Roles and Responsibilities
The Human Research Protections Program
- Assures compliance with the Federalwide Assurance (FWA)
- Assures Vanderbilt University and Vanderbilt University Medical Center’s policies and procedures are effectively applied in compliance with state and federal laws and regulations, the FWA, OHRP, FDA, NIH, OCR, and any other applicable federal agency.
- Provides interpretation and application of federal regulations.
- Develops, implements, and interprets HRPP policies and procedures.
- Takes action on non-compliance according to HRPP policies and procedures, as necessary.
- Ensures adequate resource allocation and annual review of resources.
- Actively participates in the IRB Optimization Committee.
- Supports and facilitates the IRB process.
- Maintains ongoing educational programs (e.g., News You Can Use, Research Matters, IRB Essentials, etc.) for Investigators, key study personnel, IRB Committee members, and HRPP staff.
- Participates in mandatory training, as well as other ongoing educational activities to keep abreast of current events.
- Provides regular training and education to IRB Committee members and keeps the Committees abreast of current events.
- Mentors and trains new staff as needed, including HRPP staff, Investigators, and key study personnel on human subject protections and the IRB process. Provides 3 and 6-month evaluations to the HRPP staff.
- Performs and documents quality assurance activities to assure compliance.
- Provides internal and external monitoring, which is designed to assess compliance and safety in human subjects research.
- Performs directed audits and random compliance reviews. Formulates and implements, as needed, recommendations for the Investigator and his/her staff.