YALE UNIVERSITY
INSTITUTIONAL REVIEW BOARDS
Request for Single IRB Review where Yale serves as IRB of Record for another Institution
920 FR 7a (2014-2)
This form is to be used when a Yale University investigator requests that Yale enter into an
agreement with another IRB to serve as IRB of record for another IRB.
Institution A: Yale University
Institution B: The Institution ceding IRB review.
When the form is completed, submit it by email to HRPP@yale.edu. The HRPP will review it and
contact the non-Yale institution to determine whether single IRB approval is appropriate. Once
the decision has been made, the HRPP will contact the investigator regarding the decision.
Please note: The Yale IRB Contact Person is Monika Lau, monika.lau@yale.edu; 203-737-5331.
Yale’s FWA number and IRB registration numbers are found on the HRPP website,
http://www.yale.edu/hrpp/. IRB#1 is the Yale Social/Behavioral/Educational IRB, the Human
Subjects Committee. IRBs#2-5 are Yale Biomedical IRBs, the Human Investigation Committees.
Complete all fields
1. Yale Investigator Information
Name:
Yale Academic Appointment:
Campus Address:
Campus Phone:
Email:
2. Protocol Information
Study Title:
IRB#
Funding Source:
Title of Grant:
Award Number:
Which Institution is the Primary Awardee?
Current IRB Approval Status:
Approved
Pending
Risk Level:
Minimal
Greater than minimal
High
Project Summary: (Provide a summary of the project in lay terms, including project
goals)
Page 1 of 4
Research activities that will occur at Yale: (List all)
Direct recipient of federal funds
Recruitment of subjects
Consenting subjects
Intervention with subjects (state exact interventions)
Analysis of identifiable data
Analysis of de-identified data
Other:
Research activities that will occur at the External Institution: (List all)
Direct recipient of federal funds
Recruitment of subjects
Consenting subjects
Intervention with subjects (state exact interventions)
Analysis of identifiable data
Analysis of de-identified data
Other:
3. Projected Length of Study:
4. External Investigator Information
Name:
Academic Appointment:
Institution:
Contact Information:
Campus Address:
Campus Phone:
Email:
Role in the Study: (Provide a description of the role and activities of the investigator at
the Institution ceding IRB review)
Attach:
External Investigator CV
Human Subjects Protection Training certificate
HIPAA training certificate (if Yale School of Medicine, Yale School of
Nursing)
5. Reason for Seeking Single IRB Review(Provide a description of why an agreement for
single IRB review is requested)
Page 2 of 4
6. Describe the plan for supervision and monitoring of the external site.
7. Institution A Information
Institution Name: Yale University
FWA Number: FWA#00002571
OHRP IRB Registration Numbers:
IRB Contact Person: (this is the person at the IRB office who handles Authorization
Agreements):
Contact Person email address:
Contact Person phone number:
8. Institution B Information
Institution Name:
FWA Number:
OHRP IRB Registration Numbers:
IRB Contact Person (this is the person at the IRB office who handles Authorization
Agreements):
Contact Person email address:
Contact Person phone number:
I understand that
 if this request is approved, Yale University IRBs will be the IRB of record for
this study, responsible for conducting initial and continuing review of this
protocol;
 the decision to cede IRB review is made jointly by both institutions and is not
a decision of the investigators;
 if the agreement is effected, the Yale IRB will have full responsibility for IRB
oversight of the protocol.
 if the agreement is effected , the relying institution remains responsible for the
conduct of the study at its site(s)
 an agreement is not approved until a formal IAA (Institutional Authorization
Agreement) is signed by the Institutional Official at both Institutions.
I agree to comply with all applicable requirements of the IRB of record, as well as all
requirements set out by the Yale IRB.
Signature of Yale investigator:
Printed Name:
Page 3 of 4
Signature:
Date:
Page 4 of 4