Evidence Library

Title: Consumer involvement in consent document development: a multicenter cluster randomised trial to assess study participants? understanding.
Author: Guarino, P., Elbourne, D., Carpenter, J. & Peduzzi, P.
Date Published: 2006
Reference: Clinical Trials, 3(1), 19-30.
Are service users or carers authors: No/Not Known


Aim: To compare an informed consent document (participant information sheet) developed by consumers with one developed by researchers.

Methods: The two documents were tested in a clinical trial for Gulf War veterans in the US. Different trial centres were randomised to either the researcher-developed or the consumer-developed information sheet. The researchers measured whether there was any effect on:

  • participants' satisfaction with the information sheet
  • how well people said they understood the information
  • whether people refused to take part in the clinical trial
  • whether the people who did take part in the trial did everything they were asked to do and stayed to the end.

Findings/recommendations: The results showed that asking service users to develop the information sheet made no difference in this trial. The researchers suggest this might be because the consumers didn?t make dramatic changes to the information sheet. The trial participants were also used to reading complicated documents as part of their military training. It is also possible that the conversation between researchers and potential trial participants is a more important part of the consent process than the written information.

External link: The following links will take you to information on this entry on an external website. INVOLVE is not responsible for the content or the reliability of the external websites. Link to PubMed Abstract

Related entry: none currently available

Categories: health
Designing research
impact on research ethics
impact of public involvement
journal article

Date Entered: 2007/02/20

Date Edited: 2012/11/20

Additional Info: