Applying justice in clinical trials for diverse populations.
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.
Tilburt
Jon
J
Department of Clinical Bioethics, National Institutes of Health, Bethesda, MD, USA. tilburtj@cc.nih.gov
Ford
Jean G
JG
Howerton
Mollie W
MW
Gary
Tiffany L
TL
Lai
Gabriel Y
GY
Bolen
Shari
S
Baffi
Charles
C
Wilson
Renee F
RF
Tanpitukpongse
Teerath Peter
TP
Powe
Neil R
NR
Bass
Eric B
EB
Sugarman
Jeremy
J
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