David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Ezio Di Nucci
Jack Alan Reynolds
Learn more about PhilPapers
Bioethics 28 (8):405-413 (2014)
This article focuses on maternal-fetal surgery (MFS) and on the concept of clinical equipoise that is a widely accepted requirement for conducting randomized controlled trials (RCT). There are at least three reasons why equipoise is unsuitable for MFS. First, the concept is based on a misconception about the nature of clinical research and the status of research subjects. Second, given that it is not clear who the research subject/s in MFS is/are, if clinical equipoise is to be used as a criterion to test the ethical appropriateness of RCT, its meaning should be unambiguous. Third, because of the multidisciplinary character of MFS, it is not clear who should be in equipoise. As a result, we lack an adequate criterion for the ethical review of MFS protocols. In our account, which is based on Chervenak and McCullough's seminal work in the field of obstetric ethics, equipoise is abandoned. and RCT involving MFS can be ethically initiated when a multidisciplinary ethics review board (ERB), having an evidence-based assessment of the risks involved, is convinced that the value of answering the research hypothesis, for the sake of the health interests of future pregnant women carrying fetuses with certain congenital birth defects, justifies the actual risks research participants might suffer within a set limit of low/manageable
|Keywords||ethical review randomized controlled trials maternal‐fetal surgery equipoise|
|Categories||categorize this paper)|
Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
|Through your library|
References found in this work BETA
No references found.
Citations of this work BETA
No citations found.
Similar books and articles
Franklin G. Miller & Howard Brody (2007). Clinical Equipoise and the Incoherence of Research Ethics. Journal of Medicine and Philosophy 32 (2):151 – 165.
Franklin G. Miller & Howard Brody (2002). What Makes Placebo-Controlled Trials Unethical? American Journal of Bioethics 2 (2):3 – 9.
Robert M. Veatch (2007). The Irrelevance of Equipoise. Journal of Medicine and Philosophy 32 (2):167 – 183.
David Buchanan & Franklin G. Miller (2005). Principles of Early Stopping of Randomized Trials for Efficacy: A Critique of Equipoise and an Alternative Nonexploitation Ethical Framework. Kennedy Institute of Ethics Journal 15 (2):161-178.
Fred Gifford (2007). Pulling the Plug on Clinical Equipoise: A Critique of Miller and Weijer. Kennedy Institute of Ethics Journal 17 (3):203-226.
Fred Gifford (2007). So-Called "Clinical Equipoise" and the Argument From Design. Journal of Medicine and Philosophy 32 (2):135 – 150.
Lisa R. Stines & Norah C. Feeny (2008). Unique Ethical Concerns in Clinical Trials Comparing Psychosocial and Psychopharmalogical Interventions. Ethics and Behavior 18 (2 & 3):234 – 246.
Lynn A. Jansen (2005). A Closer Look at the Bad Deal Trial: Beyond Clinical Equipoise. Hastings Center Report 35 (5):29-36.
P. Allmark (2006). Should Desperate Volunteers Be Included in Randomised Controlled Trials? Journal of Medical Ethics 32 (9):548-553.
Sven Ove Hansson (2006). Uncertainty and the Ethics of Clinical Trials. Theoretical Medicine and Bioethics 27 (2):149-167.
Fred Gifford (2000). Freedman's 'Clinical Equipoise' and Sliding-Scale All-Dimensions-Considered Equipoise'. Journal of Medicine and Philosophy 25 (4):399 – 426.
Paul B. Miller & Charles Weijer (2003). Rehabilitating Equipoise. Kennedy Institute of Ethics Journal 13 (2):93-118.
Fred Gifford (1995). Community-Equipoise and the Ethics of Randomized Clinical Trials. Bioethics 9 (2):127–148.
Added to index2012-10-02
Total downloads19 ( #167,149 of 1,781,359 )
Recent downloads (6 months)1 ( #295,021 of 1,781,359 )
How can I increase my downloads?