title: Applying justice in clinical trials for diverse populations.
abstract: BACKGROUND
  Considerable attention has focused on increasing clinical trial participation for members of "underrepresented groups". However, doing so involves clarifying how to meet the demands of justice, or fairness, which provides the ethical mandate to enhance broad trial representation.
  
  
  OBJECTIVE
  To examine the ethical principle of justice as it applies to recruiting diverse populations to clinical trials representation.
  
  
  METHODS
  In this paper, we analyse the conceptual and practical challenges in applying the principle of justice to clinical trials representation.
  
  
  RESULTS
  Different facets of justice include demands for both fair outcomes and fair processes. Including both of these facets in clinical trials policy should not only promote access to trials, but also help to provide a framework to improve fairness in representation in clinical trials. Efforts to evaluate recruitment of representation should include outcome and process measures.
  
  
  CONCLUSIONS
  The suggestions offered based on this conceptual analysis need to be tested empirically.
  
  
  CONCLUSIONS
  Those involved in the design, conduct and oversight of clinical trials should consider all of the facets of justice when assessing representation in clinical trials and attempt to balance fair access to trials with a fair process that may require protection from being unduly pressured to participate.
authors: Department of Clinical Bioethics, National Institutes of Health, Bethesda, MD, USA. tilburtj@cc.nih.gov
authors: Jon
authors: J
authors: Tilburt
authors: Jean G
authors: JG
authors: Ford
authors: Mollie W
authors: MW
authors: Howerton
authors: Tiffany L
authors: TL
authors: Gary
authors: Gabriel Y
authors: GY
authors: Lai
authors: Shari
authors: S
authors: Bolen
authors: Charles
authors: C
authors: Baffi
authors: Renee F
authors: RF
authors: Wilson
authors: Teerath Peter
authors: TP
authors: Tanpitukpongse
authors: Neil R
authors: NR
authors: Powe
authors: Eric B
authors: EB
authors: Bass
authors: Jeremy
authors: J
authors: Sugarman
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics* / Q000379:methods*; D006801:Humans; D008913:Minority Groups; D018579:Patient Selection / Q000941:ethics*; D012107:Research Design; D012935:Social Justice