Cynthia Kane, Associate Director Laura Kozma, Assistant Director

1. Capturing IRB Protocol-Proposal CongruencyFor NIH research involving human subjects at Just-In-Time (JIT) Cynthia Kane, Associate Director Laura Kozma, Assistant Director Office of Grant and Contract Administration Cathleen Montano, IRB Manager Human Research Protection Program

2. Requirement: 45 CFR 46.103(f) Proposal for research involving human subjects must be reviewed and approved by the IRB + Protocol application(s) must be reviewed and approved by the IRB = CONGRUENCY

3. Congruency Proposal for Research Aims X, Y & Z Protocols funded by Proposal? Aims X & Z Aim Y Aim A Protocol #1 Protocol #2 Protocol #3

4. What’s Changing? Nothing but the business process • The requirement is the same • Responsibility for the Proposal and Protocol Principal Investigator(s) (PI) vs Department Business Offices • Capturing of all protocols associated with a Proposal/Award and recorded in a central location IRES Proposal Tracking (PT)

5. What are the benefits? • Decreased work for Department Administrators • Minimize searching for Approval Letters • Ensures protocol congruency data in place prior to Award

6. Formalized Existing Process • Currently applies only to NIH proposals • Prior to submitting JIT documentation • Will be required beginning June 16th • Form completed by Proposal PI • Form submitted by Protocol PI(s) along with relevant IRB protocol documents (e.g., initial application or amendment request)

7. Form 100 FR.26 Yale University IRB Request for Protocol(s)-Proposal Congruency

8. Business Process • Receipt of JIT Request • JIT Checklist sent to Department Business Office (DBO) and Principal Investigator (PI) • Proposal PI completes Form 100 FR26: Yale University Institutional Review Boards Request for Protocol(s)-Proposal Congruency • Proposal PI (if also Protocol PI(s)) submits the Form 100 FR26 with relevant protocol documents to HIC/HSC; otherwise, Proposal PI forwards the Form 100 FR26 to the Protocol PI(s) to submit to the HIC/HSC along with relevant protocol documents for review and congruency determination • Once determined congruent, the completed form is sent by the HRPP office to GCA for entry into IRES PT • Review and Submission of JIT • GCA Coordinator confirms that the form is uploaded and information is entered into the record • If missing, the Coordinator will contact the DBO who will work with the PI to get the form submitted to the HIC/HSC • If not completed by time of JIT submission deadline, if awarded, setup will be restricted in accordance with the terms and conditions until complete

9. Roles and Responsibilities • Department Business Office • Works with the PI to ensure Form 100 FR26 is submitted to the HIC/HSC • GCA • Utilizes the JIT checklist to remind the PI of the requirement to submit the form to HIC/HSC • Uploads form 100 FR26 and enters the protocol(s) approval, expiration, and congruency dates in IRES PT after the receipt of form from the HIC/HSC prior to the submission of JIT • Proposal Principal Investigator (PI) • Completes Form 100 FR26 and submits the form along with relevant protocol documents to the HIC/HSC – OR - • Directs the Protocol PI(s) (if different from Proposal PI) to submit to HIC/HSC prior to the completion and submission of JIT

10. Roles and Responsibilities – cont’d • HIC/HSC • Conducts congruency review on all protocols listed on form • Issues congruency determination to the protocol PI(s) via an approval letter • Submits form 100 FR26 to GCA with congruency determination date

11. Timeline

12. Questions??

13. Resources GCA Cynthia Kane Associate Director 203-785-6762 cynthia.kane@yale.edu Laura Kozma Assistant Director 475-238-5276 laura.kozma@yale.edu HRPP Cathleen Montano IRB Manager 203-785-7182 cathleen.montano@yale.edu