Minh Thu Nguyen, Jack Goldblatt, Rosario Isasi, Marlene Jagut, Anneliene Hechtelt Jonker, Petra Kaufmann, Laetitia Ouillade, Fruszina Molnar-Gabor, Mahsa Shabani, Eric Sid, Anne Marie Tassé, Durhane Wong-Rieger, Bartha Maria Knoppers, IRDiRC-GA4GH Model Consent Clauses Task Force
Author Information
Minh Thu Nguyen: Center of Genomics and Policy, McGill University, Montreal, Quebec, H3A 0G1, Canada. thu.nguyen@mcgill.ca. ORCID
Jack Goldblatt: University of Western Australia, Perth, Australia.
Rosario Isasi: Institute for Bioethics and Health Policy, University of Miami, Miami, USA.
Marlene Jagut: IRDiRC Scientific Secretariat, Inserm US-14, Paris, France.
Anneliene Hechtelt Jonker: IRDiRC Scientific Secretariat, Inserm US-14, Paris, France.
Petra Kaufmann: AveXis, Chicago, USA.
Laetitia Ouillade: AFM-Téléthon, Evry, France.
Fruszina Molnar-Gabor: Heidelberg Academy of Sciences and Humanities, Heidelberg, Germany.
Mahsa Shabani: Centre for Biomedical Ethics and Law, Brussels, Belgium.
Eric Sid: National Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, USA.
Anne Marie Tassé: Center of Genomics and Policy, McGill University, Montreal, Quebec, H3A 0G1, Canada.
Durhane Wong-Rieger: Canadian Organization for Rare Disorders, Toronto, Canada.
Bartha Maria Knoppers: Center of Genomics and Policy, McGill University, Montreal, Quebec, H3A 0G1, Canada.
BACKGROUND: Rare 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. METHODS: A 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. RESULTS: The 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. CONCLUSION: The 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.
