A23_-_Protection_of_Human_Subjects_Assurance_Identification.pdf

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

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