Individual research results from population-based genetic and genomic research are traditionally not disclosed to research participants. Current practices of non-disclosure are, however, being challenged by an increasing number of scientists, ethicists and policy-makers who make arguments in favour of disclosing at least individual results of potential health or lifestyle significance to research participants. Simultaneously, research participants are expressing greater interest in accessing their results. This article first provides an overview of main arguments for and against the disclosure of individual research (...) results to research participants. Next, it discusses the need for a move from the current ethical framework under which researchers operate, which is rather protective of research participants and does not encourage disclosure, to a new ethical framework that would better cope with current developments within the field. Comparative analysis of existing and potential ethical frameworks favours implementation of an ethical framework aimed at enhancing the autonomy of research participants through the disclosure of individual research results. Finally, this article explores practical models of disclosure that could be used under such a new framework. A model of disclosure that takes into account the two key criteria of communicability of research results and the research participant’s preferences to determine which results to disclose is found to comply best with the selected ethical framework. (shrink)

The UK Chief Medical Officer’s 2016 Annual Report, Generation Genome, focused on a vision to fully integrate genomics into all aspects of the UK’s National Health Service. This process of integration, which has now already begun, raises a wide range of social and ethical concerns, many of which were discussed in the final Chapter of the report. This paper explores how the UK’s 100,000 Genomes Project —the catalyst for Generation Genome, and for bringing genomics into the NHS—is negotiating these ethical (...) concerns. The UK’s 100 kGP, promoted and delivered by Genomics England Limited, is an innovative venture aiming to sequence 100,000 genomes from NHS patients who have a rare disease, cancer, or an infectious disease. GEL has emphasised the importance of ethical governance and decision-making. However, some sociological critique argues that biomedical/technological organisations presenting themselves as ‘ethical’ entities do not necessarily reflect a space within which moral thinking occurs. Rather, the ‘ethical work’ conducted by organisations is more strategic, relating to the politics of the organisation and the need to build public confidence. We set out to explore whether GEL’s ethical framework was reflective of this critique, and what this tells us more broadly about how genomics is being integrated into the NHS in response to the ethical and social concerns raised in Generation Genome. We do this by drawing on a series of 20 interviews with individuals associated with or working at GEL. (shrink)

This paper proposes a refocusing of consent for clinical genetic testing, moving away from an emphasis on autonomy and information provision, towards an emphasis on the virtues of healthcare professionals seeking consent, and the relationships they construct with their patients. We draw on focus groups with UK healthcare professionals working in the field of clinical genetics, as well as in-depth interviews with patients who have sought genetic testing in the UK’s National Health Service. We explore two aspects of consent: first, (...) how healthcare professionals consider the act of ‘consenting’ patients; and second how these professional accounts, along with the accounts of patients, deepen our understanding of the consent process. Our findings suggest that while healthcare professionals working in genetic medicine put much effort into ensuring patients’ understanding about their impending genetic test, they acknowledge, and we show, that patients can still leave genetic consultations relatively uninformed. Moreover, we show how placing emphasis on the informational aspect of genetic testing is not always reflective of, or valuable to, patients’ decision-making. Rather, decision-making is socially contextualised – also based on factors outside of information provision. A more collaborative on-going consent process, grounded in virtue ethics and values of honesty, openness and trustworthiness, is proposed. (shrink)

Although there is extensive information about why people participate in clinical trials, studies are largely based on quantitative evidence and typically focus on single conditions. Over the last decade investigations into why people volunteer for health research have become increasingly prominent across diverse research settings, offering variable based explanations of participation patterns driven primarily by recruitment concerns. Therapeutic misconception and altruism have emerged as predominant themes in this literature on motivations to participate in health research. This paper contributes to more (...) recent qualitative approaches to understanding how and why people come to participate in various types of health research. We focus on the experience of participating and the meanings research participation has for people within the context of their lives and their health and illness biographies. (shrink)