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Conflicts of Interest and Commitment for Faculty and Investigators Policy

Policy Statement

Faculty and investigator activities shall be conducted in a manner that avoids inappropriate conflicts of interest and commitment. Conflicts of interest may occur when there is a divergence between a Faculty Member's private interests and professional service to the University. The goal of the University is to establish boundaries within which conflicts of interest are tolerable and beyond which they are intolerable; processes for review of actual and apparent conflicts of interest; and appropriate mechanisms for management of tolerable conflicts of interest.

Reason for Policy/Purpose 

This Policy is designed to assist faculty and investigators and the University in the identification of potential and actual conflicts of interest and to support compliance with applicable government regulations. For purposes of this Policy, the terms "Faculty" and "Faculty Member" mean those individuals defined in the Faculty Code, section I, subsections B, C, and D and the term Investigator refers to any person responsible for the design, conduct or reporting of externally sponsored University research, including without limitation Research Scientists, Senior Research Scientists and Lead Research Scientists.

Who is Governed by this Policy

  • Faculty
  • Investigators

Table of Contents

Policy Statement

Reason for Policy/Purpose

Who Needs to Know This Policy

Table of Contents

Policy/Procedures

Website Address

Contacts

Related Information

Appendices

Policy

I. GENERAL STATEMENT

A. Purpose and scope of policy.

This Policy is designed to assist faculty and the University in the identification of potential and actual conflicts of interest and to support compliance with applicable government regulations. For purposes of this Policy, the terms "Faculty" and "Faculty Member" mean those individuals defined in the Faculty Code, section I, subsections B, C, and D and the term Investigator refers to any person responsible for the design, conduct or reporting of externally sponsored University research, including without limitation Research Scientists, Senior Research Scientists and Lead Research Scientists.

B. Underlying principles.

The Faculty Code states, "faculty shall have a primary responsibility of devoting their time, thought, and energy to service of the University." Of no less importance is a Faculty Member's responsibility to further his or her own professional development and the goals of his or her professional discipline. Normally a Faculty Member's participation in activities of governmental, industrial, and professional institutions is consistent with academic interests of the University and the Faculty Member.

Conflicts of interest may occur when there is a divergence between a Faculty Member's private interests and professional service to the University. Conflicts of interest differ in nature and degree. The goal of any institution cannot be to eliminate all conflicts of interest. Rather it should be to establish boundaries within which conflicts of interest are tolerable and beyond which they are intolerable; processes for review of actual and apparent conflicts of interest; and appropriate mechanisms for management of tolerable conflicts of interest.

Faculty activities shall be conducted in a manner that avoids inappropriate conflicts of interest. As specifically described in Sections II and III, conflicts of interest may require review and oversight when:

1. the University is deprived of appropriate (compensated) time and effort of the Faculty Member due to external commitments (for example, when a Faculty Member exceeds the limitations of the "one-day-a-week" rule set forth in Section II.B.; or accepts obligations that may frequently conflict with scheduled classes or other academic responsibilities);

2. substantial use is made of human and material resources of the University for non-University purposes (for example, when a Faculty Member or Investigator inappropriately uses University equipment, supplies, personnel, and other facilities and resources for activities that yield financial benefit to the Faculty Member, Investigator or a third party; or receives outside financial incentives that distort scholarly activity or the shaping of academic goals; or facilitates the erroneous impression that the University endorses or is connected to an outside activity);  

3. the Faculty Member's or Investigator’s extra-University financial involvements affect, or reasonably appear to have a significant potential to affect, his or her academic responsibilities, or compromise basic scholarly activity or freedom of action (for example, when a Faculty Member or Investigator hires a family member; or enters into an agreement to limit or delay the free publication, or access to the results, of sponsored research, other than according to normal University practice (as in the case of patents); or has a reportable interest in a transaction described in Section III.B.; or when a Faculty Member, Investigator or his or her immediate family member is a founder, board member or equity stakeholder in a company sponsoring the Faculty Member’s or Investigator’s research); or

4. the University is deprived of appropriate potential financial gain (for example, when a Faculty Member or Investigator inappropriately seeks to obtain research support in a manner that substantially undermines responsibilities of the Office of the Vice President for Research; or has an outside commitment that provides an individual or organization, other than the University, intellectual or tangible property rights, such as patent ownership or license rights, that ought to accrue to the University).

