Ethical regulation or regulating ethics? The need for both internal and external governance of human experimentation.

Research regulation is a timely topic for discussions in bioethics and public health policy. This response to articles in the previous special issue of the Monash Bioethics Review emphasises the importance of having both internal and external controls on human experimentation. Unless both elements are incorporated into research ethics governance frameworks, they will ultimately fail to achieve what should be their primary goal: human subject protection.