Model consent clauses for rare disease research
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...
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| Format: | Article |
| Language: | English |
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BMC
2019-08-01
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| Series: | BMC Medical Ethics |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12910-019-0390-x |
| _version_ | 1818230852612521984 |
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| author | 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 on behalf of the IRDiRC-GA4GH Model Consent Clauses Task Force |
| author_facet | 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 on behalf of the IRDiRC-GA4GH Model Consent Clauses Task Force |
| author_sort | Minh Thu Nguyen |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-12T10:41:05Z |
| format | Article |
| id | doaj.art-f28b074704354c71b2611cfcbe3e4b65 |
| institution | Directory Open Access Journal |
| issn | 1472-6939 |
| language | English |
| last_indexed | 2024-12-12T10:41:05Z |
| publishDate | 2019-08-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Medical Ethics |
| spelling | doaj.art-f28b074704354c71b2611cfcbe3e4b652022-12-22T00:27:03ZengBMCBMC Medical Ethics1472-69392019-08-012011710.1186/s12910-019-0390-xModel consent clauses for rare disease researchMinh Thu Nguyen0Jack Goldblatt1Rosario Isasi2Marlene Jagut3Anneliene Hechtelt Jonker4Petra Kaufmann5Laetitia Ouillade6Fruszina Molnar-Gabor7Mahsa Shabani8Eric Sid9Anne Marie Tassé10Durhane Wong-Rieger11Bartha Maria Knoppers12on behalf of the IRDiRC-GA4GH Model Consent Clauses Task ForceCenter of Genomics and Policy, McGill UniversityUniversity of Western AustraliaInstitute for Bioethics and Health Policy, University of MiamiIRDiRC Scientific Secretariat, Inserm US-14IRDiRC Scientific Secretariat, Inserm US-14AveXisAFM-TéléthonHeidelberg Academy of Sciences and HumanitiesCentre for Biomedical Ethics and LawNational Center for Advancing Translational Sciences, National Institutes of HealthCenter of Genomics and Policy, McGill UniversityCanadian Organization for Rare DisordersCenter of Genomics and Policy, McGill UniversityAbstract 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.http://link.springer.com/article/10.1186/s12910-019-0390-xRare diseasesInformed consentResearch ethicsCore consent elementsConsent clauses |
| spellingShingle | 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 on behalf of the IRDiRC-GA4GH Model Consent Clauses Task Force Model consent clauses for rare disease research BMC Medical Ethics Rare diseases Informed consent Research ethics Core consent elements Consent clauses |
| title | Model consent clauses for rare disease research |
| title_full | Model consent clauses for rare disease research |
| title_fullStr | Model consent clauses for rare disease research |
| title_full_unstemmed | Model consent clauses for rare disease research |
| title_short | Model consent clauses for rare disease research |
| title_sort | model consent clauses for rare disease research |
| topic | Rare diseases Informed consent Research ethics Core consent elements Consent clauses |
| url | http://link.springer.com/article/10.1186/s12910-019-0390-x |
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