Course Code: ELM-901-02

GCP | The Belmont Report Explained

In 1979, the Belmont Report was issued by the National Commission for Protection of Human Subjects of Biomedical and Behavioral Research. The principles of this report are as follows:

  1. Respect for Persons: This principle acknowledges the dignity and freedom of every person. It requires obtaining informed consent from research subjects (or their legally authorized representatives).
  2. Beneficence: This principle requires that researchers maximize benefits and minimize harms associated with research. Research related risks must be reasonable in light of the expected benefits.
  3. Justice: This principle requires equitable selection and recruitment and fair treatment of research subjects.

Author

Joginder Mittal

Manager - Quality Compliance Glatt Pharma Engineering