Request for Single IRB Review by another Institution for a Yale study

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YALE UNIVERSITY
INSTITUTIONAL REVIEW BOARDS
Request for Single IRB Review where an external IRB serves as IRB of Record for Yale
University
920 FR 7b (2014-1)
This form is to be used when a Yale University investigator requests that Yale enter into an
agreement with another IRB to cede IRB review of a protocol to another IRB.
Institution A: The Institution that will be responsible for review of the protocol.
Institution B: Yale University
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:
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)
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3. External IRB 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:
4. External Principal Investigator Information
Name:
Academic Appointment:
Contact Information:
Campus Address:
Campus Phone:
Email:
5. External Protocol Information
Study Title:
Funding Source:
Title of Grant:
Award Number:
Current IRB Approval Status:
Approved
Pending
Risk Level:
Minimal
Greater than minimal
High
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
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Other:
6. Projected Length of Study:
7. Reason for Seeking Single IRB Review(Provide a description of why an agreement for
single IRB review is requested)
I understand that
 if this request is approved, Institution A 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 IRB of Institution A will have full
responsibility for oversight of the protocol.
 an agreement is not approved until a formal IAA (Institutional Authorization
Agreement) is signed by the Institutional Official at both Institutions
 once an agreement is in place, I am still responsible for complying with all
Yale University conflict of interest, training, and education requirements and
for maintaining a current and accurate protocol file with the Yale IRB, and I
will supply the Yale IRB with all study determination letters and copies of all
current informed consent/compound authorization forms.
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:
Signature:
Date:
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