C. Nature of policy.

Because precise boundaries are difficult to establish without reference to specific facts, it is prudent to establish a flexible, not formulaic, approach based on principles of fairness and trust. Fairness is advanced by policies firm enough to provide clear guidance and consistency, yet sufficiently flexible to accommodate diversity of discipline and unique circumstance. Trust is advanced by appropriate disclosure and discussion. In light of these principles, this Policy has two essential elements: (1) Faculty are provided a mechanism to report and seek guidance concerning significant actual, potential, and apparent conflicts of interest, thus to ensure appropriate disclosure and that the interests of the Faculty Member and the University are well served. To promote fairness, all faculty are required to report, as set forth in this Policy. (2) Each school shall administer in accordance with this Policy: a procedure for periodic Faculty disclosure of reportable actual, potential, and apparent conflicts of interest; disclosure by Faculty of information pertinent to such conflicts; and a procedure for review and resolution of any lack of agreement arising from disclosure of such conflicts.

D. Obligation of University.

In its promotion and administration of research and otherwise, the University shall be sensitive to prospective conflicts of interest involving Faculty and Investigators, including, for example, with respect to (1) the independence of Faculty and Investigators to determine subjects of research and scholarship and (2) enabling Faculty and Investigators to report accurately their time and effort.

II. CONSULTING, OTHER PROFESSIONAL ACTIVITIES, AND RESEARCH SUPPORT FROM OUTSIDE ENTITIES

A. The merit of external involvements.

Increasingly, industry and government rely on university faculties for advice. Such practical contributions from higher education institutions to the nonacademic world have provided many Faculty Members the opportunity to use their knowledge and talents constructively, to strengthen their competence through a greater variety of professional experiences, to enhance the Faculty Member's and the University's scholarly reputation, and to serve the public interest.

B. "One day a week" rule.

A full-time Faculty Member may spend the equivalent of up to one working day a week on average during the academic year on outside consulting and other professional activities, provided such commitments do not interfere with University obligations. Payments for such activities are negotiated by the Faculty Member directly and do not involve the University. This privilege is not extended to research Faculty Members paid wholly from research grants or contracts, or other physician Faculty Members whose University contracts preclude such activities.

C. Administration of the rule.

The department chair (or, where applicable, head of other pertinent academic unit) and the dean are responsible for ensuring compliance with this Policy and that no Faculty Member abuses this privilege. In particular, Faculty involved in private income-producing activities shall not, absent prior written approval by the Provost and Executive Vice President for Academic Affairs ("Provost and Executive Vice President"), for such purposes substantially utilize University space or resources or the services of secretaries or other University staff, provided that this Policy does not prohibit incidental use of personal office space, local telephone, library resources, and personal computer equipment.

D. Need for written sponsored-research agreements.

Before the University enters into any arrangement in which an entity outside the University provides support for research, a clearly stated written agreement should be negotiated that sets forth the Faculty Member's, the Investigator’s, the University's, and the external entity's expectations. Funding amounts and other financial arrangements, realistic timetables for mutually agreed objectives, and intellectual property agreements should be in writing before work begins. If the research project involves or may potentially involve a product or service with commercial potential, that prospect must be made known to all parties in advance.

III. REPORTABLE INTERESTS

A. Reportable interests (i.e., "significant financial interests") defined.

This Section III and the disclosure requirements contained in Section IV apply only to transactions and relationships, described in Section III.B, that involve a Faculty Member,1 Investigator or immediate family member, the University, and an outside entity. For purposes of this Policy:

  • "Immediate family member" means spouse/domestic partner and dependent children.
  • "Significant financial interest" means (1) any stock, stock option, or similar ownership interest in the outside entity by the Faculty Member or Investigator that, alone or together with interests of immediate family members, is valued at least at the lesser of $10,000 or five percent of the total ownership interests in the outside entity, excluding any interest arising solely by reason of investment by a mutual, pension, or other institutional investment fund over which neither the Faculty Member, Investigator nor an immediate family member exercises control; or (2) receipt, individually or collectively by a Faculty Member, Investigator and immediate family members, of, or the right or expectation to receive, income, whether in the form of a fee (e.g., consulting), salary, allowance, forbearance, forgiveness, interest in real or personal property, dividend, royalty derived from the licensing of technology or other processes or products, rent, capital gain, real or personal property, or any other form of compensation, or any combination thereof, that over the last 12 months exceeded or over the next 12 months is expected to exceed $10,000 in income of all types; or (3) that the Faculty Member, Investigator or immediate family member provides services as a principal investigator for, or holds a management position in, an outside entity.2

