Submitting a request for a Consent to Contact participant list via REDCap
The University’s Consent to Contact (CTC) initiative is a program by which UHealth patients can consent to be contacted about research study opportunities for which they qualify. From this CTC pool, researchers may identify potential willing research participants who meet their study criteria. All requests to utilize this tool for recruitment must be approved by the CTC Operational Committee (CTCOC), which includes representatives from Clinical Depts, Research, CTSI, General Counsel, HSRO etc.
Prior to submission, check the following:
- Feasibility – perform a feasibility check/query using existing tools (i.e. URIDE, Slicer Dicer) to verify whether UHealth has patients meeting study criteria
- Inclusion/Exclusion Criteria - Determine the applicable Diagnosis Codes (ICD-10/ICD-9) and Procedure Codes (CPT/HCPCS) as well as other relevant criteria (age ranges, providers, locations, start and end dates of service) for the population of interest
- IRB Approved Protocol – have approval and IBISResearch number
- Consent to Contact must be listed as a method of recruitment in the study protocol
- Related Consent to Contact documents (i.e. script, sample dialogues, MyUHealthChart template message ,etc.) need to be listed in IBISResearch
- Obtain a waiver of authorization from the IRB
- Study team members that will be calling the patients should be listed on the Study Team section in eProst
- Complete the Consent to Contact REDCap form available here
What to include:
- IBISResearch Number
- Project Title
- PI Name & UM e-mail
- Project Summary
- Research area/pillars
- Inclusion/Exclusion criteria
- Study team member names & c-numbers of who will be calling and accessing participant data
- Date range for request
Considerations:
- Please obtain the appropriate HIPAA waivers of authorization prior to submitting the Consent to Contact request. Please review the HSRO’s Consent to Contact page for additional information.
- Complete the Consent to Contact script template.
- If requesting use of MyUhealthChart (UChart patient portal) then this must be explicitly mentioned in protocol. Note, please indicate in Redcap request if this is the only population wanted ; this will further restrict the available pool to only those who meet the criteria AND have an active MyUHealthChart account. Please contact the CTSI CTC resource for specific training requirements, prior to making a request involving MyUHealthchart recruitment. See CTSI CTC contact information below.
- Consent to Contact subject list will only be available in REDCap for 90 days
- Extensions, data refreshes with same or modified criteria can be requested, again via the same Redcap form. Note any changes in inclusion/exclusion criteria for the CTC Redcap project need to be consistent with the underlying protocol. Sometimes this may require a formal MOD to the protocoll via IBISResearch.
- All study team members /REDCap project users should have completed UHealth’s HIPAA Privacy & Security training.
Contact Information
