From protection to entitlement: selecting research subjects for early phase clinical trials involving breakthrough therapies

Journal of Medical Ethics
June 2017 – Volume 43 – 6
http://jme.bmj.com/content/current

Extended essays
From protection to entitlement: selecting research subjects for early phase clinical trials involving breakthrough therapies
Nancy S Jecker, Aaron G Wightman, Abby R Rosenberg, Douglas S Diekema
Dr Nancy S Jecker, Department of Bioethics & Humanities, University of Washington School of Medicine, 1959 Pacific Street, Box 357120, Seattle, WA 98195-7120, USA; nsjecker@uw.edu
Abstract
Our goals are to (1) set forth and defend a multiprinciple system for selecting individuals who meet trial eligibility criteria to participate in early phase clinical trials testing chimeric antigen receptor (CAR T-cell) for acute lymphoblastic leukaemia when demand for participation exceeds spaces available in a trial; (2) show the relevance of these selection criteria to other breakthrough experimental therapies; (3) argue that distinct distributive justice criteria apply to breakthrough experimental therapies, standard research and healthcare and (4) argue that as evidence of benefit increases, the emphasis of justice in research shifts from protecting subjects from harm to ensuring fair access to benefits.