B. TRANSACTIONS COVERED

Before the University enters into any transaction potentially presenting an apparent or actual conflict of interest, and periodically thereafter, a Faculty Member or Investigator must submit to the school dean a written disclosure of any current or pending relationship of such Faculty Member, Investigator or immediate family member with the outside entity, the relationship of the proposed University activity to the entity, and, if desired, means by which the Faculty Member or Investigator will manage his or her University role in relation to the Faculty Member's, Investigator’s or immediate family member's role or interest in the entity. The Disclosure Forms annexed to this Policy pursuant to Part IV.A.1. provide descriptions of covered transactions for which Faculty Members and Investigators must make disclosure. Some examples of such covered transactions are:

1. Gifts to the University of cash or property that will be under the control, or will directly support the teaching or research activities, of a Faculty Member or Investigator from an outside entity in which the Faculty Member, Investigator or immediate family member has a significant financial interest;

2. Sponsored-project proposals as to which the involved Faculty Member, Investigator or immediate family member has a significant financial interest in the proposed sponsor or in a proposed subcontractor, vendor or collaborator;

3. University technology-licensing arrangements with an outside entity in which the Faculty Member, Investigator or immediate family member has a significant financial interest;

4. Procurement of materials or services from an outside entity in which the Faculty Member, Investigator or immediate family member has a significant financial interest, if the Faculty Member or Investigator is personally involved in or has the ability to influence the formation or implementation of the procurement transaction; and

5. Submission to an external sponsor of an application for funding of University research in the design, conduct or reporting of which a Faculty Member or Investigator plans to participate that would reasonably appear to affect the Faculty Member's, Investigator’s or immediate family member's interest in an outside entity or would reasonably appear to affect the entity's financial interests.

A Faculty Member or Investigator who seeks funding from or who works on a project funded by an external sponsor must comply with that sponsor's additional requirements, if any, related to disclosure, management, and avoidance of conflicts of interest. (See Section III.D regarding sponsored research and Appendix C regarding Public Health Service (“PHS”) research proposals and awards.)

C. Ongoing and elective disclosures.

In addition to disclosures required under Section III.B., Faculty members and Investigators shall disclose to the department chair (or, where applicable, head of other pertinent academic unit) or dean on an ad hoc basis current or prospective situations that are likely to raise questions of reportable conflict of interest under this Policy, including any new reportable significant financial interests, as soon as such situations become known to the Faculty Member or Investigator. In addition, a Faculty Member or Investigator may elect to disclose voluntarily other financial benefit to the Faculty Member, Investigator or immediate family member, related to an existing or contemplated relationship between the University and an outside entity with which the Faculty Member, Investigator or immediate family member is or expects to be involved, if the Faculty Member or Investigator deems it desirable to seek review in accordance with the procedures specified in Section IV. 

D. Additional reporting procedures for research.

Consistent with the requirements of external sponsors, including federal government agencies, this Policy is designed to identify potential, actual and apparent conflicts of interest and support compliance with applicable rules and regulations. A number of external organizations, in particular PHS and the National Science Foundation (“NSF”), have developed policies requiring the disclosure of financial conflicts of interest.

1. PHS requirements

Appendix C of this Policy sets forth additional requirements that apply to PHS research proposals and awards. Investigators who plan to participate in PHS-funded research or who are engaged in PHS-funded research must comply not only with this Policy but also with Appendix C.

2. NSF requirements

Under NSF rules,3 a Faculty Member or Investigator utilizing or seeking NSF funding has a potential conflict of interest if the Faculty Member, Investigator or his/her immediate family member has a “significant financial interest” (as defined in paragraph III.A, above) that could directly and significantly affect the design, conduct or reporting of NSF-funded research. NSF requires the University to report any conflict the University is unable to manage satisfactorily. As part of the NSF grant proposal process, the University additionally must certify that actual or potential conflicts were, or prior to funding will be, managed, reduced, or eliminated, or disclosed to NSF.

In order to manage conflicts of interest, the University may impose conditions or restrictions on itself, on the design and conduct of research, and on Faculty Members and Investigators, such as requiring:

  1. public disclosure of significant financial interests;
  2. monitoring of research by independent reviewers;
  3. modification of the research plan;
  4. disqualification from participation in all or part of the funded research;
  5. divestiture of the significant financial interest; and/or
  6. severance of relationships that create actual, potential or reasonably apparent conflicts of interest.

In accordance with NSF requirements, the University will maintain all records of financial disclosures made by Faculty Members and Investigators and actions taken by the University with respect to conflicts of interest for at least three years from the termination or completion of the relevant grant, and will make such records available in appropriate circumstances for inspection and review upon request by the agency.

