Microbiology and Infectious Diseases Clinical Research Policies, Guidance, and Tools

Good Clinical Practices and Human Subjects Protections

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.

• The DMID Good Clinical Practice Resource Guide (GCP) contains selected regulations and guidelines for GCP. The documents in this guide are among the most important GCP regulations and guidelines but are not all inclusive and may be subject to change. The pages of the guide are as follows:
  Page I Human Subjects Protections
  Page II Informed Consent
  Page III Subject Recruitment
  Page IV Research on Human Specimens: Are you conducting research using human subjects
  Page V Investigational New Drug Application regulations
  Page VI International Conference on Harmonisation Guideline for Good Clinical Practice (ICH E-6)
  Page VII Investigational Device Exemption regulations
  Page VIII Useful Internet Sites
• 45 CRF 46—informally known as the “Common Rule.” This regulation sets forth a basic set of protections for all human subjects in research conducted or supported by HHS. It also contains three subparts covering additional protections for research subjects who are: pregnant women, human fetuses, and neonates; prisoners; and children.

  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.

• NIH Certificates of Confidentiality are issued to protect identifiable research information from forced disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level.
  • Certificates are given only to projects that have IRB approval.
  • Certificates are awarded to the institution, not the investigator.
  • If the project involves an IND or IDE, the certificate is issued through FDA.

Related Links

• Protocol and Consent page
• Institutional Review and Federal Wide Assurances page
• Selected References page for
  • FDA heading for regulations (21CFR50 and 56) and FDA information sheets on payment, charging and recruitment
  • NIAID heading for
    • NIAID Human Subjects Application and Grant Handbook
    • Policy of GCP for NIAID and Awardees
  • NIH heading for
    • Certificates of Confidentiality
    • Human Subjects Protections
  • Human Subjects Protections heading for
    • Office for Human Research Protection (OHRP)
    • NIH information and guidances
    • International Research for International Research Standards
• Training Opportunities page