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Consumer involvement in consent document development: a multicenter cluster randomized trial to assess study
Peter Guarino1, Diana Elbourne, James Carpenter
1Department of Veterans Affairs, Cooperative Studies Program Coordinating Center, West Haven, CT, USA. peter.guarino@yale.edu
Clinical Trials (London, England)
|March 17, 2006
Summary
Consumer-developed informed consent documents did not improve participant understanding or satisfaction compared to investigator-developed ones. This study shows embedding consent research within clinical trials is feasible.
Area of Science:
- Clinical Research Methodology
- Informed Consent Process
- Patient Engagement in Research
Background:
- Current informed consent procedures in clinical research face scrutiny regarding their adequacy.
- Ensuring comprehensive understanding and documentation in informed consent remains a challenge.
Purpose of the Study:
- To compare the effectiveness of an informed consent document developed by consumers versus one developed by investigators.
- To assess the impact of participant-involved consent document development on understanding, satisfaction, and adherence.
Main Methods:
- A cluster randomized controlled trial embedded within a larger study of 1092 Gulf War veterans' illnesses participants.
- Randomization of 20 US medical centers to either investigator-developed or participant-developed consent documents.
- Primary outcome measured by the Informed Consent Questionnaire-4 (ICQ-4); secondary outcomes included satisfaction, refusal rates, and adherence.
Main Results:
- No significant differences were found between the two consent document groups in participant understanding (ICQ-4 scores).
- Satisfaction, study refusal rates, and adherence to the parent trial protocol did not differ significantly between groups.
- The participant-developed consent document showed no measurable benefit or harm compared to the investigator-developed document.
Conclusions:
- Consumer modification of consent documents did not yield significant improvements in understanding, satisfaction, or adherence.
- Limitations include potential lack of representativeness of the consumer group and pre-trial questionnaire validation issues.
- Embedding consent research within clinical trials is a feasible approach to study informed consent effectively without disrupting the primary research.