Conflicts of Interest and Commitment (COI and COC)

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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
SOM faculty external interests reporting system (requires NetBadge log-in)
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
UVA exemption request for conflict of interest
SOM general e-mail address for COI
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
Int'l Committee of Medical Journal Editors - uniform disclosure form for potential COI


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 represent 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 subaward 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 before the institution accepts external funding or the initiates clinical research.  The financial information required for such review is derived from the UVA on-line reporting system.  The investigator should develop a proposed management plan for any financial conflict of interest associated with research (contact: Dr. Steven Wasserman).  The plan might include methods to ensure data integrity, appointment of an ombudsman to protect the educational and professional needs of trainees, requirements for disclosure of the financial interest, etc.  In general, the Committee has been able to review and approve suitable management plans for financial conflicts of interest associated with research.

Financial 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 appropriate.

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COI and human subjects research.
The use of human subjects in research by individuals with financial COIs 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 UVA COI Committee to ensure appropriate review and management of the COI prior to protocol approval.

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Brief overview of the SOM COI Policy.
  • 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.
  • SOM faculty and investigators shall 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.
  • 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. 
  • SOM employees may not receive food, gifts, or remuneration from UVA and Medical Center vendors.  Specific restrictions are given in the COI/COC policy.
  • SOM employees may not participate in industry-sponsored speakers' bureaus when their presentations do not conform to CME regulations.
  • 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.

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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:
     John Kattwinkel, Chair (Pediatrics)
     Anita H. Clayton (Psychiatry and Neurobehavioral Sciences)
     Victor H. Engelhard (Microbiology)
     Adam J. Katz (Plastic Surgery)
     Kevin R. Lynch (Pharmacology)
     John C. Marshall (Medicine)
     one vacant position
     ----------------------------------------
     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)
     ----------------------------------------
     Steven S. Wasserman (staff, Assistant Dean for Research)

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FAQs on interactions between vendors and School of Medicine/Medical employees and trainees.

  • 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.  This decouples the sponsor from specific decisions on which activities to support.  The recommended route for such gifts is via the Medical Alumni Association.

  • May a vendor buy lunch for residents off-site 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."

  • 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.  Separating the venues for the lecture and the refreshments does not remove the functional link between them.

  • 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.

  • I am a UVA vendor and have some left-over items that I'd like to distribute at an upcoming research products show.  Is this okay?  No.  You may distribute only educational items to visitors.  These might include specification/data sheets for your products, sample test kits that users can evaluate for their research needs, or educational posters (biochemical pathways, chromosome maps, etc.).

  • An academic colleague will be giving a talk on the management of a disease in my area of specialty, at a local restaurant.  The announcement describes the talk as broad, covering clinical management rather than the use of a particular drug for that condition.  May I attend?  In all likelihood, the answer is no.  If the flyer refers to a company sponsor or a company drug, this would be considered a vendor presentation.  Under the SOM COI policy, faculty may not receive "meals, gifts or compensation, of any kind and regardless of value, for listening to a vendor presentation, whether occurring on site or off site."  Faculty should resist attending such an event even though they do not accept food or drink, since a company representative will be present and will attempt to speak with all attendees about his/her products.  Faculty can attend CME-sanctioned talks.

  • It is common to have so called "users' meetings" for hardware or software systems that take place at a meeting of my professional society or at a separate venue altogether.  These meetings feature speakers from various institutions.  Can I attend such a meeting?  If the users' group is organized under the auspices of a national society, there are no restrictions on attendance.  If, however, it is organized by the vendor of that software or hardware, consider it to be a vendor presentation - do not accept meals, gifts, or compensation for attending.  Your main consideration should be the extent to which this is an educational experience (e.g., exchange of tips and tricks in using software you already have purchased) vs. an additional sales pitch by the vendor.

  • May a vendor purchase general reference books for our residents?  No.  Please have the vendor provide an unrestricted gift to your department, which should decide what educational items or events it will support with those funds.  It is important to separate the vendor from the decision-making process.  It is okay to announce the company's financial support at an educational event. 

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