Literature DB >> 14569997

Rehabilitating equipoise.

Paul B Miller1, Charles Weijer.   

Abstract

When may a physician legitimately offer enrollment in a randomized clinical trial (RCT) to her patient? Two answers to this question have had a profound impact on the research ethics literature. Equipoise, as originated by Charles Fried, which we term Fried's equipoise (FE), stipulates that a physician may offer trial enrollment to her patient only when the physician is genuinely uncertain as to the preferred treatment. Clinical equipoise (CE), originated by Benjamin Freedman, requires that there exist a state of honest, professional disagreement in the community of expert practitioners as to the preferred treatment. FE and CE are widely understood as competing concepts. We argue that FE and CE offer separable and, in themselves, incomplete justifications for the conduct of clinical trials. FE articulates conditions under which the fiduciary duties of physician to patient may be upheld in the conduct of research. CE sets out a standard for the social approval of research by institutional review boards. Viewed this way, FE and CE are not necessarily competing notions, but rather address complementary moral concerns.

Entities:  

Keywords:  Analytical Approach; Biomedical and Behavioral Research

Mesh:

Substances:

Year:  2003        PMID: 14569997     DOI: 10.1353/ken.2003.0014

Source DB:  PubMed          Journal:  Kennedy Inst Ethics J        ISSN: 1054-6863


  27 in total

Review 1.  Equipoise: asking the right questions for clinical trial design.

Authors:  Steven Joffe; Franklin G Miller
Journal:  Nat Rev Clin Oncol       Date:  2012-01-10       Impact factor: 66.675

2.  Extending clinical equipoise to phase 1 trials involving patients: unresolved problems.

Authors:  James A Anderson; Jonathan Kimmelman
Journal:  Kennedy Inst Ethics J       Date:  2010-03

Review 3.  Should desperate volunteers be included in randomised controlled trials?

Authors:  P Allmark; S Mason
Journal:  J Med Ethics       Date:  2006-09       Impact factor: 2.903

4.  Research on environmental health interventions: ethical problems and solutions.

Authors:  David B Resnik; Darryl C Zeldin; Richard R Sharp
Journal:  Account Res       Date:  2005 Apr-Jun       Impact factor: 2.622

Review 5.  Emerging empirical evidence on the ethics of schizophrenia research.

Authors:  Laura B Dunn; Philip J Candilis; Laura Weiss Roberts
Journal:  Schizophr Bull       Date:  2005-10-19       Impact factor: 9.306

6.  Uncertainty and the ethics of clinical trials.

Authors:  Sven Ove Hansson
Journal:  Theor Med Bioeth       Date:  2006

7.  Contextualizing clinical research: the epistemological role of clinical equipoise.

Authors:  James A Anderson
Journal:  Theor Med Bioeth       Date:  2009-04-30

8.  Can significant differences in regulating medical and non-medical research be justified?

Authors:  David Hunter
Journal:  Monash Bioeth Rev       Date:  2014 Sep-Dec

Review 9.  Ethical and Regulatory Challenges with Autologous Adult Stem Cells: A Comparative Review of International Regulations.

Authors:  Tamra Lysaght; Ian H Kerridge; Douglas Sipp; Gerard Porter; Benjamin J Capps
Journal:  J Bioeth Inq       Date:  2017-02-28       Impact factor: 1.352

Review 10.  The clinical investigator-subject relationship: a contextual approach.

Authors:  David B Resnik
Journal:  Philos Ethics Humanit Med       Date:  2009-12-03       Impact factor: 2.464

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