Running an ethical trial 60 years after the Nuremberg Code.

The Nuremberg Code has served as a foundation for ethical clinical research since its publication 60 years ago. This landmark document, developed in response to the horrors of human experimentation done by Nazi physicians and investigators, focused crucial attention on the fundamental rights of research participants and on the responsibilities of investigators. Although the Nuremberg Code has provided an important framework for discussions on the requirements of ethical clinical research, and has resulted in the development of other initiatives-eg, the Declaration of Helsinki and the Belmont Report-designed to ensure the rights and safety of human beings taking part in medical research, knowledge of both past events and the current complexity of research suggests further improvements are necessary in the existing approaches to human clinical research.