Full information about trials might be given retrospectively to participants

BMJ 1999;318:736 ( 13 March )

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Full information about trials might be given retrospectively to participants

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EDITOR $---$ One of the central issues in the debate about informed consent in randomised controlled trials¹ has been the ethicsof withholding the fact of randomisation from participants $---$ forexample, in the trials of support after stroke² and of managementof sore throat.³ Psychologists recognise that it is sometimesnecessary to withhold full information from participants, to minimisebias. Our professional code of conduct (http://www.bps.org.uk/charter/codofcon.htm)states that in these situations we must "provide ... full informationretrospectively about the aims, rationale and outcomes of theprocedure as far as is consistent with a concern for the welfareof participants." Maybe a similar requirement could be introducedfor medical researchers. The planned debriefing of participantswould avoid the potential distress of those who discover fromsources other than the investigators that important informationabout the research they had participated in was withheld fromthem.⁴

The most practical option would . . . [Full text of this article]

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Informed consent: Michael Baum, I G Kestin, S E Josse, David H Brewster, Marion R S Bain, James W T Chalmers, Ann Gould, John A Dewar, W David George, John Nottingham, Andrew J Winter, David Mullis, Keith W Radcliffe, D T Wilcox, F Wilcock, L Spitz, and A Pierro
BMJ 1998 317: 947. [Extract] [Full Text]