Medical Research: future directions in the genome era

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 influential 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 first 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