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Four Faces of Fair Subject Selection.

Douglas MacKay1, Katherine Witte Saylor1

  • 1University of North Carolina at Chapel Hill.

The American Journal of Bioethics : AJOB
|January 29, 2020
PubMed
Summary
This summary is machine-generated.

Ensuring fair participant selection in clinical research involves navigating ethical dilemmas. This study breaks down fair subject selection into four sub-principles to guide ethical decision-making in participant recruitment.

Keywords:
Clinical research ethicsfair inclusionfair opportunityfair subject selectionjustice in clinical researchvulnerable populations

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Area of Science:

  • Clinical Research Ethics
  • Bioethics
  • Medical Research Methodology

Background:

  • Ethical clinical research requires fair subject selection.
  • However, principles of fair participant selection often create ethical dilemmas.
  • This conflict complicates participant selection and recruitment processes.

Purpose of the Study:

  • To diagnose the source of ethical dilemmas in fair subject selection.
  • To deconstruct the principle of fair subject selection into four distinct sub-principles.
  • To provide guidance for navigating conflicting imperatives in participant selection.

Main Methods:

  • Analysis of the principle of fair subject selection.
  • Decomposition into four sub-principles: fair inclusion, fair burden sharing, fair opportunity, and fair distribution of third-party risks.
  • Identification of conflicting imperatives in inclusion/exclusion criteria and recruitment.

Main Results:

  • Fair subject selection is a complex principle comprising four distinct sub-principles.
  • Each sub-principle generates unique ethical imperatives.
  • These imperatives can conflict, creating dilemmas in research design and participant recruitment.

Conclusions:

  • Understanding the four sub-principles of fair subject selection is crucial.
  • Decision-makers need guidance to navigate conflicting imperatives.
  • Fair participant selection requires careful consideration of inclusion, burden, opportunity, and risk distribution.