Consent to Contact for Research (CCR) Registry

Current University policies limit acceptable recruitment methods for patients, when eligibility is assessed through review of medical records, in order to keep private patient information secure. Acceptable recruitment methods typically require the patient to be introduced to a study through the patient's treating physician or on behalf of the relevant medical director. The process for contacting patients through a medical director involves several steps for which the IRB provides guidance.

The Consent to Contact for Research (CCR) Registry enables researchers to access and contact patients who indicate their willingness to be contacted for research, based on information in their medical records, without an initial connection through their treating physicians or medical director. Patients can elect to be included in this registry of patients to be contacted for research opportunities by completing a consent form in the Epic patient portal (Connect). They are then contacted via a Connect message and can provide their interest in a study, after which researchers can contact these potential participants directly.

To schedule a CCR consultation, please visit here. 

To start the CCR process, you will need to submit a modification within Rascal to utilize the CCR Registry. The modification should include the required template for outreach to patients in the CCR registry, along with a CCR-specific HIPAA Form C to the IRB protocol.

Instructions for how to submit the request to utilize the CCR registry to new protocols, renewals and modifications can be found here.

Other requirements include:

  • TRAC Request (using UNI and UNI password)
  • Study registration in the Clinical Trials Management System (CTMS) - please complete a Study Intake Form

Yes, each study must obtain IRB approval to use CCR as a recruitment method. Only IRB-approved text and language can be used to send out study information to the patients in the CCR cohort.

Once IRB approval is obtained for the use of the CCR registry, a Tripartite Request Assessment Committee (TRAC) request must be submitted and approved. The criteria and type of data that is specified in the TRAC request ticket must match the information that was submitted to the IRB and approved. Inconsistencies between the TRAC request and the IRB-approved protocol will result in delay of approval of the TRAC request.

Researchers should fill in fields with certain values to utilize CCR:

  1. In the "Business justification and what you are trying to solve" section of the form, the requester must include the following sentence: "We intend to use CCR functionality to recruit patients."
  2. In the "Data elements to display" section of the form, the requester must include the following variables:
  • Patient ID
  • Patient First Name
  • Patient Last Name
  • MRN
  • Research Study ID

No. The CCR registry does not currently include minors, as the CCR consent form is only presented to patients who are at least 18 years old. 

Patients who have consented to be contacted for research and meet the criteria to receive information about specific studies will receive the information through their Connect portal account. Only patients who have an active Connect account can sign the CCR consent form and receive CCR messages.

The IRB approved study description will be sent once to each patient via Connect, who can indicate in Connect if they are interested in receiving more information or decline the invitation. The Epic Reporting Workbench will record and track when messages are sent to the patient cohort through CCR.

Potential participants who do not respond in Connect will be sent the information by Qualtrics or REDcap. Reminders will be sent a maximum of 2 times. Investigators are responsible for recording and tracking communication through this method.