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

Gespeichert in:

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]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2019

Schlagwörter:	Rare diseases Informed consent Research ethics Core consent elements Consent clauses

Übergeordnetes Werk:	In: BMC Medical Ethics - BMC, 2003, 20(2019), 1, Seite 7
Übergeordnetes Werk:	volume:20 ; year:2019 ; number:1 ; pages:7

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.1186/s12910-019-0390-x

Katalog-ID:	DOAJ043051820

Internformat


LEADER	01000caa a22002652 4500
001	DOAJ043051820
003	DE-627
005	20230308065909.0
007	cr uuu---uuuuu
008	230227s2019 xx \|\|\|\|\|o 00\| \|\|eng c
024	7		\|a 10.1186/s12910-019-0390-x \|2 doi
035			\|a (DE-627)DOAJ043051820
035			\|a (DE-599)DOAJf28b074704354c71b2611cfcbe3e4b65
040			\|a DE-627 \|b ger \|c DE-627 \|e rakwb
041			\|a eng
050		0	\|a R723-726
100	0		\|a Minh Thu Nguyen \|e verfasserin \|4 aut
245	1	0	\|a Model consent clauses for rare disease research
264		1	\|c 2019
336			\|a Text \|b txt \|2 rdacontent
337			\|a Computermedien \|b c \|2 rdamedia
338			\|a Online-Ressource \|b cr \|2 rdacarrier
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.
650		4	\|a Rare diseases
650		4	\|a Informed consent
650		4	\|a Research ethics
650		4	\|a Core consent elements
650		4	\|a Consent clauses
653		0	\|a Medical philosophy. Medical ethics
700	0		\|a Jack Goldblatt \|e verfasserin \|4 aut
700	0		\|a Rosario Isasi \|e verfasserin \|4 aut
700	0		\|a Marlene Jagut \|e verfasserin \|4 aut
700	0		\|a Anneliene Hechtelt Jonker \|e verfasserin \|4 aut
700	0		\|a Petra Kaufmann \|e verfasserin \|4 aut
700	0		\|a Laetitia Ouillade \|e verfasserin \|4 aut
700	0		\|a Fruszina Molnar-Gabor \|e verfasserin \|4 aut
700	0		\|a Mahsa Shabani \|e verfasserin \|4 aut
700	0		\|a Eric Sid \|e verfasserin \|4 aut
700	0		\|a Anne Marie Tassé \|e verfasserin \|4 aut
700	0		\|a Durhane Wong-Rieger \|e verfasserin \|4 aut
700	0		\|a Bartha Maria Knoppers \|e verfasserin \|4 aut
700	0		\|a on behalf of the IRDiRC-GA4GH Model Consent Clauses Task Force \|e verfasserin \|4 aut
773	0	8	\|i In \|t BMC Medical Ethics \|d BMC, 2003 \|g 20(2019), 1, Seite 7 \|w (DE-627)326645403 \|w (DE-600)2041552-7 \|x 14726939 \|7 nnns
773	1	8	\|g volume:20 \|g year:2019 \|g number:1 \|g pages:7
856	4	0	\|u https://doi.org/10.1186/s12910-019-0390-x \|z kostenfrei
856	4	0	\|u https://doaj.org/article/f28b074704354c71b2611cfcbe3e4b65 \|z kostenfrei
856	4	0	\|u http://link.springer.com/article/10.1186/s12910-019-0390-x \|z kostenfrei
856	4	2	\|u https://doaj.org/toc/1472-6939 \|y Journal toc \|z kostenfrei
912			\|a GBV_USEFLAG_A
912			\|a SYSFLAG_A
912			\|a GBV_DOAJ
912			\|a GBV_ILN_11
912			\|a GBV_ILN_20
912			\|a GBV_ILN_22
912			\|a GBV_ILN_23
912			\|a GBV_ILN_24
912			\|a GBV_ILN_39
912			\|a GBV_ILN_40
912			\|a GBV_ILN_60
912			\|a GBV_ILN_62
912			\|a GBV_ILN_63
912			\|a GBV_ILN_65
912			\|a GBV_ILN_69
912			\|a GBV_ILN_73
912			\|a GBV_ILN_74
912			\|a GBV_ILN_95
912			\|a GBV_ILN_105
912			\|a GBV_ILN_110
912			\|a GBV_ILN_151
912			\|a GBV_ILN_161
912			\|a GBV_ILN_170
912			\|a GBV_ILN_206
912			\|a GBV_ILN_213
912			\|a GBV_ILN_230
912			\|a GBV_ILN_285
912			\|a GBV_ILN_293
912			\|a GBV_ILN_602
912			\|a GBV_ILN_2003
912			\|a GBV_ILN_2014
912			\|a GBV_ILN_4012
912			\|a GBV_ILN_4037
912			\|a GBV_ILN_4112
912			\|a GBV_ILN_4125
912			\|a GBV_ILN_4126
912			\|a GBV_ILN_4249
912			\|a GBV_ILN_4305
912			\|a GBV_ILN_4306
912			\|a GBV_ILN_4307
912			\|a GBV_ILN_4313
912			\|a GBV_ILN_4322
912			\|a GBV_ILN_4323
912			\|a GBV_ILN_4324
912			\|a GBV_ILN_4325
912			\|a GBV_ILN_4338
912			\|a GBV_ILN_4367
912			\|a GBV_ILN_4700
951			\|a AR
952			\|d 20 \|j 2019 \|e 1 \|h 7

