Office of Research Conflict of Interest Policy

Introduction

The President of the Association of American Medical Colleges, Jordan Cohen, has defined a conflict of interests as follows:

A conflict of interests exists whenever an individual or an institution has a primary allegiance that requires certain actions and, simultaneously, has a secondary interest that (a) could abrogate that primary allegiance and (b) is sufficiently tempting to raise a reasonable possibility that it might actually do so. Hence, a conflict of interests is like potential energy; it has the capacity to cause something to happen, but unleashed, is simply a lurking presence.

Conflicts of interests exist in many forms and are inherent to the nature of the research enterprise. Since the Bayh-Dole Act made it possible for universities and researchers to benefit financially from the products of research, the number of cases of financial conflicts of interests have risen sharply and many have been very public, leading to an erosion in public confidence in the major asset of a research university—its unbiased expert opinion. Successful handling of conflicts requires that appropriate steps be taken at an early stage through the process of disclosure and management. For example:

• A scientist who owns stock in a company supporting his/her research may need to sell the stock or submit to oversight by other researchers.

• A scientist who publishes an article on a drug, device or therapy in which he/she has a financial interest must disclose that conflict to the editor of the journal.
  While financial conflicts have received much publicity, non-financial conflicts have similar potential to undermine scientific objectivity. Transparency is key to oversight of conflicts of interests and requires ongoing internal reporting and external disclosure.

The number and complexity of relationships between universities and members of their faculties and staff on the one hand and private industry, the federal and state governments, and the nonprofit sector on the other hand have grown substantially in recent years. The purpose of this Research Policy on Conflict of Interests (hereinafter, the “Policy”) is to provide guidelines for those relationships that will help to assure the primacy of objectivity and integrity in research. Faculty and non-faculty employees are encouraged to engage in outside research relationships if the activities are consonant with the objectives of the University. Such partnerships are encouraged when they produce mutual benefits to participants as well as to society.

All faculty and non-faculty employees and other researchers at VCU must maintain their commitment to the highest intellectual and ethical standards in all aspects of research, particularly where opportunities for conflict may exist. Special care must be taken when University employees involve students either directly or indirectly in their outside professional activities. Department Chairs and Deans are charged with protecting the interests of students and monitoring the potential conflicts of faculty members. It is essential that Deans and Department Chairs be committed to ensuring that such conflicts do not interfere with the duties of the faculty with regard to training of students.

Conflicts of Interest

The term conflict of interests refers to situations in which financial or other personal considerations may directly and significantly affect, or have the appearance of directly and significantly affecting, a researcher’s professional judgment in exercising any University duty or responsibility, including the design, conduct or reporting of research. A researcher at VCU may be considered to have a conflict of interests when he or she, or any of that person’s family, possesses a financial interest in an activity that involves his or her University responsibilities.

It is the policy of the University that researchers at VCU are expected to avoid conflicts of interests that have the potential to directly and significantly (1) compromise objectivity in carrying out University research responsibilities; (2) affect the University's interests; or (3) otherwise compromise the performance of University responsibilities, unless such conflicts are managed, reduced or eliminated in accordance with this Policy.

This policy falls under the overarching Virginia State and Local Government Conflict of Interests Act. Faculty and non-faculty employees should also be fully aware of the VCU Policy on Outside Professional Activity and Employment, Research, and Continuing Education (Outside Activity Policy) and the Conflict of Interests Policy in the VCU Financial Policies (Financial Conflict of Interests).

For some activities a conflict is engendered by any financial interest at all, and for others only if the interest rises to a level generally considered material. Therefore, for purposes of this policy:

Financial Interest means 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). It does not include salary, royalties, or other remuneration originating from VCU or the VCU Health Systems, income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities, or income from service on advisory committees or review panels for public or nonprofit entities.

Significant Financial Interest means payments exceeding $10,000 per year and/or equity interests of 3% (5% in certain cases).

Review and Approval

The Principal Investigator (Project Director) and each other Investigator must attach a completed Conflict Of Interests Disclosure Statement to each new, continuation, or revised grant or contract application submitted to the Office of Sponsored Programs Administration or Office of Industrial Partnerships, and each new research subjects protocol. Investigator means any individual who is responsible for the design, conduct or reporting of a research or educational project.

If any apparent Conflict of Interests is reported on the form, it will be referred to the Conflict of Interests Review Committee, which will evaluate the report. An Investigator may not participate in research, nor may he/she assign students, post-doctoral fellows or other trainees, without prior approval of the Conflict of Interests Review Committee if:

• The Investigator has a Financial Interest and the research involves human subjects or is being conducted for the purpose of regulatory approval; or

• The Investigator has a Significant Financial Interest and the research neither involves human subjects nor is being conducted for the purpose of regulatory approval.
  Additional approval is required if the sponsor of the research is a business in which a University employee has a Significant Financial Interest.

Managing A Conflict of Interests

If a conflict of interests exists that would reasonably appear to compromise the objectivity of the research, a strategy for managing, reducing, or eliminating the conflict must be adopted prior to expenditure of any part of any sponsored research award by VCU.

Strategies for management of an actual or potential conflict of interests might include:

• public disclosure of the financial interest;

• monitoring of research by independent reviewers;

• modification of the research plan;
  disqualification of an investigator or investigators from participation in all or a portion of the research funded by the federal agency;

• divestiture of the financial interest;
  severance of relationships that create actual or potential conflicts; or

• VCU declining the award.

The investigator making the disclosure shall submit a Conflict of Interests Disclosure Form containing a suggested management strategy for ensuring research objectivity to the Conflict of Interest Review Committee. The Committee has the authority to modify and approve, or not approve the management strategy. A management strategy approved in writing by the investigator and the Conflict of Interest Review Committee must be delivered to the Director, Office of Sponsored Programs Administration or Director, Industry Partnerships prior to expenditure by VCU of any part of the affected award. This management strategy will become part of the sponsored program record maintained by VCU. An approved management strategy for a research subjects protocol must be delivered to the Director, Office of Research Subjects Protection for review by the  IRB or IACUC. The management strategy may or may not necessitate an amendment to the protocol before the IRB or IACUC makes a final determination on the status of the protocol.  This management strategy will become part of the approved protocol record maintained by VCU.

Monitoring compliance with the agreed strategy shall be the responsibility of the Dean. Reporting any such conflict and any plan for managing it to meet requirements of any external sponsor will be the responsibility of the Office of Sponsored Programs.

Policy Implementation and Policy Breaches

The Vice President for Research is responsible for overseeing the implementation of this Policy, including the process and mechanism for disclosure, and the appointment of members to the Conflict of Interests Review Committee. The Vice President for Research, or his/her delegate, will review all breaches of the evaluation and review process, including:

• failure to comply with the process (by refusal to respond, by responding with incomplete or knowingly inaccurate information, or otherwise);

• failure to remedy conflicts; and

• failure to comply with a prescribed monitoring plan.

Failure of investigators to comply with this policy, including but not limited to completely and accurately disclosing Significant Financial Interests and/or complying with provisions of any approved strategy for managing conflicts of interests shall be a violation of VCU's Policies and Procedures for Misconduct in Research and Scholarly Activities and shall be treated in accordance with that document.