The aim of this study is to discuss whether current science regulation conforms to basic rational demands on a legitimate regulative system – the complex system of norms expressed in law, soft-law, guidelines and codes. This system has mainly developed organically and we might lose track of the demands for rational regulation; that it be efficient and effective. Seven rationality criteria are used for evaluating the Helsinki Declaration, the CIOMS guidelines and other regulations: Being comprehensible, Capacity for conflict resolution, Equality, Effectiveness, Acceptability, Practicability & enforceability, and the Capacity to integrate. The conclusion drawn is that research regulations often do not meet basic criteria of rationality which risks creating a confusing, non-manageable situation. Therefore regulative development is needed, where each regulatory body is more conscious about the role it should play and about where any regulations proposed can fit with existing laws and guidelines.