Rethinking the Therapeutic Obligation in Clinical Research

Abstract

A highly debated question in the field of human medical research is the ethically fundamental distinction between clinical research and clinical care. In this regard, the “therapeutic obligation” poses an argument: as the principle of therapeutic beneficence is central to medical ethics, physicians should always promote the medical best interest of patients by offering optimal medical care. The critique of the argument of therapeutic obligation, instead, distinguishes physicians in clinical practices (who have a duty to offer optimal medical care) from physician-investigators in clinical trials (who are not offering personalized medical therapy for individual patients but seek to answer clinically relevant scientific questions by conducting experiments in groups of patients). According to this latter perspective, the process of treatment in clinical trials differs radically from routine clinical practice; even the features of research design are aimed at promoting scientific validity, not therapeutic benefit. I argue that the therapeutic obligation has a relevance superior to testing scientific hypothesis also in the field of clinical investigation. Physician-investigators have a therapeutic beneficence obligation to each research participant, not simply an obligation not to exploit participants for the sake of scientific investigation.