By Suzanne M. Rivera, Ph.D.
Of all the protections provided in the Common Rule to safeguard the rights and welfare of research participants, there’s one glaring omission: treatment of study-related injuries.
Our current regulatory apparatus is silent on whether treatment of injuries incurred while participating in a study ought to be the responsibility of the sponsor, the researcher, or the test subjects. The closest thing to guidance we are given on this topic in the Common Rule is a requirement that, if the study involves more than minimal risk, the informed consent document must provide, “an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.”
Note, the regulations do not state that plans must be made to provide treatment at no cost to the participants. In fact, the regulations don’t say treatment needs to be made available at all. Thus, it is possible to comply with the letter and spirit of the regulations by stating the following in an informed consent document, “There are no plans to provide treatment if you should be injured or become ill as a result of your participation in this study.” Or even, “The costs of any treatment of an injury or illness resulting from your participation in this study will be your responsibility.”
I have yet to encounter a person who thinks it would be reasonable to expect volunteers to enroll in a research study knowing that, in the event of study-related injury or illness, there are no plans to provide treatment. And yet, many studies are approved every year by duly constituted IRBs at reputable institutions under just such circumstances.
This does not mean subjects largely go untreated when study compounds or interventions injure them. Academic health centers and other research hospitals often do end up providing care—quietly and with fingers crossed that to do so will avoid more costly litigation. It’s not that they won’t provide it, they just don’t want to promise it up front.
Promising it up front would be tricky for a variety of reasons.
1) The federal government, which funds a great deal of clinical research in this country, does not have a way to allow budgeting up front in a grant proposal for the direct charging of injury treatment costs.
2) Obtaining insurance to cover research risks is not easy. Insurance carriers don’t know how to price a policy (akin to medical malpractice) for research risks because there are not good data about how frequently people are injured and what it costs to treat them (a problem exacerbated by the fact that much treatment of research injuries happens quietly so good records are not kept).
3) Industry sponsors, who should pay the full costs of any study they commission, often are successful in negotiating favorable terms (or complete silence on the topic) in their contracts with universities that are eager for business.
Some people talk about this issue using the term “compensation for subject injury.” This could be interpreted to include not only treatment but also other damages, such as payment for lost wages and pain and suffering. Although such considerations are not unreasonable, the more straightforward and defensible position is simply this: volunteers who are injured or made ill by a study drug, device, or procedure ought to be entitled to treatment of the study-related problem at no cost to them.
Shifting these expenses to private or governmental insurers would not be a panacea. This would still burden subjects who might be subject to co-pays and may run the risk up bumping up against a lifetime benefit cap. It also would create a situation where potential participants are subjected to a so-called “wallet biopsy,” screened for their level of insurance coverage prior to entry onto a trial. Further, when a study is sponsored by a private company, it’s just not fair for taxpayers or subscribers in private health insurance plans to pay more to cover the legitimate R&D expenses of a profit-making entity.
The Common Rule is currently under review for possible revision. Many comments have been made about the need to focus greater attention on studies that pose more than minimal risks and to loosen restrictions on surveys, questionnaires and other more innocuous interventions. If we are serious about protecting the rights and welfare of research subjects in studies that may cause them bodily harm, we should address fairly the need to treat the injuries or illnesses their participation may cause.
Hi Sue – I vaguely remember hearing something along the lines that you could use NIH funding to cover clinical trials insurance if it was a local regulatory requirement (which it is not in the US but is in some other countries). There is also a question of what counts as a local regulatory requirement – is an IRB just saying “no, we won’t approve the study without this insurance” adequate? You are absolutely right to point out that the insurance companies have no idea what to do with this.
We’ve been circling around this issue for decades – hopefully we’ll actually see some action soon!
I also recall hearing this (responding to Holly). I think it was in discussion at one of the international research panels or sessions at last year’s PRIM&R AER conference…. which would make sense! One of the speakers, I recall, was discussing research in India- and how the government (MOH?) came to the decision, resulting from an earlier negative experience, that clinical research projects with risks of injury or illness had to be insured for such.