Human Specimens Research

Initial Training for VUMC Users:

Basic initial training is obtained through the following options:

• The Learning Exchange. Search for the module "HRPP Basic Module". Go to: Learning Exchange
• The CITI Program. Choose either the Basic “Group 1: Biomedical” or “Group 2: Social and Behavioral” Research Course. CLICK HERE to access CITI Program
• A Good Clinical Practice course. GCP training is required for anyone who is involved in the conduct, oversight, or management of clinical trials. This training will count as human subjects training, if needed. 

Renewal Training for BOTH VU and VUMC:

• Online HRPP Sessions through the Learning Exchange.

• *you may choose any ONE of the HRPP modules in the Learning Exchange or Oracle to complete for this credit. 

  • HRPP 2 You/IRB 2 You In Person sessions (News You Can Use, IRB Basics, IRB Essentials, Departmental/Group In-service requests)
  • An optional course through The CITI Program (e.g. Good Clinical Practices or Responsible Conduct of Research). CLICK HERE to access CITI Program. Completion of the OHRP “Investigator 101” training module is suggested.
  • Attendance of a local, regional, or national conference regarding human subject protections.
  • Other training may be approved on a case by case basis if the content includes human subjects protections. Approval by an HRPP Manager is needed.

Both the Initial and Renewal Training are now set for 3 year cycles.  

The roles and responsibilities of the IRB include:

• Assures compliance with the Federal Wide 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.

Contact: (615) 322-2918
Website: https://www.vumc.org/irb/welcome

The Scientific Review Committee (SRC) ensures that all cancer clinical trials conducted under the auspices of the Vanderbilt-Ingram Cancer Center meet peer-reviewed standards of scientific design, including appropriate scientific rationale, specific aims, study endpoints, biostatistical analysis, and adequate ability to accrue patients. These criteria ensure that the study is conducted in accordance with the scientific principles and integrity maintained by the Vanderbilt-Ingram Cancer Center, that the scientific aims of the study can reasonably be met, and that cancer center resources used to support clinical investigation are appropriately and wisely used.

Chair: Marta Crispens, MD | marta.crispens@vumc.org
Website: https://vicc.org/clinical-trials/research