Components of Research Compliance in the School of Medicine
The School of Medicine is committed to conducting sponsored research in accordance with all relevant ethical, legal, and regulatory obligations. The SOM has structured a number of compliance programs and initiatives to ensure the effective monitoring, auditing, training, education, and communication regarding compliance issues.
Conflicts of Interest
All School of Medicine Principal Investigators and any other individuals responsible for the “design, conduct, and reporting” of research are required to disclose all Significant Financial Interests (SFIs) or confirm their absence annually using the University’s electronic Financial Interest Reporting System (FIRS). This annual reporting of financial interests aids the University in preventing, detecting, and resolving any potential conflicts of interest.
Additionally, all School of Medicine Principal Investigators and Senior/Key personnel conducting research under external funding mechanisms are required to complete Conflict of Interest (COI) training prior to commencing this research and at least every four years thereafter. Investigators are required to complete the COI module, a part of the Collaborative Institutional Training Initiative (CITI) training system. [Instructions for finding the correct CITI module are here.]
RES-006: Patenting of Discoveries or Inventions at the University (Patent Policy). Any person who may be engaged in University research is required to execute a patent agreement with the University in which the rights and obligations of both parties is defined.
Responsible Conduct of Research
All faculty, research personnel, postdoctoral research associates, postdoctoral fellows, and students are expected to follow the policies and procedures at the University of Virginia that govern the responsible conduct of research. UVa investigators are expected to: exchange their finding openly via scientific publications; provide unique research materials to qualified academic investigators; maintain detailed records of research procedures and results; and fairly assign authorship or acknowledgment in research publications to the originators of ideas, methods, and findings. The University has adopted policies regarding misconduct in research (defined as actions which cast doubt on the integrity of research and research results) and in the School of Medicine, investigation of suspected research misconduct is conducted by the SOM Research Ethics Committee.
The Institutional Review Board for Health Science Research (IRB-HSR) is responsible for reviewing all medically-related research involving human subjects conducted by UVa faculty, research staff, and students. The IRB-HSR provides assurance to the federal government and other sponsors that the University upholds all ethical and regulatory requirements concerning research that involves human subjects. The IRB-HSR also serves as the HIPAA Privacy Board for research involving Protected Health Information (PHI).
The Institutional Animal Care and Use Committee (IACUC) oversees the University’s animal care and use program, facilities, and procedures to ensure the appropriate care, use, and human treatment of all animals being used for research, testing, and education. The IACUC ensures compliance with federal regulations, inspects animal facilities and laboratories, oversees training and educational programs, and ensures that all research, teaching, and testing are conducted in accordance with the highest scientific, humane, and ethical principles.
The Institutional Biosafety Committee (IBC) is responsible for reviewing all University research and teaching activities conducted by UVa faculty, research staff, and students involving the use of biological agents, including microorganisms, recombinant or synthetic nucleic acid molecules research, materials derived from human and non-human primates, or biological toxins. The committee ensures that all investigators handle biological agents in a safe and responsible manner, and meet the requirements as set forth in the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules; the Biosafety in the Microbiological and Biomedical Laboratories Guidelines (NIH/CDC); the OSHA Bloodborne Pathogens Standard; and Virginia Department of Environmental Quality, HHS, and USDA rules and regulations for the possession, use, and transfer of select agents and toxins.
Office of Environmental Health and Safety
The Office of Environmental Health and Safety maintains comprehensive programs for the management of potential hazards (including bloodborne pathogens, radiation, hazardous chemicals, and other biological materials) that may be encountered during research activities. The Office of Environmental Health and Safety serves as the University’s liaison with external regulatory agencies, monitors compliance with current health and safety policies, and provides information on training requirements.
The Office of Export Controls is responsible for ensuring University compliance with the Federal export control regulations: International Traffic in Arms Regulations (ITAR) -Department of State; Export Administration Regulations (EAR) – Department of Commerce; and Embargoes and Trade Sanction Regulations – Department of Treasury. The Federal Government’s export control regulations may prohibit the unlicensed export of specific technologies for reasons of national security or protection of trade. Such exports may require the University to obtain a license from the Department of State or the Department of Commerce before allowing foreign nationals without US citizenship or permanent residence status to participate in research at the University. The Office of Export Controls is the University’s principal point of contact for agencies with regulatory or enforcement authority under the export control regulations.
The Office of Records Management is responsible for identifying, classifying, storing, securing, retrieving, tracking, and destroying or permanently preserving University of Virginia records in accordance with state, federal, and international laws pertaining to records retention, privacy, and other regulations. Regardless of physical form or characteristic, the recorded information is a University record if it is produced, collected, received or retained in pursuance of law or in connection with the transaction of University business. Storage of documents containing information protected under HIPAA or FERPA in unsecured areas is prohibited.