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 and ensure the study follows all government regulations.
Research Compliance is monitored through the Carilion Clinic: Office of Corporate Compliance. Activities include routine audits of IRB processes with regard to the review, approval and monitoring of human subject research protocols, including IRB research records, departmental research records, sponsor/ investigator records, human subject patient medical records, pharmacy records and accounting records.
In addition, research compliance conducts audits of the wet laboratory in accordance with national safety standards, and established institutional policies. Efforts that are undertaken by the Office of Corporate Compliance: Research Compliance support institutional compliance with federal, state, and local regulations and/or extramural/regulatory agencies’ requirements.
Research Compliance also monitors new legislation or changes in regulations that might affect the clinic’s compliance in conducting research, and recommending changes to administrative policies and procedures, as appropriate.