The first, and often only, financial concern of research participants is how much they are getting paid for participation. In studies that do nothing more than measure reaction time to identify a number in a serial string of letters, there is little reason to be concerned about other financial issues. However, for more involved research, such as clinical trials of new drugs, the possibility exists that something may go wrong. If and when it does, how should the research participant be compensated?
The Presidential Commission for the Study of Bioethical Issues recently had a meeting in Boston, at which the commission addressed the need for compensation of human research subjects who are harmed outside the scope of the research study. As noted by Mr. Kenneth Feinberg, it is not the current policy of federal sponsors of research to compensate for injuries caused by clinical studies. Conversely, most private sponsors of research cover any medical costs that may fall to the participant, either by covering what private insurance does not, or by paying for all treatment before insurance. For example, the research policy posted by Pfizer states that it “arranges for medical care for any physical injury or illness that occurs as a direct result of taking part in a Pfizer-sponsored clinical study. Pfizer reimburses this medical care at no expense to the subject.”
As simple as it may seem to say that participants should receive care for injuries that occur because of clinical research, there are always considerations that require more careful thought. Mr. Feinberg identified seven considerations that the Commission needs to consider in its final report. Some are easy, such as whether participants should be compensated for their injuries. Considering that many upfront payments for research are designed to reimburse participants for their costs and not to compensate for the risk they accept, it is only logical that they should be compensated if that risk actually occurs.
More interesting from a technological standpoint, is who (and how) a factual determination should be made that the study was responsible for the injury. For example, consider a situation where a study is comparing a standard-of-care surgically implanted device and a potentially improved device, and an injury occurs during the implantation procedure. Obviously, this only occurs when a patient is in need of the procedure in the first place. The question then becomes, was the adverse event caused by the new procedure, or a mistake during the surgery, or the natural progression of the underlying disease? Who should make this determination is a similarly difficult proposition. Under some possible theories of compensation, different causes of injury may warrant different levels of compensation. With necessarily unknown elements to research, a doctor involved in the study may be the only person with detailed enough knowledge to make the determination. However, the doctor will likely also have significant conflicts of interest. Therefore, it is clearly important that there be independent review with an emphasis on the future needs of the participants, and not just whether the study continues to be worth the risk in light of new data. Universities and other research centers could provide this review through already established ethics panels. Alternatively, the primary investigators or study sponsors could be responsible for contracting outside personnel to review as events occur over the period of the study.