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Consent revisited: The impact of return of results on participants’ views and expectations about trial participation.

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posted on 2015-05-06, 08:49 authored by Carolyn Tarrant, Clare Jackson, Mary Dixon-Woods, Sarah McNicol, Sara Kenyon, Natalie Armstrong
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.


The ORACLE Children Study was funded by the UK Medical Research Council. This work was supported by Wellcome Trust Investigator Award WT097899. Mary Dixon-Woods’ contribution to this paper was also supported by University of Leicester study leave at the Dartmouth Institute for Health Policy and Clinical Practice. Clare Jackson held a DRF Doctoral Research fellowship, supported by the National Institute for Health Research, from 2010-2013.



Health Expectations, 2015, 18 (6), pp.2042-2053

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/Organisation/COLLEGE OF MEDICINE, BIOLOGICAL SCIENCES AND PSYCHOLOGY/School of Medicine/Department of Health Sciences


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