HRPP- QIA
What is the HRPP-QIA program?
HRPP-QIA stands for Human Research Protection Program – Quality Improvement Assessment. The HRPP-QIA program is responsible for conducting periodic, routine assessments of human subjects research to determine compliance with federal, state, and UCF policies.
What is AAHRPP?
UCF is accredited by AAHRPP. AAHRPP stands for Association for the Accreditation of Human Research Protection Programs. AAHRPP accreditation is considered the “gold seal” of a high-quality human research protection program. To maintain accreditation, AAHRPP requires organizations to conduct audits to assess compliance with organizational policies and applicable laws and regulations. As such, UCF’s HRPP-QIA program supports our AAHRPP accreditation.
How are protocols selected for review?
Approximately 5 protocols are randomly selected each month. Any open protocol is eligible for selection.
How is the investigator notified if their protocol is chosen for an assessment?
A Compliance Specialist in the Research Integrity Compliance unit sends an email from HRPP-QIA@ucf.edu to the investigator notifying him/her of the selection. The Compliance Specialist will schedule an introduction meeting via Zoom or Teams to explain the process and discuss how to prepare for the assessment.
What occurs during the assessment meeting?
The Compliance Specialist meets with the investigator (or the investigator’s designee) to review study-related documents and data. The Compliance Specialist will interview the investigator and examine documents such as informed consent forms, surveys, and data spreadsheets to ascertain if the protocol and applicable policies, laws, and regulations were followed. The Compliance Specialist may request to see how study materials and data are stored and protected.
How should the investigator prepare for the assessment meeting?
The investigator needs to have all study materials available for review. This may include the following: completed informed consent forms; flyers, invitations, or marketing documents; survey documents and focus group transcripts, and any other printed participation materials used in the study. The investigator should also have all study data available for review.
What happens after the assessment meeting?
After the assessment meeting, the Compliance Specialist will send a completed assessment worksheet to the investigator for review and signature. If there are any compliance findings, the worksheet will be provided to the IRB for review. The IRB will then contact the investigator directly with the next steps.