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) Page 1 of 3 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 Page 2 of 3 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: Page 3 of 3