C. Financial Conflicts of Interest Policy

1. Preamble

Despite the increasing frequency and complexity of the relationships of the University and its faculty and staff with industry, government and other entities, these relationships are governed by one basic principle: Employees of Georgetown University owe their primary professional responsibility to Georgetown University. To fulfill that responsibility they must be alert to the possibility that outside obligations, financial interests or employment relationships run the risk of compromising their objectivity as teachers, researchers, clinicians, and administrators. Acceptance of employment with the University entails a commitment to give one’s best efforts to this end and to assign first priority to the needs and goals of Georgetown.

At the same time, the unprecedented growth of academic research and other externally sponsored programs over the last several decades has generated significant opportunities for collaboration between faculty members and companies attempting to convert program findings into commercially viable products. Accepting assistance and financial support from for-profit enterprises makes possible research and other programs on a scope unachievable without that support, and fosters the University’s interest in serving society by making the benefits of its faculty members’ research and expertise available to those who need it most. A faculty member must, however, be on guard that his or her objectivity is not threatened by obligations owed to the companies or organizations that sponsor University programs.

In addition, members of the Georgetown University community whose work is supported by public funds incur a special obligation to preserve the public trust. The Federal Government requires assurance that faculty members are aware of potential conflicts of interest arising from interrelationships with Federal agencies and commercial sponsors and of their obligation to notify appropriate University officials of all outside activities that may have conflict of interest implications. Likewise, University officers and others acting on behalf of Georgetown University have an obligation to avoid conflicts, and the appearance of conflicts, between their financial interests and the interests of the University in dealing with any organization or individual having, or seeking to have, any business relationship with the University.

To further these goals and in compliance with applicable Federal policies, Georgetown University has developed a policy to identify and address potential, actual and apparent financial conflicts of interest. This Financial Conflicts of Interest Policy (the Policy) is designed to promote four fundamental objectives.

To heighten the awareness of faculty and staff to the potential for financial conflicts of interest, to identify conduct and situations that might constitute a conflict of interest, and to provide reliable and workable processes for disclosing, and eliminating or appropriately managing potential, actual and apparent conflicts of interest.
To ensure that relationships between faculty members and external sources of funding are structured in such a manner as to enhance the University’s mission in the areas of teaching and research.
To ensure that the relationship between faculty members and external sources of funding promotes values and practices essential to the pursuit of knowledge, including free and open communication among colleagues, the widest dissemination of research results through presentation at professional meetings and publication in professional journals, the encouragement of collaborative research, and the promotion of cordiality and mutual respect among researchers.
To ensure that University faculty and staff perform their responsibilities with objectivity and integrity and do not inappropriately benefit or appear to benefit personally, directly or indirectly, from an entity or person conducting or seeking to conduct business with the University.

The Policy applies to all employees of Georgetown University. It imposes initial disclosure requirements, however, only on (1) Faculty; (2) Staff who are responsible for (i) the procurement, exchange or sale of goods, services or other assets; (ii) the negotiation or formation of contracts or other commitments affecting the assets or interests of the University; (iii) the rendering of professional advice to the University; or (iv) managerial, supervisory or advisory functions related to the conduct of Sponsored Programs; and (3) Investigators. All other employees are obliged to make appropriate disclosure and follow the approval procedures required by the Policy if and when they are in situations that require disclosure and/or approval under the Policy. Additional requirements applicable to federally sponsored research and educational activities are set out in Appendices B and C. Questions about disclosure obligations or procedures should be addressed to the appropriate Conflict of Interest Officer or to the Office of University Counsel.

This Policy does not address a variety of other practical or ethical issues that may arise during the course of University employment, such as conflicts in time commitments, misconduct in scientific research, and other ethical issues, including those involving medical or scientific experimentation using human or animal subjects. Other University policies address these issues.

2. Conflict of Interest Guidelines

Typically, a financial conflict of interest may arise when a person has the opportunity to influence University business, administrative, academic, or other decisions in ways that could lead to personal gain or advantage of any kind. A conflict of interest may also exist when a person has a Significant Financial Interest in a Business from which he or she receives Sponsored Program support or whose value may be affected by research in which the person participates.

While it is difficult to specify precisely what constitutes an objectionable conflict in all situations, the guidelines set forth below establish general standards by which individuals must evaluate their behavior. The guidelines are divided into three categories: (1) conduct presumptively prohibited; (2) conduct permitted only after review and approval; and (3) conduct merely requiring disclosure. The guidelines are not exhaustive of all potential conflict of interest situations. Where facts known to a person reasonably suggest an actual or apparent conflict of interest, the person is expected to disclose the circumstances and avoid the conflict of interest in good faith consistent with the spirit and objectives of this Policy.

