1. Capturing IRB Protocol-Proposal Congruency For 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. Protocol application(s) must be reviewed and approved by the IRB
Requirement: 45 CFR (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 Review and Submission of JIT
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
Laura

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
Tracy

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 Date Activity June 1, 2014
communication sent to the research community
June 6, 2014
G&C Alert sent
June 10, 2014
Brown Bag
June 16, 2014
New process is implemented
June 23, 2014
August 2014 (TBD)
Laura

12. Questions??

13. Resources
GCA Cynthia Kane Associate Director Laura Kozma Assistant Director HRPP Cathleen Montano IRB Manager
Laura