Testing & Research
For laboratories, research, development, quality control, and validations in the realm of Heath Law may require animal testing. To respect the gift of this participation, Hibbs Law, LLC can help you navigate USDA, FDA, NIH, and other organizational guidelines for laboratory animal care. So that you can provide the most humane treatment and highest quality of life.
Entities conducting research with human subjects, aside from some specific exclusions, must obtain their Federal wide Assurance (FWA) and form or engage an Institutional Review Board (IBR), sometimes called an Ethical Review Board. This is applicable to both NIH, and FDA, research studies. Protocols, consent forms, HIPAA privacy policies, and other materials must be reviewed and approved by IBR’s to protect the human participants. Multiple entities collaborating must align their standards and practices, often utilizing reliance agreements. The NIH and other agencies are streamlining duplicate administrative burdens by requiring a single IRB for multi-site studies, which an exciting utilization made possible through technology. Be proactive with your compliance; Hibbs Law, LLC can give you the answers you need and confidence in moving forward.