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.” Read More