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:
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