Not-For-Cause Compliance Reviews

Post-Approval Monitoring

One way that ETSU’s Human Research Protection Program (HRPP) ensures participant protection is through post-approval monitoring, which includes procedures such as administrative check-ins and compliance reviews. These procedures are used to confirm that researchers are adhering to the IRB-approved protocol.  

Compliance reviews can be “for-cause” or “not-for-cause" (NFC). The purpose of not-for-cause compliance reviews is to promote ethical and effective practices in research with human subjects. These reviews are intended to educate the research community and improve the quality of research at ETSU.  

No less than nine studies per calendar year will be randomly selected for a not-for-cause compliance review in accordance with the ETSU IRB’s Quality Assurance Policy, and they will be conducted by the IRB Education & Quality Specialist.

Types of Not-For-Cause Compliance Reviews 

Not-for-cause compliance reviews could include the entire study, or they may only focus on specific components of the study. For the duration of 2025, the HRPP will primarily conduct focused reviews. Focus areas are subject to change annually based on needs identified by the HRPP and IRB. The focus areas for 2025 are as follows: 

• 
  Informed Consent Documents (ICDs) & Procedures
  • ICD Self-Review Checklist
• Data Storage
  • Data Storage Self-Review Checklist
• Recruitment & Participant Selection
  • Recruitment & Participant Selection Self-Review Checklist

What to Expect

• Step 1: Initial Notice

  • The PI, study CC recipients, and faculty advisor (if applicable) will be notified no less than 3 weeks prior to review.
  • The notice will include the area of focus and corresponding self-review tool. 
  • If the HRPP is unable to reach the PI, then the HRPP may contact the PI’s department leadership as appropriate.  
• Step 2: Scheduling

  • The PI and/or designated study staff member will work with the IRB Education & Quality Specialist to schedule the review (review should take place approximately 3 weeks from initial notice). 
    • Some reviews may require the attendance of a Faculty Mentor or another study staff member. The IRB Education & Quality Specialist will let you know if additional personnel need to attend your review. 
  • The PI may choose whether to have the not-for-cause compliance review in person or via Zoom.
  • The IRB Education & Quality Specialist will let the PI know what documents will be needed for the review.
• Step 3: Preparing for the Review

  • The PI will use the self-review tool to ensure that their study is following all relevant procedures as approved by the IRB. 
  • The PI will make sure all necessary documents are accessible by the time of review. 
  • If the PI finds that their study is not following protocol as approved by the IRB, then they may contact the IRB Education & Quality Specialist for guidance on how to proceed ahead of the review. 
• Step 4: Review is Conducted

  • The PI and at least one study staff member (if applicable) must be present for the review.  
    • Student PI’s must have their Faculty Mentor present. 
  • The PI will provide the IRB Education & Quality Specialist with all requested documents.  
    • For Zoom reviews, paper documents must be scanned and shared at least 1 business day before the review. 
  • The IRB Education & Quality Specialist may interview the PI and study staff member separately (if applicable).  
  • The review will only include questions from the applicable self-review tool. Because the self-review tool uses “Yes/No” questions, the IRB Education & Quality Specialist will review study documents and ask for descriptions of different study procedures to determine final “Yes/No” answers.  
    • The IRB Education & Quality Specialist will not ask about anything that is not included in the self-review tool, unless there appears to be noncompliance. In the event of apparent noncompliance, the IRB Education & Quality Specialist will need to ask further questions.
• Step 5: Report of the Review

  • The IRB Education & Quality Specialist will compile a report of the review findings and any recommended corrective actions to present to the HRPP Director. 
    • The IRB Education & Quality Specialist may contact the PI if clarifying information is needed. 
  • Once the HRPP Director approves the report, it will be shared with the PI and documented in OneAegis. In OneAegis, the PI will sign to verify that they have read and understand the report.  
  • If necessary, the IRB Education & Quality Specialist will contact the PI to discuss any necessary corrective actions. Depending on the recommendations, a follow-up meeting may be required. 
    • If non-compliance is found, then the IRB Education & Quality Specialist will procede with reporting non-compliance as outlined in the ETSU IRB's Non-compliance Policy.  
• Step 6: Review Completion & IRB Notice

  • If no recommended actions are included in the report, then the not-for-cause compliance review will officially be complete once the PI has acknowledged and signed the report in OneAegis. 
  • If the report does include recommended actions, then the review will not be complete until all recommended actions have been fulfilled.  
  • At the end of each semester (Spring, Summer, and Fall), the IRB Education & Quality Specialist will present a report of that semester’s not-for-cause reviews to the IRB.  

How Studies are Selected

Criteria used for random study selection may vary and are subject to change annually. For the 2025 calendar year, selection criteria will be based on each area of focus. To select a study, the IRB E&Q Specialist will run a report of active studies that meet the relevant criteria, then use a random number generator to choose a study from that report. The selection criteria for each focus area are as follows:

• Informed Consent Documents (ICDs) & Procedures
  • Open studies with a signed informed consent process and/or parental permission process
• Data Storage
  
  • All open studies are eligible for a Data Storage NFC Compliance Review
• Recruitment & Participant Selection
  • Open studies currently enrolling participants and not solely reliant on seconday data analysis
    
    

A PI may request that their study be selected for a not-for-cause review by contacting the IRB Education & Quality Specialist. The HRPP may decline to review a study if it does not meet the selection criteria.  

Who to Contact