Trial reportJournal of epidemiology2012
A randomized controlled trial of short and standard-length consent forms for a genetic cohort study: is longer better?
Trial report in Journal of epidemiology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
23 citing papers in PubMed.
- Randomized, Double-Blind Trial on the Impact of Word Count in Cancer Clinical Trial Consent Forms.JCO oncology practice · 2021Trial
- Randomized comparison of two interventions to enhance understanding during the informed consent process for research.Clinical trials (London, England) · 2021Trial
- Permission form synopses to improve parents' understanding of research: a randomized trial.Journal of perinatology : official journal of the California Perinatal Association · 2017Trial
- Improved participants' understanding in a healthy volunteer study using the SIDCER informed consent form: a randomized-controlled study.European journal of clinical pharmacology · 2016Trial
- Improved informed consent documents for biomedical research do not increase patients' understanding but reduce enrolment: a study in real settings.British journal of clinical pharmacology · 2015Trial
- Participants' recall and understanding of genomic research and large-scale data sharing.Journal of empirical research on human research ethics : JERHRE · 2013Trial
- Analysis of pediatric assent information in early-phase cancer clinical trials through a children's research advisory group.Frontiers in psychology · 2025Article
- Unveiling readability challenges: An extensive analysis of consent document accessibility in clinical trials.Journal of clinical and translational science · 2024Article
- What information and the extent of information to be provided in an informed assent/consent form of pediatric drug trials.BMC medical ethics · 2022Article
- Participant recall and understandings of information on biobanking and future genomic research: experiences from a multi-disease community-based health screening and biobank platform in rural South Africa.BMC medical ethics · 2022Article
- A novel metadata management model to capture consent for record linkage in longitudinal research studies.Informatics for health & social care · 2019Article
- Developing informed consent materials for non-English-speaking participants: An analysis of four professional firm translations from English to Spanish.Clinical trials (London, England) · 2018Article
- Rethinking informed consent in pediatric research: a time for regulatory policy change?Pediatric research · 2018Article
- What information and the extent of information research participants need in informed consent forms: a multi-country survey.BMC medical ethics · 2018Article
- Evidence-Based Strategies for Shortening Informed Consent Forms in Clinical Research.Journal of empirical research on human research ethics : JERHRE · 2017Article
- Article
- The MICHR Genomic DNA BioLibrary: An Empirical Study of the Ethics of Biorepository Development.Journal of empirical research on human research ethics : JERHRE · 2015Article
- A pilot study of simple interventions to improve informed consent in clinical research: feasibility, approach, and results.Clinical trials (London, England) · 2015Article
- Research into a functional cure for HIV in neonates: the need for ethical foresight.The Lancet. Infectious diseases · 2014Article
- Informed consent for phase I oncology trials: form, substance and signature.Journal of clinical medicine research · 2014Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
Abstract
backgroundAlthough 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.
methodsStandard (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.
resultsFew 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.
conclusionsA 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.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.