The CTSA One Health Alliance's recent publication, "A CTSA One Health Alliance guidance on institutional review of veterinary clinical studies," offers a comprehensive framework for the ethical review and approval of veterinary clinical studies. This guidance is essential for practitioners who aim to enhance their research methodologies and ensure ethical rigor in their studies. Here, we break down the key takeaways and how you can apply them to improve your practice.
Key Focus Areas
The guidance document identifies six critical areas for review and approval of veterinary clinical studies:
- Protocol Review
- Review Committee Composition
- Post-Approval Monitoring
- Adverse Event Reporting
- Special Circumstances (e.g., satellite sites, use of healthy subjects)
- Informed Consent Process
Implementing Best Practices
1. Protocol Review
The protocol review process should be thorough and methodical. Ensure that all vital elements such as risk/benefit analysis, scientific validity, and societal value are evaluated. Questions to consider include:
- Does the patient stand to benefit directly?
- Are the risks clearly defined and mitigated?
- Is the scientific approach justified and outcomes relevant?
2. Review Committee Composition
A well-rounded review committee should include experts in various fields:
- Scientific Reviewer
- Clinical Reviewer
- Clinical Study Coordinator
- Administrator
- IACUC Member
- Quantitative Evaluator
- Lay Evaluator
This diverse composition ensures comprehensive evaluation from multiple perspectives.
3. Post-Approval Monitoring
Ongoing monitoring is crucial for maintaining study integrity. Conduct yearly reviews to assess:
- Number of cases enrolled
- Changes to the study team
- Summary of adverse events
- Consent form updates
4. Adverse Event Reporting
Develop a robust plan for identifying, managing, and reporting adverse events. Use standardized terminology and ensure timely communication across study sites.
5. Special Circumstances
Address unique scenarios such as multi-center studies and the use of healthy subjects. Ensure that satellite sites adhere to the same rigorous standards and that informed consent is obtained and documented appropriately.
6. Informed Consent Process
The informed consent process must be clear and comprehensive. Ensure that consent forms are congruent with the study design and that all potential risks and benefits are clearly articulated.
Encouraging Further Research
The guidance document highlights areas where further research and resource development are needed. As a practitioner, you can contribute to this evolving field by:
- Engaging in multi-center studies to enhance data robustness
- Participating in training programs for ethical review and approval
- Collaborating with other institutions to harmonize review processes
To read the original research paper, please follow this link:
A CTSA One Health Alliance guidance on institutional review of veterinary clinical studies.
