ArticleBMC medical ethics2018
What information and the extent of information research participants need in informed consent forms: a multi-country survey.
Article in BMC medical ethics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 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
15 citing papers in PubMed, 40 citations in OpenAlex.
- Trial
- Cisnormative Language and Erasure of Trans* and Genderqueer Student Representation in Biology Education Research.CBE life sciences education · 2025Article
- Analysis of pediatric assent information in early-phase cancer clinical trials through a children's research advisory group.Frontiers in psychology · 2025Article
- Effect of a Smoking Cessation Education Program on the Knowledge, Attitude, and Self-Efficacy of Community Pharmacists in Japan: A Quasi-Experimental Study.Tobacco use insights · 2024Article
- Continuous quality improvement: reducing informed consent form signing errors.BMC medical ethics · 2023Article
- Informed consent in cancer clinical drug trials in China: a narrative literature review of the past 20 years.Trials · 2023Review
- Fragmented understanding: exploring the practice and meaning of informed consent in clinical trials in Ho Chi Minh City, Vietnam.BMC medical ethics · 2023Article
- Using provocative design to foster electronic informed consent innovation.BMC medical informatics and decision making · 2022Article
- What information and the extent of information to be provided in an informed assent/consent form of pediatric drug trials.BMC medical ethics · 2022Article
- Factors Influencing Successful Recruitment of Racial and Ethnic Minority Patients for an Observational HIV Cohort Study in Washington, DC.Journal of racial and ethnic health disparities · 2022Observational
- Citizens, Research Ethics Committee Members and Researchers' Attitude Toward Information and Consent for the Secondary Use of Health Data: Implications for Research Within Learning Health Systems.Journal of empirical research on human research ethics : JERHRE · 2021Article
- Researchers' views on, and experiences with, the requirement to obtain informed consent in research involving human participants: a qualitative study.BMC medical ethics · 2020Article
- Why 'understanding' of research may not be necessary for ethical emergency research.Philosophy, ethics, and humanities in medicine : PEHM · 2020Review
- Informational needs for participation in bioequivalence studies: the perspectives of experienced volunteers.European journal of clinical pharmacology · 2019Article
- Co-creation with research participants to inform the design of electronic informed consent.Digital healthArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
60 authors at 20 institutions in 8 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe use of lengthy, detailed, and complex informed consent forms (ICFs) is of paramount concern in biomedical research as it may not truly promote the rights and interests of research participants. The extent of information in ICFs has been the subject of debates for decades; however, no clear guidance is given. Thus, the objective of this study was to determine the perspectives of research participants about the type and extent of information they need when they are invited to participate in biomedical research.
methodsThis multi-center, cross-sectional, descriptive survey was conducted at 54 study sites in seven Asia-Pacific countries. A modified Likert-scale questionnaire was used to determine the importance of each element in the ICF among research participants of a biomedical study, with an anchored rating scale from 1 (not important) to 5 (very important).
resultsOf the 2484 questionnaires distributed, 2113 (85.1%) were returned. The majority of respondents considered most elements required in the ICF to be 'moderately important' to 'very important' for their decision making (mean score, ranging from 3.58 to 4.47). Major foreseeable risk, direct benefit, and common adverse effects of the intervention were considered to be of most concerned elements in the ICF (mean score = 4.47, 4.47, and 4.45, respectively).
conclusionsResearch participants would like to be informed of the ICF elements required by ethical guidelines and regulations; however, the importance of each element varied, e.g., risk and benefit associated with research participants were considered to be more important than the general nature or technical details of research. Using a participant-oriented approach by providing more details of the participant-interested elements while avoiding unnecessarily lengthy details of other less important elements would enhance the quality of the ICF.
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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.