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

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 to 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 of the trial intervention arms. Data analysis was base

SUBMITTER: Tarrant C 

PROVIDER: S-EPMC4737222 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature