ABSTRACT
Over a decade ago the National Bioethics Advisory Commission (NBAC) declared unequivocally that ‘[p]rotecting the rights and welfare of those who volunteer to participate in research is a fundamental tenet of ethical research’ (2001a: i). This infl uential report went on to note that ‘increasingly, the current system is being viewed as uneven in its ability to simultaneously protect the rights and welfare of research participants and promote ethically responsible research’ (NBAC 2001a : i; Chalmers 2004 ). The fi rst decade of this millennium saw an international reform effort to align the proper protection of human research participants with the accelerating expansion and pace of both academic and commercial research activity. There has been a sustained move to update research ethics and avoid the criticism that ‘the philosophy of the state, its ethics – are always yesterday’ (Brodsky 1987 ). This chapter will discuss the development of medical research ethics internationally, and the required future directions for the regulation of medical research and its ability to meet the challenges in the increasingly internationalised context of research in the ‘Genome Era’. 2
The traditional starting point for an account of the current principles of medical research ethics is the Nuremberg Code 1947 and the Declaration of Helsinki 1964. Both the Code and the Declaration were developed by reference to standards of medical ethics and, in the case of the Code , the complete failure to respect such standards. The fi fth principle of the Nuremberg Code – that ‘[n]o experiment should be conducted where there is an a priori reason to believe that death or injury will occur’ – derives from the central tenet of the Hippocratic Oath to do no harm to the
1 Professor, Faculty of Law, University of Tasmania, and Foundation Fellow of the Australian Academy of Law, Chair Gene Technology Ethics and Community Consultation Committee and past Chair of the Australian Health Ethics Committee (from 1994 to 2000). Acknowledgements to the Australian Research Council (DP11010069) and to the National Health and Medical Research Council (Program Grant 490037) for support.
