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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
INFORMED-CONSENT, REIDENTIFICATION, PRIVACY, Rare diseases, Informed consent, Research ethics, Core consent elements, Consent clauses

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Please use this url to cite or link to this publication:

MLA
Nguyen, Minh Thu et al. “Model Consent Clauses for Rare Disease Research.” BMC MEDICAL ETHICS 20 (2019): n. pag. Print.
APA
Nguyen, M. T., Goldblatt, J., Isasi, R., Jagut, M., Jonker, A. H., Kautmann, P., Ouillade, L., et al. (2019). Model consent clauses for rare disease research. BMC MEDICAL ETHICS, 20.
Chicago author-date
Nguyen, Minh Thu, Jack Goldblatt, Rosario Isasi, Marlene Jagut, Anneliene Hechtelt Jonker, Petra Kautmann, Laetitia Ouillade, et al. 2019. “Model Consent Clauses for Rare Disease Research.” Bmc Medical Ethics 20.
Chicago author-date (all authors)
Nguyen, Minh Thu, Jack Goldblatt, Rosario Isasi, Marlene Jagut, Anneliene Hechtelt Jonker, Petra Kautmann, Laetitia Ouillade, Fruszina Molnar-Gabor, Mahsa Shabani, Eric Sid, Anne Marie Tasse, Durhane Wong-Rieger, Bartha Maria Knoppers, Petra Kaufmann, Bartha Knoppers, and Anne-Marie Tasse. 2019. “Model Consent Clauses for Rare Disease Research.” Bmc Medical Ethics 20.
Vancouver
1.
Nguyen MT, Goldblatt J, Isasi R, Jagut M, Jonker AH, Kautmann P, et al. Model consent clauses for rare disease research. BMC MEDICAL ETHICS. 2019;20.
IEEE
[1]
M. T. Nguyen et al., “Model consent clauses for rare disease research,” BMC MEDICAL ETHICS, vol. 20, 2019.
@article{8629771,
  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.},
  articleno    = {55},
  author       = {Nguyen, Minh Thu and Goldblatt, Jack and Isasi, Rosario and Jagut, Marlene and Jonker, Anneliene Hechtelt and Kautmann, Petra and Ouillade, Laetitia and Molnar-Gabor, Fruszina and Shabani, Mahsa and Sid, Eric and Tasse, Anne Marie and Wong-Rieger, Durhane and Knoppers, Bartha Maria and Kaufmann, Petra and Knoppers, Bartha and Tasse, Anne-Marie},
  issn         = {1472-6939},
  journal      = {BMC MEDICAL ETHICS},
  keywords     = {INFORMED-CONSENT,REIDENTIFICATION,PRIVACY,Rare diseases,Informed consent,Research ethics,Core consent elements,Consent clauses},
  language     = {eng},
  pages        = {7},
  title        = {Model consent clauses for rare disease research},
  url          = {http://dx.doi.org/10.1186/s12910-019-0390-x},
  volume       = {20},
  year         = {2019},
}

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