NIH Investigator Manual for Human Subjects Research

• Created by Swan, Jeremy (NIH/NICHD) [C], last modified by Pauly, Kelly (NIH/OD) [E] on Mar 20, 2024

Chapter 5 - Submitting Your Initial Review

---

Overview

Key Points

• Ensure that all required documents and approvals are uploaded in the electronic IRB system.
  
  
• Incomplete submissions will result in delay of the IRB's review of your protocol.

What forms and documentation do I need to provide with my submission for initial review of my protocol by the IRB?

• Protocol
  
  
• All consents and assents
  
  
• FDA approvals and letters
  
  
• Drug Investigator Brochures/Package Inserts
  
  
• Recruitment materials
  
  
• Forms or videos that collect or provide research specific information that are used by subjects such as questionnaires, drug diaries, temperature tracking logs, etc.

Once I submit my Initial Review for non-exempt human subjects research in the electronic IRB submission system, what happens next with my submission?

1. Pre-review Clarifications: Before your submission is reviewed by the IRB, one of the IRB Analysts will review your submission to make sure that the submission package is complete. They may send stipulations in the electronic IRB system asking for additional information or corrections to the submission. The goal of this process is to address any potential barriers that may cause delays in approval before the protocol is reviewed by the IRB.
   
   
2. Expedited Review vs. Full Board:
   1. Expedited Review: If the protocol is eligible for expedited review, an IRB Chair or an IRB Chair Designee will review the protocol for approval. An IRB Chair Designee must be an experienced IRB member. The period of approval begins on the day research is approved by the designated expedited reviewer and continues until the date the study is closed or through a specified date according to Continuing Review (CR) requirements. (Refer to the earlier section of the manual that relates to expedited review for more information.)
      OR
   2. Full Board IRB Review: The protocol must be reviewed by a fully convened IRB to receive approval. The protocol will be assigned a meeting date that can be viewed in electronic IRB system.
      
      
3. Possible IRB Determinations after Expedited Review of the protocol:
   1. Approval: The Expedited Reviewer has determined that the protocol has met the criteria for IRB approval of research. Please see the next chapter for additional actions that must take place before starting enrollment after IRB approval.
   2. Modifications Required to Secure Approval: The Expedited Reviewer has determined that the initial review submission needs modification to meet the criteria for IRB approval of research. This may include changes to the protocol/consent; the submission of additional information; or additional actions that need to take place before the protocol can be reconsidered for approval. The Expedited Reviewer will work with the research team to ensure that the protocol meets all approval criteria.
   3. During the expedited review process, it is always possible that additional information may be discovered that requires the protocol be referred for review by the Full Board. The reason for this change should be communicated to you by the Expedited Reviewer or IRB Analyst.
      
      
4. Possible IRB Determinations after Full Board Review of the protocol:
   1. Approval: The IRB has determined that the protocol has met the criteria for IRB approval of research. Please see the next chapter for additional actions that must take place before starting enrollment after IRB approval.
   2. Modifications Required to Secure Approval: The IRB has determined that the protocol has met the criteria for IRB approval of research; however, this is dependent on the acceptance of changes required by the IRB. This option is used when the IRB is able to provide specific necessary changes that avoids deferral of the submission and delayed IRB approval.
   3. Deferred: The convened IRB is unable to determine that the criteria for IRB approval have been met. The IRB will require modifications to the submission that may include changes to the protocol/consent; the submission of additional information; and/or additional actions that need to take place before the protocol can be reconsidered for approval. The changes will require review by the convened IRB.
   4. Disapproved: The IRB has determined that the protocol does not meet the criteria for IRB approval of research. The research team will have to submit a new initial review submission if this occurs.
      
      

---