Conduct Presumptively Prohibited
This section of the guidelines describes conduct that is “presumptively prohibited”. Presumptively prohibited conduct presents a prima facie conflict of interest and may not ordinarily be engaged in by any person covered under this Policy. The presumption may be rebutted and the conduct permitted if the person establishes by clear and persuasive evidence that such permission is justified by compelling circumstances. The following factors, among others, may be considered in evaluating whether the person has made a sufficient showing of compelling circumstances: the nature of the research or educational activities or the University business involved; the magnitude of the interest and the degree to which it is related to the research or educational activities or the University business involved; in clinical research, the degree of risk to the human subjects involved that is inherent in the research; and the extent to which the interest is amenable to effective oversight and management. Section 4 (and, where applicable, Appendices B and C) of the Policy, set forth the applicable processes for review and approval in such cases.
1. Significant Financial Interest in a Business
  If a person, a member of his or her Family, or an Associated Entity possesses a Significant Financial Interest (other than a Consulting Relationship) in a Business, then the person may not
  1. receive Sponsored Program support from the Business; or
  2. assign students, postgraduate students, fellows or other trainees to projects supported wholly or partially by Sponsored Program funding from the Business.
2. Participation in University Decisions
  A person may not participate in any University decision that relates to or has any effect on a Business (1) in which the person, a member of the person’s Family, or an Associated Entity has a Significant Financial Interest or (2) with which the person, a member of the person’s Family, or an Associated Entity has or is negotiating to have any paid consulting or employment relationship. Under such circumstances, a person shall promptly and fully disclose the conflict and recuse himself or herself from any participation in such a decision.
3. Gratuities, Gifts and Favors
  A person may not solicit or accept gratuities, gifts, favors or anything of monetary value, in excess of $100 per year per source, from an individual or a Business that (1) provides Sponsored Program support to that person or (2) has or seeks to have a business association with the University over which the person has authority or influence. Moreover, a person participating in the selection, award or administration of agreements using Federal funds may not solicit or accept gratuities, gifts, favors or anything of monetary value from grantees/contractors or potential grantees/contractors, regardless of value. Receipt of anything of monetary value permitted under this paragraph may additionally be subject to and must comport with other applicable University policies. Nothing in this paragraph shall preclude a person from soliciting or accepting gifts, donations, or bequests of any kind or in any amount on behalf of the University.
Conduct Permitted Only After Review and Approval
This section of the guidelines describes conduct a person may engage in only after review and approval in accordance with Section 4 of the Policy. The factors specified in Section 2.a above may also be considered in addressing requests under this section.
1. Significant Financial Interest in a Business
  If a person, a member of his or her Family or an Associated Entity possesses a Significant Financial Interest (other than a Consulting Relationship) in a Business, then unless he or she first discloses the Significant Financial Interest and receives approval in accordance with Section 4 of the Policy, the person may not
  1. engage in research on projects that, whether or not sponsored by the Business, involve Technology owned by or contractually obligated (for example, through a license) to the Business;
  2. assign students, post-graduate students, fellows or other trainees to projects listed in Section 2.b.i.1 above; or,
  3. make clinical referrals to such a Business.
2. Consulting Relationships
  A person may neither enter into nor continue a Consulting Relationship with a Business from which he or she receives Sponsored Program support or that has or seeks to have a business association with the University over which the person has authority or influence, unless the person first discloses the facts and receives approval in accordance with Section 4 of the Policy. In addition, a person who enters into such a Consulting Relationship may not assign students, fellows or other trainees to projects that are either supported wholly or partially by Sponsored Program funding from the Business engaging him or her for consulting or that involve Technology owned by or contractually obligated to that Business without first receiving specific approval, in accordance with Section 4 of the Policy, to make such assignments.
3. Service in an Executive Position with a Non-University Entity
  A person may not serve in a compensated or uncompensated Executive Position in, or serve with or without compensation on the advisory board of, a Business (not including a government agency, nonprofit organization, or an accredited educational institution) from which the person receives Sponsored Program support, unless the person first discloses the facts and receives approval in accordance with Section 4 of the Policy.
4. Use of the University’s Name
  A person who has a Significant Financial Interest in a Business or is affiliated with or performs services for a Business, may not authorize that Business to use the University’s name, symbols, or logo to imply endorsement of the Business by the University, or to give undue prominence to the fact that the person is associated with the University, unless the person first discloses the facts and receives approval in accordance with Section 4 of the Policy. In addition, the person must comply with any other applicable University requirements.
5. Use of University Facilities
  A person may not enter into an agreement with a Business involving the use of facilities or resources belonging to or utilized by the University, including the person’s office or laboratory, unless the person first discloses the facts and receives approval in accordance with Section 4 of the Policy. This procedure supplements and does not supersede space allocation procedures utilized by the University and its campuses.
6. Government-Funded Activities
  If a person, a member of his or her Family, or an Associated Entity has a Significant Financial Interest in a Business, the person may not without prior disclosure and approval in accordance with Section 4 of the Policy:
  1. be responsible for the design, conduct or reporting of or otherwise participate in government-funded research, educational, or clinical care activities that could directly and significantly be affected by such Business interest; or
  2. participate by testifying, making recommendations, or voting, in any internal or external decision-making process involving the award or distribution of government funds where the testimony, recommendation or vote would reasonably appear to be directly and significantly influenced by such Business interest.
Conduct Requiring Disclosure
This section of the guidelines describes conduct which, while not presumptively prohibited or subject to prior approval of an institutional official, must be disclosed in accordance with Section 3 of the Policy. Conduct requiring disclosure is subject to review in accordance with Section 4 of this policy and, depending on the circumstances, may be conditioned or prohibited. Such conduct may also be subject to other University policies. The factors specified in Section 2.a above may also be considered in addressing matters disclosed under this section.
1. Service in an Executive Position with a Non-University Entity
  If a person assumes or holds a compensated or uncompensated Executive Position in, or serves with or without compensation on any advisory board of, a Business (not including a government agency, nonprofit organization, or an accredited educational institution) with which the University has a substantial business relationship known to the person, the person must promptly and fully disclose the facts in accordance with Section 3 of the Policy and recuse himself or herself from participation in any University decision that relates to or has an effect on the subject Business.
2. Publications or Presentations
  If a person, a member of his or her Family, or an Associated Entity possesses a Significant Financial Interest in a Business, the person may not publish or give a public oral presentation on the results of research sponsored by such a Business, or of research on Technology owned by or contractually obligated to such a Business, without first disclaiming in the publication or presentation any endorsement by the University. The person must also disclose the Significant Financial Interest to the potential Publisher or sponsor of the public presentation, regardless of whether the Publisher requires such a disclosure.
3. Consulting Relationships
  If a person enters into a Consulting Relationship with a Business and the Consulting Relationship is in the field of the person’s professional responsibility at the University, he or she must fully and promptly disclose the facts in accordance with Section 3 of the Policy, regardless of whether or not the person receives Sponsored Program support from the Business or has any other Significant Financial Interest in the Business, and recuse himself or herself from participation in any University decision that relates to or has an effect on the subject Business. This paragraph may supplement but does not supersede other requirements detailed in the Faculty Handbook or other University policies.

