Trial reportContemporary clinical trials2012
Randomization to standard and concise informed consent forms: development of evidence-based consent practices.
Trial report in Contemporary clinical trials, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 2 of them syntheses that pooled it.
What it found
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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
26 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Strategies to improve recruitment to randomised trials.The Cochrane database of systematic reviews · 2018Pooled it
- Audio-visual presentation of information for informed consent for participation in clinical trials.The Cochrane database of systematic reviews · 2014Pooled it
- A randomized control trial of re-designed and shorter research informed consent forms to improve comprehension.Clinical trials (London, England) · 2026Trial
- Randomized, Double-Blind Trial on the Impact of Word Count in Cancer Clinical Trial Consent Forms.JCO oncology practice · 2021Trial
- Does an interactive trust-enhanced electronic consent improve patient experiences when asked to share their health records for research? A randomized trial.Journal of the American Medical Informatics Association : JAMIA · 2019Trial
- Trial
- Permission form synopses to improve parents' understanding of research: a randomized trial.Journal of perinatology : official journal of the California Perinatal Association · 2017Trial
- Cluster randomized trial assessing the effects of rapid ethical assessment on informed consent comprehension in a low-resource setting.BMC medical ethics · 2016Trial
- 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
- A Community-Engaged Approach to Enhancing Participation in Genomic Research in Rare and Understudied Cancer Populations.International journal of environmental research and public health · 2025Article
- Experimenting with modifications to consent forms in comparative effectiveness research: understanding the impact of language about financial implications and key information.BMC medical ethics · 2022Article
- Assessing Parent Decisions About Child Participation in a Behavioral Health Intervention Study and Utility of Informed Consent Forms.JAMA network open · 2020Article
- Shortened consent forms for genome-wide sequencing: Parent and provider perspectives.Molecular genetics & genomic medicine · 2020Article
- 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
- Development of Plain Language Supplemental Materials for the Biobank Informed Consent Process.Journal of cancer education : the official journal of the American Association for Cancer Education · 2017Article
- Improving biobank consent comprehension: a national randomized survey to assess the effect of a simplified form and review/retest intervention.Genetics in medicine : official journal of the American College of Medical Genetics · 2017Article
- Evidence-Based Strategies for Shortening Informed Consent Forms in Clinical Research.Journal of empirical research on human research ethics : JERHRE · 2017Article
- Article
Corrections and comments
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Authors and funding
7 authors.
Funding
Abstract
backgroundConsent to participate in research is an important component of the conduct of ethical clinical trials. Current consent practices are largely policy-driven. This study was conducted to assess comprehension of study information and satisfaction with the consent form between subjects randomized to concise or to standard informed consent forms as one approach to developing evidence-based consent practices.
methodsParticipants (N=111) who enrolled into two Phase I investigational influenza vaccine protocols (VRC 306 and VRC 307) at the NIH Clinical Center were randomized to one of two IRB-approved consents; either a standard or concise form. Concise consents had an average of 63% fewer words. All other aspects of the consent process were the same. Questionnaires about the study and the consent process were completed at enrollment and at the last visit in both studies.
resultsSubjects using concise consent forms scored as well as those using standard length consents in measures of comprehension (7 versus 7, p=0.79 and 20 versus 21, p=0.13), however, the trend was for the concise consent group to report feeling better informed. Both groups thought the length and detail of the consent form were appropriate.
conclusionsRandomization of study subjects to different length IRB-approved consent forms as one method for developing evidence-based consent practices, resulted in no differences in study comprehension or satisfaction with the consent form. A concise consent form may be used ethically in the context of a consent process conducted by well-trained staff with opportunities for discussion and education throughout the study.
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