Request Consent To Contact

The University’s Consent to Contact (CTC) program enables UHealth patients to consent to being contacted about research studies for which they may qualify. Researchers can use this pool to identify potential participants who meet study criteria. To request access, you must follow the steps below and obtain approval from the CTC Operational Committee (CTCOC), which includes representatives from Clinical Departments, Research, CTSI, General Counsel, HSRO, and others.

  • Step 1: Confirm Feasibility
    • Use tools like Slicer Dicer to check if UHealth has patients meeting your study criteria.
  • Step 2: Define Study Criteria
    • Identify:
      • Diagnosis Codes (ICD-10)
      • Procedure Codes (CPT/HCPCS)
      • Other relevant criteria (age range, provider, location, service dates, medications).
  • Step 3: Ensure IRB Compliance
    • Obtain IBISResearch IRB Study ID and full approval.
    • Confirm Consent to Contact is listed as a recruitment method in your protocol.
    • Include related documents:
    • Secure waiver of authorization from IRB.
    • List all study team members who will contact participants in the IRB Study Team section (include names and UM emails).
  • Step 4: Complete HIPAA Training
    • All team members accessing participant data must complete UHealth HIPAA Privacy & Security training.
  • Step 5: Complete the REDCap form
  •  Include:
    • IRB Study ID
    • Project Title
    • PI Name & UM email
    • Project Summary
    • Research area/pillars
    • Inclusion/Exclusion criteria
    • Study team member names & C-numbers
    • Date range for request
  • Step 6: Address Special Considerations
    • If using MyUHealthChart:
      • Mention explicitly in protocol.
      • Indicate in REDCap if this is the only population desired.
      • Contact CTSI for training before requesting MyUHealthChart recruitment.
  • Step 7: Submit and Track
    • Submit the REDCap form.
    • Track participant responses in REDCap (required for future approvals).
    • Answer the question: “Has the participant been enrolled in the clinical study?”
  • Step 8: Manage Access
    • Participant list is available for 90 days.
    • For extensions or data refreshes:
      • Submit via the same REDCap form.
      • Ensure any changes align with the protocol (may require formal modification in IBISResearch).

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