Four Faces of Fair Subject Selection

• Published in: American journal of bioethics Vol. 20; no. 2; pp. 5 - 19
• Main Authors: MacKay, Douglas, Saylor, Katherine Witte
• Format: Journal Article
• Language: English
• Published: United States Taylor & Francis 01.02.2020
• Subjects: Clinical research ethics; fair inclusion; fair opportunity; fair subject selection; justice in clinical research; vulnerable populations; Clinical research ethics; fair inclusion; vulnerable populations; fair opportunity; justice in clinical research; fair subject selection
• ISSN: 1526-5161; 1536-0075; 1536-0075
• DOI: 10.1080/15265161.2019.1701731

Although the principle of fair subject selection is a widely recognized requirement of ethical clinical research, it often yields conflicting imperatives, thus raising major ethical dilemmas regarding participant selection. In this paper, we diagnose the source of this problem, arguing that the principle of fair subject selection is best understood as a bundle of four distinct sub-principles, each with normative force and each yielding distinct imperatives: (1) fair inclusion; (2) fair burden sharing; (3) fair opportunity; and (4) fair distribution of third-party risks. We first map out these distinct sub-principles, and then identify the ways in which they yield conflicting imperatives for the design of inclusion and exclusion criteria, and the recruitment of participants. We then offer guidance for how decision makers should navigate these conflicting imperatives to ensure that participants are selected fairly.