Update to the Just-In-Time/118 Letter Process
As a reminder, the Office of Sponsored Programs (OSP) and the School of Medicine Sponsored Programs Office (SOMSPO) are providing guidance on National Institutes of Health (NIH) Just-In-Time (JIT) requests related to human subjects research.
If an Institutional Review Board (IRB) approval of a protocol is needed for a sponsored program, either the approved IRB protocol number or a 118 Letter from the Office of Human Research Ethics (OHRE) must be provided.
Just-in-Time / 118 Letter
OHRE issues a letter, known internally as the “118 Letter,” for federally-funded applications and proposals that do not have definite plans for involving human subjects.
This letter does NOT constitute IRB approval.
Therefore, do not enter the date of the 118 Letter in the IRB approval date field in the JIT module of eRA Commons.
Project Delays
For projects facing significant delays in start date or IRB approval, it is advisable to request a delay in onset from the sponsor if the project will be submitted to the IRB for a 118 Letter.
JIT/118 Process Reminders
Department Responsibilities:
- Provide either the IRB study record number or 118 Letter via the RAMSeS Internal Processing Form.
- Date of the IRB study approval document should be entered as the IRB approval date in the JIT module of eRA Commons.
Central Office (OSP/SOMSPO) Responsibilities:
- Approve and submit all JIT materials to the sponsor.
- Confirm approval date of the IRB study record number is accurately reported during the JIT process.
- During JIT submission, only the IRB approval date will be shared. Full IRB documentation is provided only upon request by the sponsor.
Additional Resources
- OHRE Just-In-Time/118 Letter Process
- OSP – 300.10, Procedure 1 – Completing JIT Requirements for NIH Proposals
- OSP – 300.10 – Just-in-Time Submission Requirements
- NIH JIT Procedures
- NIH JIT Procedures for Grants Involving Human Subjects
- Submit a JIT in eRA Commons
Contacts
- Contact your department’s OSP SPS or SOMSPO Grants Analyst for questions on specific proposals.
- Contact OHRE for questions regarding IRB review and process.
- Contact SponsoredPrograms@unc.edu for all other questions.