ArticleTrials2017
An integrated conceptual framework for evaluating and improving 'understanding' in informed consent.
Article in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis 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
9 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Operationalizing and Measuring Informed Choice in Health Care: An Umbrella Review.Medical decision making : an international journal of the Society for Medical Decision Making · 2026Pooled it
- Verbal consent in biomedical research: moving toward a future standard practice?Frontiers in genetics · 2025Review
- Incorporating Community Partner Perspectives on eHealth Technology Data Sharing Practices for the California Early Psychosis Intervention Network: Qualitative Focus Group Study With a User-Centered Design Approach.JMIR human factors · 2023Article
- Fragmented understanding: exploring the practice and meaning of informed consent in clinical trials in Ho Chi Minh City, Vietnam.BMC medical ethics · 2023Article
- Four reasons why too many informed consents to clinical research are invalid: a critical analysis of current practices.BMJ open · 2022Review
- Stakeholder involvement in the development of trial material for a clinical trial.Health expectations : an international journal of public participation in health care and health policy · 2021Article
- Informed consent for controlled human infection studies in low- and middle-income countries: Ethical challenges and proposed solutions.Bioethics · 2020Article
- Readability of consent forms in veterinary clinical research.Journal of veterinary internal medicine · 2019Article
- Participatory improvement of a template for informed consent documents in biobank research - study results and methodological reflections.BMC medical ethics · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe development of understandable informed consent (IC) documents has proven to be one of the most important challenges in research with humans as well as in healthcare settings. Therefore, evaluating and improving understanding has been of increasing interest for empirical research on IC. However, several conceptual and practical challenges for the development of understandable IC documents remain unresolved.
methodsIn this paper, we will outline and systematize some of these challenges. On the basis of our own experiences in empirical user testing of IC documents as well as the relevant literature on understanding in IC, we propose an integrated conceptual model for the development of understandable IC documents.
resultsThe proposed conceptual model integrates different methods for the participatory improvement of written information, including IC, as well as quantitative methods for measuring understanding in IC.
conclusionsIn most IC processes, understandable written information is an important prerequisite for valid IC. To improve the quality of IC documents, a conceptual model for participatory procedures of testing, revising, and retesting can be applied. However, the model presented in this paper needs further theoretical and empirical elaboration and clarification of several conceptual and practical challenges.
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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.