Declaration of Helsinki. In 1964, the World Medical Association established recommendations guiding medical doctors in biomedical research involving human subjects. The Declaration governs international research ethics and defines rules for "research combined with clinical care" and "non-therapeutic research." The Declaration of Helsinki was revised in 1975, 1983, 1989 and 1996 and is the basis for Good Clinical Practices used today.

Issues addressed in the Declaration of Helsinki include:

Research with humans should be based on the results from laboratory and animal experimentation

Research protocols should be reviewed by an independent committee prior to initiation

Informed consent from research participants is necessary

Research should be conducted by medically/scientifically qualified individuals

Risks should not exceed benefits.