3. Initial and Annual Disclosure Requirements

The following disclosure requirements are intended to elicit the basic information the University needs to determine whether a person has an actual or apparent conflict of interest, as detailed in Section 2 above. More detailed information may be requested and required by the Conflict of Interest Officer to ensure the appropriate consideration and resolution of any such actual or apparent conflict of interest.

Initial Disclosure
All (1) Faculty; (2) Staff who are responsible for (i) the procurement, exchange, or sale of goods, services, or other assets; (ii) the negotiation or formation of contracts or other commitments affecting the assets or interests of the University; (iii) the rendering of professional advice to the University; or (iv) managerial, supervisory, or advisory functions related to the conduct of Sponsored Programs; and (3) Investigators are required to complete and submit a disclosure form upon their employment by the University.
Annual and Updated Disclosures
All Investigators are required to submit a disclosure form on an annual basis during the pendency of an award. In addition, all persons whose initial or subsequent disclosure reveals an actual or apparent conflict of interest are required to submit disclosure forms on an annual basis until relieved of that obligation by the appropriate Conflict of Interest Officer. All persons identified in Section 3.a of the Policy are also required to submit revised forms at any point at which their most recent disclosure becomes incomplete or inaccurate (e.g., if a Significant Financial Interest arises or changes, a research activity commences, a funding application is submitted, or the person’s University authority or influence changes). With the approval of the University Conflict of Interest Committee (see Section 4.b of the Policy), each campus and University Services area of the University will develop a procedure to notify Faculty, Staff, and Investigators annually of their reporting obligations. Specific information regarding the reporting procedures for each campus and University Services area may be accessed at https://fcoi.georgetown.edu/.
Disclosure Form
Disclosures shall be made on a form or in a format approved by the University Conflict of Interest Committee. While all such forms must meet the requirements set forth in the Policy, the three campuses and University Services may, with the Committee’s approval, use different forms and formats for the purposes of the reporting required under this Policy. All disclosure forms will require individuals identified in Sections 3.a and 3.b of this Policy to disclose any activities or relationships described in Section 2 of the Policy. Investigators must additionally make disclosures in accordance with Appendices B and C of the Policy.Disclosure forms will be considered strictly confidential, to the extent permitted by law, and the information on the disclosure forms will be shared only with those who have a need to know under this Policy and/or applicable law. The appropriate Office of the Executive Vice President, Vice President, or Director, as the case may be under Section 4.a of the Policy, will establish procedures for maintaining and preserving confidentiality. Completed disclosure forms will be forwarded to the appropriate Conflict of Interest Officer designated under Section 4.a of the Policy. Investigators must provide any required disclosures to the appropriate designated individual prior to the submission of an application to PHS (including the National Institutes of Health) or the National Science Foundation (“NSF”) and as provided in Appendices B and C of the Policy.
1. Disclosure of Ownership Interest or Executive Position
  When the disclosure required is a disclosure of an ownership interest or of an Executive Position, the disclosure must contain the following information, when applicable:
  1. the name and address of the Business and a general description of the Business;
  2. a statement of the fair market value of the investment or interest held described in broad categories similar to that on Federal disclosure forms;
  3. a statement indicating whether the interest, when aggregated for the person and his or her Family, represents more than five percent of total ownership in the entity; and
  4. the position held in the Business by the person.
2. Disclosure of Income, Fees, Loans or Other Significant Financial Interests
  When the disclosure required to be given is of income, fees, loans or other sums, the disclosure shall include the following information, when applicable:
  1. the name and address of the Business and a general description of the Business activity;
  2. a statement of the aggregate annual amount of income/compensation received from the Business described in broad categories similar to that on Federal disclosure forms;
  3. in the case of a loan, the annual interest rate, the security, the terms for repayment and the names of any guarantors.

4. Implementation of the Conflict of Interest Policy

Initial Campus Review
1. As detailed in Section 4.a.ii below, each campus and each University Services area shall appoint an individual (the “Conflict of Interest Officer”) who shall be responsible for:All determinations made under Sections 4.a.i.2 , 4.a.1.3 and 4.a.i.4 above shall be communicated to the affected party in the form of a written statement that sets forth the basis for the decision.
  1. distributing, collecting and reviewing the disclosure forms required by Section 3 of the Policy;
  2. determining if conduct governed by Sections 2.a and 2.b of the Policy will be permitted, and if so, under what, if any, restrictions or limitations. Appropriate restrictions and limitations may include, without limitation, public disclosure of Significant Financial Interests, monitoring of research by independent reviewers, modification of the research plan, divestiture of Significant Financial Interests, severance of relationships that create actual or potential conflicts, and disqualification from participation in all or a portion of the research or other activity;
  3. determining whether a Financial Conflict of Interest exists as specified in Appendices B and C to the Policy, if applicable;
  4. determining whether alleged noncompliance or breach of the Policy has occurred;
  5. transmitting appeals of his or her determinations under Section 4.a.i.2 and 4.a.i.3 above to the appropriate individual referenced in Section 4.b.iii.1 of the Policy;
  6. transmitting his or her determinations under Section 4.a.i.4 above, and any appeal of such determinations, to the University Conflict of Interest Committee for action in accordance with Section 4.b.iii.2 of the Policy.
2. In the case of the Main Campus, the Medical Center and the Law Center, the Executive Vice President for the respective campus shall appoint the Conflict of Interest Officer referenced in 4.a.i above. In the case of the University Services areas, the Senior Vice President and Chief Operating Officer shall appoint the Conflict of Interest Officer referenced in 4.a.1 above. Specific information regarding individual appointments for each campus and University Services area may be accessed at https://fcoi.georgetown.edu/.Conflict of Interest Officers shall submit their disclosure forms, and any request to engage in conduct covered by Section 2.a or Section 2.b of the Policy, to the Executive Vice President or Senior Vice President responsible for their appointment, who shall discharge the review functions referenced in 4.a.i above with regard to the Conflict of Interest Officer.University employees who are subject to the Code of Conduct for the Officers and Senior Administrators of Georgetown University (“Code of Conduct”) shall make initial, subsequent and annual disclosures as required by the Code of Conduct to the Secretary of the University, who holds an appointment from the University Board of Directors and is vested with the duty and authority of the conflict of interest officer under the Code of Conduct.
The University Conflict of Interest Committee
1. Composition
  The University Conflict of Interest Committee (the Committee) shall consist of seven (7) principal members, three (3) appointed from the ranks of the full-time Faculty, three (3) appointed from the ranks of campus non-Faculty employees, and one (1) appointed by the Senior Vice President and Chief Operating Officer as detailed below.
  1. The Faculty Senate shall select or elect the three (3) Faculty members, one (1) from the Main Campus, one (1) from the Medical Center, and one (1) from the Law Center.
  2. The Executive Vice Presidents of the three campuses shall each appoint one (1) non-Faculty member from their respective campuses.
  3. The Senior Vice President and Chief Operating Officer shall appoint one (1) individual from a University Services area.
  4. The following personnel or their designees (designees must be appointed for a full term) shall also serve as advisors to the Committee in the prescribed circumstances:
  the director of the sponsored programs office of the campus from which the issue originates when the matter at issue involves Sponsored Program support;
  the Vice President for Technology Commercialization of the Office of Technology Licensing when the matter at issue involved the transfer of intellectual property;
  the Conflict of Interest Officer who made the determination that has been appealed to the Committee.
  
  Seven (7) alternate Committee members, to serve when principal members are unavailable in adequate number, shall also be appointed with the Faculty Senate selecting or electing one (1) Faculty member from each of the three campuses, the Executive Vice Presidents appointing one (1) non-Faculty member from their respective campuses and the Senior Vice President and Chief Operating Officer selecting one (1) individual from a University Services area.
  
  The normal terms of service for members, whether principal or alternate, elected or appointed, is three years. Members, with the exception of the ex officio members, are not eligible to serve more than two terms consecutively. Terms commence on July 1 and expire on June 30, but a member may continue to participate in any case pending on the date his or her term expires. The University President shall appoint from the members of the Committee a Chair and Vice Chair to serve three years each.
2. Duties of the Committee
  The Committee shall:
  1. set policies for conflict of interest consistent with this document;
  2. conduct annual reviews of the past year’s decisions to allow conduct covered by Section 2.a and Section 2.b;
  3. establish specific requirements for the disclosure forms described in Section 3 of the Policy;
  4. develop and publish procedures supplemental to those set forth in the Policy for implementing the disclosure and approval process; and
  5. make final determinations in matters appealed to the Committee in accordance with Section 4.b.iii.1 or Section 4.b.iii.2 of the Policy.
3. Committee Case Disposition
  Committee decisions regarding compliance with this Policy fall under two separate headings. Class I covers cases in which a person appeals a decision by the individual designated under Section 4.a of the Policy to disallow or restrict conduct covered by Section 2.a or 2.b of the Policy where such a decision has in turn been upheld by the relevant official described in Section 4.b.iii.1 below. Class II covers cases in which an allegation has been made that a person has violated the Policy and may therefore be subject to disciplinary measures.Decisions in Class I cases are final and not subject to Faculty or other relevant grievance code procedures, but proposed or actual administrative actions pursuant to Class II decisions are subject to such procedures. All decisions of the Committee shall be in the form of a written statement setting forth the basis for the decision and shall be by majority vote of those voting, with a majority of the Committee constituting a quorum. Persons who are the subject of cases shall have the right to ask the chair of the Committee to replace any member for actual or apparent bias.
  1. Class I Cases
    Decisions of a Conflict of Interest Officer to disallow or restrict conduct covered by Section 2.a or 2.b of the Policy shall, upon request of the affected person, be reviewed by the Executive Vice President or Senior Vice President who appointed the responsible Conflict of Interest Officer. Decisions by these reviewers or by the University Secretary pursuant to Section 4.a.ii above to allow such conduct shall be final and not subject to appeal. Decisions by these reviewers or by the University Secretary pursuant to Section 4.a.ii to disallow or restrict such conduct may be appealed to the Committee. All decisions on review shall be provided to the affected party and shall be in the form of a written statement setting forth the basis for the decision. Pending review of a decision under this subsection, the responsible Conflict of Interest Officer or the Secretary may require such interim action, such as disallowing or restricting conduct under a federal award, as he or she deems necessary to comply with federal regulations or serve the best interests of the University.The Committee will decide appeals in accordance with this Policy and with the policies established from time to time by the Committee. The Committee shall endeavor to develop a consistent body of decisions that can guide the Committee in future deliberations on similar cases. All decisions of the Committee shall be provided to the affected person and shall be in the form of a written statement setting forth the basis for the decision. Decisions of the Committee shall be transmitted by the Committee to the University President and shall be final unless overruled within thirty (30) days by the President. Any decision by the President to overrule a decision of the Committee shall be in the form of a written statement setting forth the basis for the President’s action.
    
