Research project: Ethical Preparedness in Genomic Medicine (EPPiGen)

Our interest in ethical preparedness has grown out of practical, clinical and academic experience. This project will attempt to construct an understanding of ethical preparedness which draws upon empirical and theoretical bioethics practice in the interests of serving practitioners and ultimately patients. Using genomics as a timely case study the various work packages will contribute in different ways to building this concept into something which could be useful in this and many other settings.

Our hypothesis is that in order to facilitate ethical preparedness in the context of clinical practice there needs to be a significant and effective cross-fertilisation of ideas between those who are ‘doing the work', those for whom the work is being done, and those who theorise or conceptualise about it.  In turn, there needs to be a clear line of communication between these groups and those charged with creating policy and guidance, understanding of course that all these groups may well overlap in terms of membership.

Using three interlinking work streams we will research ethical preparedness in genomic medicine

Work Stream One: Empirical Bioethics

Through a series of interconnected studies this work stream will focus on the beliefs, attitudes and experience of staff in laboratories and clinics and will focus on ethical preparedness (at an individual and structural level) to deliver whole genome analyses in practice. It will also capture the patient/ participant perspective with a view to informing and preparing practitioners for future interactions.

Capturing observed and self-reported ethical preparedness in the workplace utilising methodology developed across a range of successful projects, we will undertake a qualitative research to capture the views attitudes and behaviours of health professionals and scientists operating within genomic medicine with the initial aim of establishing the degree to which and how (if at all) ‘ethical preparedness’ figures in practitioners’ accounts of contemporary genomic medicine. We will concurrently conduct research with patients to establish their level of ethical preparedness, but also importantly to inform our work with practitioners

Methods:

1. An observational study of groups of professionals and the spaces within which genomic medicine is constructed and delivered.
2. In depth interviews with practitioners involved in the delivery of genomic medicine.
3. Ethical Discussion Groups with practitioners.
4. Concurrent in depth interviews with specific patient/ participant groups engaged in genomic medicine.
5. Testing and amplification of the emerging findings generated from 1-4 above through engagement with for example, Genethics UK, and the Genomics England Clinical Interpretation Partnership (GeCIP)

Work stream Two: Constructing sound conceptual and theoretical

At the core of this project is the concept of ethical preparedness which we plan to develop and make conceptually robust. In this work stream we will be undertaking theoretical and normative analysis based on data from our empirical work. As the data comes through we will be looking for concepts and claims which need philosophical clarification and/or examination. We anticipate that our work could sometimes challenge the professionals’ presentation of the ethical issues and raise questions about their habitual responses so we will take every opportunity to support a productive iterative process.

If we wish practitioners to generate bespoke ethical responses to the particular (and complex) needs of patients and families seeking genomic diagnoses we need them to have the courage and the confidence to do so, and to understand and become sensitive to the moral salience of particular facts in a clinical setting. We will support practitioners by providing robust ethical analysis which speaks to clinical concerns.

We will use our empirical data as a hook and a guide, but we will also move beyond our data and use our analytical skills and conceptualising abilities to explore what is happening when ethical preparedness appears lacking, where professional understandings of what is or is not ethical are out of tune with compelling accounts in the formal literature and why this might be so, or to offer theoretical or conceptual insight where practitioners have become ‘stuck’ due to a lack of conceptual clarity or confusion.

Over the course of the project we will hold four two day workshops focussing on the normative and conceptual issues raised by our empirical work and on-going interrogation of the bioethics literature.

Work Stream Three: Enhancing Practice Development through Professional Engagement

The findings from our empirical research will be melded with our study of the theoretical philosophical and social scientific work in the field to reveal overlaps, amplifications, triangulations, absences, silences and contradictions. As our findings emerge genomics practitioners will continue to inform and critique the work we produce, as they become exposed to ideas that could either challenge or reinforce their current practice and shared beliefs.

Through our interactions with the GeCIP programme for Practical Ethics the Genethics Forum and the ethics and policy committee of the British Society of Genetic Medicine, we will build upon and capture responses to our empirical findings and conceptual work and further examine the ethical preparedness of health professionals. Over time, we will launch and establish an identity as Genethics-UK by building on and drawing together the existing activities we co-organise and facilitate. Additional activities will include hosting regular meetings and support an online and social media presence and encouraging and moderating public discussions, which will serve to triangulate and enhance our research findings and effectively disseminate them to major stakeholders.