Who pays when trial subjects are injured?

Institutions need to develop own policy

By J. Mark Waxman, JD

A basic tenet of research involving human subjects is those who agree to be participate must give their informed consent after being informed about the known and unknown risks inherent in their participation. One category of risk is the possibility of injury. The scope of potential injuries is broad, ranging from injury while en route to the hospital for a follow-up interview or test to a reaction to the study drug. Additionally, an adverse result from an unforeseen psychological trauma could occur.

In each example, there would likely be no fault that might be assessed against the institution or principle investigator (PI) conducting the trial. Yet, the question arises, who should bear the risks of those injuries and, in turn, the resultant costs?

On this issue, the rules regarding informed consent are nonexistent. Other than mandating that the risks and benefits of treatment be assessed, there is little guidance for IRBs and institutions grappling with this problem. Other source documents offer some additional guidance in framing the issue, but little help in resolving it. The Belmont Report, for example, does reference the notion of "distributive justice" in the sense of avoiding unjust distribution of the burdens and benefits of research. It also notes that in making a risk/benefit assessment, "economic harm" should be addressed. There is not, however, a specific reference to research related injuries, or how their costs might be borne as a result of the devised consideration.

How then can an IRB and an institution approach this problem? First, we can simply list the potentially involved parties — the patient; the institution; the PI; the sponsor; any other trial funder; the potential commercial beneficiary of the research; or, where otherwise qualifying, the taxpayer through Medicare or Medicaid program support; or the private insurers.

Second, we might consider who within this group could, would, or should have insurance to help spread the risk among a larger group. In the ordinary course, an institution would not have insurance to cover the costs of a research-related injury that required care and treatment — for example, for an unanticipated adverse side effect. On the other hand, in some cases Medicare may help. Under its National Coverage Determination (NCD), Medicare will cover "reasonable and necessary" items and services used to diagnose and treat "complications" arising from participation in clinical trials. Whether commercial carriers will offer similar coverage will require a careful review of the specific terms and conditions of coverage.

In this regard, some state laws specifically mandate coverage in a variety of instances. For example, in Massachusetts, the law provides that defined patient care services provided as a part of a "qualified clinical trial" (e.g., one intended to treat a diagnosed cancer) must be covered and reimbursed.1

Different institutions will address these issues differently, and there is a range of possible outcomes. Some have adopted rules that require, without exception, that commercial sponsors to indemnify the institution and the patients against the costs. On the other hand, the institution itself will bear the costs of governmentally or institutionally sponsored trials. The theory for this result is twofold — the commercial sponsor likely has (or should have) the necessary insurance as a cost of doing business, and that the commercial sponsor has the most to gain directly in a commercial sense from the conduct of the trial. At the extreme, a number of institutions have chosen to simply state that the trial participant is on their own — e.g., "there is no commitment to provide monetary compensation or free medical care to you in the event of a study-related injury." Or stronger, "The institution assumes no obligation to pay any money or provide free medical care in case this project results in any harm to me . . . . The costs may include medical treatments, laboratory test, and a possible stay in the hospital. I understand that the exact cost cannot be determined at this time since any harm to me would be unforeseen. My insurance company may not pay for such treatments, in which case payment of costs will be my responsibility . . ."

Other approaches might distinguish between the various injuries that might occur. For example, in South Africa, the policy in the area provides, among other things, that "compensation should only be paid in the more serious injury of an enduring or disabling character (including exacerbation of an existing condition) and not for temporary pain or discomfort or less serious or curable complaints."2

One choice to be made is whether billing of available third-party insurance will be required. If this occurs, in a macro sense, the cost of injury are borne by the patients. In the more specific case, it means that the deductible and copayments are borne by the patient. Indeed, were there amounts to be forgiven, there is a risk that the insurance would not be extended to cover the injury costs at all.

In the end, each institution must reach its own conclusions on the issues presented in this area. That should involve a review of its own policies, its view of the ethics of each presented situation, the likelihood of serious injury and other relevant factors. Whatever the result of that process, the conclusion should be explained to the participant to ensure the informed consent process includes this important element.

References

1. Mass Gen. Laws, Ch.175 §110L.

2. Guidelines for Medical Experiments In Non-Patient Human Volunteers, Association of British Pharmaceutical Industry. Web site: www.sahealthinfo.org/ethics/book1appen4.htm; March 1988, as amended May 1990.

J. Mark Waxman, JD, is General Counsel, CareGroup Healthcare System, Boston.