    Except as provided in the Policy, all information generated or used in the proceedings of the Committee shall be held in strictest confidence. The complete file of the proceedings shall be preserved on a confidential basis in the Office of the Secretary of the University. At the discretion of the Committee, decisions rendered in previous cases shall be available to persons who demonstrate a specific need, such as a need to prepare a case before the Executive Vice President or the Committee, or a need for guidance in determining whether or not to undertake or approve a proposed activity. The Committee shall redact all identifying characteristics when releasing previous decisions.
  2. Class II Cases
    When, consistent with Section 4.a.i.6 of this Policy, a Conflict of Interest Officer or the University Secretary transmits to the Committee for action his or her determination that an alleged infraction of the Policy has in fact occurred, or when such a determination is appealed to the Committee by the affected person, the Committee shall review the matter and make its own determination. The initial referral by the Conflict of Interest Officer will be promptly reported by the Committee to the person who has allegedly committed the infraction. The Committee shall receive any written or oral submission that the person may wish to provide within a reasonable time set by the Committee for such submissions, and he or she shall have the right to know the evidence against him or her on which the allegation of an infraction is based. If the Committee upholds the determination that an infraction has occurred, the Committee will make recommendations to the referring Conflict of Interest Officer with regard to further action. Such further action may include without limitation oral admonishment, written reprimand, reassignment, ineligibility for future grants, IRB approval or supervision of graduate students, demotion, suspension with or without pay, or separation. The recommendation made by the Committee to the Conflict of Interest Officer shall be in writing and a copy shall be provided to the affected person. Actions taken subsequently by any campus official on the basis of the Committee’s recommendation shall be subject to review under any relevant provision of an established University grievance procedure.

5. Interpretation and Application

The Policy shall be interpreted and applied in a manner that best advances its goals and purposes and best serves the interests of the University. It may be revised periodically by the Committee to reflect developments in the applicable law and to reflect and clarify the Policy’s institutional interpretation and application.

6. Appendix A – Definitions

An “Associated Entity” means any trust, foundation, partnership or other privately held entity in which a person, alone or together with one or more members of the person’s Family, holds any interest in income or assets.
“Business” means any corporation, firm or other legal entity organized forprofit or charitable purposes, excluding Georgetown University.
For the purposes of this Policy only, “University Services” means any component of the University not under the administrative jurisdiction of one of the three campus Executive Vice Presidents. Authority granted in the Policy to the Director of a University Services area is not in addition to that of a relevant Vice President, but rather shall only exist when the University Services area does not report to a Vice President.
“Consulting Relationship” means any arrangement by which a person provides services for more than $10,000 in compensation of any kind in any given year as an independent contractor or employee to any entity other than Georgetown University. For the purposes of this Policy it also means publication agreements for which an individual receives more than $10,000 in compensation of any kind. In addition, an Investigator has a Consulting Relationship with a Business if the Investigator provides services for and has a Significant Financial Interest in the Business.
An “Executive Position” means a position as director, officer, partner, trustee or other position of management in a Business. This term does not include a position on a scientific advisory board.
The term “Faculty” as used in the Policy includes all full-time faculty members, part-time faculty members, and visiting faculty members. Although the term does not include volunteer faculty members, a department chairperson may, under appropriate circumstances and with notice to the person affected, designate a volunteer faculty member in his or her department as “faculty” for the purposes of the Policy. In addition, the Executive Vice President for each of the three campuses may at his or her discretion in writing exempt as a class part-time and/or visiting faculty from this definition and from all or a portion of the Policy, provided exempted individuals are not engaged in research or educational activities funded by the Federal government.
The “Family” of a person includes that person’s spouse and dependent children.
“Investigator” means the principal investigator, co-principal investigator(s), co-investigator(s), project director and any other person, regardless of title or position, who is responsible for the design, conduct or reporting of research or educational activities funded by a federal government agency or other external sponsor, or proposed for such funding.
“PHS Awarding Component” means the organizational unit of the PHS that funds the research.
“Publisher” refers to the publisher of a book, journal, or other scholarly work in which a Faculty or Staff member publishes the results of activities conducted at Georgetown University, using Georgetown University resources, or under Georgetown University’s auspices; the sponsor of a seminar, conference or academic gathering at which such research is discussed; and the editorial staff of any publication in which the results of such research appear. “Publishing” includes what is ordinarily considered as publishing in any written or electronic medium, as well as speeches, public communications and other formal presentations.
A “Significant Financial Interest” means any of the following when aggregated for a person and members of his or her Family:
1. an equity interest in a Business, such as stock, stock options, or warrants, if the value of such ownership is more than $10,000, or if the ownership interest represents more than 5% of ownership interests in that Business, or any other ownership interest with a value of more than $10,000. This definition does not include any interest owned solely by reason of investment in a Business by a mutual fund, pension fund, or other institutional investment fund over which the person or Family member exercises no control;
2. an interest in intellectual property (such as a patent or copyright), or any royalty or other payment or entitlement related to the intellectual property interest, expected to exceed $10,000 over the next twelve months;
3. the right to receive from a Business compensation, such as salary, consulting fees, honorarium, or any other form of payment for services (including the value of goods and services) in an annual amount of more than $10,000; and
4. a loan from, or other indebtedness to, a Business, regardless of the amount.
For Investigators, Significant Financial Interest includes, in addition to the interests described in section 6.k.i-iv above, the interests described in Appendix B and Appendix C, each as applicable.
The term “Sponsored Program” as used in the Policy is a research or other activity supported or paid for in whole or in part, directly or indirectly, from external sources. “Sponsored Program Support” means the funds or other things of value given to enable a Sponsored Program to be performed.
1. a. An external source can include a government department or agency (foreign, federal, state, or local); a not-for-profit foundation, corporation or organization; a for-profit corporation or Business entity; and any natural person who supports research or other activities through the donation or commitment of funds other than University funds.
2. b. Programs or research qualify as Sponsored Programs even if the Sponsored Program Support comes from University funds. Programs or research also qualify if the Sponsored Program Support comes from a University-administered fund and the research or program and Investigators are selected by University personnel, so long as the sponsored program support comes from an extramural source and the extramural source is aware that some or all of its funding has been placed in a University-administered research or program fund.
The term “Staff” as used in the Policy includes all those University employees who are not “Faculty” as defined above, including non-teaching academic staff.
The term “Technology” is used inclusively in this Policy to mean any instrument, machine, device, process, software, compound, drug, or diagnostic, medical or surgical procedure.
The term “University Responsibilities,” as used in Appendix B and Appendix C of this Policy, includes professional responsibilities on behalf of the University, including, but not limited to, teaching, research, research consultation, professional practice, institutional committee membership, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards. [This definition applies only to Investigators under the Policy.]

