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OHRP Guidance – FWA Instructions – U.S. InstitutionsThe signature of the Signatory Official and the date of the signature must be provided on the FWA form. The FWA form with the original signature must be submitted to OHRP.
Type or print the full name, degree(s) or suffix, institutional title (e.g., administrative title such as President, CEO, Provost, Vice President, Dean for Research, etc.), institution name, telephone and fax numbers, e-mail address, and full mailing address for the Signatory Official. The e-mail address is very important, as this will provide the means for effective communication from OHRP (e.g., sending of new information regarding the FWA or other guidance from OHRP). If any of these fields are not available, please indicate accordingly rather than leaving the field blank.
ITEM #8 - FWA ApprovalLeave this item blank. This section is for use by OHRP for approval of the FWA.
Submitting an FWA Form to OHRP
Please review and proofread all materials to be submitted and ensure that all parts of the FWA form are complete and accurate. Submitting FWA forms that are complete will expedite review and approval by OHRP. Submission of an incomplete FWA form may delay processing and approval of the FWA.
Please submit the FWA form on single-sided pages and with the signature of the Signatory Official by fax (240-453-8202), regular mail, express mail, or hand delivery to OHRP at:
Division of Policy and Assurances
Notification of Approval of an FWAWhen an institution submits an FWA electronically, the person submitting the electronic file, the Human Protections Administrator, and the Signatory Official will receive an automatically generated e-mail notifying them of the approval of the FWA and providing them with the FWA number assigned to the institution. This, of course, is dependent upon the electronic file submitted to OHRP providing e-mail addresses as requested. When an institution submits an FWA in hard (paper) copy, it will need to monitor the OHRP website (http://ohrp.cit.nih.gov/search/asearch.asp#ASUR) to ensure that the FWA has been approved.
If you have any questions, please do not hesitate to contact the Division of Policy and Assurances, OHRP, at (240) 453-6900 or within the U.S., 1-866-447-4777.
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