A plea for pragmatism in clinical research ethics.
Pragmatism is a distinctive approach to clinical research ethics that can guide bioethicists and members of institutional review boards (IRBs) as they struggle to balance the competing values of promoting medical research and protecting human subjects participating in it. After defining our understanding of pragmatism in the setting of clinical research ethics, we show how a pragmatic approach can provide guidance not only for the day-to-day functioning of the IRB, but also for evaluation of policy standards, such as the one that addresses acceptable risks for healthy children in clinical research trials. We also show how pragmatic considerations might influence the debate about the use of deception in clinical research. Finally, we show how a pragmatic approach, by regarding the promotion of human research and the protection of human subjects as equally important values, helps to break down the false dichotomy between science and ethics in clinical research.
Brendel
David H
DH
Harvard Medical School, McLean Hospital, Belmont, MA 02478, USA. dbrendel@partners.org
Miller
Franklin G
FG
D001675:Bioethics / Q000639:trends*; D002648:Child; D002986:Clinical Trials as Topic / Q000941:ethics*; D008192:Deception; D028781:Ethical Relativism; D028663:Ethical Theory; D028744:Ethics Committees, Research; D026690:Ethics, Clinical; D032984:Ethics, Research; D028601:Euthanasia, Active; D033161:Government Regulation; D006805:Human Experimentation / Q000941:ethics*; D006801:Humans; D007258:Informed Consent; D009014:Morals; D011340:Problem Solving; D012107:Research Design; D035842:Research Subjects; D017236:Suicide, Assisted; D014481:United States