Genomic data is generated, processed and analysed at an increasingly rapid pace. This data is not limited to the medical context, but plays an important role in other contexts in society, such as commercial DNA testing, the forensic setting, archaeological research, and genetic surveillance. Genomic information also crosses the borders of these domains, e.g. forensic use of medical genetic information, insurance use of medical genomic information, or research use of commercial genomic data. This paper (1) argues that an informed consent (...) approach for genomic information has limitations in many societal contexts, and (2) seeks to broaden the bioethical debate on genomic information by suggesting an approach that is applicable across multiple societal contexts. I argue that the contextual integrity framework, a theory rooted in information technology and big data ethics, is an effective tool to explore ethical challenges that arise from genomic information within a variety of different contexts. Rather than focusing on individual control over information, the contextual integrity approach holds that information should be shared and protected according to the norms that govern certain distinct social contexts. Several advantages of this contextual integrity approach will be discussed. The paper concludes that the contextual integrity framework helps to articulate and address a broad spectrum of ethical, social, and political factors in a variety of different societal contexts, while giving consideration to the interests of individuals, groups, and society at large. (shrink)

Much has been published about the ethical issues encountered by clinicians in genetics/genomics, but those experienced by clinical laboratory scientists are less well described. Clinical laboratory scientists now frequently face navigating ethical problems in their work, but how they should be best supported to do this is underexplored. This lack of attention is also reflected in the ethics tools available to clinical laboratory scientists such as guidance and deliberative ethics forums, developed primarily to manage issues arising within the clinic.We explore (...) what ethical issues are being experienced by clinical scientists, how they think such issues could be best analysed and managed, and whether their practice might be enhanced by more situated approaches to ethics deliberation and practice such as ethical preparedness. From thematic analysis of cases presented by clinical scientists at a specially convened meeting of the UK Genethics Forum, we derived three main ethical themes: (1) the redistribution of labour and responsibilities resulting from the practice of genomic medicine; (2) the interpretation and certainty of results and (3) the proposal that better standardisation and consistency of ethical approaches (for example, more guidelines and policy) could resolve some of the challenges arising.We argue that although standardisation is important for promoting shared understandings of good (including ethical) practice, supplementary approaches to enhance and sustain ethical preparedness will be important to help clinical scientists and others in the recently expanded genetic/genomic medicine environment foster quality ethical thinking. (shrink)

Considerations of the notion of preparedness have come to the fore in the recent pandemic, highlighting a need to be better prepared to deal with sudden, unexpected and unwanted events. However, the concept of preparedness is also important in relation to planned for and desired interventions resulting from healthcare innovations. We describe ethical preparedness as a necessary component for the successful delivery of novel healthcare innovations, and use recent advances in genomic healthcare as an example. We suggest that practitioners and (...) organisations charged with delivering innovative and ambitious healthcare programmes can only succeed if they are able to exhibit the attribute of ethical preparedness. (shrink)

Research ethics committees (RECs) have a crucial role in protecting children in research. However, studies on REC members’ perspectives on paediatric research are scarce. We conducted a qualitative study to explore Swedish scientific REC members’ perspectives on ethical aspects in applications involving children with severe health conditions. The REC members considered promoting participation, protecting children and regulatory adherence to be central aspects. The results underscored the importance of not neglecting ill children’s rights to adapted information and participation. REC members supported (...) a contextual and holistic approach to vulnerability and risk, which considers the child’s and parents’ psychological wellbeing and the child’s integrity, both short and long term. The ethical complexity of paediatric research requires continuous ethical competence development within RECs. (shrink)

BackgroundBiobanks and biomedical research data repositories collect their samples and associated data from volunteer participants. Their aims are to facilitate biomedical research and improve health, and they are framed in terms of contributing to the public good. Biobank resources may be accessible to researchers with commercial motivations, for example, researchers in pharmaceutical companies who may utilise the data to develop new clinical therapeutics and pharmaceutical drugs. Studies exploring citizen perceptions of public/private interactions associated with large health data repositories/biobanks indicate that (...) there are sensitivities around public/private and/or non-profit/profit relationships and international sample and data sharing. Less work has explored how biobanks communicate their public/private partnerships to the public or to their potential research participants. MethodsWe explored how a biobank’s aims, benefits and risks, and private/public relationships have been framed in public facing recruitment documents.ResultsBiobank documents often communicate their commercial access arrangements but not the detail about what these interactions would entail, and how risks and benefits would be distributed to the public.ConclusionWe argue that this leads to a polarised discourse between public and private entities and/or activities, and fails to attend to the blurred lines between them. This results in a lack of attention to more important issues such as how risks and benefits in general are distributed to the public. We call for a nuanced approach that can contribute to the much-needed dialogue in this space. (shrink)

Concerns about research’s environmental impacts have been articulated in the research arena, but questions remain about what types of role responsibilities are appropriate to place on researchers, if any. The research question of this paper is: what are the views of UK health researchers who use data-intensive methods on their responsibilities to consider the environmental impacts of their research? Twenty-six interviews were conducted with UK health researchers using data-intensive methods. Participants expressed a desire to take responsibility for the environmental impacts (...) of their research, however, they were unable to consolidate this because there were often obstacles that prevented them from taking such role responsibilities. They suggested strategies to address this, predominantly related to the need for regulation to monitor their own behaviour. This paper discusses the implications of adopting such a regulatory approach as a mechanism to promote researchers’ role responsibilities using a neo-liberal critique. (shrink)