Ethical issues and best practice in clinically based genomic research: Exeter Stakeholders Meeting Report

Abstract

Current guidelines on consenting individuals to participate in genomic research are diverse. This creates problems for participants and also for researchers, particularly for clinicians who provide both clinical care and research to their patients. A group of 14 stakeholders met on 7 October 2015 in Exeter to discuss the ethical issues and the best practice arising in clinically based genomic research, with particular emphasis on the issue of returning results to study participants/patients in light of research findings affecting research and clinical practices. The group was deliberately multidisciplinary to ensure that a diversity of views was represented. This report outlines the main ethical issues, areas of best practice and principles underlying ethical clinically based genomic research discussed during the meeting. The main point emerging from the discussion is that ethical principles, rather than being formulaic, should guide researchers/clinicians to identify who the main stakeholders are to consult with for a specific project and to incorporate their voices/views strategically throughout the lifecycle of each project. We believe that the mix of principles and practical guidelines outlined in this report can contribute to current debates on how to conduct ethical clinically based genomic research.

How can NHS trusts in England optimise strategies to improve the mental health and well-being of hospital doctors? The Care Under Pressure 3 (CUP3) realist evaluation study protocol

“…24 As part of the process, we will also evaluate how well these interventions are described (or not) using the template for intervention description and replication (TIDieR) framework 34 and the Health Service and Delivery Research checklist, 35 in order to encourage future publications to provide the detailed information needed to interpret the findings and/or implement them in other settings. To refine the typology, we will also draw on the programme theory from CUP1 15 ; wider methodological literature 34 ; and relevant intervention studies/ evidence published recently (eg, mental health hubs for hospital staff traumatised by the impact of COVID-19 36 ). This will allow us to ensure the wording and components of the typology are relevant for secondary care settings in England.…”

Focusing attention on ancestral diversity within genomics research: a potential means for promoting equity in the provision of genomics based healthcare services in developing countries

“…This creates problems for participants, who may not have the confidence to give their consent, and also for researchers/ clinicians who provide both clinical care and research to their patients. Current approaches to consent do not sufficiently take into account the researchers' or participants' interests and the specific issues that genomic research raises such as the thin boundary line between research and clinical care (Carrieri et al 2016). Patient/ participant data cannot be de-identified (e.g., pseudoanonymized and anonymized) in the clinical context.…”

“…There is also the need for development of a greater understanding of genomics among members of research ethics or scientific review committees for whom genomics may be a relatively new concept, and who raise concerns because of lack of familiarity (Parker and Kwiatkowski 2016). Ethics committees should address the return of research findings to participants/patients, for example, by introducing a policy on returning summary or aggregated research results to participants at the end of the study (Carrieri et al 2016). In addition, the democratic and pluralistic debate on ethical and scientific application of genetics/genomics in healthcare, involving all stakeholders such as parent-patient organizations, health professionals, social movements, ethicists, policy makers, and industry should be encouraged.…”

Ethical issues in genomic research: Proposing guiding principles co-produced with stakeholders

“…The aim of the first workshop was to identify important ethical issues, areas of best practices, general principles, and practical guidance. 6 Building on these themes, the two subsequent workshops were organised to co-produce ethical principles and guidance specifically aimed at researchers/clinicians and NHS Research Ethics Committees (RECs) members, with the understanding that these principles would also be relevant and accessible to other stakeholders involved in genomic research. Consensus on the principles and guidance was reached in the following way:…”