To help you avoid common delays and obtain IRB approval more efficiently, the following consolidated list outlines key reasons for processing delays and practical tips to address them:

1. Incomplete submission – Missing or Inadequate Supporting Documents

• Use the appropriate application checklist (i.e., Full Board, Exempt, Expedited, Facilitated) to ensure all required forms (e.g., informed consent, HIPAA authorization, recruitment materials) are included.
• If requesting expedited review, include the Request for Expedited Review Form
• If requesting exemption, include the Request for Exemption Form
• Start your IRB application after you have finalized your protocol and supporting documents.
• Always attach any required checklists, such as the Main Consent Form Checklist and/or Recruitment Material Checklist

2. Incomplete or Poorly Written Protocol

• Your protocol must clearly describe the research design, procedures, timeline, and all study phases—planning, implementation, and evaluation.
• Use the protocol template provided on the HSPP/IRB website.
• Include a thorough explanation of recruitment, informed consent, study procedures, risk minimization, and data protection.

3. Missing Required Signatures or CITI Training

• Ensure all UConn Health personnel have completed the appropriate CITI Human Subjects Protection Training, including any required modules specific to UConn Health and affiliated with UConn Health (to ensure completion of all required training modules, and training will be auto-updated in their IRIS account)
• For external collaborators, submit proof of equivalent training from their home institution.
• Go to CITI Instructions for Human Subjects Training at UConn Health on the HSPP/IRB website for additional information.
• Track the submission history and remind key personnel to sign off on the submission.  Do not cancel any sign-off tasks on the initial submission.

4. Inconsistencies Between Documents

• Make sure information is consistent across your protocol, informed consent form, and IRB application (e.g., number of participants, procedures, study duration).
• Review all documents before submission and, if possible, have a second person conduct a final quality check.

5. Inadequate Description of Recruitment and Consent Procedures

• Clearly explain:
  • How and by whom participants will be identified and approached.
  • Any relationships between the research team and participants that could influence consent.
• Consent forms must:
  • Be written in plain language.
  • Include all required elements.
  • Have required elements as noted on the Main Consent Form Checklist.
  • Consider using the Main Consent Template on the HSPP/IRB website

6. Incomplete Risk/Benefit Analysis

• Provide a thoughtful evaluation of potential risks (physical, emotional, confidentiality, etc.) and steps to minimize them.
• Clearly state potential benefits to participants and/or society.
• Ensure risks and steps to minimize them are consistent among the application, protocol and consent.

7. Lack of a Robust Data Confidentiality Plan

• Describe how data will be:
  • Collected, stored, and secured.
  • Accessed (by whom).
  • De-identified or anonymized.
  • Retained or destroyed after the study ends.

8. Ignoring Pre-Review Feedback

• A Regulatory Specialist will pre-screen your submission and may issue a Submission Correction Form with required edits.
• Respond promptly and thoroughly to avoid delays in full review.

9. Failure to complete submission or sign-offs

• If your submission was ‘sent’ to the IRB more than a week ago and you haven’t heard anything, it’s most likely that the submission is stuck somewhere on the study team side.  Go into IRIS and look at the submission process.  Reach out to the IRB for assistance.

By proactively addressing these common issues and following the outlined tips, your IRB submission process will be smoother and more efficient.