Contact us: Human Subjects
- For help with the
IRB review process:
- Phone: 812-855-3067
- Email: iub_hsc@indiana.edu
Federalwide Assurances (FWAs) |
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The Federalwide Assurance (FWA) is an assurance of compliance with the federal regulations for the protection of human subjects in research. It is approved by the Office for Human Research Protections (OHRP) for all human subjects research conducted or supported by the Department of Health and Human Services (HHS). The FWA is also approved by OHRP for Federalwide use, which means that other departments and agencies that have adopted the Federal Policy for the Protection of Human Subjects (also known as the Common Rule) may rely upon the FWA for the research that they conduct or support.
Each institution that is engaged in HHS-conducted or -supported human subjects research must submit an FWA to Research Compliance Administration. In general, an institution is engaged in human subjects research whenever:
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(a) the institution’s employees or agents intervene or interact with human subjects for research purposes;
(b) the institution’s employees or agents obtain individually identifiable private information about human
subjects for research purposes; or
(c) the institution receives a direct HHS award to conduct human subjects research, even where all activities
involving human subjects are carried out by a subcontractor or collaborator.
For more information to determine whether or not an institution may be engaged in HHS-conducted or -supported human subjects research, please review the Engagement of Institutions in Research guidance on the OHRP website.
Because Indiana University has voluntarily extended the Common Rule and Subparts B, C, and D of the HHS regulations at 45 CFR 46 to all research regardless of support, it must comply with this commitment for all research to which the FWA applies that is not federally-conducted or –supported.
The following is a list of all related Federalwide Assurances (FWAs) and their current expiration dates. Please be aware that, depending upon where your research is being conducted, you may need to reference multiple FWA numbers. To see a list of current components for each institution (parts of the main institution that will be covered by the institution’s FWA) and a list of Institutional Review Boards (IRBs) designated by the institution, please click the appropriate link to view the institution’s FWA on the OHRP website.
