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.

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“…The Nuremberg Code established patients’ rights to voluntary informed consent in the aftermath of World War II [ 88 ]. US courts consistently support informed consent as a fundamental right for patients’ autonomy [ 89 ]. Informed consent procedures must provide clear distinctions between risks that are frequently observed, risks that occur rarely, and the more obvious risk of lack of effectiveness or waning immunity, which is separate from the risk of SAEs.…”

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“…The number of views for 2023 nearly doubled compared to 2022, reaching a little over 29 thousand. The most viewed article in 2023 was a position paper entitled "The coverage of medical injuries in company trial informed consent forms" by David Healy and co-authors [4]. We thank our authors and contributors to IJRSM for their hard work and support.…”