Access to the benefits of clinical research on human subjects. Virtue ethics vs. Normative ethics.

Abstract

Post-trial access (PTA) for participants in clinical trials subsequent to research emerged as an important consideration during the work for the first antiretroviral drugs for AIDS. It evolved into a stringent ethical mandate in the 2000 iteration of the Declaration of Helsinki. The recent version of this Declaration (October 2024) places greater demands on this aspect of research, in part because over the past two decades tangible progress in actualizing PTA, particularly in developing nations, has been scant, notwithstanding the presence of PTA-related information on numerous pharmaceutical company websites. This article presents recent empirical data underscoring the limited availability of PTA in practice. It scrutinizes the guidelines put forth by prominent international benchmarks in clinical research. We highlight the intricacies associated with mandating universal compliance and advocate for an approach transcending mere normative ethics toward a virtuous ethics paradigm, one that fosters more equitable and supportive research endeavors.