Indexfelder

author_variant	m t n mtn j g jg r i ri m j mj a h j ahj p k pk l o lo f m g fmg m s ms e s es a m t amt d w r dwr b m k bmk o b o t i g m c c t f obotigmcctf
matchkey_str	article:14726939:2019----::oecnetluefraeie
hierarchy_sort_str	2019
callnumber-subject-code	R
publishDate	2019
allfields	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
spelling	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
allfields_unstemmed	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
allfieldsGer	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
allfieldsSound	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
language	English
source	In BMC Medical Ethics 20(2019), 1, Seite 7 volume:20 year:2019 number:1 pages:7
sourceStr	In BMC Medical Ethics 20(2019), 1, Seite 7 volume:20 year:2019 number:1 pages:7
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Rare diseases Informed consent Research ethics Core consent elements Consent clauses Medical philosophy. Medical ethics
isfreeaccess_bool	true
container_title	BMC Medical Ethics
authorswithroles_txt_mv	Minh Thu Nguyen @@aut@@ Jack Goldblatt @@aut@@ Rosario Isasi @@aut@@ Marlene Jagut @@aut@@ Anneliene Hechtelt Jonker @@aut@@ Petra Kaufmann @@aut@@ Laetitia Ouillade @@aut@@ Fruszina Molnar-Gabor @@aut@@ Mahsa Shabani @@aut@@ Eric Sid @@aut@@ Anne Marie Tassé @@aut@@ Durhane Wong-Rieger @@aut@@ Bartha Maria Knoppers @@aut@@ on behalf of the IRDiRC-GA4GH Model Consent Clauses Task Force @@aut@@
publishDateDaySort_date	2019-01-01T00:00:00Z
hierarchy_top_id	326645403
id	DOAJ043051820
language_de	englisch
fullrecord	<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">DOAJ043051820</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230308065909.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">230227s2019 xx \|\|\|\|\|o 00\| \|\|eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1186/s12910-019-0390-x</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)DOAJ043051820</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)DOAJf28b074704354c71b2611cfcbe3e4b65</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="050" ind1=" " ind2="0"><subfield code="a">R723-726</subfield></datafield><datafield tag="100" ind1="0" ind2=" "><subfield code="a">Minh Thu Nguyen</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Model consent clauses for rare disease research</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2019</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="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.</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Rare diseases</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Informed consent</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Research ethics</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Core consent elements</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Consent clauses</subfield></datafield><datafield tag="653" ind1=" " ind2="0"><subfield code="a">Medical philosophy. Medical ethics</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Jack Goldblatt</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Rosario Isasi</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Marlene Jagut</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Anneliene Hechtelt Jonker</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Petra Kaufmann</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Laetitia Ouillade</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Fruszina Molnar-Gabor</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Mahsa Shabani</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Eric Sid</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Anne Marie Tassé</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Durhane Wong-Rieger</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Bartha Maria Knoppers</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">on behalf of the IRDiRC-GA4GH Model Consent Clauses Task Force</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="773" ind1="0" ind2="8"><subfield code="i">In</subfield><subfield code="t">BMC Medical Ethics</subfield><subfield code="d">BMC, 2003</subfield><subfield code="g">20(2019), 1, Seite 7</subfield><subfield code="w">(DE-627)326645403</subfield><subfield code="w">(DE-600)2041552-7</subfield><subfield code="x">14726939</subfield><subfield code="7">nnns</subfield></datafield><datafield tag="773" ind1="1" ind2="8"><subfield code="g">volume:20</subfield><subfield code="g">year:2019</subfield><subfield code="g">number:1</subfield><subfield code="g">pages:7</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">https://doi.org/10.1186/s12910-019-0390-x</subfield><subfield code="z">kostenfrei</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">https://doaj.org/article/f28b074704354c71b2611cfcbe3e4b65</subfield><subfield code="z">kostenfrei</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">http://link.springer.com/article/10.1186/s12910-019-0390-x</subfield><subfield code="z">kostenfrei</subfield></datafield><datafield tag="856" ind1="4" ind2="2"><subfield code="u">https://doaj.org/toc/1472-6939</subfield><subfield code="y">Journal toc</subfield><subfield