ABSTRACT
Creation of the current regulatory system governing research with human subjects was impelled by shock over reports of scientific experimentation conducted with little regard for human autonomy, dignity, or even the minimization of pain. This chapter argues that there is flexibility in the federal review scheme to allow reasonable therapeutic responses to emergencies that are genuine and that this was not a case of justified lawbreaking to advance research. It considers whether some of the allegedly more common examples of circumvention of the federal regulatory process can be justified as lawbreaking in the interests of science. The chapter also argues that none can be defended as analogous to more classic forms of justified lawbreaking such as conscientious refusal and civil disobedience. It suggests that where scientific lawbreaking seems appropriate, it does so because of analogies to entirely legal ways of proceeding in emergency situations.
