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Objectivity in Research
Summary
Background
Objectivity in Research Policy
Relationship Between Current
Commonwealth/University Conflict of Interest Policy and the Federal Guidelines
Disclosure Procedure
Managing Conflicts of Interest Potentially Affecting Research Objectivity
Remedies
 
Flow Chart of the Objectivity in Research Policy Process. Chart (PDF).

Summary
Federal guidelines require the University to develop and implement an "objectivity in research policy." It is clear that federal funding agencies expect the University to develop a uniform policy for all sponsored research, not merely research funded by federal agencies. Investigators who have financial interests that might reasonably appear to be affected by the funded research grant are required to provide information on those financial interests at the time of proposal submission. The University will review the information provided by the investigator(s) to determine whether a conflict of interest exists. If there is a conflict, the University will, if possible, develop a strategy to manage the conflict of interest prior to any expenditure of the award.

Background
Regulations from the National Science Foundation and the Department of Health and Human Services establish standards and procedures to be followed by institutions that apply for research funding to ensure that the design, conduct, and reporting of research "will not be biased by any conflicting financial interest of those investigators responsible for the research."

Under these rules, investigators are required to disclose to an official(s) a listing of significant financial interests (and those of his/her spouse and dependent children) that would reasonably appear to be affected by the research proposed for funding. The institutional official(s) are charged with reviewing those disclosures to determine whether any of the reported financial interests could directly and significantly affect the design, conduct, or reporting of the research. If so, the institution must, prior to any expenditure of awarded funds, report the existence of such conflicting interests to the funding agency and act to protect the funded research from bias due to the conflict of interest.

In order to comply with the Federal Regulations a Conflict of Interest Committee, comprised of University faculty and administrators, has worked with the Office of the Vice President for Research and Graduate Studies to develop an objectivity in research policy. The federal regulations were published in final form in the Federal Register in July, 1995, with an implementation date of October 1, 1995. The Objectivity in Research Policy reflects the efforts of the Conflict of Interest Committee and the prior work of the University Research Policy Advisory Committee (URPAC). The policy deals specifically with the federal requirements and does not deal with broader and complicated issues related to conflicts of commitment. Consideration of these issues by the Conflict of Interest Committee is ongoing.

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Objectivity in Research Policy
The University of Virginia strives to support the highest standards of teaching, research, and public service. In an environment where personal integrity has been an integral part of the moral climate for nearly two centuries, a relationship of trust has been able to flourish. The importance of maintaining objectivity in all faculty endeavors, and continuing to make efforts in this direction, is paramount. To this end, the University has adopted an Objectivity in Research Policy.

Investigators submitting sponsored research proposals will be asked to identify significant financial interest that might reasonably appear to be affected by the sponsored research project. Significant financial interests include anything of monetary value including but not limited to salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights, and royalties from such rights).

READ the Conflicts of Interest Committee policy and operating procedures.

The following are excluded from the definition of a relevant significant financial interest:

  an equity interest that when aggregated for the investigator and the investigator's spouse and dependent children, meets both the following tests: does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more that a 3 percent ownership interest in any single entity
  salary, royalties, or other payments that when aggregated for the investigator and the investigator's spouse and dependent children over the next twelve months are not expected to exceed $10,000
  salary, royalties, or other remuneration from the University of Virginia
  income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities
  income from service on advisory committees or review panels for public or nonprofit entities
  any ownership interests in the business, if the business is an applicant under the Small Business Innovative Research (SBIR) program
     

This policy applies to the principal investigator and any other person who is responsible for the design, conduct, or reporting of research. It is the responsibility of the principal investigator to alert all personnel on the proposed project about this reporting requirement. Principal investigators should also alert personnel at other institutions of this requirement prior to entering into a subcontract as part of the proposed project.

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Relationship Between Current Commonwealth/University Conflict of Interest Policy and the Federal Guidelines

University of Virginia employees are subject to the requirements of the Virginia Conflict of Interests Act. In compliance with the act, the University has adopted the conflicts policy and procedures published in the U.Va. Financial and Administrative Policies Manual (Policy XV.A.1) and the U.Va. Financial and Administrative Procedures Manual. The act and the University policies and procedures govern, among other things, an employee's (or his or her immediate family's) personal financial interest in firms which contract or otherwise transact business with the University, and an employee's receipt of gifts or professional opportunities (e.g., consulting or other employment) from such firms or from other entities whose interests might be affected by the employee's work at the University. For the most part, any such conflicts of interest are forbidden. However, certain research and development contracts with companies in which an employee has an interest may be exempt from the Virginia Acts prohibitions, provided the employee makes required disclosures and the University approves the arrangement. Faculty should consult the Financial and Administrative Policy (Policy XV.A.1) and Procedures Manuals (15-5) for additional information on how to comply with the Virginia Conflict of Interests Act.

Although the federal guidelines deal with research objectivity affected by financial interests in businesses that are not sponsoring the research, and the Virginia Conflicts of Interests Act deals primarily with situations in which the investigator has a financial interest in the research sponsor, the Virginia Act does deal with gifts and professional opportunities, thus creating an area of potential overlap between the Virginia Act and federal regulations. An example of this situation is when an employee may consider accepting outside professional opportunities with a firm whose business interests may be affected by the results of the employee's federally sponsored research. However, in nearly all of these cases compliance with the federal regulations will also satisfy Virginia Conflict of Interest concerns. Both bodies of law - the Virginia Act and the federal regulations - aim at ensuring objectivity in research efforts through disclosure, evaluation, and appropriate management of potential conflicts of interest.

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Disclosure Procedure
Prior to submitting a proposal for sponsored research, investigators should provide to their department chair a letter reporting their significant financial interests that would reasonably appear to be affected by the sponsored research. A statement should also be provided as to how these financial interests might be affected by the proposed research. If the department chair determines that no conflict of interest exists, the investigator's letter detailing financial interests and the chair's recommendation will be forwarded in writing to the dean and then to The Vice President for Research and Public Service for review. After review, The Vice President for Research and Public Service will provide the investigator with a letter indicating the University's position on whether or not a conflict of interest exists.

If the department chair determines that a conflict of interest exists, the chair will develop, along with the investigator, a plan to manage the conflict. The management plan along with the letter detailing relevant financial interests will be forwarded to the appropriate dean for approval and then to the vice president for research and public service. The Vice President for Research and Public Service will review the plan. When an acceptable plan has been agreed upon, The Vice President for Research and Public Service will notify the principal investigator, the department chair, and the dean of the management plan and alert the appropriate federal funding agency that a conflict of interest exists and that a management plan has been devised (the funding agencies require only notification, they do not require financial details).

The Vice President for Research and Public Service will appoint a standing committee of University faculty and administrators. The committee will provide advice to The Vice President for Research and Public Service on research objectivity issues and assist, as requested, in the development of specific management plans. The committee will also accept appeals from faculty when there is disagreement about the proposed management plan. In these cases the committee will provide a recommendation to The Vice President for Research and Public Service who will make the final determination regarding the management plan. No sponsored research funds may be expended until a management plan has been approved.

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Managing Conflicts of Interest Potentially Affecting Research Objectivity
Managing conflicts of interest potentially affecting research objectivity may be achieved by one or more of the following actions:

  public disclosure of significant financial interest
  monitoring of research by independent reviewers
  modification of the research plan
  disqualification from participation in all or a part of the research project
  divestiture of significant financial interests
  severance of relationships that create actual or potential conflicts

 

 

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  Maintained by: Office of the Vice President for Research
Last Modified: Monday, 21-Jun-2010 14:00:47 EDT
Copyright 2014 by the Rector and Visitors of the University of Virginia

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