A Randomized Controlled Trial of Short and Standard-Length Consent Forms for a Genetic Cohort Study: Is Longer Better?
Open Access
- 1 January 2012
- journal article
- research article
- Published by Japan Epidemiological Association in Journal of Epidemiology
- Vol. 22 (4), 308-316
- https://doi.org/10.2188/jea.je20110104
Abstract
Although the amount of detail in informed consent documents has increased over time and the documents have therefore become very long, there is little research on whether longer informed consent documents actually result in (1) better informed research subjects or (2) higher consent rates. We therefore conducted an add-on randomized controlled trial to the Takashima Study, a prospective Japanese population-based genetic cohort study, to test the hypothesis that a shorter informed consent form would satisfy both of the above goals. Standard (10 459 words, 11 pages) and short (3602 words, 5 pages) consent forms in Japanese were developed and distributed using cluster-randomization to 293 potential cohort subjects living in 9 medico-social units and 288 subjects in 8 medico-social units, respectively. Few differences were found between the 2 groups with regard to outcome measures, including participants’ self-perceived understanding, recall of information, concerns, voluntariness, trust, satisfaction, sense of duty, and consent rates. A short informed consent form was no less valid than a standard form with regard to fulfilling ethical requirements and securing the scientific validity of research.Keywords
This publication has 30 references indexed in Scilit:
- The length of consent documents in oncological trials is doubled in twenty yearsAnnals Of Oncology, 2009
- Voluntary Participation and Informed Consent to International Genetic ResearchAmerican Journal of Public Health, 2006
- Quantitative aspects of informed consent: considering the dose response curve when estimating quantity of informationJournal of Medical Ethics, 2005
- Payment of clinical research subjectsJCI Insight, 2005
- Interventions to Improve Research Participants' Understanding in Informed Consent for ResearchJAMA, 2004
- Informed consent in a clinical trial of a novel treatment for rheumatoid arthritisArthritis Care & Research, 2003
- Voluntariness of Consent for ResearchMedical Care, 2002
- Does the current consent process minimize the risks of genetics research?American Journal of Medical Genetics, 2002
- Money for Research Participation: Does It Jeopardize Informed Consent?American Journal of Bioethics, 2001
- Can the written information to research subjects be improved?--an empirical study.Journal of Medical Ethics, 1999