Background

Clinical genetic activity, particularly research into rare inherited disorders, is threatened by current research governance requirements.

Relevance

In the UK, DNA-testing for hereditary cancers and high risk cancer surveillance takes place either as part of research protocols (leading to a requirement to obtain ethical approval from a research ethics committee) or is offered as an NHS clinical service. The route chosen may depend on arbitrary factors but can have a significant impact on the subsequent 'research' or 'clinical investigation'. There is a need to determine the impact that this arrangement has on research and clinical practice in cancer genetics.

Aims

This multidisciplinary project, bringing together researchers at Edinburgh, Southampton and Oxford Universities (the Ethox Centre) is investigating healthcare professionals’, patients’ and regulators’ understandings of cancer genetics activities within the UK. It aims to establish how these individuals conceive of the research-clinical practice distinction, identify any perceived ambiguities and look at the practical and/or ethical problems that are generated for the different actors as a result.

Plan

To understand lay and professional perceptions and experiences semi-structured interviews (n=100) will be conducted with 3 groups: healthcare professionals who are involved in cancer genetics research and/or provide a clinical cancer genetics service/refer patients to such a service; patients involved in cancer genetics research (DNA and or clinical studies) and regulators who play a role in the regulation of clinical research or clinical practice.

Funding

This research is funded by Cancer Research UK