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BMC Med Ethics. 2019 Aug 1;20(1):55. doi: 10.1186/s12910-019-0390-x.

Model consent clauses for rare disease research.

Author information

1
Center of Genomics and Policy, McGill University, Montreal, Quebec, H3A 0G1, Canada. thu.nguyen@mcgill.ca.
2
University of Western Australia, Perth, Australia.
3
Institute for Bioethics and Health Policy, University of Miami, Miami, USA.
4
IRDiRC Scientific Secretariat, Inserm US-14, Paris, France.
5
AveXis, Chicago, USA.
6
AFM-Téléthon, Evry, France.
7
Heidelberg Academy of Sciences and Humanities, Heidelberg, Germany.
8
Centre for Biomedical Ethics and Law, Brussels, Belgium.
9
National Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, USA.
10
Center of Genomics and Policy, McGill University, Montreal, Quebec, H3A 0G1, Canada.
11
Canadian Organization for Rare Disorders, Toronto, Canada.

Abstract

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.

KEYWORDS:

Consent clauses; Core consent elements; Informed consent; Rare diseases; Research ethics

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