Clinical Trial Review Board (CTRB) & Institutional Animal Care and Use Committee (IACUC)
Clinical Trial Review Board (CTRB)
The VMTH established the Clinical Trial Review Board (CTRB) several years ago to:
- Protect the welfare of clients and client-owned animals recruited into clinical research activities conducted under the auspices of the Veterinary Medical Teaching Hospital (VMTH);
- Aid in the design and execution of clinical trials and clinical research in client-owned animals; and,
- Help enhance the ability of investigators to successfully undertake clinical investigations in the veterinary patient population.
The main responsibility of the CTRB is to determine whether clinical research projects place VMTH patients at increased risk. If this information is determined to be true, the following questions must be specifically addressed:
- Are patient risks minimized and outweighed by the potential benefits of the study?
- Will the rights and welfare of patients and clients be adequately protected?
- Will legally and ethically appropriate informed consent be obtained from clients?
- Is the trial protocol consistent with the mission of the VMTH?
Other responsibilities include:
- Advising the UC Davis the Institutional Animal Care and Use Committee (IACUC), the regulatory committee charged with ensuring the welfare of animals used for research and education on campus
- Pre-reviewing all protocols involving VMTH patients
- Working with individual clinical investigators to develop client-information sheets and/or consent forms for new technologies or procedures that do not require a clinical trial because:
- It is believed to be in the best interest of the patient; or,
- It falls under compassionate use (for assistance, please contact the CTRB Chair, Dr. Robert Rebhun, at email@example.com or (530) 754-5028).
- CHAIR: Dr. Robert Rebhun, Assistant Professor, Oncology
- Dr. David Wilson, VMTH Director and Associate Dean for Clinical Programs
- Dr. Karent Vernau, Associate Professor, Neurology
- Dr. Claudia Sonder, Assistant Director, Center for Equine Health
- Dr. Akinyi Nyaoke, California Animal Health and Food Safety (CAHFS) Laboratory System
- Dr. Frank Verstraete, Professor, Dentistry & Oral Surgery
- Dr. Nicola Pusterla, Professor, Equine Health
- Dr. Bruno Pypendop, Professor, Dept. of Surgical and Radiological Sciences
Ex. Officio member(s): Dr. Chrissy Kapelewski, Clinical Trials Analyst, Veterinary Center for Clinical Trials (VCCT)
- Dr. Victor Lukas, Campus Attending Veterinarian
- Dr. Valerie Wiebe, Clinical Pharmacy Coordinator
- Dr. Matt Mellema, Assistant Professor, Dept. of Surgical and Radiological Sciences
Administration: Diana Gomez, Administrative Assistant to the VMTH Director
The Institutional Animal Care and Use Committee (IACUC) & the New Protocol Review Process
Many funding agencies and scientific journals now require IACUC approval for funding or publication, but do not recognize CTRB approval as an valid alternative. Therefore, the IACUC and CTRB have joined forces to streamline the review process for protocols involving client-owned animals.
As of May 1, 2013, investigators must submit protocols using client-owned animals (including the owner informed consent form) to the IACUC. The protocol will be reviewed by CTRB and IACUC; however, only the IACUC can approve the protocol.
Protocols, including amendments, can be submitted to the IACUC at any time. The turn-around time for new protocols is about five weeks. Once submitted, the best way to reduce the turn-around time is to promptly respond to all follow-up questions. All personnel working with the animals must be listed on the protocol roster.
Once approved, the study can begin. As per federal regulations, IACUC protocols must be reviewed annually and renewed every three years. Any changes to the protocol must be approved in advance of implementation. Any animal work must stop immediately if the protocol expires. For assistance, please contact the IACUC office at firstname.lastname@example.org or (530) 752-2364.
- Flow chart of the Review Process for IACUC/CTRB Protocols (PDF)
- IACUC Protocol Form (HTML)
- Information about Protocols & Amendments (HTML)
- IACUC Policies & Guidelines (HTML)
- Owner Informed Consent form* (DOC)
- Guideline to Assist in Completing the IACUC Protocol for a UC Davis VMTH Clinical Trial (PDF)
* Instructions included
- To be approved on an IACUC protocol, you and your personnel must complete and pass Animal Care and Use (ACU) 101 and the Occupational Health courses.
- If you are planning on having someone that is not affiliated with UC Davis work under your protocol, that individual is required to take the ACU 101 and Occupational Health courses through UC Davis. The individual needs to become a "Temporary Affiliate" to take the required courses and be included on the protocol.