ArticleEuropean journal of human genetics : EJHG2016
Improving the informed consent process in international collaborative rare disease research: effective consent for effective research.
Article in European journal of human genetics : EJHG, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 1 of them a synthesis that pooled it.
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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.
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Who cites it
32 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Stakeholders' perspectives on the post-mortem use of genetic and health-related data for research: a systematic review.European journal of human genetics : EJHG · 2020Pooled it
- Trial
- Individuals' preferences for future biological sample and genomic data sharing in the Australian Reproductive Genetic Carrier Screening Project.European journal of human genetics : EJHG · 2026Article
- Guidance on communication and informed consent with patients and their families for experimental individualized treatments.American journal of human genetics · 2026Review
- Regulatory aspects of optogenetic research and therapy for retinitis pigmentosa under EU law.Frontiers in medical technology · 2025Review
- Reference Materials for Improving Reliability of Multiomics Profiling.Phenomics (Cham, Switzerland) · 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
- Improving prenatal diagnosis through standards and aggregation.Prenatal diagnosis · 2024Review
- Knowledge and Attitudes of Clinical Trials among Patients with Rare Diseases and the Guardians in China.Therapeutic innovation & regulatory science · 2024Article
- Together4RD position statement on collaboration between European reference networks and industry.Orphanet journal of rare diseases · 2023Article
- 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
- The Cure SMA Clinical Trial Experience Survey: A Study of Trial Participant Perspectives on Clinical Trial Management and Patient-Centric Management Practices.Neurology and therapy · 2022Article
- 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
- Public Views About Involvement in Decision-Making on Health Data Sharing, Access, Use and Reuse: The Importance of Trust in Science and Other Institutions.Frontiers in public health · 2022Article
- Anticipatory Governance in Biobanking: Security and Risk Management in Digital Health.Science and engineering ethics · 2021Article
- Sources of potential bias when combining routine data linkage and a national survey of secondary school-aged children: a record linkage study.BMC medical research methodology · 2020Article
- Ethical, legal, and social issues (ELSI) in rare diseases: a landscape analysis from funders.European journal of human genetics : EJHG · 2020Article
- The GDPR and the research exemption: considerations on the necessary safeguards for research biobanks.European journal of human genetics : EJHG · 2019Article
- Model consent clauses for rare disease research.BMC medical ethics · 2019Article
- Share and protect our health data: an evidence based approach to rare disease patients' perspectives on data sharing and data protection - quantitative survey and recommendations.Orphanet journal of rare diseases · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The increased international sharing of data in research consortia and the introduction of new technologies for sequencing challenge the informed consent (IC) process, adding complexities that require coordination between research centres worldwide. Rare disease consortia present special challenges since available data and samples may be very limited. Thus, it is especially relevant to ensure the best use of available resources but at the same time protect patients' right to integrity. To achieve this aim, there is an ethical duty to plan in advance the best possible consent procedure in order to address possible ethical and legal hurdles that could hamper research in the future. Therefore, it is especially important to identify key core elements (CEs) to be addressed in the IC documents for international collaborative research in two different situations: (1) new research collections (biobanks and registries) for which information documents can be created according to current guidelines and (2) established collections obtained without IC or with a previous consent that does not cover all CEs. We propose here a strategy to deal with consent in these situations. The principles have been applied and are in current practice within the RD-Connect consortia - a global research infrastructure funded by the European Commission Seventh Framework program but forward looking in terms of issues addressed. However, the principles established, the lessons learned and the implications for future research are of direct relevance to all internationally collaborative rare-disease projects.
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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.