Conflicts of Interest and Commitment
(COI and COC)
Summary and quick links
Overview
COI and human subjects research
Brief overview of the SOM Policy on COI and COC
Disclosing your external activities and interests:
SOM faculty disclosure system (requires NetBadge log-in)
How to disclose your external activities and interests (UVA intranet)
SOM Conflict of Interest Committee
Conflict of Interest/Commitment policies:
UVA Policy on Conflict of Interest
SOM Policy on Conflict of Interest and Conflict of Commitment
Frequently asked questions - SOM policy and vendors (work in progress)
Exemption request for conflict of interest (UVA)
For additional information:
SOM COI general e-mail address
SOM COI Committee staff (Assistant Dean for Research)
Stewart Craig (Interim Director, Grants & Contracts)
Frequently asked questions on conflict of interest - UVA site
NIH tutorial on COI - highly recommended for NIH Principal Investigators
FASEB Web site on COI and industry relations
Overview.
COI regulations govern situations in which financial considerations may compromise an individual's conduct or reporting of research, patient care, educational activities, or procurement decisions on behalf of the University. The University understands that many of the external activities of its faculty are beneficial to the mission of the institution and that financial interests do not equate to conflicts of interest.
Federal regulations and UVA policies recognize that faculty may have financial interests in corporate sponsors or in entities whose business interests relate to their research. The Commonwealth of Virginia defines "financial interest" as ownership/liability of 3% of company assets or property used by a company; or income/salary/other compensation totaling $10,000 annually. UVA COI policy is not meant to discourage ownership, consulting, or other activities related to the corporate sector. Rather, if such a conflict exists, the University is required to remove, mitigate, or manage the conflict. Under the Virginia COI statute, the University President can sign a waiver of COI when a contract (e.g., NIH SBIR subawrd or purchase from a faculty-owned company) is involved. See the UVA FAQs on conflict of interest for more information.
Potential conflicts relating to research activities are reviewed by the UVA Conflicts of Interest Committee prior to acceptance of any external funding or the initiation of clinical research. The financial information required for such review is derived from the UVA on-line disclosure system. The COI Committee may request that the Principal Investigator recommend a management plan if there is a conflict of interest (contact: Dr. Steven Wasserman). The Committee recommends acceptance, rejection, or acceptance with conditions on the award, gift, or research activity - commonly referred to as a management plan. Such a plan might include data review to ensure unbiased analysis/interpretation, appointment of an ombudsman to protect the educational and professional needs of trainees, requirements for disclosure of the financial interest, etc. The Committee has been able to fashion suitable management plans for the overwhelming majority of financial conflicts of interest associated with research.
Conflicts of interest associated with the teaching and patient care missions of the SOM are appearing in the media all too frequently. Financial incentives in the form of large consulting agreements, faculty participation in speakers' bureaus, and company gifts appear to be heading toward greater regulation or public scrutiny. These financial interests are reviewed by the SOM Conflict of Interest Committee, described in greater detail below. Again, data from annual disclosures are used by the Committee to make recommendations to the Dean where warranted.
COI and human subjects research.
The use of human subjects in research by individuals with COI warrants additional scrutiny. Refer to the DHHS Office for Human Research Protections guidance document on financial COI in human subjects research and the AAMC/AAU recommendations on financial conflicts of interest in human subjects research. The PI must disclose all financial interests of study personnel to the IRB when submitting a research protocol, regardless of the source of funding for the study. The IRB will coordinate with the COI Committee to ensure appropriate review of the COI prior to protocol approval.
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Healthy and candid interactions with outside entities can be highly beneficial to scientific, educational, and therapeutic progress.
- University business, training, patient care, or research shall not be conducted under circumstances in which a reasonable person would infer that the integrity of these activities was compromised by the desire for or expectation of external personal (economic or otherwise) advantage.
- Complete disclosure of financial interests to the School of Medicine will satisfy legal requirements and assure the public that its missions and activities are not being unduly influenced by financial considerations. Hence, faculty and investigators will disclose all significant professional financial and commitment relationships with external entities.
- Potential conflicts of interest will be reviewed and eliminated, reduced, or managed so as to maximize the credibility of intellectual products coming from the institution.
- Disclosures also will be examined for potential conflicts of commitment.
- School of Medicine resources shall not be used by faculty/investigators for the financial benefit of external entities, unless authorized by the institution.
- Publication and presentation of research findings shall not be constrained as a result of a financial conflict of interest.
- Failure to abide by the terms of this policy or release of confidential disclosures may lead to adjudication and disciplinary action to include possible forfeiture of employment.
School of Medicine COI Committee.
The COI Committee is appointed by the Dean, and is charged with the following responsibilities:
- Review of conflicts of interest for all areas other than research, the latter being reviewed by the UVA Committee.
- Development of management plans for actual or potential conflicts.
- Development and periodic review of the SOM Conflict of Interest Policy.
- Development of standards for which financial conflicts of interest require committee review and potential management plans.
- Coordination with the UVA Committee and the Institutional Review Boards to ensure appropriate flow of information on actual and potential conflicts of interest, especially those affecting two or more missions of the University.
- Oversight of staff reviewing disclosure information.
- Periodic review and update of the SOM on-line financial disclosure system, in collaboration with Information Technology and Communication and the Vice President for Research and Graduate Studies.
- Education of SOM personnel on COI policy and procedures, to include the development and maintenance of a Web site.
Current committee members:
Raymond A. Costabile, Chair (Urology)
Anita H. Clayton (Psychiatry and Neurobehavioral Sciences)
Victor H. Engelhard (Microbiology)
John Kattwinkel (Pediatrics)
Joel Linden (Medicine)
member to be added
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Stewart P. Craig (ex officio, Interim Director, Office of Grants & Contracts)
Sally N. Barber (ex officio, Counsel, Medical Center)
Lynne R. Fleming (ex officio, General Counsel's Office)
Erik L. Hewlett (ex officio, Senior Associate Dean)
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Steven S. Wasserman (staff, Assistant Dean for Research)
FAQs on interactions between vendors and School of Medicine/Medical employees and trainees.
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If a vendor gives the department an unrestricted grant for use in funding educational activities, can the department use some of the money to purchase food for residents? Yes. The issue is decoupling the sponsor from specific decisions on what activities to support. The recommended route for such gifts is via the Medical Alumni Association.
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May a vendor buy lunch for residents off-site (e.g., the Corner) and provide a lecture at that venue? No. The policy states that "meals, gifts or compensation, of any kind and regardless of value, for listening to a Vendor presentation, whether occurring on site or off site."
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May a vendor buy lunch for residents off-site, after which the group returns to UVA for a his/her presentation? Alternately, can the vendor give a lecture at UVA and then join attendees off-site for food or drinks, picking up the tab? Neither of these is permissible under the policy. Decoupling the venues for the lecture and the refreshments does not remove the functional link between them.
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May a vendor purchase lunch for a Health System employee even if the employee has stated unequivocally that s/he had no intention of buying, using, or instructing trainees in the use of the vendor's products? No. The reason for this proscription is that there is a growing body of literature demonstrating a link between even de minimis gifts (e.g., a lunch) and subsequent behavior of the recipient.