Human Subjects Protection

Overview

All research involving human subjects that is conducted or supported by Centers for Disease Control and Prevention (CDC) must comply with the Health and Human Services (HHS) Policy for Protection of Human Research Subjects (45 CFR Part 46). This includes research conducted by CDC employees or supported by CDC through funding or provision of other tangible support. It also applies whether research is conducted inside or outside the United States.

Unless exempt, all such research must be approved by an institutional review board (IRB) prior to the start of the research. CDC's Human Research Protection Office (HRPO) facilitates the work of the IRB. It also provides consultations and training for CDC staff engaged in research involving human subjects. Clinical investigations that involve the use of drugs, biologics, or devices—whether unlicensed or used outside standard medical practice—are subject to IRB review and approval under 21 CFR Part 50 and 21 CFR Part 56.

CDC Institutional Review Boards

CDC has two Institutional Review Boards (IRBs), properly constituted in accordance with 45 CFR Part 46 and 21 CFR Part 56:

• Centers for Disease Control and Prevention IRB
• Centers for Disease Control and Prevention—NIOSH IRB

Centers for Disease Control and Prevention IRB

Based in Atlanta, Georgia, this IRB convenes monthly on the third Thursday of each month. Some adjustments may be made for federal holidays. The CDC IRB may convene on an ad hoc basis for urgent reviews. This IRB reviews protocols from all CDC Centers, Institutes, and Offices (with exception of the National Institute for Occupational Safety and Health).

Centers for Disease Control & Prevention—NIOSH IRB

Based in Cincinnati Ohio, this IRB reviews human research conducted or supported by the National Institute for Occupational Safety and Health. This board meets on the second Tuesday of each month and as needed for emergency situations.

Service on an IRB

IRB members serve for three years. They may serve longer at the discretion of the CDC Human Research Protection Office, the IRB chair, and the member. Service on an IRB is considered vital to the continuing research efforts of the agency and volunteers are always welcome.

The IRB chairs and vice-chairs collectively form the IRB Executive Committee. This committee meets as needed to discuss matters of common interest to the IRBs, to refine policy and practice, and to strive for reasonable consistency across the IRBs.

Training requirements for conducting research on human subjects at CDC

CDC investigators and scientific administrative staff involved in the conduct or oversight of federally funded human research are required to maintain competency in research ethics and human research regulations. This is done by completing specific trainings via the Collaborative Institutional Training Initiative (CITI) prior to initiating activities. It is also required at certain intervals afterwards.

• For partners working under an existing Federal Wide Assurance (FWA), CDC will continue to verify the active FWA.
• Individual investigators not working under separate FWA (i.e., collaborating with CDC under an Individual Investigator Agreement) will be asked to submit proof of having completed human subject research training within the past 3 years.

Resources

• Office for Human Research Protections (OHRP): HHS Regulation 45 CFR part 46
• OHRP: HHS Guidance
• Food and Drug Administration (FDA): Protection of Human Subjects 21 CFR Part 50
• FDA: Institutional Review Boards 21 CFR Part 56
• FDA: Investigational Device Exemptions 21 CFR Part 812
• FDA: Investigational New Drug Application 21 CFR Part 312
• FDA: Good Clinical Practice and Clinical Trials

Historical resources

• The Belmont Report: Written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
• Declaration of Helsinki: International doctrine, written in 1964 by the World Medical Association and revised several times since then. The Declaration defines basic tenets of human rights in biomedical research involving human subjects.
• Nuremberg Code: The ethical guideline written as a result of World War II Nazi war crimes against humanity.
• CDC's Guidelines for Defining Public Health Research and Public Health Nonresearch
• Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Biomedical Research Involving Human Subjects

For additional information regarding human subjects research conducted or supported by CDC, please contact huma@cdc.gov.