3. Food and Drug Administration requirements

Faculty Members and Investigators also should be aware of Food and Drug Administration (FDA) regulations (21 CFR Part 54) regarding conflicts of interest, which apply to any applicant who submits a marketing application for a human drug, biological product or device, and who submits clinical studies covered by the regulation. The regulations require the disclosure of conflicts or a certification that no financial conflicts exist.

4. Other requirements

Other sponsors may have specific requirements regarding the disclosure of financial interests. For more information, contact the sponsor or the Office of the Vice President for Research.

IV. PROCEDURES FOR REVIEW

A. Review of disclosure form; management of disclosure conflicts.

  1. Faculty Members and Investigators shall supply the periodic and ad hoc disclosures required by Section III on the annexed Disclosure Forms, for confidential review by the Administration. Each dean shall forward to the Provost and Executive Vice President a copy of each Disclosure Form submitted by a Faculty Member or Investigator, any related material submitted by a Faculty Member or Investigator, and the dean's recommendation for action.
  2. If the dean, with the concurrence of the Provost and Executive Vice President, determines that the conduct disclosed is permissible under this Policy, the Faculty Member or Investigator shall be so informed in writing. Guidance on types of conduct approved shall be provided the Faculty from time to time, without identifying Faculty Members or Investigators who received approval.
  3. If the dean or the Provost and Executive Vice President determines that the conduct may present an actual conflict of interest, or reasonably appears to present a significant potential for such a conflict of interest, within the scope of this Policy, conditions or restrictions to manage or prohibit the conflict, agreeable to the Provost and Executive Vice President, may be imposed. Such conditions or restrictions may include, but are not limited to: Public disclosure of significant financial interests; monitoring of research by independent reviewers; modification of the research plan; disqualification from participation in all or part of an externally funded research project; divestiture of significant financial interests; and severance of relationships that create actual or reasonably apparent conflicts of interest.  
  4. It is not the object of this Policy to discourage outside activities by Faculty and Investigators that present no actual or reasonably apparent conflict of interest within the scope of this Policy. Instead, the review process is designed to allow Faculty Members and Investigators to undertake permissible activities without concern about later criticism, to provide the University accurate information about those Faculty and Investigator activities, and to be fair to all involved.

B. Procedures for resolving disputes about conflicts.

  1. If a dean learns from a Faculty Member, Investigator or otherwise of conduct the dean believes presents a significant question under this Policy, the dean should discuss the conduct with the Faculty Member or Investigator; shall relate his or her findings to the Provost and Executive Vice President, and subject to the concurrence of the Provost and Executive Vice President shall advise the Faculty Member or Investigator whether (a) the conduct is permissible under this Policy without conditions or restrictions; (b) may be undertaken subject to conditions or restrictions as described in Section A.3 above; (c) or should cease, subject to further review. If the dean or Provost and Executive Vice President determines that conditions or restrictions should be imposed, the Faculty Member or Investigator shall, as the case may be, cease the conduct, accept the conditions or restrictions agreeable to the Provost and Executive Vice President, or seek review of the matter by the school's Conflicts Consultation Committee.
  2. Any member of the University community ("Complainant") may bring directly to the attention of a school's Committee a probative and not frivolous matter alleged to be reportable under this Policy. A Faculty Member or Investigator whose activity has been questioned shall be entitled to know the identity of the person or persons bringing such allegations to the Committee and the full extent of the allegations.
  3. A school's Conflicts Consultation Committee, unless otherwise authorized by the Provost and Executive Vice President, shall be composed of at least five Faculty Members of the school, elected, ordinarily periodically, by the Faculty of the school. The Committee's function shall be to conduct a hearing if necessary, to make written findings about any disputed facts, and to write a reasoned recommendation as to whether the conduct entails a reportable conflict of interest under this Policy and whether the conduct may be undertaken subject to conditions or restrictions.
  4. The dean, the Provost and Executive Vice President, the Complainant, the Faculty Member or the Investigator may consult a member of the Conflicts Consultation Committee informally, with that member's consent, before the matter is referred to it, to discuss whether a given activity would entail a reportable conflict of interest under this Policy and/or what if any conditions or restrictions would be appropriate, but no such informal advice should bind any party to the process described above. The Committee member who has provided such consultation shall not participate in the hearing or decision.
  5. The Provost and Executive Vice President shall review the Committee's recommendation, confer with the Dean, and render a formal decision.
  6. A Faculty Member or Investigator dissatisfied with the Provost and Executive Vice President's decision may appeal it to the University Conflicts Resolution Panel ("Panel"), which shall be composed of five Faculty Members nominated by the Faculty Senate Executive Committee in consultation with the Provost and Executive Vice President and elected by the Faculty Senate. Members of the Panel shall ordinarily serve for staggered three-year terms.
  7. The Panel shall be bound by the factual findings of the school Conflicts Consultation Committee unless in the judgment of the Panel the school Committee clearly failed to consider important facts submitted to it. Ordinarily there should be no need for a hearing before the University Panel and no augmenting of the factual record.
  8. A member of the Panel from the school from whose Committee the appeal is taken may not participate in the appeal. No informal or other ex parte communication with members of the Panel shall be permitted as to a matter that has been or may be brought before the Panel.
  9. The Panel shall render its report to the affected Faculty Member or Investigator, the dean, and the Provost and Executive Vice President. The conclusion of the Panel shall be forwarded to the Administration for final disposition.
  10. To the extent that conduct of Faculty or Investigators who are identified in Section I.D.1. is ultimately determined to be impermissible under this Policy, the Provost and Executive Vice President (or other supervisors, for Investigators) may impose sanctions not inconsistent with the substantive and procedural requirements of the Faculty Code (or other applicable procedures).
  11. A Faculty Member or Investigator whose conduct has been ultimately determined to be permissible under this Policy shall be insulated from school or University sanction for that conduct. However, another Faculty Member or Investigator may not rely on an approval that addressed a different Faculty Member's or Investigator’s conduct, as it may have been based on unique circumstances.

