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Ten years of dynamic consent in the CHRIS study: informed consent as a dynamic process

The Cooperative Health Research in South Tyrol (CHRIS) is a longitudinal study in Northern Italy, using dynamic consent since its inception in 2011. The CHRIS study collects health data and biosamples for research, and foresees regular follow-ups over time. We describe the experience with the CHRIS...

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Autores principales: Mascalzoni, Deborah, Melotti, Roberto, Pattaro, Cristian, Pramstaller, Peter Paul, Gögele, Martin, De Grandi, Alessandro, Biasiotto, Roberta
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9441838/
https://www.ncbi.nlm.nih.gov/pubmed/36064788
http://dx.doi.org/10.1038/s41431-022-01160-4
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author Mascalzoni, Deborah
Melotti, Roberto
Pattaro, Cristian
Pramstaller, Peter Paul
Gögele, Martin
De Grandi, Alessandro
Biasiotto, Roberta
author_facet Mascalzoni, Deborah
Melotti, Roberto
Pattaro, Cristian
Pramstaller, Peter Paul
Gögele, Martin
De Grandi, Alessandro
Biasiotto, Roberta
author_sort Mascalzoni, Deborah
collection PubMed
description The Cooperative Health Research in South Tyrol (CHRIS) is a longitudinal study in Northern Italy, using dynamic consent since its inception in 2011. The CHRIS study collects health data and biosamples for research, and foresees regular follow-ups over time. We describe the experience with the CHRIS study dynamic consent, providing an overview of its conceptualization and implementation, and of the participant-centered strategies used to assess and improve the process, directly linked to participation and communication. In order to comply with high ethical standards and to allow broadness in the areas of research, CHRIS dynamic consent was conceived as an interactive process: based on a strong governance and an ongoing tailored communication with participants, it aims to promote autonomy and to develop a trust-based engaged relationship with participants, also relevant for retention. Built within an online platform, the consent allows granular choices, which can be changed over time. In a process of co-production, participants views have been investigated and kept into account in policy development. Participants showed a high degree of participation, thus enabling the consolidation of the CHRIS resources. Even though a low change rate was reported in the baseline, participants valued the possibility of changing their informed consent choices. Communication (language-tailored, ongoing, multimedia) was important for participants, and for participation and retention. In our experience, dynamic consent was proven to be a flexible consent model, which allowed to meet ethical and legal standards for participation in research, and to accommodate participants’ and researchers’ needs.
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spelling pubmed-94418382022-09-06 Ten years of dynamic consent in the CHRIS study: informed consent as a dynamic process Mascalzoni, Deborah Melotti, Roberto Pattaro, Cristian Pramstaller, Peter Paul Gögele, Martin De Grandi, Alessandro Biasiotto, Roberta Eur J Hum Genet Article The Cooperative Health Research in South Tyrol (CHRIS) is a longitudinal study in Northern Italy, using dynamic consent since its inception in 2011. The CHRIS study collects health data and biosamples for research, and foresees regular follow-ups over time. We describe the experience with the CHRIS study dynamic consent, providing an overview of its conceptualization and implementation, and of the participant-centered strategies used to assess and improve the process, directly linked to participation and communication. In order to comply with high ethical standards and to allow broadness in the areas of research, CHRIS dynamic consent was conceived as an interactive process: based on a strong governance and an ongoing tailored communication with participants, it aims to promote autonomy and to develop a trust-based engaged relationship with participants, also relevant for retention. Built within an online platform, the consent allows granular choices, which can be changed over time. In a process of co-production, participants views have been investigated and kept into account in policy development. Participants showed a high degree of participation, thus enabling the consolidation of the CHRIS resources. Even though a low change rate was reported in the baseline, participants valued the possibility of changing their informed consent choices. Communication (language-tailored, ongoing, multimedia) was important for participants, and for participation and retention. In our experience, dynamic consent was proven to be a flexible consent model, which allowed to meet ethical and legal standards for participation in research, and to accommodate participants’ and researchers’ needs. Springer International Publishing 2022-09-05 2022-12 /pmc/articles/PMC9441838/ /pubmed/36064788 http://dx.doi.org/10.1038/s41431-022-01160-4 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Article
Mascalzoni, Deborah
Melotti, Roberto
Pattaro, Cristian
Pramstaller, Peter Paul
Gögele, Martin
De Grandi, Alessandro
Biasiotto, Roberta
Ten years of dynamic consent in the CHRIS study: informed consent as a dynamic process
title Ten years of dynamic consent in the CHRIS study: informed consent as a dynamic process
title_full Ten years of dynamic consent in the CHRIS study: informed consent as a dynamic process
title_fullStr Ten years of dynamic consent in the CHRIS study: informed consent as a dynamic process
title_full_unstemmed Ten years of dynamic consent in the CHRIS study: informed consent as a dynamic process
title_short Ten years of dynamic consent in the CHRIS study: informed consent as a dynamic process
title_sort ten years of dynamic consent in the chris study: informed consent as a dynamic process
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9441838/
https://www.ncbi.nlm.nih.gov/pubmed/36064788
http://dx.doi.org/10.1038/s41431-022-01160-4
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