Protection Of Human Subjects Assurance Identification/irb Certification/declaration Of Exemption Form
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1OMB No. 0990 0263
-
Approved for use through March 31, 2018
Protection of Human Subjects
Assurance Identification/IRB Certification/Declaration of Exemption
(Common Rule)
Policy : Research activities involving human subjects may not be
Institutions must have an assurance of compliance that applies to
conducted or supported by the Departments and Agencies
the research to be conducted and should submit certification of
adopting the Common Rule (56FR28003, June 18, 1991) unless
IRB review and approval with each application or proposal unless
the activities are exempt from or approved in accordance with the
otherwise advised by the Department or Agency.
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.
1. Request Type
2. Type of Mechanism
3. Name of Federal Department or Agency and, if known,
Application or Proposal Identification No.
[ ] ORIGINAL
[ ] GRANT [ ] CONTRACT [ ] FELLOWSHIP
[ ] CONTINUATION
[ ] COOPERATIVE AGREEMENT
[ ] EXEMPTION
[ ] OTHER:
4. Title of Application or Activity
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 Registration/Identification No.__________________(if applicable)
[ ]
No assurance has been file
d 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___________.
7. Certification of IRB Review (Respond to one of the following IF you have an Assurance on file)
[ ]
This activity has been reviewed and approved by the IRB in accordance with the Common Rule and any other governing regulations.
[ ]
[ ]
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.
8. Comments
9. The official signing below certifies that the information provided above is
10. Name and Address of Institution
correct and that, as required, future reviews will be performed until study
closure and certification will be provided.
11. Phone No. (with area code)
12. Fax No. (with area code
13. Email:
14. Name of Official
15. Title
16. Signature
17. Date
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 . 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
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