Model consent clauses for rare disease research

BMC Medical Ethics
Minh Thu NguyenIRDiRC-GA4GH Model Consent Clauses Task Force

Abstract

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. 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. 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...Continue Reading

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Citations

Feb 20, 2020·EMBO Molecular Medicine·Fruzsina Molnár-Gábor, Jan O Korbel
May 10, 2020·Molecular Genetics & Genomic Medicine·Emma C HitchcockAlison M Elliott
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Oct 30, 2020·Risk Management and Healthcare Policy·Jaroslav KacetlAli Selamat

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Software Mentioned

GA4GH
MCC
IRDiRC

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