Improving decisions about access to stem cell interventions

This project addresses a crucial social, ethical and policy question: how can we assist regulators, clinicians and patients in making decisions about access to stem cell-based interventions (SCBIs)? More specifically, this research will generate principles, guidelines, and recommendations for determining when access should be confined to clinical trials, when interventions should be offered as a type of clinical innovation, and when they should be offered as standard clinical practice. It will also generate principles for education and communication to help patients understand their options. This research is urgently needed because governance of access to SCBIs is often inconsistent, uncertain and contested. It is also currently difficult for patients to understand the options that they have, why particular modes of access might or might not be available, and their associated risks and benefits.

The research will be conducted over three years: In Phase 1 we will engage with stakeholders through interviews in order to describe their experiences and elicit their perspectives regarding different modes of access to SCBIs. In Phase 2 we will explore the issues through a number of sociological, ethical and regulatory lenses, integrate these insights with the stakeholder views expressed in Phase 1 and generate ethical and legal principles. In Phase 3 we will develop recommendations and guidelines for decision making and communication and devise an implementation plan for their translation into policy and practice.

The outputs of this research will facilitate governance decisions about access to SCBIs that are fair, transparent, evidence-based, accountable, economically sustainable, and that promote the welfare of both individuals and the community. It will also facilitate research and ensure that patients make decisions about modes of access that are informed, autonomous and truly reflective of their values, needs and healthcare goals.