Vol XII, Issue 3 Date of Publication: July 03, 2015
DOI: https://doi.org/10.20529/IJME.2015.046

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More on SUPPORT: the controversy continues

Ruth Macklin
Abstract:
The article by Sunita VS Bandewar in the January–March issue does an excellent job of describing the controversy over informed consent in the SUPPORT clinical trial. As one of the authors of the duelling articles Bandewar cites, I commend the author's conclusions calling for disclosure not only of randomisation in so-called "standard of care" clinical trials, but also the comprehensive disclosure of risks in this type of research (also known as "comparative effectiveness research [CER]"). Bandewar surmises that the disclosure of randomisation could result in a "much higher chance of patients declining to participate in a randomised trial"; and that this may be one of the motives of those who argue for non-disclosure of randomisation. In fact, at least some supporters of limited disclosure of the risks in CER trials have expressly acknowledged their concerns about the recruitment of participants if all the risks of "standard of care" treatments are mentioned in the consent forms.


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©Indian Journal of Medical Ethics 2016: Open Access and Distributed under the Creative Commons license ( CC BY-NC-ND 4.0),
which permits only non-commercial and non-modified sharing in any medium, provided the original author(s) and source are credited.

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