code="z">kostenfrei</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_USEFLAG_A</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">SYSFLAG_A</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_DOAJ</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_11</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_20</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_22</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_23</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_24</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_39</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_40</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_60</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_62</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_63</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_65</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_69</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_73</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_74</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_95</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_105</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_110</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_151</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_161</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_170</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_206</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_213</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_230</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_285</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_293</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_602</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2003</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2014</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4012</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4037</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4112</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4125</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4126</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4249</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4305</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4306</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4307</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4313</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4322</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4323</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4324</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4325</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4338</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4367</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4700</subfield></datafield><datafield tag="951" ind1=" " ind2=" "><subfield code="a">AR</subfield></datafield><datafield tag="952" ind1=" " ind2=" "><subfield code="d">20</subfield><subfield code="j">2019</subfield><subfield code="e">1</subfield><subfield code="h">7</subfield></datafield></record></collection>
callnumber-first	R - Medicine
author	Minh Thu Nguyen
spellingShingle	Minh Thu Nguyen misc R723-726 misc Rare diseases misc Informed consent misc Research ethics misc Core consent elements misc Consent clauses misc Medical philosophy. Medical ethics Model consent clauses for rare disease research
authorStr	Minh Thu Nguyen
ppnlink_with_tag_str_mv	@@773@@(DE-627)326645403
format	electronic Article
delete_txt_mv	keep
author_role	aut aut aut aut aut aut aut aut aut aut aut aut aut aut
collection	DOAJ
remote_str	true
callnumber-label	R723-726
illustrated	Not Illustrated
issn	14726939
topic_title	R723-726 Model consent clauses for rare disease research Rare diseases Informed consent Research ethics Core consent elements Consent clauses
topic	misc R723-726 misc Rare diseases misc Informed consent misc Research ethics misc Core consent elements misc Consent clauses misc Medical philosophy. Medical ethics
topic_unstemmed	misc R723-726 misc Rare diseases misc Informed consent misc Research ethics misc Core consent elements misc Consent clauses misc Medical philosophy. Medical ethics
topic_browse	misc R723-726 misc Rare diseases misc Informed consent misc Research ethics misc Core consent elements misc Consent clauses misc Medical philosophy. Medical ethics
format_facet	Elektronische Aufsätze Aufsätze Elektronische Ressource
format_main_str_mv	Text Zeitschrift/Artikel
carriertype_str_mv	cr
hierarchy_parent_title	BMC Medical Ethics
hierarchy_parent_id	326645403
hierarchy_top_title	BMC Medical Ethics
isfreeaccess_txt	true
familylinks_str_mv	(DE-627)326645403 (DE-600)2041552-7
title	Model consent clauses for rare disease research
ctrlnum	(DE-627)DOAJ043051820 (DE-599)DOAJf28b074704354c71b2611cfcbe3e4b65
title_full	Model consent clauses for rare disease research
author_sort	Minh Thu Nguyen
journal	BMC Medical Ethics
journalStr	BMC Medical Ethics
callnumber-first-code	R
lang_code	eng
isOA_bool	true
recordtype	marc
publishDateSort	2019
contenttype_str_mv	txt
container_start_page	7
author_browse	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
container_volume	20
class	R723-726
format_se	Elektronische Aufsätze
author-letter	Minh Thu Nguyen
doi_str_mv	10.1186/s12910-019-0390-x
author2-role	verfasserin
title_sort	model consent clauses for rare disease research
callnumber	R723-726
title_auth	Model consent clauses for rare disease research
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.
collection_details	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
container_issue	1
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
remote_bool	true
author2	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
author2Str	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
ppnlink	326645403
callnumber-subject	R - General Medicine
mediatype_str_mv	c
isOA_txt	true
hochschulschrift_bool	false
doi_str	10.1186/s12910-019-0390-x
callnumber-a	R723-726
up_date	2024-07-03T15:26:51.624Z
_version_	1803572123206156288
