However, the complexities of modern medicine research necessitate a more elaborate set of guidelines that address a Physician’s ethical and scientific responsibilities such as obtaining informed consent or disclosing risk while involved in biomedical research.
Good Clinical Practice is a set of guidelines for biomedical studies which encompasses the design, conduct, termination, audit, analysis, reporting and documentation of the studies involving human subjects.
The fundamental tenet of GCP is that in research on man, the interest of science and society should never take precedence over considerations related to the well being of the study subject.
It aims to ensure that the studies are scientifically and ethically sound and that the clinical properties of the pharmaceutical substances under investigation are properly documented.
The guidelines seek to establish two cardinal principles: protection of the rights of human subjects and authenticity of biomedical data generated.
These guidelines have been evolved with consideration of WHO, ICH, USFDA and European GCP guidelines as well as the Ethical Guidelines for Biomedical research on Human Subjects issued by the Indian Council of Medical Research.
They should be followed for carrying out all biomedical research in India at all stages of drug development, whether prior or subsequent to product registration in India.