Do you have a plan for research-related injuries?

Most don’t have a subject compensation plan

No investigator or coordinator wants to believe it could happen. But in clinical trials, injuries or adverse events are always a possibility.

The question for many is, What will happen to study subjects who are injured in the course of their research participation? Beyond any emergency medical care, will they be compensated for the cost of any needed medical follow-up? What about lost time at work or a lingering disability?

Although many researchers believe that ethically research subjects should not have to absorb the costs of research-related injures, there often is little help available for subjects injured during a trial.

"Federal regulations do not require institutions or sponsors to have policies in place to compensate subjects for research-related injuries," says Larry D. Scott, MD, assistant vice president of the human subjects program at the University of Texas Health Science Center (UTHSC) at Houston. "The regulations only require that they disclose to subjects whether or not any such compensation is available."

Consequently, most institutions do not have an established policy for compensating injured subjects, he says.

At UTHSC, the institutional review board often requires device manufacturers and pharmaceutical companies who sponsor trials there to agree to pay for the cost of the medical care needed by any subject injured during the course of the study.

But for all other studies, the informed consent documents usually indicate that although the costs of immediate emergency medical care will be covered, there is no provision for compensation for other costs due to research-related injury beyond what is paid for by the participant’s own health plan, he says, noting that some payers will not cover costs related to an injury sustained as part of a research study.

"There are valid arguments for and against asking health plans to compensate injured subjects," Scott notes. Although some feel it should not be the responsibility of an individual’s insurer to cover costs related to research, others argue that health plans have a responsibility to further progress in medical science and technology, and this means supporting research participation by not excluding claims for injuries related to the participation of their members.

Medicare, in fact, does cover costs associated with research-related injuries for its beneficiaries as long as the research study involved some potential for benefit to the participant, Scott adds.

Because research-related injuries are very rare, most institutions are not giving this issue a high priority, Scott notes.

But with the media coverage given to the deaths of research subjects Jesse Gelsinger at the University of Pennsylvania and Ellen Roche at Johns Hopkins University, the public is beginning to get the impression that participation in medical research is a very dangerous and risky proposition.

This may seriously affect research participation in the future, Scott reports.

"I definitely think this is a question that IRBs [institutional review boards] need to be asking more often and investigators need to be asking more often," he says. "If someone is injured during the course of this trial, what compensation is available to that person?"

There are actually a number of options that go unexplored at many institutions, Scott notes.

First, as at UTHSC, the IRBs or investigators can negotiate a compensation plan with industry sponsors.

Second, they can explore whether some third-party payers or the research institution itself would be willing to compensate subjects in the event of an injury.

As he noted before, Medicare does cover some research-related injuries incurred by its beneficiaries. And Veterans Affairs (VA) covers medical costs related to the injuries incurred by subjects at VA-sponsored trials at their medical centers.

Institutional plans

A few research centers have implemented their own policies about compensation for research-related injuries.

The University of Washington in Seattle, for example, has a self-insured plan to compensate subjects injured during the course of an IRB-approved research study as long as certain conditions are met (see chart.):

  • The injury is a physical injury — the plan does not cover impairment of mental processes or emotional distress.
  • The injury is clearly not the result of procedures or processes the person would normally encounter as part of medical treatment for his or her condition.
  • The injury is not the result of noncompliance with the research protocol.
  • The study sponsor does not have a plan for compensating research-related injuries.

Since its implementation in 1972, the program has not had to bear extensive costs of research-related injuries and has been a cost-effective program for the institution, Scott notes.

Although they are hopeful that other institutions will follow their example, without a set nationwide standard and absent a regulatory requirement, it’s not very likely, notes Helen McGough, director of the human subjects division of the University of Washington.

"I do not believe there is a standard in the [research] community regarding compensation for research-related injuries," she says. "It is common practice to expect that sponsors will pay the costs of treating research-related injuries in commercially sponsored research, but there is no guarantee since there is no regulatory requirement. And again, because there is no regulatory requirement, institutions themselves vary in their willingness to absorb the costs."

Few institutions go as far at the University of Washington, says Scott. He is aware of only one other center with a similar policy — Wake Forest University in Winston-Salem, NC.

Even then, the compensation plans only cover the direct medical costs associated with physical injuries.

There is often no provision for economic losses incurred due to loss of work or to long-term follow-up care, Scott notes.

In the future, as research trials of new medical technologies become more complex, yet offer much more potential for benefit to the society at large, the federal government should explore large-scale measures to support research participation, he explains. "Gene transfer studies are a good example. They carry significant risks for participants, but the knowledge that could be gained could have enormous potential for the public good."

In much the same way as Congress enacted the National Vaccine Injury Compensation Plan (NVICP) to protect vaccine manufacturers from lawsuits and ensure adequate production of vaccines to benefit the public health, the government could consider setting up a fund to compensate research subjects.

"Particularly for studies deemed to have significant potential for improving medical knowledge or discovering new treatments, this could be a solution," Scott says.

Industry sponsors should also shoulder some of the responsibility for supporting research, by establishing common standards relating to compensation for injuries, says McGough.

"One of my hopes is that pharmaceutical companies, device manufacturers and biotech companies will develop industry standards and unequivocally accept their responsibility to pay for the costs of treating research-related injuries," she says. "Our institution spends many, many hours negotiating with individual sponsors — hours that could better be spent on other protection issues if there were industry standards."

A second option, McGough notes, is to ask federal sponsors of research to look into the costs of providing coverage as part of the grant and contracting process, she adds. "The first steps have already been taken through the Veterans Administration and Medicare. A third avenue is to ask the private health insurance companies, perhaps through an industry association, to develop clear guidelines for covering the costs of research-related injuries in clinical trials."