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4. Title of Application or Activity
This activity has been reviewed and approved by the IRB in accordance with the Common Rule and any other governing regulations.
OMB No. 0990-0263
Approved for use through April 30, 2021
Protection of Human Subjects
Assurance Identification/IRB Certification/Declaration of Exemption
(Common Rule)
Policy: Research activities involving human subjects may not be
conducted or supported by the Departments and Agencies adopting the
Common Rule (56FR28003, June 18, 1991) unless the activities are
exempt from or approved in accordance with the Common Rule. See
section 101(b) of the Common Rule for exemptions. Institutions submitting
applications or proposals for support must submit certification of
appropriate Institutional Review Board (IRB) review and approval to the
Department or Agency in accordance with the Common Rule.
Institutions must have an assurance of compliance that applies to the
research to be conducted and should submit certification of IRB review and
approval with each application or proposal unless otherwise advised by the
Department or Agency.
1. Request Type
3. Name of Federal Department or Agency and, if known,
[ ] ORIGINAL
[ ] GRANT [ ] CONTRACT [ ] FELLOWSHIP
Application or Proposal Identification No.
[ ] CONTINUATION
[ ] COOPERATIVE AGREEMENT
[ ] EXEMPTION
[ ] OTHER:_____________________________
5. Name of Principal Investigator, Program Director, Fellow, or
Other
6. Assurance Status of this Project (Respond to one of the following)
[ ] This Assurance, on file with Department of Health and Human Services, covers this activity:
Assurance Identification No. , the expiration date IRB Registration No. ____________________
[ ] This Assurance, on file with (agency/dept)____________________________________________________________________, covers this activity.
Assurance No._____________________, the expiration date_ __ IRB R
egistration/Identification No.__________________(if applicable)
[ ] No assurance has been filed for this institution. This institution declares that it will provide an Assurance and Certification of IRB review and
approval upon request.
[ ] Exemption Status: Human subjects are involved, but this activity qualifies for exemption under Section 101(b), paragraph___________.
Certification of IRB Review (Respond to one of the following IF you have an Assurance on file)
[ ]
by:
[ ] Full IRB Review on (date of IRB meeting) _____ or [ ] Expedited Review on (date)
[ ] If less than one year approval, provide expiration date _____________________
[ ] This activity contains multiple projects, some of which have not been reviewed. The IRB has granted approval on condition that all projects
covered by the
Common Rule will be reviewed and approved before they are initiated and that appropriate further certification will be submitted.
9. The official signing below certifies that the information provided above is
correct and that, as required, future reviews will be performed until study
closure and certification will be provided.
10. Name and Address of Institution
11. Phone No. (with area code)
12. Fax No. (with area code)
13. Email:
Authorized for local Reproduction Sponsored by HHS
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB
control number. The valid OMB control number for this information collection is 0990-0263. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays a currently valid OMB control number. The time required to complete this information
collection is estimated to average 30 minutes per response.If you have comments concerning the accuracy of the time estimate(s) or suggestions for improving
this form, please write to: U.S. Department of Health & Human Services, OS/OCIO/PRA, 200 Independence Ave., S.W., Suite 336-E, Washington D.C.
20201,Attention: PRA Reports Clearance Officer.
