There is considerable controversy over the ethics of pragmatic clinical trials comparing two standard of care interventions (SOC PCTs). Some authors have characterized such trials as automatically minimal risk (because the two arms are both clinically standard treatments) and thereby qualifying for a consideration of a consent waiver. We extend our previous argument against this view by contrasting such trials with a novel study design, Decision Architecture Randomization Trial (DART), which is a form of ‘randomized encouragement’(randomization to one of two alternative but easily ignorable nudges) trial that is readily integrated into everyday clinical care at low cost. Through a comparative analysis of three consent designs (DART SOC PCTs, ordinary SOC PCTs with consent, and ordinary SOC PCTs with a waiver of consent) we isolate and specify the meaning of ‘research risk’ in each case, and argue for when a SOC PCT can be ethical without traditional informed consent. We argue that the research risk of a PCT is minimal to the extent that decision-making based on individual patient interests is preserved for all participants, lending DART an edge over ordinary SOC PCTs. However, we also argue that respect for persons and the importance of trust in healthcare systems will likely require a meaningful form of transparency combined with an opt out mechanism.
James Flory, MD – Assistant Attending Physician, Endocrinology, Memorial Sloan Kettering Cancer Center; Scott Kim, MD, PhD – Faculty, Bioethics, Clinical Center, National Institutes of Health