Two primary international codes govern the conduct of medical research involving human subjects. The Declaration of Helsinki is a document promulgated by the World Medical Association “as a guide to each doctor in clinical research.” The Nuremberg Code arose from the Nuremberg trials of Nazi war criminals accused of conducting medical experiments on prisoners that caused great suffering and many deaths. The code sets forth principles designed to protect human subjects from abuses related to medical research. The code’s statement of the ethical framework for medical research is considered to be the policy behind federal and state regulation of human- subject–based research.

Neither of these codes has the force of law, but they set the moral tone for all medical research, including research unregulated by state or federal law. These codes are admissible in court as evidence of the proper standard of care for medical experimentation. Every physician who is involved in medical research should read and be familiar with these codes.