ArticleBMC medical ethics2017
Participatory improvement of a template for informed consent documents in biobank research - study results and methodological reflections.
Article in BMC medical ethics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.
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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.
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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.
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Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Digital tools in the informed consent process: a systematic review.BMC medical ethics · 2021Pooled it
- Public awareness and attitudes toward biobank and sample donation: A regional Chinese survey.Frontiers in public health · 2022Article
- The Attitude of Patients from a Romanian Tertiary Cardiology Center Regarding Participation in Biomarker-Based Clinical Trials.Medicina (Kaunas, Lithuania) · 2021Article
- The reconfiguration of biobanks in Europe under the BBMRI-ERIC framework: towards global sharing nodes?Life sciences, society and policy · 2020Article
- The reported impact of public involvement in biobanks: A scoping review.Health expectations : an international journal of public participation in health care and health policy · 2020Article
- Public awareness of and attitudes towards research biobanks in Latvia.BMC medical ethics · 2020Article
- Biobanks-A Platform for Scientific and Biomedical Research.Diagnostics (Basel, Switzerland) · 2020Review
- [Ethical, legal and social issues publications on biobanks 2011-2018. A scoping review.]Revista espanola de salud publica · 2020Article
- Focus group findings on the migraine patient experience during research studies and ideas for future investigations.Cephalalgia : an international journal of headache · 2020Article
- Improving Informed Consent for Novel Vaccine Research in a Pediatric Hospital Setting Using a Blended Research-Design Approach.Frontiers in pediatrics · 2020Article
- Biobanking in health care: evolution and future directions.Journal of translational medicine · 2019Review
- Article
- Emerging infectious disease laboratory and diagnostic preparedness to accelerate vaccine development.Human vaccines & immunotherapeutics · 2019Review
- The Public's Awareness of and Attitude Toward Research Biobanks - A Regional German Survey.Frontiers in genetics · 2018Article
- The Attitude of Patients from a Romanian Tertiary Cardiology Center as Regards Participation in Biomarker-Based Clinical Trials - Survey Methodology.Journal of medicine and lifeArticle
Corrections and comments
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Authors and funding
5 authors.
Funding
Abstract
backgroundFor valid informed consent, it is crucial that patients or research participants fully understand all that their consent entails. Testing and revising informed consent documents with the assistance of their addressees can improve their understandability. In this study we aimed at further developing a method for testing and improving informed consent documents with regard to readability and test-readers' understanding and reactions.
methodsWe tested, revised, and retested template informed consent documents for biobank research by means of 11 focus group interviews with members from the documents' target population. For the analysis of focus group excerpts we used qualitative content analysis. Revisions were made based on focus group feedback in an iterative process.
resultsFocus group participants gave substantial feedback on the original and on the revised version of the tested documents. Revisions included adding and clarifying explanations, including an info-box summarizing the main points of the text and an illustrative graphic.
conclusionOur results indicate positive effects on the tested and revised informed consent documents in regard to general readability and test-readers' understanding and reactions. Participatory methods for improving informed consent should be more often applied and further evaluated for both, medical interventions and clinical research. Particular conceptual and methodological challenges need to be addressed in the future.
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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.