 

1Principal investigators should take the lead in identifying those individuals in their organizations who are "responsible for the design, conduct or reporting” of externally sponsored University research and therefore are Investigators potentially subject to conflict of interest disclosure requirements. Such individuals may not be limited to the PI and/or co-PI, but could include, depending on the circumstances, persons such as technicians, other staff members and unpaid lab workers.

2“Significant financial interest” does not include: (1) salary, royalties or other remuneration from the University; (2) income from seminars, lectures or teaching engagements sponsored by public or non-profit entities; or (3) income from service on advisory committees or review panels for public or non-profit entities.

3NSF conflict of interest rules are incorporated into the NSF Award & Administration Guide, Ch. IV.A, “Conflict of Interest Policies,” NSF Proposal and Award Policies and Procedures Guide. See Section V of this Policy for a list of resources providing information on financial conflicts of interest.

Website Addresses for This Policy

GW University Policies

Contacts

Subject Contacts Telephone
Conflicts of Interests and Commitment Office of the Provost and Executive Vice President for Academic Affairs  202-994-6510
Sponsored Research and Requirements Office of the Vice President for Research 202-994-6510

Related Information


NSF home page:

www.nsf.gov

NSF “Award & Administration Guide, Chapter IV – Grantee Standards”:

https://www.nsf.gov/pubs/policydocs/pappguide/nsf16001/aag_4.jsp

FDA home page:

www.fda.gov

IDE Financial Disclosure:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm051337.htm

DHHS final guidance “Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection”:

https://www.hhs.gov/ohrp/regulations-and-policy/guidance/financial-conflict-of-interest/index.html

National Bioethics Advisory Committee publication: “Ethical and Policy Issues in Research Involving Human Participants”:

http://bioethics.georgetown.edu/nbac/pubs.html

Association of American Medical Colleges and Association of American Universities report “Protecting Patients, Preserving Integrity, Advancing Health – Accelerating the

Implementation of COI Policies in Human Subjects Research”:

https://www.aamc.org/data-reports/faculty-institutions/report/protecting-patients-preserving-integrity-advancing-health-accelerating-implementation-coi-policies

Council on Governmental Relations, “Recognizing and Managing Personal Financial Conflicts of Interest” (2002) (available in hard copy from the University Office of the Vice President for Research)

https://www.cogr.edu/sites/default/files/151633.pdf

See Appendix C for resources regarding conflicts of interest in PHS-funded research.

Appendices

For the Periodic Faculty Member and Investigator Disclosure Form, please contact the Office of Ethics, Compliance, and Privacy at [email protected]

For research related disclosure forms (Appendix B and C), please visit OVPR's Research Integrity website or contact [email protected]

 

 

 

Responsible University Official: Interim Provost and Executive Vice President for Academic Affairs
Responsible Office: Office of the Provost and Executive Vice President for Academic Affairs

Last Reviewed: March 9, 2016

 

Non-compliance with this policy can be reported through this website.