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...
Ausführliche Beschreibung
Autor*in: |
Minh Thu Nguyen [verfasserIn] Jack Goldblatt [verfasserIn] Rosario Isasi [verfasserIn] Marlene Jagut [verfasserIn] Anneliene Hechtelt Jonker [verfasserIn] Petra Kaufmann [verfasserIn] Laetitia Ouillade [verfasserIn] Fruszina Molnar-Gabor [verfasserIn] Mahsa Shabani [verfasserIn] Eric Sid [verfasserIn] Anne Marie Tassé [verfasserIn] Durhane Wong-Rieger [verfasserIn] Bartha Maria Knoppers [verfasserIn] on behalf of the IRDiRC-GA4GH Model Consent Clauses Task Force [verfasserIn] |
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Englisch |
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2019 |
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In: BMC Medical Ethics - BMC, 2003, 20(2019), 1, Seite 7 |
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volume:20 ; year:2019 ; number:1 ; pages:7 |
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DOI / URN: |
10.1186/s12910-019-0390-x |
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DOAJ043051820 |
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520 | |a 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. | ||
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10.1186/s12910-019-0390-x doi (DE-627)DOAJ043051820 (DE-599)DOAJf28b074704354c71b2611cfcbe3e4b65 DE-627 ger DE-627 rakwb eng R723-726 Minh Thu Nguyen verfasserin aut Model consent clauses for rare disease research 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Rare diseases Informed consent Research ethics Core consent elements Consent clauses Medical philosophy. Medical ethics Jack Goldblatt verfasserin aut Rosario Isasi verfasserin aut Marlene Jagut verfasserin aut Anneliene Hechtelt Jonker verfasserin aut Petra Kaufmann verfasserin aut Laetitia Ouillade verfasserin aut Fruszina Molnar-Gabor verfasserin aut Mahsa Shabani verfasserin aut Eric Sid verfasserin aut Anne Marie Tassé verfasserin aut Durhane Wong-Rieger verfasserin aut Bartha Maria Knoppers verfasserin aut on behalf of the IRDiRC-GA4GH Model Consent Clauses Task Force verfasserin aut In BMC Medical Ethics BMC, 2003 20(2019), 1, Seite 7 (DE-627)326645403 (DE-600)2041552-7 14726939 nnns volume:20 year:2019 number:1 pages:7 https://doi.org/10.1186/s12910-019-0390-x kostenfrei https://doaj.org/article/f28b074704354c71b2611cfcbe3e4b65 kostenfrei http://link.springer.com/article/10.1186/s12910-019-0390-x kostenfrei https://doaj.org/toc/1472-6939 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 20 2019 1 7 |
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10.1186/s12910-019-0390-x doi (DE-627)DOAJ043051820 (DE-599)DOAJf28b074704354c71b2611cfcbe3e4b65 DE-627 ger DE-627 rakwb eng R723-726 Minh Thu Nguyen verfasserin aut Model consent clauses for rare disease research 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Rare diseases Informed consent Research ethics Core consent elements Consent clauses Medical philosophy. Medical ethics Jack Goldblatt verfasserin aut Rosario Isasi verfasserin aut Marlene Jagut verfasserin aut Anneliene Hechtelt Jonker verfasserin aut Petra Kaufmann verfasserin aut Laetitia Ouillade verfasserin aut Fruszina Molnar-Gabor verfasserin aut Mahsa Shabani verfasserin aut Eric Sid verfasserin aut Anne Marie Tassé verfasserin aut Durhane Wong-Rieger verfasserin aut Bartha Maria Knoppers verfasserin aut on behalf of the IRDiRC-GA4GH Model Consent Clauses Task Force verfasserin aut In BMC Medical Ethics BMC, 2003 20(2019), 1, Seite 7 (DE-627)326645403 (DE-600)2041552-7 14726939 nnns volume:20 year:2019 number:1 pages:7 https://doi.org/10.1186/s12910-019-0390-x kostenfrei https://doaj.org/article/f28b074704354c71b2611cfcbe3e4b65 kostenfrei http://link.springer.com/article/10.1186/s12910-019-0390-x kostenfrei https://doaj.org/toc/1472-6939 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 20 2019 1 7 |
