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Commentary: Why we didn't ask patients for their consent

^a Department of Clinical Neurosciences University of Edinburgh Western General Hospital Edinburgh EH4 2XU

	Commentary

In our trial we asked patients to consent to follow up but not to consent to randomisation itself. There were several reasons for adopting this approach, which was approved by our local ethics committee. Firstly, we did not expect our intervention to be harmful, though whether this expectation was fulfilled must be judged from our results. Secondly, patients and their carers could refuse to see our stroke family care worker or follow up psychologist whenever they wished. Thus half the patients and their carers were asked to consent to the intervention and all were asked to consent to follow up after randomisation. Thirdly, we were concerned that if we tried to obtain informed consent this might bias our results. For instance, if we made patients and their families aware of the help they might receive from the stroke family care worker and then . . . [Full text of this article]

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Relevant Article

Informed consent in medical research

David E Bratt, Pat Soutter, Martin Bland, Paul Little, Ian Williamson, Dennis O Chanter, Sarah Stewart-Brown, Hazel Thornton, Wendy Holmes, Joseph N E Ana, Colin Morley, Moli Paul, A Hassiotis, Mark F G Hulbert, Carl E Counsell, Peter A G Sandercock, Peter Wilmshurst, Michael Baum, Charles Montgomery, Anna Lydon, Keith Lloyd, Christopher Wiltshire, A C Frosh, and J Hanif
BMJ 1997 314: 1477. [Extract] [Full Text]

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