Model consent clauses for rare disease research

IRDiRC-GA4GH Model Consent Clauses Task Force

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Number of pages1
JournalBMC medical ethics
Volume20
Issue number1
DOIs
StatePublished - Aug 1 2019

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Rare Diseases
Disease
Research
Consent Forms
Information Storage and Retrieval
Advisory Committees
Duty to Recontact
Information Dissemination
harmonization
family member
new technology
Technology
death
participation
trend

Keywords

  • Consent clauses
  • Core consent elements
  • Informed consent
  • Rare diseases
  • Research ethics

ASJC Scopus subject areas

  • Issues, ethics and legal aspects
  • Health(social science)
  • Health Policy

Cite this

Model consent clauses for rare disease research. / IRDiRC-GA4GH Model Consent Clauses Task Force.

In: BMC medical ethics, Vol. 20, No. 1, 01.08.2019.

Research output: Contribution to journalArticle

IRDiRC-GA4GH Model Consent Clauses Task Force 2019, 'Model consent clauses for rare disease research', BMC medical ethics, vol. 20, no. 1. https://doi.org/10.1186/s12910-019-0390-x
IRDiRC-GA4GH Model Consent Clauses Task Force. / Model consent clauses for rare disease research. In: BMC medical ethics. 2019 ; Vol. 20, No. 1.
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title = "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 consent clauses for rare diseases research, in order to improve data interoperability, to meet the informational needs of participants, and to ensure proper ethical and legal use of data sources and participants' overall protection. METHODS: A global Task Force was set up to develop model consent clauses specific to rare diseases research, that are comprehensive, harmonized, readily accessible, and internationally applicable, facilitating the recruitment and consent of rare disease research participants around the world. Existing consent forms and notices of consent were analyzed and classified under different consent themes, which were used as background to develop the model consent clauses. RESULTS: The IRDiRC-GA4GH MCC Task Force met in September 2018, to discuss and design model consent clauses. Based on analyzed consent forms, they listed generic core elements and designed the following rare disease research specific core elements; Rare Disease Research Introductory Clause, Familial Participation, Audio/Visual Imaging, Collecting, storing, sharing of rare disease data, Recontact for matching, Data Linkage, Return of Results to Family Members, Incapacity/Death, and Benefits. CONCLUSION: The model consent clauses presented in this article have been drafted to highlight consent elements that bear in mind the trends in rare disease research, while providing a tool to help foster harmonization and collaborative efforts.",
keywords = "Consent clauses, Core consent elements, Informed consent, Rare diseases, Research ethics",
author = "{IRDiRC-GA4GH Model Consent Clauses Task Force} and Nguyen, {Minh Thu} and Jack Goldblatt and Rosario Isasi and Marlene Jagut and Jonker, {Anneliene Hechtelt} and Petra Kaufmann and Laetitia Ouillade and Fruszina Molnar-Gabor and Mahsa Shabani and Eric Sid and Tass{\'e}, {Anne Marie} and Durhane Wong-Rieger and Knoppers, {Bartha Maria}",
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AU - IRDiRC-GA4GH Model Consent Clauses Task Force

AU - Nguyen, Minh Thu

AU - Goldblatt, Jack

AU - Isasi, Rosario

AU - Jagut, Marlene

AU - Jonker, Anneliene Hechtelt

AU - Kaufmann, Petra

AU - Ouillade, Laetitia

AU - Molnar-Gabor, Fruszina

AU - Shabani, Mahsa

AU - Sid, Eric

AU - Tassé, Anne Marie

AU - Wong-Rieger, Durhane

AU - Knoppers, Bartha Maria

PY - 2019/8/1

Y1 - 2019/8/1

N2 - 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.

AB - 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.

KW - Consent clauses

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KW - Informed consent

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KW - Research ethics

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