ArticleBMC medical ethics2019
Model consent clauses for rare disease research.
Article in BMC medical ethics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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Who cites it
11 citing papers in PubMed.
- Guidance on communication and informed consent with patients and their families for experimental individualized treatments.American journal of human genetics · 2026Review
- Verbal consent in biomedical research: moving toward a future standard practice?Frontiers in genetics · 2025Review
- Astronaut omics and the impact of space on the human body at scale.Nature communications · 2024Review
- Landscape analysis of available European data sources amenable for machine learning and recommendations on usability for rare diseases screening.Orphanet journal of rare diseases · 2024Article
- Challenges in mapping European rare disease databases, relevant for ML-based screening technologies in terms of organizational, FAIR and legal principles: scoping review.Frontiers in public health · 2023Article
- Routine omics collection is a golden opportunity for European human research in space and analog environments.Patterns (New York, N.Y.) · 2022Review
- Benefits and Risks of Sharing Genomic Data for Research: Comparing the Views of Rare Disease Patients, Informal Carers and Healthcare Professionals.International journal of environmental research and public health · 2022Article
- Sharing and Safeguarding Pediatric Data.Frontiers in genetics · 2022Article
- Shortened consent forms for genome-wide sequencing: Parent and provider perspectives.Molecular genetics & genomic medicine · 2020Article
- Genomic data sharing in Europe is stumbling-Could a code of conduct prevent its fall?EMBO molecular medicine · 2020Article
- Ethical Questions Linked to Rare Diseases and Orphan Drugs - A Systematic Review.Risk management and healthcare policy · 2020Article
Corrections and comments
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Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRare Disease research has seen tremendous advancements over the last decades, with the development of new technologies, various global collaborative efforts and improved data sharing. To maximize the impact of and to further build on these developments, there is a need for model consent clauses for rare diseases research, in order to improve data interoperability, to meet the informational needs of participants, and to ensure proper ethical and legal use of data sources and participants' overall protection.
methodsA global Task Force was set up to develop model consent clauses specific to rare diseases research, that are comprehensive, harmonized, readily accessible, and internationally applicable, facilitating the recruitment and consent of rare disease research participants around the world. Existing consent forms and notices of consent were analyzed and classified under different consent themes, which were used as background to develop the model consent clauses.
resultsThe IRDiRC-GA4GH MCC Task Force met in September 2018, to discuss and design model consent clauses. Based on analyzed consent forms, they listed generic core elements and designed the following rare disease research specific core elements; Rare Disease Research Introductory Clause, Familial Participation, Audio/Visual Imaging, Collecting, storing, sharing of rare disease data, Recontact for matching, Data Linkage, Return of Results to Family Members, Incapacity/Death, and Benefits.
conclusionThe model consent clauses presented in this article have been drafted to highlight consent elements that bear in mind the trends in rare disease research, while providing a tool to help foster harmonization and collaborative efforts.
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Registered trials
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