Methodology
Key research questions
The research project involves empirical (qualitative) and theoretical (applied ethical and legal) research methods and policy development. The research will investigate three key research questions:
- What are the views and experiences of stakeholders* regarding modes of access to cell therapies, and how information about them is communicated?
- What are the ethical, legal and socio-political challenges of current systems for governing access to cell therapies, and how and by whom might these be addressed?
- What practical resources are needed to support those governing, prescribing and communicating about modes of access to cell therapies?
*The term stakeholders refers to: people considering, seeking or who have accessed cellular therapies at various stages of the research to clinic pathway, carers, policymakers, regulators, stem cell researchers, clinicians and representatives of patient advocacy organisations.
Research stages
We seek to answer these questions across three interrelated phases over three years:
In Stage 1 (Gathering evidence) we will engage with stakeholders through semi-structured interviews asking them to describe their experiences and perspectives regarding different modes of access to cell therapies.
In Stage 2 (Socio-ethical and legal analysis), we will explore the issues surrounding stem cell based interventions through a number of sociological, ethical and regulatory lenses.
In Stage 3 (Translation) we will develop and refine legal and policy recommendations and guidelines and devise an implementation plan for their translation into policy and practice. We will also develop recommendations and guidelines for communicating with people who are considering or seeking access to cell therapies through research or clinical care.