The use of human tissue samples in medical research: Legal issues for human research ethics committees

Abstract

This article provides a framework for considering some of the legal issues that arise from the use of human tissue samples in medical research, particularly when human research ethics committees (HRECs) scrutinise research protocols for ethics approval. While the National Statement on Ethical Conduct in Research Involving Humans (revising the NHMRC Statement on Human Experimentation and Supplementary Notes) provides the backbone for the regulation of medical research in Australia, HRECs also face a variety of legal issues in relation to the research. This article identifies some typical issues faced by HRECs in relation to human tissue samples before outlining the legal framework within which these issues arise. Australian human tissue legislation is discussed, together with the likely non-application of this legislation in a variety of contexts where human tissue samples are obtained. The article reviews some unresolved legal issues that emerge from research uses of human tissue, and concludes with discussion of the dual role of HRECs in seeking to ensure compliance with both ethical and legal standards.