7. Appendix B – Addiotional Provisions Applicable to Research and Educational Activities Sponsored by an External Sponsor Other than the U.s. Public Health Service (PHS)

Research and educational activities funded by or proposed for funding by an external sponsor other than the U.S. Public Health Service (PHS) are subject to the requirements set forth in the Policy and this Appendix B. To the extent of any conflict between a provision of the Policy and a provision of this Appendix B, the provision of this Appendix B shall govern. Requirements related to research and other activities sponsored by PHS are addressed in Appendix C.

Significant Financial Interest
For Investigators who conduct research covered by this Appendix B, a “Significant Financial Interest” includes, in addition to the interests described in section 6.k.i-iv of Appendix A, a financial interest consisting of one or more of the following interests of the Investigator or a member of the Investigator’s Family that reasonably appears to be related to the Investigator’s University Responsibilities:
1. With regard to any publicly traded entity, a Significant Financial Interest exists if the value of (i) any remuneration received from the entity by the Investigator or Family member in the twelve-month period immediately prior to the disclosure, plus (ii) any remuneration expected from the entity by the Investigator or Family member in the twelve-month period immediately following the disclosure, plus (iii) any equity interest held by the Investigator or Family member in the entity as of the date of disclosure, when aggregated, exceeds $5,000, or the equity interest in the entity represents more than five percent (5%) ownership. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value. This definition does not include any interest owned solely by reason of investment in an entity by a mutual fund, pension fund, or other institutional investment fund over which the Investigator or Family member exercises no control;
2. With regard to any non-publicly traded entity, a Significant Financial Interest exists if the value of any remuneration received from the entity by the Investigator or Family member in the twelve-month period immediately prior to the disclosure, plus the value of any remuneration expected from the entity by the Investigator or Family member in the twelve-month period immediately following the disclosure exceeds $5,000, or the Investigator (or Family member) holds any equity interest (e.g., stock, stock option, or other ownership interest);
3. Any intellectual property rights (e.g., patents, copyrights), royalties from such rights, and agreements to share in royalties related to such rights.
  The term Significant Financial Interest as defined in this Appendix B does not include the following types of financial interests: (i) salary, royalties, or other remuneration paid by the University to the Investigator if the Investigator is currently employed or otherwise appointed by the University, including intellectual property rights assigned to the University and agreements to share in royalties related to such rights; (ii) income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education; (iii) income from service on advisory committees or review panels for a Federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.
“University Responsibilities” include professional responsibilities on behalf of the University, including, but not limited to, teaching, research, research consultation, professional practice, institutional committee membership, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.
Disclosure of Significant Financial Interests
In addition to the disclosure obligations set forth in Section 3 of the Policy, prior to the submission of a proposal to an external sponsor each Investigator who is planning to participate in the funded research or activity must have on file a current disclosure form that reports his/her Significant Financial Interests and such other information as may be requested by the Conflict of Interest Officer. Disclosures must be updated at least annually during the period of the sponsored activity to reflect any information not disclosed initially or updates to any previously-disclosed Significant Financial Interests (e.g., the updated value of previously disclosed equity interests). In addition, Investigators are required to report new Significant Financial Interests within 30 days of discovering or acquiring the interest.
Determination of Financial Conflicts of Interest
Upon receipt of a disclosure of a Significant Financial Interest of an Investigator, the Conflict of Interest Officer will determine under the procedures in Section 4 of the Policy (a) whether the Significant Financial Interest is related to the externally sponsored research and, if so related, (b) whether the Significant Financial Interest is a Financial Conflict of Interest. An Investigator’s Significant Financial Interest is related to the externally sponsored research when the Conflict of Interest Officer reasonably determines that the Significant Financial Interest could be affected by the externally sponsored research or is in an entity whose financial interest could be affected by the research. A Financial Conflict of Interest exists when the University reasonably determines that the Significant Financial Interest could directly and significantly affect the design, conduct or reporting of the externally sponsored research.
Management Plans
If a Financial Conflict of Interest is identified pursuant to section 7.c of this Appendix B, prior to the expenditure of award funds the Conflict of Interest Officer, as designated in Section 4 of the Policy, will develop and implement a management plan specifying the actions that have been or will be taken to manage, reduce or eliminate the Financial Conflict of Interest.
Examples of conditions or restrictions that might be imposed to manage a Financial Conflict of Interest include, but are not limited to:
1. Public disclosure of the Financial Conflict of Interest (e.g., when presenting or publishing the research);
2. For research projects involving human subjects, disclosure of Financial Conflicts of Interest directly to participants:
3. Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the Financial Conflict of Interest;
4. Modification of the research plan;
5. Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;
6. Reduction or elimination of the financial interest (e.g., sale of an equity interest); or
7. Severance of the relationships that create actual or potential financial conflicts.
Determination of the existence of a Financial Conflict of Interest and the means identified for eliminating or managing the conflict will be communicated in writing to the affected Investigator and other appropriate personnel. When applicable, the appropriate manager responsible for grant and contract administration will also be notified of pertinent facts needed for grant administration and regulatory compliance.

