Participants' Understanding of Informed Consent in a Randomized Controlled Trial for Chronic Knee Pain
Marilys Guillemin, Emma Barnard, Hannah Walker, Kim Bennell, Rana Hinman, Lynn Gillam
Journal of Empirical Research on Human Research Ethics | SAGE PUBLICATIONS INC | Published : 2015
This study explored participants' experiences of randomized controlled trial (RCT) participation to examine their understanding of the trial design and whether their consent was indeed informed. A nested qualitative interview study was conducted with 38 participants from a sample of 282 who participated in a complex RCT evaluating the effectiveness of laser compared with needle acupuncture for chronic knee pain. Overall participants had a good understanding of the RCT, and concepts such as randomization and placebo. Their experiences of being in the trial were largely positive, even if they did not experience any knee pain improvement. Their responses to unblinding at the end of the study we..View full abstract
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This research was supported by an Office for Research Ethics and Integrity grant, University of Melbourne.