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Human Subjects

FWAs

Federalwide Assurances (FWA)

The Federalwide Assurance (FWA) is a declaration 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 & 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 have an approved FWA on file with OHRP. The Human Subjects Office coordinates submission and updating of FWAs for Indiana University affiliates and partners. In general, an institution is engaged in human subjects research whenever:

  1. the institution’s employees or agents intervene or interact with human subjects for research purposes;
  2. the institution’s employees or agents obtain individually identifiable private information about human subjects for research purposes; or
  3. 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 an institution may be engaged in HHS-conducted or supported human subjects research, please review the External Link Engagement of Institutions in Research guidance.

FWA Numbers

The following is a list of all related Federalwide Assurances (FWAs). Please be aware that, depending upon where your research is being conducted, you may need to reference multiple FWA numbers.

To search for a list of expiration dates, current components for each institution, and a list of Institutional Review Boards (IRBs) designated by the institution, please click to visit the External Link Office of Human Research Protections (OHRP) FWA database.

Institution Federalwide Assurance Number

Indiana University

FWA00003544

Indiana University Health

FWA00003566

IU Medical Group - Specialty Care (IUMG-SC)

FWA00010921

IU Health, Inc. (formerly IU Medical Group)

FWA00002719

Health & Hospital Corporation of Marion County

FWA00003543

Larue D. Carter Memorial Hospital

FWA00003556

Regenstrief Institute, Inc.

FWA00003345

Richard L. Roudebush Veterans Affairs Medical Center

FWA00001506

Indiana Institute for Medical Research

FWA00017027

See the IU IRB Statement of Compliance on the For Sponsors page.

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