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BMJ 2005;331:110 (9 July), doi:10.1136/bmj.331.7508.110-a
| The first 150 words of the full text of this article appear below. |
EDITORIn response to Sackett's editorial on participants in research Laurence writes that the patient information sheets, and a consent form signed by both parties, contain the contract terms for participants in research (previous letter).1 They may legally do so, but the quality of information sheets for patients is suboptimal,2 patients' understanding of them is poor, and their purpose misconstrued. The parties to the contract are unequal, and patients' rights and responsibilities are poorly understood. Public understanding of the research process is poor; the purpose of reducing uncertainties about the effects of treatment (both old and new) by the risk limiting method of trials is only hazily appreciated.
The notion of adhering to the trial's objectives for its duration to ensure that robust data are produced demands a jointly drawn-up contract from the outset of the trial. In other words, the contract to run a trial should include knowledgeable
Hazel Thornton, honorary visiting fellow, Department of Health Sciences, University of Leicester
"Saionara," Colchester CO5 7EA hazelcagct@aol.com