VetRB
Focusing on animal welfare and ethical aspects of veterinary clinical study protocols and associated consent forms (ICF: Informed Consent Forms).
Veterinary clinical studies consist of clinical research involving companion animal patients, often to improve our understanding of their disease, and not lab animal research or using animals solely for human research.
Our Primary Focus is the Participants
We pay particular attention to the welfare of the animals enrolled in the study (most important), the absence of conflicts of interest, and the safety of the animals and participants.
VCSC
A Veterinary Clinical Studies Committee as defined by the American Veterinary Medical Association (AVMA) is a team of individuals who review proposed clinical research protocols i.e., research to be performed on client-owned animal patients, and the associated consent forms. This is a process similar to the review of human clinical study proposals by an Institutional Review Board.
Animal Welfare
Animal Welfare is vital to the veterinary profession in general and particularly when studies are performed. The AVMA states:
Decisions regarding animal care, use, and welfare shall be made by balancing scientific knowledge and professional judgment with consideration of ethical and societal values.
Clinical studies require the input and participation of the animal’s owner(s) and others involved in the animal’s wellbeing.
Participants
Clinical studies involve several parties.
1. The patient, who is obviously central to the process
2. The patient’s owners and others who may influence the animal’s care at home (e.g., family members, dog walkers, referring veterinarians,…)
3. The veterinarians and their staff who provide care for the patient during the study and will perform the clinical study procedures
4. The Sponsors (and, if applicable CRO) and scientists who initiate and fund the study, design and write the study protocol, oversee the study, and conduct the analysis of the resulting data.
About VetRB
We created VetRB to provide those involved in veterinary clinical research the opportunity to have their planned study protocols and consent forms reviewed by an independent organization. Such review processes often already exist in established research facilities where the institution owns research animals, but private veterinary practices usually don’t have access to this type of assistance.
As recommended by recent publications and consistent with AVMA guidance, VetRB’s committee consists in a panel of individuals who have experience participating in Institutional Animal Care and Use Committees (IACUCs). IACUCs review research with facility-owned (laboratory) animals.
These are mostly clinical veterinarians and veterinarians specialized in laboratory animal medicine and scientists who work with animals in their research. To keep similarities with traditional IACUCs, we also have non-scientist community representatives on our panels. When the veterinary specialty concerned with the study requires additional knowledge e.g., orthopedics or oncology, specialists are consulted and/or added to the team.
For more information, please see publications including the following:
Recommendations for Ethical Review of Veterinary Clinical Trials
Jessica A. Bertout, Philippe J.R. Baneux and Carol K. Robertson-Plough
A CTSA One Health Alliance guidance on institutional review of veterinary clinical studies
S. A. Moore, A. O’Kell, H. Borghese, R. Garabed, H. O’Meara, P. Baneux & CTSA One Health Alliance
Perspectives on implementing veterinary clinical studies committees
Philippe J. R. Baneux et al.
Obtaining informed consent in veterinary clinical trials mini review.
CVM GFI #282 Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals
Clinical and Translational Science Award One Health Alliance Consent template
How We Work
Please contact us at info@VetRB.com
with information on the study you envision.
We review your request and have a dialogue with you. Once we have a complete understanding of the study and ICF, we propose a time frame and cost.
If agreed on terms, you forward the latest version of the protocol and ICF for our review, after which we send you an official report which can include requirements for modifications for the panel to approve your protocol and ICF.
Subsequent to satisfactory modifications (if required) an official approval document is sent which you can use to document ethical review of your study such as requested by many if not all editors of scientific journals.
If funded by a US government agency (e.g., NIH, DOD, …) approval of the protocol by an IACUC is still necessary. We can assist you with that process. VetRB’s review will function as a consultant to the IACUC, offering veterinary clinical advice and review of the consent form.