Protection_of_Human_Subject_Assurance_Attachment_J-8.pdf

OMB No. 0990-0263 Approved for use through 3/31/2015

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

[ ] ORIGINAL

[ ] CONTINUATION

[ ] EXEMPTION

2. Type of Mechanism

[ ] GRANT [ ] CONTRACT [ ] FELLOWSHIP

[ ] COOPERATIVE AGREEMENT

[ ] OTHER:_____________________________

3. Name of Federal Department or Agency and, if known, Application or Proposal Identification No.

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. IRB Registration/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

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 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:

14. Name of Official

15. Title

16. Signature

17. Date

Authorized for local Reproduction Sponsored by HHS

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