The Conflict of Interest Officer may monitor Investigator compliance with any management plan implemented pursuant to this section on an ongoing basis until completion of the sponsored research project.
Subawardees and Collaborators
If the University carries out externally sponsored research or other activities through a subrecipient (e.g., subgrantees, contractors, or collaborators), the University will take reasonable steps to ensure that:
1. The entity has its own policies in place that meet any conflict of interest requirements of the sponsor; or
2. Investigators working for such entities follow this Policy and this Appendix B as applied to University Investigators.
Notification to External Sponsors
The University will make reports to appropriate external sponsors to the extent required by and in accordance with its funding agreement with the sponsor and applicable law and regulation. For NSF funded research and educational activities, the University will keep NSF’s Office of General Counsel appropriately informed if the University finds that it is unable to satisfactorily manage a conflict of interest.
Record Retention
Records relating to all Investigator disclosures of financial interests related to externally sponsored research and activities and the University’s review of, and response to, such disclosures will be maintained for at least three years from the termination or completion of the external research or activity or for such longer periods as prescribed in the external agreement or applicable regulations. Upon authorized request of a sponsoring agency, disclosure documents and related records pertaining to the specific sponsored project will be made available to appropriate officials.

8. Appendix C – Additional Provisions Applicable to U.S. Public Health Service (PHS) Funded Research

Research funded by or proposed for funding by the U.S. Public Health Service (PHS), including the National Institutes of Health, is subject to certain requirements imposed by PHS regulations, as amended from time to time (see http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf). Such research is also subject to the Policy and this Appendix C. To the extent of any conflict between a provision of the Policy and a provision of this Appendix C, the provision of this Appendix C shall govern.

The University has implemented the PHS requirements as follows.

Significant Financial Interest
For Investigators who conduct research covered by this Appendix C, a “Significant Financial Interest” includes, in addition to the interests described in section 6.k.i-iv of Appendix A, a financial interest consisting of one or more of the following interests of the Investigator or a member of the Investigator’s Family that reasonably appears to be related to the Investigator’s University Responsibilities:
1. With regard to any publicly traded entity, a Significant Financial Interest exists if the value of (i) any remuneration received from the entity by the Investigator or Family member in the twelve-month period immediately prior to the disclosure, plus (ii) any remuneration expected from the entity by the Investigator or Family member in the twelve-month period immediately following the disclosure, plus (iii) any equity interest in the entity held by the Investigator or Family member as of the date of disclosure, when aggregated, exceeds $5,000, or the equity interest in the entity represents more than five percent (5%) ownership. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value. This definition does not include any interest owned solely by reason of investment in an entity by a mutual fund, pension fund, or other institutional investment fund over which the Investigator or Family member exercises no control;
2. With regard to any non-publicly traded entity, a Significant Financial Interest exists if the value of any remuneration received from the entity by the Investigator or Family member in the twelve-month period immediately prior to the disclosure, plus the value of any remuneration expected from the entity by the Investigator or Family member in the twelve-month period immediately following the disclosure exceeds $5,000, or the Investigator (or Family member) holds any equity interest (e.g., stock, stock option, or other ownership interest);
3. Any intellectual property rights (e.g., patents, copyrights), royalties from such rights, and agreements to share in royalties related to such rights.
  The term Significant Financial Interest as defined in this Appendix C does not include the following types of financial interests: (i) salary, royalties, or other remuneration paid by the University to the Investigator if the Investigator is currently employed or otherwise appointed by the University, including intellectual property rights assigned to the University and agreements to share in royalties related to such rights; (ii) income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education; (iii) income from service on advisory committees or review panels for a Federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.
“University Responsibilities” include professional responsibilities on behalf of the University, including, but not limited to, teaching, research, research consultation, professional practice, institutional committee membership, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.
Disclosure of Significant Financial Interests
In addition to the disclosure obligations set forth in Section 3 of the Policy, prior to the submission of a proposal to PHS, each Investigator who is planning to participate in the PHS funded research or activity must have on file a current disclosure form that reports his/her Significant Financial Interests and such other information as may be requested by the Conflict of Interest Officer. Disclosures must be updated at least annually during the period of the sponsored activity to reflect any information not disclosed initially or updates to any previously-disclosed Significant Financial Interests (e.g., the updated value of previously disclosed equity interests). In addition, Investigators are required to report new Significant Financial Interests within 30 days of discovering or acquiring the interest.In addition, Investigators engaged in PHS funded research also must disclose the occurrence of any reimbursed or sponsored travel related to their Institutional Responsibilities, unless the travel is reimbursed or sponsored by a Federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. The disclosure must include, at a minimum, the purpose of the trip, the identity of the sponsor/organization, the destination, and the duration. Sponsored travel means travel that is paid on behalf of the Investigator and not reimbursed to the Investigator (so that the exact monetary amount may not be readily determined).
Determination of Financial Conflicts of Interest
Upon receipt of a disclosure of a Significant Financial Interest of an Investigator engaged in PHS-funded research, the Conflict of Interest Officer will determine under the procedures in Section 4 of the Policy (a) whether the Significant Financial Interest is related to the PHS-funded research and, if so related, (b) whether the Significant Financial Interest is a Financial Conflict of Interest. An Investigator’s Significant Financial Interest is related to PHS-funded research when the Conflict of Interest Officer reasonably determines that the Significant Financial Interest could be affected by the PHS-funded research or is in an entity whose financial interest could be affected by the research. A Financial Conflict of Interest exists when the University reasonably determines that the Significant Financial Interest could directly and significantly affect the design, conduct or reporting of the PHS-funded research.If during the course of an ongoing PHS-funded project a Significant Financial Interest is disclosed by a new Investigator or an existing Investigator discloses a Significant Financial Interest not previously reported, or it comes to the attention of University officials that a Significant Financial Interest related to the PHS-funded research was not disclosed in a timely manner by an Investigator, the interest shall be reviewed pursuant to Section 4 of the Policy and this Appendix C within 60 days and a decision shall be made as to whether the Significant Financial Interest constitutes a Financial Conflict of Interest. If the Conflict of Interest Officer determines that a Financial Conflict of Interest exists, the Conflict of Interest Officer shall implement, on at least an interim basis, a management plan that shall specify the actions that have been, or will be taken, to manage the Financial Conflict of Interest.
Management Plans
If a Financial Conflict of Interest is identified pursuant to section 8.c of this Appendix C, prior to the expenditure of award funds, the Conflict of Interest Officer, as designated in Section 4 of the Policy, will develop and implement a management plan specifying the actions that have been or will be taken to manage, reduce or eliminate the Financial Conflict of Interest.
Examples of conditions or restrictions that might be imposed to manage a Financial Conflict of Interest include, but are not limited to:
1. Public disclosure of the Financial Conflict of Interest (e.g., when presenting or publishing the research);
2. For research projects involving human subjects, disclosure of Financial Conflicts of Interest directly to participants;
3. Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the Financial Conflict of Interest;
4. Modification of the research plan;
5. Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;
6. Reduction or elimination of the financial interest (e.g., sale of an equity interest); or
7. Severance of the relationships that create actual or potential financial conflicts.
Determination of the existence of a Financial Conflict of Interest and the means identified for eliminating or managing the conflict will be communicated in writing to the affected Investigator and other appropriate personnel. When applicable, the appropriate manager responsible for grant and contract administration will also be notified of pertinent facts needed for grant administration and regulatory compliance.

