Beneficence is one of the four principles that form the basis of the Australian National Statement. The aim of this paper is to explore the philosophical development of this principle and to clarify the role that beneficence plays in contemporary discussions about human research ethics. By examining the way that guidance documents, particularly the National Statement, treats beneficence we offer guidance to researchers and human research ethics committee members on the practical application of what can be a conceptually difficult principle.

Medical care of critically ill and injured infants and children globally should be based on best research evidence to ensure safe, efficacious treatment. In South Africa and other low and middle-income countries, research is needed to optimise care and ensure rational, equitable allocation of scare paediatric critical care resources.

Demands for improved access to innovative therapies have prompted a discourse that claims patients have rights to access treatments that may be of benefit, even if evidence that demonstrates safety and efficacy is lacking. This rights-based discourse is grounded in accounts of autonomy and assertions claiming that the state ought to not interfere with the free choices of patients and clinical decision-making. In this essay, we scrutinise these arguments to defend the ethical and legal permissibility of interference in contexts where (...) the uncertainty of benefit and potential for harm creates vulnerabilities that undermine patient capacity for self-determination. In support of this argument, we draw on two theoretical approaches to explore the limits of autonomy in innovative contexts and analyse the legal bases of the rights-based discourse. We then apply this analysis to the case example of stem cell transplantation as an innovative treatment for multiple sclerosis. (shrink)