Adherence to the principles of good clinical practice (GCP), including adequate human subject protection (HSP), is universally recognized as a critical requirement for the conduct of research involving human subjects. GCP encompasses the responsibilities and expectations of investigators, monitors, sponsors, and IRBs in the conduct of clinical trials. Many countries have adopted the GCP principles set forth in the International Congress on Harmonisation (ICH) Guideline (E-6). DMID has developed guidances and policies that are consistent with ICH GCP. All clinical research studies funded by the Division of Microbiology and Infectious Diseases (DMID) must comply with the U.S. Department of Health and Human Services (HHS) human subjects protections regulations set forth in 45 Code of Federal Regulations (CFR) part 46 and Food and Drug Administration (FDA) regulations if under and Investigational New Drug Application (IND) or Investigational Device Exemption (IDE). Local regulations may also apply.
Studies conducted under an IND or IDE must also comply with 21CFR50, the FDA regulations for human subjects protections. Studies outside of the United States must also comply with local regulations and ethical standards.
Last Updated March 14, 2013