It is anticipated that by 2020 there could be considerable advances in genomic medicine. However, even with demonstrated clinical utility it is uncertain whether such advances will have benefits for patients, because research findings are not routinely implemented into clinical care. To facilitate translational research new sets of partnerships and ways of working are needed between patients, clinicians, researchers and commercial partners. Biobanks potentially lie at the heart of these new relationships, as they can be used for patient care, but also for different kinds of research. For biobanks to become key nodes in translational research new practices, policies and protocols are needed. This research will carry out a number of interviews and workshops with stakeholders involved in the Oxford Radcliffe Biobank (ORB)) and the Oxford Radcliffe Hospitals NHS Trust (ORHT). It will use this as a case study to identify the way that current practices, policy, procedures and governance frameworks need to be adapted, changed or renewed to make biobanks a potent tool for translational research. It will also draw on best practice elsewhere in the world, particularly the US and the Netherlands, to help develop practical solutions in this rapidly changing field. This research will provide an evidence base for national policy formulation which could make ORB an exemplar of best practice for clinical biobanks in the UK. Lessons learnt within ORB could be applied elsewhere in the UK and Europe where similar initiatives are underway.

The core aim of this research proposal is to identify the changes in practice, protocols, policy and governance mechanisms that are required to embed the Oxford Radcliffe Biobank (ORB) within the UK healthcare structure so that it can be utilised as a tool for ‘translational research’ and in the future ‘genomic medicine’. In fulfilling this core aim the proposed research has six objectives:

1. To carry out a background literature review and analysis of the law and ethical principles which apply to translational research and genomic medicine.

2. To carry out a series of qualitative interviews and focussed workshops with ORB stakeholders to develop an evidence base that can be used to inform ORB activities and policy deliberations.

3. To use insights, knowledge and experience developed in translational research within the US, the Netherlands, and Canada to add to this evidence base.

4. To identify normative principles that could underpin the development of new practice, protocols, policies and governance mechanisms within ORB.

5. To use this analysis to develop practical solutions that are ethically sound and legally compliant to guide the ORB’s integration into the healthcare structure as a tool to support translational research and clinical care.

6. To develop a strategy for the rapid dissemination of the research findings within ORB, within the UK and elsewhere through contacts, publications, reports and presentations.

This project is funded under a Wellcome Trust University Award to Prof.  Jane Kaye.