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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

Towards a national genomics medicine service: the challenges facing clinical-research hybrid practices and the case of the 100,000 genomes project
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 co-dependent. The 100,000 genomes project (100kGP) is a hybrid venture where a person can obtain a clinical investigation only if they agree 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. We explore the appropriateness of Faden et al.’s framework of ethical obligations for when research and clinical care are completely integrated, for addressing the tensions identified. We also argue that enabling on-going transparent and trustworthy communication between patients/families and professionals around the kinds of research that should be permitted in 100kGP will help understanding and ensure 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.
1473-4257
Lucassen, Anneke
2eb85efc-c6e8-4c3f-b963-0290f6c038a5
Dheensa, Sandeep
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Samuel, Gabrielle
a457aef2-11d6-4d4e-afec-605f1a9e9392
Farsides, Bobbie
91ee245a-9670-4024-94f4-53af12a3c42f
Lucassen, Anneke
2eb85efc-c6e8-4c3f-b963-0290f6c038a5
Dheensa, Sandeep
d7d7e2bb-8def-4fad-9e1d-33d8141a0c9c
Samuel, Gabrielle
a457aef2-11d6-4d4e-afec-605f1a9e9392
Farsides, Bobbie
91ee245a-9670-4024-94f4-53af12a3c42f

Lucassen, Anneke, Dheensa, Sandeep, Samuel, Gabrielle and Farsides, Bobbie (2018) Towards a national genomics medicine service: the challenges facing clinical-research hybrid practices and the case of the 100,000 genomes project. Journal of Medical Ethics. (doi:10.1136/medethics-2017-104588).

Record type: Article

Abstract

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 co-dependent. The 100,000 genomes project (100kGP) is a hybrid venture where a person can obtain a clinical investigation only if they agree 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. We explore the appropriateness of Faden et al.’s framework of ethical obligations for when research and clinical care are completely integrated, for addressing the tensions identified. We also argue that enabling on-going transparent and trustworthy communication between patients/families and professionals around the kinds of research that should be permitted in 100kGP will help understanding and ensure 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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Journal of Medical Ethics Manuscript Revised 1612 CLEAN-1 - Accepted Manuscript
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More information

Accepted/In Press date: 5 February 2018
e-pub ahead of print date: 1 March 2018

Identifiers

Local EPrints ID: 418568
URI: https://eprints.soton.ac.uk/id/eprint/418568
ISSN: 1473-4257
PURE UUID: fa5520b2-9a15-4a9d-b118-78fffc420eee

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Date deposited: 12 Mar 2018 17:30
Last modified: 20 May 2019 16:30

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Contributors

Author: Anneke Lucassen
Author: Sandeep Dheensa
Author: Gabrielle Samuel
Author: Bobbie Farsides

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