In alignment with the language in the Duke University Health System (DUHS) Notice of Privacy Practices (NPP) Brochure, the IRB Recruitment and Engagement Policy allows study teams to engage patients through contacts including, but not limited to; portal messages, mobile health devices, telephone, electronic surveys at clinic visits or hospital admissions, or directly via one or more clinicians. Any of these methods may be used to engage patients in research related to their health, if approved by the DUHS Institutional Review Board (IRB), and if the individual has not opted out of these notifications.
Modifying Recruitment Plans
CRU’s can modify existing study recruitment plans or submit new studies with a recruitment plan that conforms with the updated policy.
Study teams interested in utilizing updated strategies for recruitment will need to complete the following steps:
- All key personnel must have completed the online training. See the tip sheets listed below for additional information on submitting a training confirmation.
- The IRB application should outline the specific procedures that will be used for the recruitment of subjects.
- Patient opt-out status within Maestro Care is reviewed before potential subjects are approached or communicated with.
Completion of the online training module on the policy is required prior to the IRB approving updated recruitment plans utilizing these expanded recruitment options.
Interested in additional training? Check out the Engagement, Recruitment, and Retention Certificate Program - A yearly certificate program designed to help staff develop and expand competency in participant engagement, recruitment, and retention. Nominations for the program are open July - August.
Resources and Support Materials
- Tip Sheet: Maestro Care Restricted Communication Process for Recruitment and Engagement Policy - This tip sheet contains step by step instructions with screen shots for viewing the opt out status of a Duke Patient in Maestro Care.
- CRC Script - This is a script that a study team member can use if a patients communicates they would like to opt out of research related contacts.
- FAQs - This document contains frequently asked questions regarding the Recruitment and Engagement Policy and its implementation. A good place to start if you have questions regarding the policy.
- Recruitment and Engagement Policy - The Recruitment and Engagement Policy can be found on the DUHS IRB website.
- Tip Sheet: Training Confirmation for New Amendments - All new amendments for Recruitment and Engagement require the Regulatory Coordinator to submit a statement verifying that all Key personnel (KP) listed on a study at the time of submission have completed this required training. This tip sheet demonstrates two ways to verify training completion.
- How to Run an LMS Employee Transcript - This tip sheet shows Regulatory Coordinators how to generate LMS completed learning documentation for the Recruitment and Engagement required course that can be uploaded into the iRIS system.
- How to Run a Course Completion Report in the LMS - This tip sheets details the steps necessary to generate a Course Completion Report in the LMS.
REDCap Opt Out Request Survey
Research Navigators and Study Team members should fill out this REDCap Survey if a patient selects the opt-out status.