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 Associate Director for Laboratory Programs
      Research Protections Office
    
      
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**Institutional Review Board (IRB)**

The NIST IRB was established by the NIST Director to review all research conducted by NIST that involves human subjects, identifiable data about or from human subjects, and identifiable specimens from human subjects.  The purpose of the IRB is to protect the rights and welfare of human subjects and to ensure that all NIST research involving human subjects is conducted in accordance with federal, institutional and ethical guidelines. The IRB is constituted to meet the requirements for Institutional Review Boards as set out in 15 CFR Part 27 and is guided by the ethical principles of the Belmont Report.

The IRB is one component of the Human Subjects Protection Program managed by the RPO. The NIST IRB reports to the ADLP, who serves as the Institutional Official. The NIST IRB Chair has a direct line of communication and access to the ADLP.

The IRB is charged with these objectives:

(1) To protect the safety, rights, and welfare of participants in research that is under the purview of the NIST IRB.

(2) To serve as a safeguard to prevent the unethical treatment of humans in research that might lead to physical, psychological, social, or other harms.

(3) To assure that the design and conduct of NIST research involving human subjects complies with applicable federal regulatory requirements, as well as with NIST policy and procedures.



**Administrative Review in the Notice of Funding Opportunity (NOFO) or Request for Application (RFA)**

The RPO will conduct an administrative review of any NIST-funded extramural research that potentially involves human subjects

**15 CFR 27.112 – Review by Institution**

“Research covered by this policy that has been approved by an Institutional Review Board (IRB) may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those officials may not approve the research if it has not been approved by an IRB.”Administrative Review is defined and described in each NIST NOFO or RFA that is referenced in an award under:  Research Activities Involving Human Subjects

RPO will review and verify the performing institution’s determination for research not involving human subjects or exempt human subjects research.
	In addition, for exempt research requiring limited IRB review and non-exempt human subjects research, the RPO will review and confirm that the research and performing institution(s) are in compliance with 15 CFR 27, which means RPO will:
	confirm the engaged institution(s) possess, or are covered under a Federalwide Assurance
		review the research study documentation submitted to the IRB and verify the IRB’s determination of level of risk and approval of the study for compliance with 15 CFR 27
		review and verify IRB-approved substantive changes to an approved research study before the changes are implemented
		review and verify that the IRB conducts a continuing review at least annually, as appropriate

    
    Contacts
      
        

Anne Andrews
    
      
  anne.andrews@nist.gov
  (301) 975-5445

Created August 22, 2022
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