The Duke University Health System (DUHS) has revised language in the Notice of Privacy Practices (NPP) Brochure. To align with the revised NPP, the Recruitment and Engagement Policy will allow 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).
Modifying Recruitment Plans
The graduated roll out of changes to subject recruitment completed in June 2019. All CRU’s can now 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 recruitment of subjects.
- Patient opt-out status within Maestro Care is reviewed before potential subjects are approached or communicated with.
DOCR is studying the impact of changes to the recruitment policy under an approved protocol. If you are modifying your recruitment plan in alignment with the new policy, please contact Michelle Mack (email@example.com).
Training on the new policy is required prior to the IRB approving updated recruitment plans utilizing these expanded recruitment options.
Resources and Support Materials
- Tip Sheet: Maestro Care Opt Out 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.
- Viewing Duke Patient Opt-Out Status in Maestro Care Video - This video contains step by step instructions 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.
- Committee Recruitment and Engagement Policy | PDF Version - This slide deck provides background information about the Recruitment and Engagement Policy and its roll out to the Duke Clinical Research Community.
- 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 training documentation for all Key personnel (KP) listed on a study at the time of submission. Training documentation must be included with the amendment at the time of submission
- 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.