An FWA is the only type of assurance currently accepted and approved by OHRP.
It is required whenever an Institution becomes engaged in human subjects research conducted or supported by any U.S. federal department or agency that has adopted the Common Rule, unless the research is otherwise exempt from the requirements of the Common Rule or a U.S. federal department or agency conducting or supporting the research determines that the research shall be conducted under a separate assurance.
For step-by step instructions on filing an FWA, please see OHRP’s guidance here.
The following documentation must be submitted for consideration during Board review of any site/institution that adopts the common rule for all non-exempt research regardless of funding source:
- Standard Single-Site Study Submission Documentation
- Standard Multisite Study Submission Documentation
- Standard Site Submission Documentation
- A completed IRB Authorization Agreement
- A list of key personnel working on the project and documentation that they have completed Protection of Human Subjects Training (OHRP’s video training series, CITI or equivalent).