Introduction

14.1 As discussed in Chapter 13, the present regulatory framework for the ethical conduct of human research is centred on the National Health and Medical Research Council’s (NHMRC) National Statement on Ethical Conduct in Research Involving Humans (the National Statement)^[1] and on review of research proposals by Human Research Ethics Committees (HRECs).

14.2 This chapter examines the regulatory status of the National Statement and the consequences of non-compliance for researchers or research organisations. The chapter then discusses whether this status is adequate to protect participants involved in genetic research wherever conducted in Australia. The chapter also considers whether the current regulatory framework is adequate to protect genetic samples and information or whether different accountability and enforcement mechanisms are required.