There are a number of parties that oversee research at Carilion Clinic and ensure compliance.
The Institutional Review Board is an independent group of medical and non–medical professionals appointed to review and approve the research studies to be conducted at the Carilion Clinic. The Institutional Review Board is charged with verifying the study is safe for human subject participation, ensuring the study follows all government regulations and auditing of research studies.
Corporate Compliance, the IRB, and Research and Development may each conduct audits of Carilion’s research activities. These audits can be of actual research study records, any Clinic process related to research, R&D processes and procedures, IRB activities, Wet Lab procedures, or other areas as deemed necessary. Audits are conducted to help ensure research activities are in compliance with both internal policies and procedures, as well as federal, state and local regulations and regulatory agencies’ requirements. They also ensure any non–compliance is identified and corrected.
Legislation and resulting changes in regulations that may affect the Clinic’s research compliance are monitored. Recommendations for changes to policies and procedures are made as needed when regulations change.