Jenkins, Simon, Calvert, Melanie J. and Draper, Heather (2020) Potential research participants’ use of information during the consent process : a qualitative pilot study of patients enrolled in a clinical trial. PLOS ONE, 15 (6). e0234388. doi:10.1371/journal.pone.0234388

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Abstract

There is increasing evidence that clinical trial participants are uninformed about the trials in which they participate, raising ethical concerns regarding informed consent. The aim of this pilot study was to explore clinical trial participants’ use of consent discussions and information sheets when considering participating in clinical trials research. A qualitative, interview-based pilot study was designed in order to elicit, through dialogue, details of the reasons for participants’ use of, and preferences regarding, different modes of information provision. Semi-structured interviews were undertaken with two different groups of patients who were participants in the Reinforcement of Closure of Stoma Site trial. The first group comprised newly-consented trial participants, who had been recruited up to 72 hours before our interview; the second group comprised patients attending a follow-up clinic 12 months after joining the trial. Thirteen participants were recruited in total: three newly-consented patients, and ten follow-up patients. The study found that participants’ use of consent discussions to gain information about clinical trials was varied, and that they only minimally used information sheets after providing initial consent for the trial. Participants demonstrated varying degrees of knowledge about the trial, with some having forgotten that they were still involved in the trial. Participants reported a high level of trust in medical staff as a reason for not seeking more information about the trial. Some participants reported dissatisfaction with the timing of information provision. Some were amenable to novel ways of receiving trial information, such as web-based methods. The pilot study demonstrated the feasibility of a larger study into the provision of information to prospective clinical trial participants. The results suggest that considering alternative ways of providing information and the appropriateness of existing information provision may be acceptable to and useful for potential trial participants.

Item Type:	Journal Article
Alternative Title:
Subjects:	R Medicine > R Medicine (General)
Divisions:	Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School > Health Sciences > Social Science & Systems in Health (SSSH) Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Clinical trials, Medical ethics, Human experimentation in medicine
Journal or Publication Title:	PLOS ONE
Publisher:	Public Library of Science
ISSN:	1932-6203
Official Date:	18 June 2020
Dates:	Date Event 18 June 2020 Available 25 May 2020 Accepted
Date of first compliant deposit:	15 June 2020
Volume:	15
Number:	6
Article Number:	e0234388
DOI:	10.1371/journal.pone.0234388
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access
RIOXX Funder/Project Grant:	Project/Grant ID RIOXX Funder Name Funder ID G0800808 Medical Research Council http://dx.doi.org/10.13039/501100000265
Related URLs:	Publisher

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