Trial reportBMC medical ethics2010
Comparison of group counseling with individual counseling in the comprehension of informed consent: a randomized controlled trial.
Trial report in BMC medical ethics, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 2 of them syntheses that pooled it.
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
15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 24 citations in OpenAlex.
- Measuring and evaluating participant understanding of consent processes in clinical trials: a systematic review.Trials · 2026Pooled it
- Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials.BMC medical ethics · 2013Pooled it
- Pilot study demonstrating effectiveness of targeted education to improve informed consent understanding in AIDS clinical trials.AIDS care · 2011Trial
- Article
- Trials Methodology Research: what is it and why should India invest in it?The Lancet regional health. Southeast Asia · 2024Review
- Autonomy with responsibility ¿Is informed consent just a signature on a paper? Evaluation in patients who underwent spine's surgery.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2023Article
- Experiences and practices of key research team members in obtaining informed consent for pharmacogenetic research among people living with HIV: a qualitative study.Research ethics · 2022Article
- Quality of Informed Consent Practices around the Time of Childbirth: A Cross-Sectional Study in Italy.International journal of environmental research and public health · 2022Article
- What empirical research has been undertaken on the ethics of clinical research in India? A systematic scoping review and narrative synthesis.BMJ global health · 2021Article
- A qualitative study on aspects of consent for genomic research in communities with low literacy.BMC medical ethics · 2020Article
- Bioethical reflexivity and requirements of valid consent: conceptual tools.BMC medical ethics · 2019Article
- Consent for participating in clinical trials - Is it really informed?Developing world bioethics · 2018Article
- Consent and community engagement in diverse research contexts.Journal of empirical research on human research ethics : JERHRE · 2013Article
- US IRBs confronting research in the developing world.Developing world bioethics · 2012Article
- Tailoring information provision and consent processes to research contexts: the value of rapid assessments.Journal of empirical research on human research ethics : JERHRE · 2012Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundStudies on different methods to supplement the traditional informed consent process have generated conflicting results. This study was designed to evaluate whether participants who received group counseling prior to administration of informed consent understood the key components of the study and the consent better than those who received individual counseling, based on the hypothesis that group counseling would foster discussion among potential participants and enhance their understanding of the informed consent.
methodsParents of children participating in a trial of nutritional supplementation were randomized to receive either group counseling or individual counseling prior to administration of the informed consent. To assess the participant's comprehension, a structured questionnaire was administered approximately 48-72 hours afterwards by interviewers who were blinded to the allocation group of the respondents.
resultsA total of 128 parents were recruited and follow up was established with 118 (90.2%) for the study. All respondents were aware of their child's participation in a research study and the details of sample collection. However, their understanding of study purpose, randomization and withdrawal was poor. There was no difference in comprehension of key elements of the informed consent between the intervention and control arm.
conclusionsThe results suggest that the group counseling might not influence the overall comprehension of the informed consent process. Further research is required to devise better ways of improving participants' understanding of randomization in clinical trials.
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What OpenQuestion holds
Registered trials
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.