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

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Institutional Review and Federal Wide Assurance

An institutional review board (IRB) may also be known outside of the United States as an independent ethics committee (IEC). The IRB/IEC acts as an independent body whose responsibility is to ensure the protection of the rights, safety, and well-being of human subjects involved in clinical research. For human subjects research funded by the U.S. Department of Health and Human Services (HHS), composition and operating procedures must comply with 45 Code of Federal Regulations part 46 (45CFR46). Institutions must use an IRB/IEC that is registered with the HHS Office for Human Research Protection (OHRP).

All sites and institutions participating in DMID-funded clinical research that involves human subjects are required to have the protocol, consent, and other appropriate documents reviewed and approved by an IRB/IEC and must comply with all applicable national, state, and local regulatory requirements for IRB/IEC review. In addition to the initial review of the protocol and associated documents, the research must be reviewed at least once a year and whenever changes occur in the approved research. Investigators are responsible for knowing IRB/IEC procedures and reporting requirements at their site(s).

A Federal Wide Assurance (FWA) provides assurance that the institution receiving HHS support will follow HHS regulations for human subjects found in 45CFR46. Institutions engaged in DMID human subjects research must obtain a FWA. Before obtaining a FWA, an institution must either register its own IRB/IEC with OHRP (an “internal” IRB/IEC) or designate an already registered IRB/IEC operated by another organization (an “external” IRB/IEC), after establishing a written agreement with the other organization.

The IRB and FWA requirement is for all human subjects research. The OHRP website provides decision trees and other guidance to determine if a research project is considered human subjects research.

DMID Policies

Related Links

  • Selected References page
    • Human Subjects Protections heading for the Office of Human Research Protections for information of IRB registration, obtaining a FWA, and engagement in human subjects research, decision trees
    • IRB heading
    • NIAID heading for Clinical Terms of Award

Last Updated March 14, 2013