The Research Participant Advocate (RPA) ensures that human research protections are accorded the highest priority in all studies, and it serves as a sounding board for current and prospective research participants. The RPA:
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Oversees the CCTS Quality Assurance/Quality Improvement Program. Reviews quality improvement/quality assurance audits. Conveys concerns to appropriate channels in CCTS and/or UK.
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Audits research protocols for subject safety.
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Coordinates a CCTS Data and Safety Monitoring Board and reviews Data and Safety Monitoring Plans.
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Monitors adverse event reporting.
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Works with investigators to ensure that monitoring plans approved by the Institutional Review Board (IRB) are fully implemented and that studies are carried out in compliance with the IRB-approved protocol.
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Meets with research participants or potential research participants to discuss topics of interest or concern related to participation in clinical research studies.
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The RPA also cooperates in advocacy training within the CCTS:
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Advises on participant protections in all CCTS training.
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Assists in CCTS research staff development to ensure that participant advocacy and protections are accorded high priority.
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Assists in the development and delivery of Web-based and direct outreach training to regional CCTS site personnel.
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UK Research Compliance Officer
All IRB-approved consent forms include a confidential contact housed in the UK Office of Research Integrity – the UK Research Compliance Officer – who is also designated to handle participant suggestions or concerns (phone 1-866-400-9428).
To request an appointment with the Research Participant Advocate, please use the Contact Information.