Research Roundtable: Just-in-Time (JIT) Submissions to the IRB

The JIT typically includes Institutional Review Board (IRB) approval. However, in many cases, submissions that are awaiting funding awards do not have all of the human subjects specifics laid out yet. So, how can you receive IRB approval without a completely fleshed-out study? This edition of “Research Roundtable” describes the process to follow in order to submit a JIT submission in Click and how to receive an IRB “approval” that has been accepted by NIH and NSF.

Your study will fall into one of two categories: it will either be complete and ready for typical IRB review, or incomplete with not all study details and documents present. How you submit your study in Click and the review process itself depends on this.

If your IRB submission is complete and ready to be reviewed by the IRB, you can complete your Click submission as you would with any other study. (For more details on how to submit your study in Click, refer to “Research Roundtable: Understanding Your IRB Workflow.”) This includes completed versions of documents related to your study, such as the HRP-503 Protocol, relevant HRP-502 Consent Forms, study questionnaires, etc. You will need to submit your study in Central Study Registration first if you have not already done so.

After submitting your study in Click, select “Add a comment” to inform the IRB that your study is a JIT submission and is time sensitive. This will move the IRB to prioritize your submission. You may also call the IRB office at 716-888-4888 or email ub-irb@buffalo.edu.

A complete submission will go through the normal IRB review process required for approval, such as checking on study team members’ Conflict of Interest disclosures and completion of CITI courses. The IRB reviewer may ask for clarifications on study documents to ensure the study meets all applicable categories on the HRP-314 Criteria for Approval Worksheet, or the HRP-312 Exempt Worksheet for Exempt studies.

Many JIT submissions occur in which the grant submission is complete, but finer study details and specifics have not yet been created. For example, you may have an idea of specific questionnaires you want to use or how many study visits there are, but you do not have a recruitment plan or know what should be included in your Consent Form.

If your IRB submission falls into this category, follow these instructions to receive IRB acknowledgment of your submission:

• Submit your JIT IRB submission as a “Reportable New Information” (RNI) in Click. This is available on the left-hand side of your IRB home page.

• Complete the RNI form by answering the questions to the best of your ability. Question 3, “Identify the categories that represent the new information,” can be left unchecked, as these do not apply for JIT submissions and it is not a required field.
• In question 7, “Attach files containing supporting information,” attach the study grant proposal and a completed UBIRB HRP-511 Just-In-Time Study Information Form. The HRP-511 Form is available in the Click Library under the “Worksheets” tab. An image of the form and its questions is seen below, along with question 7 in the RNI form.

• Remember to “Add a comment” when submitting your study to inform the IRB that this is a JIT submission. Doing so will notify the IRB to prioritize this submission as quickly as possible. You may also call the IRB at 716-888-4888 or email at ub-irb@buffalo.edu.

The IRB will review the submission and send an Acknowledgement Letter that the study meets the requirements of 45 CFR 46.118. Both NIH and NSF have accepted these Acknowledgement Letters using this process. The IRB review will likely take place more quickly than a complete submission would because only an acknowledgement will be given, rather than full approval.

Note that receiving the IRB acknowledgment of a JIT submission letter is NOT an IRB approval.

The UB IRB requires that a complete study submission must be submitted for IRB review within one year of IRB acknowledgment of the JIT. No human subjects activity, including recruitment, can occur until the complete study is reviewed and approved by the IRB. Conducting research before receiving IRB approval will result in serious non-compliance and could be reportable to the Office for Human Research Protections (OHRP).

When you are ready to submit your new study for full IRB approval, please include the RNI number of the original JIT submission in a comment.

NOTE: If you have already entered your JIT study into Central Study Registration (CSR) before going through the IRB process, put a comment in CSR to let administrative staff know that it is a JIT submission.

If you have any questions or concerns about your JIT submission, please call or email the UB IRB at 716-888-4888 or ub-irb@buffalo.edu.

The Click Library includes the HRP-511 Just-In-Time Study Information Form in the “Worksheets” tab. The “General” includes a document with much of the same information as this article, titled “Tips from the IRB ­ JIT Submissions.”

Some helpful links for 45 CFR 46.118 include:

• https://www.hhs.gov/ohrp/regulations-and-policy/regulations/2018-req-preamble/index.html#46.118 
• https://www.hhs.gov/ohrp/regulations-and-policy/regulations/annotated-2018-requirements/index.html#46.118  

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