Compliance

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.

StageCompliance requirements due 
Proposal
SFI Disclosures - RES-005: All 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). Investigators are also required to update their disclosure within thirty days of discovering or acquiring a new Significant Financial Interest.
Patent Agreement - RES-006:  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 are defined.
Foreign Influence Disclosure (internal) - Foreign Support and Affiliations: All Investigators are required to acknowledge relevant policies and procedures regarding reporting of foreign support and affiliations. This acknowledgement is made annually via the University's Financial Interest Reporting System (FIRS).
Foreign Influence Disclosure on Biosketch - NOT-OD-21-073: All NIH applicants are required to provide full transparency and disclosure of all research activities, foreign and domestic. See NIH Biosketch instructions, templates, and FAQs here.
Pre-Award
[Just-In-Time]
COI Training - RES-005: All 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. See instructions here.

Other Support - All Senior/Key Personnel are required to submit Other Support as requested by sponsors to ensure there is no scientific, budgetary, or commitment overlap. See NIH Other Support instructions, templates, and FAQs here.

Foreign Influence Disclosure on Other Support - NOT-OD-21-073: All NIH applicants are required to report all resources made available to a researcher in support of and/or related to all of their research endeavors, regardless of whether or not they have monetary value and regardless of whether they are based at the institution the researcher identifies for the current grant.
Animal Subjects - The Institutional Animal Care and Use Committee (IACUC) oversees the appropriate care, use, and humane treatment of all animal subjects being used for research, testing, and education, and ensures that all animal research is conducted in full compliance with all relevant federal, state, and institutional regulations and policies.

Compliance Requirement: All Investigators are required to acquire verification of IACUC approval for the use of vertebrate animal subjects prior to commencing research. The Verification of Approval (VOA) document shows congruence between an approved protocol and the specific grant under which the animal research will occur.
Human Subjects (Medical) - The Institutional Review Board for Health Sciences Research (IRB-HSR) is responsible for reviewing and approving all medically-related research involving human subjects and ensuring that the University upholds all federal, state, and institutional ethical and regulatory requirements for this research.

Compliance Requirement: All Investigators are required to have an IRB-HSR-approved human subject protocol (or protocols) prior to commencing medical research involving human subjects.
Human Subjects (Non-Medical) - The Institutional Review Board for the Social and Behavioral Sciences (IRB-SBS) is the IRB responsible for reviewing all non-medical behavioral human subject research (studies which are considered medically non-invasive) for compliance with federal-, state-, and institutionally-mandated research guidelines.

Compliance Requirement: All investigators involved in non-medical behavioral human subject research are required to have an IRB-SBS-approved human subject protocol (or protocols) prior to commencing research.
Controlled Substances - The Institutional Biosafety Committee (IBC) is responsible for reviewing all research 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 the University meets federal, state, and institutional requirements for the possession, use, and transfer of select agents and toxins.

Compliance Requirement: All Investigators using controlled biological agents are required to acquire certification from the IBC prior to commencing research using controlled biologics.
AwardAccount Reconciliation - FIN-023: Every unit is required to reconcile all Revenue Projects, Expenditure Projects, and Clearing Projects in order to maintain the integrity of the University’s accounting records and to protect the interests of the University.
Effort Reporting & Certification - FIN-027: The University uses effort certifications completed via the internal reporting system (Effort@UVa) to fulfill the requirements regarding compensation for personnel services on sponsored programs. This includes ensuring that committed effort on sponsored activities is documented, whether or not the financial support for the effort is provided by the sponsor or other University funding sources; verifying that payroll costs charged to specific sponsored activities is commensurate with the certified effort expended toward those activities; documenting effort toward various clinical activities; and accounting for 100% of University effort.
Research Integrity - RES-004: It is a fundamental responsibility of UVA faculty, staff, students and administration to maintain the trust of the public in all research and scholarly activity and to preserve the University's reputation for high standards of scholarly integrity. It is our shared responsibility to: maintain honesty and fairness in proposing, performing, and reporting research; maintain accuracy and fairness in representing contributions to research proposals and reports; ensure proficiency and fairness in peer review; ensure collegiality in scientific interactions, communications and sharing of resources; ensure disclosure of conflicts of interest; provide protection of human subjects in the conduct of research; provide humane care of animals in the conduct of research; ensure adherence to the mutual responsibilities of mentors and trainees; report suspected academic and research misconduct; ensure that academic and research misconduct is dealt with in a timely and effective manner.
Other - Additional Compliance OfficesOffice of Export Controls - The Office of Export Controls is responsible for ensuring University compliance with 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.
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.
Records Management - 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.
Vice President for Research - The Vice President for Research Office (VPR) is responsible for the strategic vision for research, developing and executing initiatives to accomplish the vision, as well as the various compliance and support areas. The VPR works to catalyze, support and safeguard UVA research.
SOM Clinical Trials Office - The Clinical Trials Office (CTO) offers consulting services to the SOM, including CRC mentoring, protocol development and preparation, continuing education, monitoring, and quality assurance.
Licensing & Ventures Group - The UVA Licensing & Ventures Group (LVG) partners with faculty, entrepreneurs, and investors to bring innovations discovered at UVA into the marketplace.