The coverage of medical injuries in company trial informed consent forms.

Abstract

Best practice consent forms in company clinical trials detail the financial coverage for medical treatment of injuries. In trials undertaken for licensing purposes these arrangements can raise concerns. We detail three cases in which elements of the consent forms appear misleading and designed to elicit a consent to participation that might not be forthcoming if volunteers for these clinical trials were aware that what is outlined in principle is not likely to happen in practice. Beyond clinical trial participants, these consent forms have wider implications. Medical coverage of injuries sustained in a clinical trial is a nexus where business, scientific and ethical considerations meet. It is not clear that anyone to date has grappled with the issues posed. This paper uses three clinical trials to illustrate the problems to be addressed.