FWA Questions and Answers
What is the FWA?
Why does the University have an FWA?
What are the key components and requirements of the FWA?
What are the key components and requirements of the FWA?
How does the Terms of Assurance relate to the FWA?
What are the key components and requirements of the Terms of Assurance?
What is the FWA?
The FWA is an agreement with the Office for Human Research Protections (OHRP), an agency within the Department of Health and Human Services (DHHS). The agreement covers human subject research conducted at UT. It is the University’s written assurance that it will follow all requirements in the DHHS Regulations for the Protection of Human Subjects – Title 45 CFR Part 46, and that it will educate University researchers regarding those requirements.
Why does the University have an FWA?
According to federal regulations, each institution engaged in human subject research that is covered by federal regulations and is conducted or supported by a federal department or agency shall provide written assurance satisfactory to DHHS that it will comply with the requirements set forth in this policy. [DHHS 45 CFR 46.103]
What are the key components and requirements of the FWA?
Through the FWA, the President of UT has provided assurance in writing to DHHS that:
· All research conducted at UT will be:
o guided by the ethical principles of The Belmont Report, and
o in compliance with DHHS Regulations for the Protection of Human Subjects – Title 45 CFR Part 46.
· All UT-related research activities will comply with the Terms of Assurance
· All UT-related Research will be reviewed by an IRB designated in UT’s FWA
· UT will provide appropriated education regarding human subject protections to IRB members, researchers and relevant staff
How does the Terms of Assurance relate to the FWA?
By the terms of the FWA, Dr. Jacobs has assured that all activities related to human subject research at the University of Toledo will comply with the Terms of Assurance for Protection of Human Subjects
What are the key components and requirements of the Terms of Assurance?
· Researchers will comply with the Terms of Assurance whenever they:
o Intervene or interact with living individuals for research purposes; or
o Obtain, release, or access individually identifiable private information for research purposes
· All human subject research conducted at UT will be guided by The Belmont Report and other relevant ethical principles
· Research will be conducted in compliance with DHHS Regulations for the Protection of Human Subjects – Title 45 CFR Part 46.
· The IRB has written procedures {HYPERLINK TO POLICIES & PROCEDURES} for operation that comply with federal regulations
· The institution requires review, prospective approval and continuing review of all human subject research by the IRB
· Informed consent will be sought from each prospective subject, and consent will be obtained in writing and a copy given to the subject unless the IRB has approved a waiver or alteration of the consent procedures
· The University must have written agreements with independent investigators who are not otherwise affiliated with the institution
· The Institution must provide sufficient meeting space and staff to support the IRB
· The University must comply with the Terms of Assurance
· Assurance training should be completed by the University’s signatory official (Dr. Jacobs), the human protection administrator contact person and the IRB chairs
· The University has established educational training and oversight mechanisms for investigators, IRB members and staff, and other research personnel that are sufficient to ensure continuing knowledge of relevant ethical principles, federal regulations, written IRB policies and procedures, institutional policies, OHRP guidance, and federal and state laws and regulations for the protection of human subjects. Training should be completed prior to involvement with human research.
· The University must renew its assurance every 36 months