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OMB No. 0990-0263
Approved for use through 07/31/2005
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Protection of Human Subjects
Assurance Identification/IRB Certification/Declaration of Exemption
(Common Rule)
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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. |
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1. Request Type
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ORIGINAL
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CONTINUATION
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EXEMPTION
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2. Type of Mechanism
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GRANT
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CONTRACT
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FELLOWSHIP
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COOPERATIVE AGREEMENT
[] OTHER:____________________________
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3. Name of Federal Department
or Agency and, if known, Application or Proposal Identification
No.
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| 4. Title of Application or Activity
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5. Name of Principal Investigator, Program Director,
Fellow, or Other
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| 6. Assurance Status
of this Project (Respond to one of the following)
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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 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.
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Exemption Status: Human
subjects are involved, but this activity qualifies for exemption
under Section 101(b), paragraph___________.
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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.
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| 8. Comments
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| 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
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| 11. Phone No. (with area code)
12. Fax No. (with area code)
13. Email: |
| 14. Name of Official
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14. Title |
| 16. Signature
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17. Date |
| Authorized for local
Reproduction |
Sponsored by HHS
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of information is estimated to average less than an hour per response.
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. Send comments regarding this burden estimate
or any other aspect of this collection of information, including suggestions
for reducing this burden to: OS Reports Clearance Officer, Room 503 200 Independence Avenue, SW., Washington, DC 20201. Do
not return the completed form to this address.
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