OHRP Compliance

 

United States Federal Wide Assurance (FWA)

Under the United States Department of Health and Human Services (DHHS) Code of Federal Regulations 45: Part 46 A Protection of Human Subjects Section 46.103, every institution engaged in human subjects research supported or conducted by any United States Federal Department or Agency must have assurance of compliance approved by the United States Office for Human Research Protections (OHRP). The Assurance formalizes the institution’s commitment to protect human subjects.

OHRP Federalwide Assurance (FWA) and Institutional Review Board (IRB) assurance have been obtained for the REB 4: Health Research Ethics Board - Biomedical Panel (REB is the Canadian terminology for an IRB). Click on the type of assurance below for more information:

Type of Assurance

Policy Number

Federal Wide (see details)

FWA00000077

Institutional Review Board (see details)

IRB00000927

 

Individuals who contribute to the scientific development or execution of a project in a substantive, measurable way for NIH-funded human subjects research must fulfill the NIH education requirement. Any Senior/Key Person personnel listed on the local ethics application must attach their certificate of training on the protection of human subjects.  This can be uploaded to Section Documentation (11.0) of the REMO application.  The certificate of training will be considered valid for five (5) years from date of issue, after which time the training will have to be renewed and a new certificate uploaded if the study is ongoing.

The NIH does not endorse any specific programs to fulfill the requirement for education on the protection of human subjects.  Training in fulfillment of this requirement can be obtained through completion of the ICH-GCP Training through the CITI program or by completing the NIH Office of Extramural Research Course.

 

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