The Ethics of All This

The first trial to test the safety and efficacy of stem cells for spinal cord injury (SCI) is currently underway, but controversy regarding whom to recruit for these trials remains unresolved. Empirical evidence suggests that changes along the full continuum of recruitment to consent in these trials are needed. Our research and theorectical work specifically call into question whether existing processes for consent for individuals in sub-acute stages post-injury adequately offer the tools for informed decision-making. Personal definitions of risk, and reliance on professional and personal networks, have emerged as key variables in the equation of support for decision-making. Results suggest, however that neither individuals themselves, nor their surrounding support networks, have the information needed for the task and, moreover, that each has this expectation of the other. Empirical investigations of motivation and risk perception, and the development of novel models of consent such as those involving staging and peer support, are needed to fill this gap and enrich the knowledge base of all stakeholders. While the burden of advancing and testing such models will fall largely to the academic community, the onus, the cost of implementation, and commitment to them must be borne by clinical trial sites themselves.