Table 3 Recommended committee composition for review and approval of veterinary clinical studies. While all members are encouraged to provide feedback on the entire protocol, they should provide, at a minimum, specific and formative feedback in their area of expertise. Committee size and composition will vary by institution and some members may cover more than one expert domain
From: A CTSA One Health Alliance guidance on institutional review of veterinary clinical studies
Member | Specific review items |
|---|---|
Scientific reviewer | Assessment of scientific validity and investigator justification for study design. This member need not be a content expert related to the protocol but rather should have familiarity with basic scientific study design and research conduct. |
Clinical reviewer | Assessment of clinical validity, ethics and investigator justification for clinical study design. This member need not be a content expert related to the protocol but rather should have familiarity with basic clinical research design and conduct as well as applicability of the study to veterinary medicine at large. |
Clinical study coordinator or equivalent | Assessment of infrastructure, caseload and other aspects of institutional feasibility. |
Administrator | Assessment of infrastructure, caseload and other aspects of institutional feasibility. |
IACUC member | Assessment of ethics and compliance with all relevant institutional and federal requirements for use of animals in research. |
Quantitative evaluator | Assessment of sample size calculations, proposed treatment effects and overall study design. |
Lay evaluator | Representation of community perspective on the proposed research with particular focus on readability of consent forms. Unlike federal guidelines for human subjects research review, there is no stipulation that this member be unaffiliated with the institution. Rather, they should simply represent a non-medical perspective on the presentation and conduct of the research. |
Ad hoc members | Additional ad hoc members may be required for assessment of items such as biosafety, complex ethical or legal issues, particular scientific questions or conflicts of interest as such cases arise. |