Cargando…
A tiered-layered-staged model for informed consent in personal genome testing
In recent years, developments in genomics technologies have led to the rise of commercial personal genome testing (PGT): broad genome-wide testing for multiple diseases simultaneously. While some commercial providers require physicians to order a personal genome test, others can be accessed directly...
Autores principales: | , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Nature Publishing Group
2013
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3658183/ https://www.ncbi.nlm.nih.gov/pubmed/23169494 http://dx.doi.org/10.1038/ejhg.2012.237 |
_version_ | 1782270228749615104 |
---|---|
author | Bunnik, Eline M Janssens, A Cecile J W Schermer, Maartje H N |
author_facet | Bunnik, Eline M Janssens, A Cecile J W Schermer, Maartje H N |
author_sort | Bunnik, Eline M |
collection | PubMed |
description | In recent years, developments in genomics technologies have led to the rise of commercial personal genome testing (PGT): broad genome-wide testing for multiple diseases simultaneously. While some commercial providers require physicians to order a personal genome test, others can be accessed directly. All providers advertise directly to consumers and offer genetic risk information about dozens of diseases in one single purchase. The quantity and the complexity of risk information pose challenges to adequate pre-test and post-test information provision and informed consent. There are currently no guidelines for what should constitute informed consent in PGT or how adequate informed consent can be achieved. In this paper, we propose a tiered-layered-staged model for informed consent. First, the proposed model is tiered as it offers choices between categories of diseases that are associated with distinct ethical, personal or societal issues. Second, the model distinguishes layers of information with a first layer offering minimal, indispensable information that is material to all consumers, and additional layers offering more detailed information made available upon request. Finally, the model stages informed consent as a process by feeding information to consumers in each subsequent stage of the process of undergoing a test, and by accommodating renewed consent for test result updates, resulting from the ongoing development of the science underlying PGT. A tiered-layered-staged model for informed consent with a focus on the consumer perspective can help overcome the ethical problems of information provision and informed consent in direct-to-consumer PGT. |
format | Online Article Text |
id | pubmed-3658183 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2013 |
publisher | Nature Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-36581832013-06-01 A tiered-layered-staged model for informed consent in personal genome testing Bunnik, Eline M Janssens, A Cecile J W Schermer, Maartje H N Eur J Hum Genet Article In recent years, developments in genomics technologies have led to the rise of commercial personal genome testing (PGT): broad genome-wide testing for multiple diseases simultaneously. While some commercial providers require physicians to order a personal genome test, others can be accessed directly. All providers advertise directly to consumers and offer genetic risk information about dozens of diseases in one single purchase. The quantity and the complexity of risk information pose challenges to adequate pre-test and post-test information provision and informed consent. There are currently no guidelines for what should constitute informed consent in PGT or how adequate informed consent can be achieved. In this paper, we propose a tiered-layered-staged model for informed consent. First, the proposed model is tiered as it offers choices between categories of diseases that are associated with distinct ethical, personal or societal issues. Second, the model distinguishes layers of information with a first layer offering minimal, indispensable information that is material to all consumers, and additional layers offering more detailed information made available upon request. Finally, the model stages informed consent as a process by feeding information to consumers in each subsequent stage of the process of undergoing a test, and by accommodating renewed consent for test result updates, resulting from the ongoing development of the science underlying PGT. A tiered-layered-staged model for informed consent with a focus on the consumer perspective can help overcome the ethical problems of information provision and informed consent in direct-to-consumer PGT. Nature Publishing Group 2013-06 2012-11-21 /pmc/articles/PMC3658183/ /pubmed/23169494 http://dx.doi.org/10.1038/ejhg.2012.237 Text en Copyright © 2013 Macmillan Publishers Limited http://creativecommons.org/licenses/by-nc-nd/3.0/ This work is licensed under the Creative Commons Attribution-NonCommercial-No Derivative Works 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/3.0/ |
spellingShingle | Article Bunnik, Eline M Janssens, A Cecile J W Schermer, Maartje H N A tiered-layered-staged model for informed consent in personal genome testing |
title | A tiered-layered-staged model for informed consent in personal genome testing |
title_full | A tiered-layered-staged model for informed consent in personal genome testing |
title_fullStr | A tiered-layered-staged model for informed consent in personal genome testing |
title_full_unstemmed | A tiered-layered-staged model for informed consent in personal genome testing |
title_short | A tiered-layered-staged model for informed consent in personal genome testing |
title_sort | tiered-layered-staged model for informed consent in personal genome testing |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3658183/ https://www.ncbi.nlm.nih.gov/pubmed/23169494 http://dx.doi.org/10.1038/ejhg.2012.237 |
work_keys_str_mv | AT bunnikelinem atieredlayeredstagedmodelforinformedconsentinpersonalgenometesting AT janssensacecilejw atieredlayeredstagedmodelforinformedconsentinpersonalgenometesting AT schermermaartjehn atieredlayeredstagedmodelforinformedconsentinpersonalgenometesting AT bunnikelinem tieredlayeredstagedmodelforinformedconsentinpersonalgenometesting AT janssensacecilejw tieredlayeredstagedmodelforinformedconsentinpersonalgenometesting AT schermermaartjehn tieredlayeredstagedmodelforinformedconsentinpersonalgenometesting |