fullrecord_marcxml	<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">DOAJ043051820</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230308065909.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">230227s2019 xx \|\|\|\|\|o 00\| \|\|eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1186/s12910-019-0390-x</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)DOAJ043051820</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)DOAJf28b074704354c71b2611cfcbe3e4b65</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="050" ind1=" " ind2="0"><subfield code="a">R723-726</subfield></datafield><datafield tag="100" ind1="0" ind2=" "><subfield code="a">Minh Thu Nguyen</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Model consent clauses for rare disease research</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2019</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="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.</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Rare diseases</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Informed consent</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Research ethics</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Core consent elements</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Consent clauses</subfield></datafield><datafield tag="653" ind1=" " ind2="0"><subfield code="a">Medical philosophy. Medical ethics</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Jack Goldblatt</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Rosario Isasi</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Marlene Jagut</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Anneliene Hechtelt Jonker</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Petra Kaufmann</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Laetitia Ouillade</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Fruszina Molnar-Gabor</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Mahsa Shabani</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Eric Sid</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Anne Marie Tassé</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Durhane Wong-Rieger</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Bartha Maria Knoppers</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">on behalf of the IRDiRC-GA4GH Model Consent Clauses Task Force</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="773" ind1="0" ind2="8"><subfield code="i">In</subfield><subfield code="t">BMC Medical Ethics</subfield><subfield code="d">BMC, 2003</subfield><subfield code="g">20(2019), 1, Seite 7</subfield><subfield code="w">(DE-627)326645403</subfield><subfield code="w">(DE-600)2041552-7</subfield><subfield code="x">14726939</subfield><subfield code="7">nnns</subfield></datafield><datafield tag="773" ind1="1" ind2="8"><subfield code="g">volume:20</subfield><subfield code="g">year:2019</subfield><subfield code="g">number:1</subfield><subfield code="g">pages:7</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">https://doi.org/10.1186/s12910-019-0390-x</subfield><subfield code="z">kostenfrei</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">https://doaj.org/article/f28b074704354c71b2611cfcbe3e4b65</subfield><subfield code="z">kostenfrei</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">http://link.springer.com/article/10.1186/s12910-019-0390-x</subfield><subfield code="z">kostenfrei</subfield></datafield><datafield tag="856" ind1="4" ind2="2"><subfield code="u">https://doaj.org/toc/1472-6939</subfield><subfield code="y">Journal toc</subfield><subfield code="z">kostenfrei</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_USEFLAG_A</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">SYSFLAG_A</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_DOAJ</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_11</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_20</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_22</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_23</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_24</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_39</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_40</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_60</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_62</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_63</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_65</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_69</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_73</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_74</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_95</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_105</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_110</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_151</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_161</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_170</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_206</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_213</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_230</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_285</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_293</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_602</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2003</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2014</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4012</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4037</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4112</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4125</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4126</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4249</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4305</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4306</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4307</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4313</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4322</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4323</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4324</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4325</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4338</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4367</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4700</subfield></datafield><datafield tag="951" ind1=" " ind2=" "><subfield code="a">AR</subfield></datafield><datafield tag="952" ind1=" " ind2=" "><subfield code="d">20</subfield><subfield code="j">2019</subfield><subfield code="e">1</subfield><subfield code="h">7</subfield></datafield></record></collection>
score	7.3986073

Nicht das Richtige dabei?

Schreiben Sie uns!

Model consent clauses for rare disease research

Nicht das Richtige dabei?

Zugang & Verfügbarkeit

Vorhandene Bände

Nicht das Richtige dabei?