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Table 1 Recommended items for consideration during review and approval of veterinary clinical studies. Associated with each review item are several questions the committee may ask themselves as they review a proposed study

From: A CTSA One Health Alliance guidance on institutional review of veterinary clinical studies

Review item Associated questions
Risk/benefit Does the individual patient stand to benefit?
Is the potential for benefit proportional to potential for harm?
Are risks clearly defined, balanced, and mitigated?
Societal value In the absence of direct patient benefit, is the benefit to the veterinary or translational science community at least clearly defined and proportional to potential harm?
Scientific validity Is the scientific approach justified by the study team?
Has the protocol had previous scientific merit review?
Are inclusion/exclusion criteria clearly stated and appropriate?
Are outcomes relevant and justified?
Is proposed sample size appropriately justified?
Infrastructure Is the study team qualified to conduct the proposed work?
Are infrastructure and staffing adequate to support the project?
Does hospital or regional caseload support feasibility?
Will other competing studies affect enrollment?
Biosafety considerations Are animal, study team, owner, and environmental risks appropriately mitigated?
Are all institutional biosafety approvals in place?
The consent process Is the consent form structured to enhance readability and understanding?
Are risks and benefits clearly defined to the owner?
Are adverse event descriptions current based on accumulating data?
Does the form and process permit withdrawal of consent?
Is the consent form congruent with protocol and study design?
Are financial requirements of, and compensation to the owner, including adverse event coverage, clearly articulated?
Are future, yet undefined, uses of samples or data intended? If so, is this addressed?
Is there any aspect of the consent process (hierarchical relationship, undue inducement, etc.) that would diminish the owner’s agency in consenting for their animal?
Adverse event reporting Are procedures for reporting clearly defined?
To whom will minor versus serious adverse events be reported and with what frequency?
How will reporting across sites be handled?
What criteria will determine if a patient is removed from the study?
What criteria might necessitate the study being halted entirely?
Conflict of interest Does a conflict of interest exist for any member of the study team?
Does a conflict of interest exist with the funding source?
Is a conflict management plan in place?
Incentives Are incentives reasonable with consideration to avoid undue inducement?
Other considerations Is privacy/confidentiality protected as required by legal and institutional guidelines?
Are datasets and data risks managed per institutional policy?