This Article Full Text (PDF) References Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Saved Citations Download to citation manager Request Permissions Request Reprints Add to My Marked Citations Citing Articles Citing Articles via Google Scholar Citing Articles via Scopus Google Scholar Articles by Guarino, P. Articles by Peduzzi, P. Search for Related Content PubMed PubMed Citation Articles by Guarino, P. Articles by Peduzzi, P. Social Bookmarking                   What's this?

Consumer involvement in consent document development: a multicenter cluster randomized trial to assess study participants' understanding

Department of Veterans Affairs, Cooperative Studies Program Coordinating Center (151A), VA CT Healthcare System, 950 Campbell Avenue, West Haven, CT 06516, USA; London School of Hygiene & Tropical Medicine, London, UK peter.guarino{at}yale.edu

Diana Elbourne

James Carpenter

London School of Hygiene & Tropical Medicine, London, UK

Peter Peduzzi

Department of Veterans Affairs, Cooperative Studies Program Coordinating Center, West Haven, CT, USA

Background Despite widespread agreement on the importance of informed consent in clinical research, uncertainty remains about the adequacy of current consent procedures and documentation.

Methods The objective of the study was to compare an informed consent document developed by a consumer group of potential study participants to one developed by the study investigators. The study was a cluster randomized, controlled study embedded in a ‘parent’ randomized controlled trial of 1092 participants with Gulf War veterans’ illnesses recruited in 1999–2000 at 20 US medical centers. Centers were randomized to the investigator-developed or participant-developed consent document. The primary outcome measure was an Informed Consent Questionnaire-4 (ICQ-4), a validated four-item scale measuring self-reported participant understanding scored from 0 to 1. Secondary outcomes included the Client Satisfaction Questionnaire-8 and measures of study refusal and adherence to the parent trial protocol.

Results There were no significant differences between consent documents on the ICQ-4 score overall or at any of the time points. Mean (95% CI) treatment differences ranged from 0.020 (0.015, 0.055) (better understanding) at entry to 0.021 (0.054, 0.012) (worse understanding) at three-months for the participant versus the investigator document group. There were also no significant differences in satisfaction, adherence to the protocol, or in the proportion of patients who refused to participate in the trial.

Limitations The consumer group may not have been representative of the study participants and they did not suggest dramatic changes to the consent document. The outcome assessment questionnaire was not validated prior to the trial's initiation.

Conclusions Consumer modification of the consent document did not lead to either benefit or harm in understanding, satisfaction, or study refusal and adherence rates. This study did demonstrate, however, that embedding consent studies in a clinical trial is feasible and can address important questions about informed consent without disrupting the primary study.

Clinical Trials, Vol. 3, No. 1, 19-30 (2006)
DOI: 10.1191/1740774506cn133oa


CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?