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Four Faces of Fair Subject Selection.

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 prin...

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Published in:American Journal of Bioethics Vol. 20; no. 2; pp. 5 - 20
Main Authors: MacKay, Douglas, Saylor, Katherine Witte
Format: review tables/charts Journal Article
Published: Taylor & Francis Ltd Feb2020
Online Access:View this record in EBSCOhost
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      dt: Feb2020
      vid: 20
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      pub: Taylor & Francis Ltd
      place: Philadelphia, Pennsylvania
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        10.1080/15265161.2019.1701731
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        atl: Four Faces of Fair Subject Selection.
      aug:
        au:
          MacKay, Douglas
          Saylor, Katherine Witte
        affil: University of North Carolina at Chapel Hill
      sug:
        subj:
          Research Subject Recruitment Ethical Issues
          Clinical Research
          Research Ethics
          Study Design
          Research Subjects Psychosocial Factors
          Decision Making
          Public Policy
          Special Populations
          Consent (Research)
      ab: 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.
      pubtype: Academic Journal
      doctype:
        review
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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