Law, ethics and professional guidelines in medical research

The volume of law and other regulation in medical research has expanded enormously within the last five years. Researchers need an awareness of how these legal instruments are hierarchically related, so they know which regulation to apply where there is a conflict of norms. They also express concern on whether there is any space left for ethical and professional guidelines in the light of all this formal regulation. This paper addresses these two issues. It is argued that when drafting new legislation or guidelines, room must be left for responsible individual decision-making. © YOZMOT 2004.