What is the purpose of a Federal Wide Assurance (FWA)?

The purpose of a Federal Wide Assurance (FWA) is to ensure that an institution complies with federal regulations that govern research involving human subjects. This assurance is a formal agreement between the institution and the U.S. Department of Health and Human Services (HHS) where the institution commits to uphold ethical principles and the relevant rules established to protect human subjects participating in research. The FWA is essential for both the institution and the researchers because it demonstrates a commitment to compliance with regulatory standards, supports the ethical conduct of research, and facilitates the institution's ability to receive federal funding for studies involving human subjects.

This assurance is particularly vital because it underscores the importance of safeguarding the rights and welfare of participants in research, which is a cornerstone of ethical research practices. Compliance with an FWA is a requirement for any institution engaged in such research activities and involves ongoing adherence to federal guidelines throughout the research process.