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.

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.

Certificates of Confidentiality for NIH Funded Research

Certificates of Confidentiality (CoC) protect the privacy of research subjects by prohibiting disclosure of identifiable, sensitive research information to anyone not connected to the research except when the subject consents or in a few other specific situations. NIH funded researchers are automatically issued a CoC through their award. NIH will no longer issue a physical certificate.  You may point to your Notice of Award and the NIH Grants Policy Statement as documentation of the CoC protection.

For studies in which informed consent is sought, NIH expects investigators to inform research participants of the protections and the limits to protections provided by a CoC.

1. Researchers with a CoC may ONLY disclose identifiable, sensitive information in the following circumstances:

  • if required by other Federal, State, or local laws, such as for reporting of communicable diseases,
  • if the subject consents, or
  • for the purposes of scientific research that is compliant with human subjects regulations,

2.  AND you must ensure that anyone who is conducting research as a sub-awardee or receives a copy of identifiable sensitive information protected by the policy understand they are they are also subject to the disclosure restrictions, even if they are not funded directly by NIH.

Additional Information

Content last reviewed on October 11, 2017