Article Text
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 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.
- ethics
- genetic screening/testing
- informed consent
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/
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Footnotes
SD and GS contributed equally.
Contributors All authors contributed to this paper. SD helped with data analysis, provided intellectual input and coproduced the first draft of the paper. Further drafts were developed with the help of AML and BF. GS collected and analysed the data and coproduced the first draft of the paper. Further drafts were developed with the help of AML and BF. AML and BF provided intellectual input into the paper and helped with paper revisions to produce the final draft.
Funding This work was supported by Wellcome Trust (grant number 086034).
Competing interests None declared.
Ethics approval Ethics approval was received from Brighton and Sussex Medical School Research Governance and Ethics Committee: 16/014/FAR.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement This data cannot be made open access due to confidentiality. Please contact the corresponding author if you have questions about the data.
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