ABSTRACT
The duty of the physician (and, by extension, any assistant to whom he delegates clinical tasks and duties) is primarily to his patient, to protect him from harm and if possible to treat his illness. During clinical research, the desire for scientific discovery or the impulse to reach a successful outcome must never be allowed to supersede this primary duty. The safety of the subject is the physician’s chief responsibility, no matter what his job title, no matter who is paying him. The most important mechanisms for protection for the subject are: choice of competent investigators, review of
all protocols by ethics committees, thorough monitoring by the sponsor’s agent to ensure that the protocol and GCP guidelines are followed, and independent audit of safety issues.
