Patient-Outreach Recruitment

MUSC as an Opt-Out Institution

MUSC, along with many other prestigious academic medical centers across the country, is an opt-out institution with regards to cold-contacting patients for study recruitment purposes. Being an opt-out institution means that, with proper IRB approval, research personnel, regardless of their clinical relationship with a patient, can contact anyone who has not indicated an “Opt-Out” Research Contact Preference. There are currently 3 ways that patients can indicate their opt-out preference: Completing the Research Contact Preference Questionnaire in MyChart, contacting MUSC, and having the Research Preferences Manager log their preference, or expressing their desire to opt-out when contacted by a study team about participating in a research study.

As an opt-out institution we are able to reach more people about research and ensure that discoveries made lead to the best possible outcomes for our diverse communities. Every member of the community should have the opportunity to learn how to be a part of the research process, to experience any benefits that might come from that participation, and to contribute to the overall health and well-being of the greater community. We believe that our obligation, as a leading academic medical center, is to offer the very best care to our patients; this includes providing increased research awareness and opportunities to the lives we touch.

MUSC patients can receive additional information about research participation and our opt-out policy at Clinical Trials & Research at MUSC.

Employing Patient-Outreach Methods for MUSC Patient Recruitment

MUSC defines patient-outreach recruitment, also known as cold-contact recruitment, as when an individual is contacted by someone they do not know and the contact is unexpected. Applied to clinical research, MUSC considers patient-outreach recruitment to be when a patient is contacted by a study team and neither the Principal Investigator (PI) nor the Co-Investigator (Co-Is) is a member of the patient’s clinical care team. This method of recruitment may employ various modes of communication including phone calls, emails, MyChart message, etc.

If the PI or Co-Is of a research study (or their delegated study team members) is contacting his/her own clinical patients about participating in a research study, this is NOT considered patient-outreach recruitment.

Patient-outreach is listed as a potential strategy for recruitment in the MUSC Institutional Review Board’s (IRB) Recruitment of Research Participants policy (HRPP Section 7.8). Patient-outreach recruitment, however, may not be appropriate for all studies. If you desire to utilize a patient-outreach recruitment strategy, it is important that you provide a compelling justification for the appropriateness of this type of recruitment strategy in your IRB application. Patient-outreach recruitment, like any other recruitment strategy, cannot be employed without proper IRB approval. The IRB will review every application on a case-by-case basis and make the determination as to whether patient-outreach is allowable for a specific study.

A consultation with the Research Preferences Manager is available to discuss the use of patient-outreach recruitment at a protocol level and can be requested by submitting a ”Patient-Outreach Recruitment Consultation” in SPARCRequest.

IRB approval for patient-outreach recruitment is required prior to submitting a Research Data Request. Please review the IRB’s Recruitment of Research Participants policy (HRPP Section 7.8) to determine the appropriateness of utilizing patient-outreach recruitment strategies.

Guidance on submitting an application for an expedited/full board study utilizing patient-outreach recruitment is available here.

IRB submissions requesting to utilize cold-calling will be required to utilize the Cold-Call Script template. Please download the template, add the appropriate study information, ensure that the IRB watermark is included within the document, and submit as part of your IRB application.

In order to utilize patient-outreach recruitment, your study must have a REDCap recruitment project created by an MUSC honest broker, containing potentially eligible patients who have not opted out of research contact. The steps below outline the process of requesting/obtaining a REDCap Recruitment Project for your study.

1) Submit a Research Data Request in SPARCRequest.

2) Upon receipt of your Research Data Request, and honest broker will send you a Research Data Request Mini Form. The Research Data Request Mini Form Completion Instructions provide guidance on best practices for completing this form for cold-contact recruitment.

3) The study team will have a consultation with the assigned honest broker to complete the Research Data Request Form.

*Please note, this data request cannot be fulfilled until IRB approval for cold-contact recruitment has been obtained.

4) Once the Data Request Committee (DRC) has approved your request, the honest broker will create your REDCap recruitment project. Prior to gaining access to the project, any study staff wanting access will be required to attend a consultation with the Research Preferences Manager to receive training. PIs and Co-Is (with the exception of students and trainees) will be invited to attend the consultation but are not required.

*Students and trainees acting as PIs or Co-Is, as well as their mentors, will be required to attend a consultation with the Research Preferences Manager to gain access to their REDCap recruitment projects.

In addition to the training received from the Research Preferences Manager during the mandatory “Patient-Outreach Recruitment Consultation”, the study team is also provided detailed written instructions for utilizing REDCap recruitment projects and documenting patient contact when they are granted access to the project.

Documentation of patient contact is an imperative aspect of MUSC’s Patient-Outreach recruitment process. We must be able to demonstrate respect for our patients by ensuring that we are not burdening them with excessive contact. Regular monitoring of study team documentation will occur, and any study teams failing to accurately document patient contact will be prevented from receiving any additional recruitment projects.

The Research Preferences Manager is available to assist study teams with any aspect of the cold-contact recruitment process. To schedule a meeting, please submit a "Patient-Outreach Recruitment Consultation" through SPARCRequest.

Stedman Jones
Research Preferences Manager
jonested@musc.edu | 843-792-6959