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., Oneness Research Solution, Slicer Dicer) to determine if UHealth has patients that meets the study criteria.
- Inclusion/Exclusion Criteria - Determine the applicable Diagnosis Codes (ICD-10) and Procedure Codes (CPT/HCPCS) as well as other relevant criteria (age ranges, providers, locations, start and end dates of service, medications etc.) for the population of interest.
- IRB Approved Protocol – have IBISResearch IRB Study ID number and full approval.
- Consent to Contact must be listed as a method of recruitment in the study protocol
- Related Consent to Contact documents (i.e. phone script template, sample dialogues, MyUHealthChart template message ,etc.) need to be included in the protocol submission documents
- Obtain a waiver of authorization from the IRB
- Study team members that will be calling/contacting the Consent to Contact participants should be listed on the Study Team section in IRB Study ID number.
- Have names and UM e-mail.
- Complete the Consent to Contact REDCap form on the CTSI CTC page available here.
What to include:
- IBISResearch IRB Study ID 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 phone 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 CTSI for specific training requirements prior to making a request involving MyUHealthChart recruitment. See CTSI CTC contact information below.
- Consent to Contact participant list will only be available in REDCap for 90 days. After 90 days, you will be required to submit an extension of access via the CTSI CTC REDCap form available here.
- Requests for extensions and data refreshes, whether using the same criteria or modified criteria, can be submitted through 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 protocol via IBISResearch.
- All study team members /REDCap project users should have completed UHealth’s HIPAA Privacy & Security training.
- Ensure to track participants’ responses in the REDCap project. Lack of tracking will result in disapproval of future Consent to Contact requests.
- Ensure to answer the question of “Has the participant been enrolled in the clinical study?” This question is critical to secure continuous use of Consent to Contact for the recruitment of the study.
Contact Information
