Definitions for "Declaration of Helsinki"
recommendations guiding physicians in biomedical research involving human subjects; adopted by the World Medical Assembly in 1964.
A set of recommendations or basic principles that guide medical doctors in the conduct of biomedical research involving human subjects. It was adopted by the 18th World Medical Assembly (Helsinki, Finland, 1964) and revised by the 29th (Tokyo, 1975) and 35th (Venice, Italy, 1983) World Medical Assemblies. The full text is in 21 CFR 312.120, in an appendix to the Nordic Council on Medicines Guidelines for Good Clinical Practice, and in other reference materials.
A series of guidelines adopted by the 18th World Medical Assembly in Helsinki, Finland in 1964. The Declaration addresses ethical issues for physicians conducting biomedical research involving human subjects. Recommendations include the procedures required to ensure subject safety in clinical trials, including informed consent and Ethics Committee reviews.