Att. 11 Protection of Human Subject Assurance.pdf
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This is a federal form template for Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption under the Common Rule (OMB No. 0990-0263), approved for use through June 30, 2024.
The form serves as a certification document for research activities involving human subjects conducted or supported by federal departments and agencies that have adopted the Common Rule. It accommodates both the pre-2018 Common Rule (originally promulgated in 1991 and amended in 2005) and the 2018 Common Rule (published in 2017 and amended in 2018). The form requires institutions to document the type of request (original, continuation, or exemption), funding mechanism (grant, contract, fellowship, cooperative agreement, or other), and relevant project identification information. Section 6 addresses assurance status, with institutions required to indicate whether an assurance has been filed with the Department of Health and Human Services or another federal agency, provide the assurance number and expiration date, declare that no assurance has been filed with a commitment to provide one upon request, or claim exemption status under either the pre-2018 or 2018 Common Rule. Section 7 requires certification of IRB review, specifying whether the activity received full or expedited review, approval expiration dates for less than one-year approvals, and conditional approval status for multiple-project activities. The form concludes with institutional contact information and signature blocks for authorized officials. The estimated completion time is 30 minutes per response.
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OMB No. 0990-0263
Approved for use through June 30, 2024
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 unless the activities are exempt from or approved in accordance with the Common Rule. The “pre-2018 Common Rule (or pre-2018
Requirements)” was originally promulgated in 1991 and amended on June 23, 2005 (70 FR
36325). The “2018 Common Rule (or 2018 Requirements)” was originally published on January
19, 2017 (82 FR 7149) and amended on January 22, 2018 (83 FR 2885) and June 19, 2018 (83
FR 28497). The categories of exempt research are provided in Section 101(b) of the pre-2018
Common Rule and Section 104(d) of the 2018 Common Rule.
The pre-2018 Common Rule requires institutions to certify that each application or proposal for research has been reviewed and approved by an Institutional Review Board (IRB) (Section
103(f)). The 2018 Common Rule requires institutions to certify that each proposed research study has been reviewed and approved by an IRB (Section 103(d)). 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, or proposed research study, 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 the 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 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 the pre-2018 Common Rule, Section 101(b), paragraph .
[ ] Exemption Status: Human subjects are involved, but this activity qualifies for exemption under the 2018 Common Rule, Section 104(d), 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
10. Name and Address of Institution performed until study closure and certification will be provided.
11. Phone No. (with area code)
12. Email:
13. Name of Official
14. Title
15. Signature
16. 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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