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10.1186/s12910-019-0390-x doi (DE-627)DOAJ043051820 (DE-599)DOAJf28b074704354c71b2611cfcbe3e4b65 DE-627 ger DE-627 rakwb eng R723-726 Minh Thu Nguyen verfasserin aut Model consent clauses for rare disease research 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Rare diseases Informed consent Research ethics Core consent elements Consent clauses Medical philosophy. Medical ethics Jack Goldblatt verfasserin aut Rosario Isasi verfasserin aut Marlene Jagut verfasserin aut Anneliene Hechtelt Jonker verfasserin aut Petra Kaufmann verfasserin aut Laetitia Ouillade verfasserin aut Fruszina Molnar-Gabor verfasserin aut Mahsa Shabani verfasserin aut Eric Sid verfasserin aut Anne Marie Tassé verfasserin aut Durhane Wong-Rieger verfasserin aut Bartha Maria Knoppers verfasserin aut on behalf of the IRDiRC-GA4GH Model Consent Clauses Task Force verfasserin aut In BMC Medical Ethics BMC, 2003 20(2019), 1, Seite 7 (DE-627)326645403 (DE-600)2041552-7 14726939 nnns volume:20 year:2019 number:1 pages:7 https://doi.org/10.1186/s12910-019-0390-x kostenfrei https://doaj.org/article/f28b074704354c71b2611cfcbe3e4b65 kostenfrei http://link.springer.com/article/10.1186/s12910-019-0390-x kostenfrei https://doaj.org/toc/1472-6939 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 20 2019 1 7 |
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10.1186/s12910-019-0390-x doi (DE-627)DOAJ043051820 (DE-599)DOAJf28b074704354c71b2611cfcbe3e4b65 DE-627 ger DE-627 rakwb eng R723-726 Minh Thu Nguyen verfasserin aut Model consent clauses for rare disease research 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Rare diseases Informed consent Research ethics Core consent elements Consent clauses Medical philosophy. Medical ethics Jack Goldblatt verfasserin aut Rosario Isasi verfasserin aut Marlene Jagut verfasserin aut Anneliene Hechtelt Jonker verfasserin aut Petra Kaufmann verfasserin aut Laetitia Ouillade verfasserin aut Fruszina Molnar-Gabor verfasserin aut Mahsa Shabani verfasserin aut Eric Sid verfasserin aut Anne Marie Tassé verfasserin aut Durhane Wong-Rieger verfasserin aut Bartha Maria Knoppers verfasserin aut on behalf of the IRDiRC-GA4GH Model Consent Clauses Task Force verfasserin aut In BMC Medical Ethics BMC, 2003 20(2019), 1, Seite 7 (DE-627)326645403 (DE-600)2041552-7 14726939 nnns volume:20 year:2019 number:1 pages:7 https://doi.org/10.1186/s12910-019-0390-x kostenfrei https://doaj.org/article/f28b074704354c71b2611cfcbe3e4b65 kostenfrei http://link.springer.com/article/10.1186/s12910-019-0390-x kostenfrei https://doaj.org/toc/1472-6939 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 20 2019 1 7 |
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10.1186/s12910-019-0390-x doi (DE-627)DOAJ043051820 (DE-599)DOAJf28b074704354c71b2611cfcbe3e4b65 DE-627 ger DE-627 rakwb eng R723-726 Minh Thu Nguyen verfasserin aut Model consent clauses for rare disease research 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Rare diseases Informed consent Research ethics Core consent elements Consent clauses Medical philosophy. Medical ethics Jack Goldblatt verfasserin aut Rosario Isasi verfasserin aut Marlene Jagut verfasserin aut Anneliene Hechtelt Jonker verfasserin aut Petra Kaufmann verfasserin aut Laetitia Ouillade verfasserin aut Fruszina Molnar-Gabor verfasserin aut Mahsa Shabani verfasserin aut Eric Sid verfasserin aut Anne Marie Tassé verfasserin aut Durhane Wong-Rieger verfasserin aut Bartha Maria Knoppers verfasserin aut on behalf of the IRDiRC-GA4GH Model Consent Clauses Task Force verfasserin aut In BMC Medical Ethics BMC, 2003 20(2019), 1, Seite 7 (DE-627)326645403 (DE-600)2041552-7 14726939 nnns volume:20 year:2019 number:1 pages:7 https://doi.org/10.1186/s12910-019-0390-x kostenfrei https://doaj.org/article/f28b074704354c71b2611cfcbe3e4b65 kostenfrei http://link.springer.com/article/10.1186/s12910-019-0390-x kostenfrei https://doaj.org/toc/1472-6939 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 20 2019 1 7 |
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abstract |
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. |
abstractGer |
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. |
abstract_unstemmed |
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. |
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title_short |
Model consent clauses for rare disease research |
url |
https://doi.org/10.1186/s12910-019-0390-x https://doaj.org/article/f28b074704354c71b2611cfcbe3e4b65 http://link.springer.com/article/10.1186/s12910-019-0390-x https://doaj.org/toc/1472-6939 |
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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 |
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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 |
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