The heterogeneity of rare diseases combined with the small number of patients for each disorder, often precludes conventional discovery approaches. To facilitate international data sharing, coordinated consent processes between research centers is crucial. While a framework for data sharing and accompanying policies have been developed, such advances have not yet provided practical and procedural tools for consent elements in the context of rare diseases, and in particular, model consent clauses in pediatric rare disease research are currently lacking. This Task Force will gather rare disease research policy experts to develop model consent clauses specific to rare diseases that are comprehensive, harmonized, readily-accessible, and internationally applicable, enabling the recruitment and consent of rare disease research participants around the world. The resulting consent clauses will take into account international socio-ethical, legal and cultural differences. Furthermore, this resource will further IRDiRC’s aim to promote and catalyze collaborative multi-national studies through interoperable and responsible research practices.
The overarching purpose of this Task Force is to gather international policy researchers in rare diseases to address specific consent needs. The objectives of the Task Force:
- Develop a series of model consent clauses for rare disease researchers based on robust bioethical and legal approaches, addressing the complexity of the scientific, ethical and legal issues that arise when conducting rare disease research
- Address issues such as participant privacy, use of identifiable images, and return of results to participants.
- Enable rare disease researchers to use clauses specific to their research context and participant populations, consequently assisting in the customization of their own consent documents.
These model consent clauses will provide useful guidance and offer a mechanism to streamline consent practices.
- Jack Goldblatt – University of Western Australia, Australia (Co-Chair)
- Petra Kaufmann – AveXis, USA (Co-Chair)
- Bartha Knoppers – Center of Genomics and Policy, McGill University, Canada (Co-Chair)
- Jill Clayton-Smith – University of Manchester, UK
- Rosario Isasi – Institute for Bioethics and Health Policy, USA
- Fruzsina Molnar Gabor – Heidelberg Academy of Sciences and Humanities, Germany
- Minh Thu Nguyen – Center of Genomics and Policy, McGill University, Canada
- Laetitia Ouillade – Atos/Telethon, France
- Laura Rodriguez – National Human Genome Research Institute Home at NIH, USA
- Eric Sid – National Center for Advancing Translational Sciences at NIH, USA
- Masha Shabani – Centre for Biomedical Ethics and Law, Belgium
- Anne-Marie Tassé – Center of Genomics and Policy, McGill University, Canada
- Susan Wallace – University of Leicester
- Durhane Wong-Rieger – CORD, Canada
Comments and suggestions
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