Form 0990-0263

OMB No. 0990-0263
Approved for use through XXXXXX

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

2. Type of Mechanism

[ ] ORIGINAL
[ CONTINUATION
[ ] EXEMPTION

[ ] GRANT
[ ] CONTRACT
[ ] FELLOWSHIP
[ ] COOPERATIVE
AGREEMENT
[ ] OTHER:

4. Title of Application or Activity

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

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.
Registration No.

, the expiration date

IRB

[ ] This Assurance, on file with (agency/dept)
activity.
Assurance No.
Registration/Identification No.

, covers this

, the expiration date
(if applicable)

IRB

[ ] 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)
[ ] Expedited Review on (date)

or

[ ] 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
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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.