marta, JD, MSN, CPHQ, attorneys in the Washington, DC, office of Epstein, Becker & Green, say they’ve discussed the implications of the Tulsa case with many of their clients who are involved in research.

"I can’t help but think that we’ll see more of these cases, simply because now we’ve seen one on the books," Dimond says.

Advice for IRBs

They and others have advice for institutions that are examining their IRBs’ potential legal exposure:

Check insurance coverage. Milstein says IRB members often fall between the cracks of a research institution’s standard insurance coverage. He says they’re usually not covered under such categories as malpractice insurance, directors’ and officers’ liability insurance, or general liability coverage.

Dimond agrees that insurance is a huge issue.

"It’s possible that IRB members may be covered for their responsibilities, and it’s also very possible that they’re not covered," she says. "What we’ve been doing with clients is suggesting that they talk with their brokers and insurance carriers to determine what exactly is the situation."

The question is particularly tricky as it relates to nonaffiliated members, who wouldn’t be covered in the same way that employees of the institution would. Dimond and Marta say a government institution, such as a state or municipal hospital, may be limited in its ability to indemnify, or take on the liability, of the nonaffiliated members, depending on the laws of that particular state.

Isidor says his previous career as a trial lawyer helped him recognize early the potential for IRB members to be pulled into lawsuits.

"I read the regulations and I figured at some point in time it could lead to litigation, including the naming of IRB members," he says. "Many years ago, we purchased insurance, and we also sought indemnification agreements from the sponsors specifically for IRB members."

Isidor advises IRBs to explicitly discuss the issue with all potential candidates for membership. "We do that. We have always done it. I’ve told them that they could be individually named."

Examine agreements with sponsors. Marta says an institution needs to carefully review indemnification provisions in its contracts with research sponsors, to be sure that IRB members are covered.

Generally, Dimond says, sponsors are willing to indemnify, because they realize the risk that research sites bear.

"If someone’s not particularly savvy with the indemnification, it may be an issue that they just didn’t know to ask the right questions or to look for the right language in the indemnification provision with the sponsor," she says.

Review all pertinent regulations and policies. In the end, Bass says, the best way to minimize IRB members’ risk is to ensure they’re following all the necessary regulations and policies that apply to the IRB.

"The general answer is always do your duty," she says. "There’s no sort of magic solution to this."

Dimond and Marta note that failure to comply with the any of the state, federal, or institutional rules that govern IRBs could be argued as negligence in a lawsuit.

Milstein says many IRBs simply lack the resources to properly monitor all of the studies that go on at their institutions.

"Some of the major institutions are conducting between 3,000-5,000 studies at once and there’s just no way in the world that one, two, three, four, or five IRBs can handle that many studies. It’s just impossible."