The ethics and scientific quality of human clinical trials is regulated by international standards set by the International Conference on Harmonization (ICH) in the form of guidelines known as Good Clinical Practice (GCP).
These guidelines are accepted worldwide and must be followed during any study involving human subjects. Adherence to GCP ensures the rights and safety of the participants and facilitates mutual acceptance of clinical data from one research centre to another.
The main objectives of GCP are:
To ensure the protection of the rights, safety and well-being of subjects participating in clinical studies,
To guarantee scientific quality of studies and respect of ethics,
To promote harmonization of clinical studies worldwide (Canada, United States, European Union…) according to the requirements of regulatory agencies,
To standardize the test methods (HRIPT, 48-hr patch test, SPF testing of sunscreens, etc.).
