Randomized Controlled Trials of Maternal‐Fetal Surgery: A Challenge to Clinical Equipoise

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)
DOI 10.1111/j.1467-8519.2012.02008.x
 Save to my reading list
Follow the author(s)
My bibliography
Export citation
Find it on Scholar
Edit this record
Mark as duplicate
Revision history Request removal from index
Download options
PhilPapers Archive

Upload a copy of this paper     Check publisher's policy on self-archival     Papers currently archived: 15,865
External links
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.

Add more references

Citations of this work BETA

No citations found.

Add more citations

Similar books and articles
Robert M. Veatch (2007). The Irrelevance of Equipoise. Journal of Medicine and Philosophy 32 (2):167 – 183.
Fred Gifford (2007). So-Called "Clinical Equipoise" and the Argument From Design. Journal of Medicine and Philosophy 32 (2):135 – 150.
Sven Ove Hansson (2006). Uncertainty and the Ethics of Clinical Trials. Theoretical Medicine and Bioethics 27 (2):149-167.
Paul B. Miller & Charles Weijer (2003). Rehabilitating Equipoise. Kennedy Institute of Ethics Journal 13 (2):93-118.

Monthly downloads

Added to index


Total downloads

19 ( #144,871 of 1,725,153 )

Recent downloads (6 months)

1 ( #349,161 of 1,725,153 )

How can I increase my downloads?

My notes
Sign in to use this feature

Start a new thread
There  are no threads in this forum
Nothing in this forum yet.