Consent revisited: the impact of return of results on participants' views and expectations about trial participation.
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 to a clinical trial after they received results showing adverse outcomes in some arms of the trial.


METHODS
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 of the trial 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.
SAPPHIRE, Department of Health Sciences, University of Leicester, Leicester, UK.
Carolyn
C
Tarrant
SAPPHIRE, Department of Health Sciences, University of Leicester, Leicester, UK.
Clare
C
Jackson
SAPPHIRE, Department of Health Sciences, University of Leicester, Leicester, UK.
Mary
M
Dixon-Woods
The Education & Social Research Institute, Manchester Metropolitan University, Manchester, UK.
Sarah
S
McNicol
School of Health and Population Sciences, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, UK.
Sara
S
Kenyon
SAPPHIRE, Department of Health Sciences, University of Leicester, Leicester, UK.
Natalie
N
Armstrong
D000328:Adult; D002986:Clinical Trials as Topic; D003657:Decision Making; D030881:Disclosure; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007258:Informed Consent / Q000523:psychology; D007407:Interviews as Topic; D008875:Middle Aged; D011247:Pregnancy; D036301:Qualitative Research; D035502:Trust
UK; clinical trial; decision-making; informed consent; qualitative; research results