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Towards a national genomics medicine service: the challenges facing clinical-research hybrid practices and the case of the 100 000 genomes project

Clinical practice and research are governed by distinct rules and regulations and have different approaches to, for example, consent and providing results. However, genomics is an example of where research and clinical practice have become codependent. The 100 000 genomes project (100kGP) is a hybri...

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Autores principales: Dheensa, Sandi, Samuel, Gabrielle, Lucassen, Anneke M, Farsides, Bobbie
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5992369/
https://www.ncbi.nlm.nih.gov/pubmed/29496751
http://dx.doi.org/10.1136/medethics-2017-104588
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author Dheensa, Sandi
Samuel, Gabrielle
Lucassen, Anneke M
Farsides, Bobbie
author_facet Dheensa, Sandi
Samuel, Gabrielle
Lucassen, Anneke M
Farsides, Bobbie
author_sort Dheensa, Sandi
collection PubMed
description Clinical practice and research are governed by distinct rules and regulations and have different approaches to, for example, consent and providing results. However, genomics is an example of where research and clinical practice have become codependent. The 100 000 genomes project (100kGP) is a hybrid venture where a person can obtain a clinical investigation only if he or she agrees to also participate in ongoing research—including research by industry and commercial companies. In this paper, which draws on 20 interviews with professional stakeholders involved in 100kGP, we investigate the ethical issues raised by this project’s hybrid nature. While some interviewees thought the hybrid nature of 100kGP was its vanguard, interviewees identified several tensions around hybrid practice: how to decide who should be able to participate; how to determine whether offering results might unduly influence participation into wide-ranging but often as yet unknown research and how to ensure that patients/families do not develop false expectations about receiving results. These areas require further debate as 100kGP moves into routine healthcare in the form of the national genomic medicine service. To address the tensions identified, we explore the appropriateness of Faden et al.’s framework of ethical obligations for when research and clinical care are completely integrated. We also argue that enabling ongoing transparent and trustworthy communication between patients/families and professionals around the kinds of research that should be permitted in 100kGP will help to understand and ensure that expectations remain realistic. Our paper aims to encourage a focused discussion about these issues and to inform a new ‘social contract’ for research and clinical care in the health service.
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spelling pubmed-59923692018-06-11 Towards a national genomics medicine service: the challenges facing clinical-research hybrid practices and the case of the 100 000 genomes project Dheensa, Sandi Samuel, Gabrielle Lucassen, Anneke M Farsides, Bobbie J Med Ethics Research Ethics Clinical practice and research are governed by distinct rules and regulations and have different approaches to, for example, consent and providing results. However, genomics is an example of where research and clinical practice have become codependent. The 100 000 genomes project (100kGP) is a hybrid venture where a person can obtain a clinical investigation only if he or she agrees to also participate in ongoing research—including research by industry and commercial companies. In this paper, which draws on 20 interviews with professional stakeholders involved in 100kGP, we investigate the ethical issues raised by this project’s hybrid nature. While some interviewees thought the hybrid nature of 100kGP was its vanguard, interviewees identified several tensions around hybrid practice: how to decide who should be able to participate; how to determine whether offering results might unduly influence participation into wide-ranging but often as yet unknown research and how to ensure that patients/families do not develop false expectations about receiving results. These areas require further debate as 100kGP moves into routine healthcare in the form of the national genomic medicine service. To address the tensions identified, we explore the appropriateness of Faden et al.’s framework of ethical obligations for when research and clinical care are completely integrated. We also argue that enabling ongoing transparent and trustworthy communication between patients/families and professionals around the kinds of research that should be permitted in 100kGP will help to understand and ensure that expectations remain realistic. Our paper aims to encourage a focused discussion about these issues and to inform a new ‘social contract’ for research and clinical care in the health service. BMJ Publishing Group 2018-06 2018-03-01 /pmc/articles/PMC5992369/ /pubmed/29496751 http://dx.doi.org/10.1136/medethics-2017-104588 Text en © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/
spellingShingle Research Ethics
Dheensa, Sandi
Samuel, Gabrielle
Lucassen, Anneke M
Farsides, Bobbie
Towards a national genomics medicine service: the challenges facing clinical-research hybrid practices and the case of the 100 000 genomes project
title Towards a national genomics medicine service: the challenges facing clinical-research hybrid practices and the case of the 100 000 genomes project
title_full Towards a national genomics medicine service: the challenges facing clinical-research hybrid practices and the case of the 100 000 genomes project
title_fullStr Towards a national genomics medicine service: the challenges facing clinical-research hybrid practices and the case of the 100 000 genomes project
title_full_unstemmed Towards a national genomics medicine service: the challenges facing clinical-research hybrid practices and the case of the 100 000 genomes project
title_short Towards a national genomics medicine service: the challenges facing clinical-research hybrid practices and the case of the 100 000 genomes project
title_sort towards a national genomics medicine service: the challenges facing clinical-research hybrid practices and the case of the 100 000 genomes project
topic Research Ethics
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5992369/
https://www.ncbi.nlm.nih.gov/pubmed/29496751
http://dx.doi.org/10.1136/medethics-2017-104588
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