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• All research subjected to FDA regulation requires at least an annual CR, regardless of whether the research is subject to the pre-2018 or 2018 Common Rule.
• If the study is under the pre-2018 Common Rule, all non-exempt research requires a continuing review.
• If the study is under the 2018 Common Rule, all non-exempt research that requires full board review requires a continuing review.
• TIP: If your protocol has an expiration date, your protocol requires continuing review. The outcome letter from the approval of the Initial Review will contain the expiration date of the CR.

What protocols only require an Annual Progress Report instead of a full CR?

• Unless the IRB determines otherwise, if the study is under the 2018 Common Rule and falls into one of the categories below, no continuing review is required, but an annual progress report may still be required by the NIH IRB.
  • Eligible for expedited review (Unless it is FDA regulated or determined to be expedited under category 9 or category 8b)
  • Research under limited IRB Review
• Research that has progressed to only data analysis with identifiable information/specimens, or research is limited to only follow-up data collection from subjects undergoing clinical care.
• In this case the same Progress Report Form is used but required information will be more limited.
• TIP: If your protocol does not have an expiration date, only an Annual Progress Report is required. You will receive a reminder in iRIS before the due date of the Annual Progress Report.

How often must my protocol go through Continuing Review?

• The IRB determines the timeframe of the subsequent CR at time of protocol review. Most protocols will be reviewed every 12 months. However, the timeframe may be shortened by the IRB if the IRB determines that more frequent review is required. Possible reasons the IRB may require more frequent CR is if the protocol is high risk, or the protocol requires prompt modifications. This will be indicated on the outcome letter from the IRB meeting and the exact expiration date will be provided.
• The expiration date cannot be extended and there is no grace period.
• The time between two CRs can be no more than 364 Days. The expiration date will be set from either the date of the Full Board IRB meeting or the date the submission is approved by the expedited reviewer. The date will be included in the Continuing Review NIH IRB Approval letter.
• You will receive a reminder in iRIS the eIRB system that the due date for the CR is approaching. It is recommended that you submit the Progress Report Continuing Review Form in the electronic IRB system at least six weeks before the due date to ensure that the protocol does not expire.

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What forms must be submitted in the electronic IRB system for a Continuing Review?

• Note that no changes Modifications to the protocol or consent form(s) are permitted as part of the Continuing Review (CR). However, any changes can be submitted as a separate amendment and both submissions may be reviewed at the same meeting.
• Progress Report (Check box format)
  • Updated demographic information on enrolled subjects and study accrual
  • High-level summary of reportable events and adverse events (See Tips & Tricks for When Submitting to the NIH IRB.)
  • Any unresolved subject complaints
  • DEC clearance for covered protocols
  • DSMB/SMC/IMC Review (consistent with the protocol DSMP)
  • Progress of Research and Justification to continue
  • Updates on Publications or Risk information
• Whether there are modifications or not, you must complete the Modification/CR Form to submit your continuing review.
• Modification/CR Form: the following information is collected via check box format, as applicable
  
  • Information about any subjects who experienced unexpected harm
  • Any anticipated adverse events that have taken place with greater frequency or severity than expected  
  • Subjects who withdrew from the study    
  • Any unanticipated problems involving risks to subjects or others    
  • Unresolved complaints about the study    
  • Publications in the literature relevant to risks or potential benefits  
  • Any interim findings    
  • Any multi-center trial reports    
  • Data safety monitoring reports    
  • Regulatory actions that could affect safety and risk assessment  
  • Other relevant information regarding the study, especially information about risks    
  • Explanation if the PI thinks the risks and potential benefits have changed
  • Any modifications to the protocol that have not been submitted to the IRB  
  • Any problems that require prompt reporting to the IRB have not been submitted
  • Information about use of the short form process   
  • Any non-compliance that has occurred (including minor or major deviations)   
• Study Information Form
  
  • Double check that the study information is complete.
  • For multicenter studies,
  Study Application
  • Double check that the study personnel is listed completely and correctly in the proper sections.
  • Review for updates or changes since the last CR. These most likely would be from an Amendment that was approved during the review period.
  • For multicenter studies. make sure the information related to the sponsor, the coordinating entity, and other sites is up to date and correct.
• Attachments
  • Redacted consents (See Tips & Tricks for When Submitting to the NIH IRB.)
    • The latest consent and/or assent of all available document types. (i.e., Healthy Volunteer, Standard, Screening, Recipient, Donor, etc.)
    • If there has been no enrollment during the Continuing Review period, this is not required.
    DEC clearance for covered protocol
  • DSMB/SMC/IMC Report
  • For multicenter studies: If the NIH is the coordinating center and there are sites under local IRB review, provide the CR approval letters from the local IRBs or Ethics Committees.
  • Any supporting documentation from sponsors or manufacturers including updated investigational brochures.
  • Audit results relevant to the continuation of the research.

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• The submission will undergo a pre-review by one of the IRBO Analysts. They will make sure that the submission is correct and contains all the needed components. They will also anticipate the needs of the IRB and may request additional information by sending back pre-review stipulations a request for clarification to the research team.
• The submission will then be assigned to an IRB meeting or an expedited reviewer. You will be able to see the date that the submission will be reviewed in the electronic IRB system.
• Once the IRB reviews the submission, the following outcomes will be communicated by an outcome letter in the electronic IRB system:
  • Approved
  • Modifications required to secure approval
  • Deferred
  • Disapproved 
  • Reviewed-Response Required: This means that they have reviewed the study, but certain information is required, or action needs to take place before your study is approved.
  • Approval with Stipulations: The study has been approved, but there are certain actions that are required for this approval. The CR approval period may be shortened to make sure these actions occur.
  • Approval: The study has been approved until the next CR.

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