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Title: Consent revisited: The impact of return of results on participants’ views and expectations about trial participation.
Authors: Tarrant, Carolyn
Jackson, Clare
Dixon-Woods, Mary
McNicol, Sarah
Kenyon, Sara
Armstrong, Natalie
First Published: 30-Apr-2015
Publisher: Wiley
Citation: Health Expectations, 2015, 18 (6), pp.2042-2053
Abstract: Background Increasingly, the sharing of study results with participants is advocated as an element of good research practice. Yet little is known about how receiving the results of trials may impact on participants’ perceptions of their original decision to consent. Objective We explored participants’ views of their decision to consent in a clinical trial after they received results showing adverse outcomes in some arms of the trial. Method Semi-structured interviews were conducted with a purposive sample of 38 women in the UK who participated in a trial of antibiotics in pregnancy. All had received results from a follow-up study that reported increased risk of adverse outcomes for children of participants in some intervention arms. Data analysis was based on the constant comparative method. Results Participants’ original decisions to consent to the trial had been based on hope of personal benefit and assumptions of safety. On receiving the results, most made sense of their experience in ways that enabled them to remain content with their decision to take part. But for some, the results provoked recognition that their original expectations might have been mistaken or that they had not understood the implications of their decision to participate. These participants experienced guilt, a sense of betrayal by the maternity staff and researchers involved in the trial, and damage to trust. Conclusions Sharing of study results is not a wholly benign practice, and requires careful development of suitable approaches for further evaluation before widespread adoption.
DOI Link: 10.1111/hex.12371
ISSN: 1369-6513
eISSN: 1369-7625
Version: Publisher Version
Status: Peer-reviewed
Type: Journal Article
Rights: © 2015 The Authors Health Expectations Published by John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution License (CC BY 4.0) (, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
Appears in Collections:Published Articles, Dept. of Health Sciences

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