What is a Federal Wide Assurance?
A Federal Wide Assurance (FWA) is a document that outlines the terms and conditions that institutions must follow when they conduct research with human subjects. This agreement is between an institution and the federal government’s Office for Human Research Protections (OHRP).
Why is a Federal Wide Assurance important?
A FWA is important because it assures the federal government that an institution is conducting research according to ethical standards and regulations. It also provides protection for human subjects who are participating in research studies.
How do institutions obtain a Federal Wide Assurance?
Institutions can obtain a FWA by submitting an application to the OHRP. This application includes information about the institution's research program and policies. The OHRP reviews the application and, if approved, issues a FWA to the institution.
What does a Federal Wide Assurance include?
A FWA includes:
- The name and address of the institution
- The person responsible for ensuring compliance with the terms of the FWA
- Assurances that the institution will comply with all regulations related to research with human subjects
- The agreement to follow specific ethical principles, such as obtaining informed consent from subjects and protecting their privacy and confidentiality
- Information about the institutional review board (IRB) that will review and approve research studies
Who needs a Federal Wide Assurance?
Any institution that conducts research with human subjects and receives federal funding or support must have a FWA.
Is a Federal Wide Assurance permanent?
No, a FWA is not permanent. It must be reviewed and renewed every three years. The institution must also notify the OHRP of any changes to its research program or policies that may affect its compliance with the FWA.
FAQs
What is the difference between a FWA and an IRB?
A FWA is an agreement between an institution and the federal government that outlines the terms and conditions for conducting research with human subjects. An IRB, on the other hand, is a committee that reviews and approves research studies to ensure that they are ethical and comply with regulations.
What happens if an institution violates its Federal Wide Assurance?
If an institution violates its FWA, the federal government may suspend or terminate its funding or support for research. The institution may also face penalties or legal action.
Can an institution have more than one Federal Wide Assurance?
No, an institution can only have one FWA at a time. However, if the institution has multiple campuses or research facilities, each location may need its own FWA.