The Conflict of Interest Officer may monitor Investigator compliance with any management plan implemented pursuant to this section on an ongoing basis until completion of the sponsored research project.
Retrospective Review
Whenever a Financial Conflict of Interest involving PHS-funded research is not identified in a timely manner, including failure by the Investigator to disclose a Significant Financial Interest that is determined by the Conflict of Interest Officer to constitute a Financial Conflict of Interest, failure by the Conflict of Interest Officer to review or by the University to manage such a Financial Conflict of Interest, or failure by the Investigator to comply with a management plan, the University Conflict of Interest Committee shall appoint a person or committee to conduct a retrospective review of the PHS-funded research to determine whether any PHS-funded research, or portion thereof, conducted during the time period of noncompliance was biased in design, conduct, or reporting of such research. Such retrospective review shall be completed within 120 days of the determination of noncompliance.The respective review will be documented by the individual or committee appointed by the University Conflict of Interest Committee. Such documentation shall include the following elements: (i) Project/Contract number and title; (ii) principal investigator/project director; (iii) name of the Investigator with the Financial Conflict of Interest; (iv) name of entity in which the Investigator has a Significant Financial Interest that gives rise to the Financial Conflict of Interest; (v) reason for the retrospective review; (vi) detailed methodology used for the retrospective review; (vii) findings of the review; and (viii) conclusions of the review.
Financial Conflict of Interest Reports to PHS
Prior to the University’s expenditure of any funds under a PHS-funded research project, the University will provide the PHS Awarding Component with a Financial Conflict of Interest Report (“Report”) regarding any Significant Financial Interests, including Significant Financial Interests of subrecipient Investigators, related to the PHS-funded research that the University finds to be conflicting and, to the extent required by regulation, will ensure that the University has implemented a management plan as set forth in section 8.d of Appendix C the Policy. In addition, during the course of a PHS-funded research project, the University will provide the PHS Awarding Component with a Report within 60 days of identifying any Significant Financial Interest that the University identifies as conflicting subsequent to its initial Report.The Report will contain all elements required by regulation, which may include: (i) Project/Contract number; (ii) principal investigator/project director; (iii) name of the Investigator with the Financial Conflict of Interest; (iv) name of entity in which the Investigator has a Significant Financial Interest that gives rise to the Financial Conflict of Interest; (v) nature of the financial interest; (vi) value of the financial interest, within dollar ranges, or if the value cannot be readily determined through reference to public prices or other reasonable measures, a statement to that effect; (vii) a description of how the financial interest relates to the PHS-funded research and the basis for the University’s determination that the financial interest conflicts with such research; and (viii) a description of the key elements of the management plan, including (a) the role and principal duties of the conflicted Investigator in the research project, (b) conditions of the management plan, (c) how the management plan is designed to safeguard objectivity in the research project, (d) confirmation of the Investigator’s agreement to the management plan, (e) how the management plan will be monitored to ensure Investigator compliance, and (f) other information as needed.

If a retrospective review is performed as provided for in section 8.e of this Appendix C, previously submitted Reports affected by the review will be updated to specify the actions taken to manage the Financial Conflict of Interest going forward. If the retrospective review finds that the PHS-funded research was biased, the University will promptly notify the PHS Awarding Component and submit a mitigation report, which shall include: (i) the key elements documented in the retrospective review; (ii) a description of the impact of the bias on the research project; and (iii) the University’s plan of action or actions taken to eliminate or mitigate the effect of the bias.

The University will submit updated Reports annually to PHS, addressing the status of previously identified Financial Conflicts of Interest and any changes to management plans, including whether the Financial Conflict of Interest is still being managed or, if it no longer exists, an explanation as to why it no longer exists. Reports will be submitted for the duration of the PHS-funded project period.
Subawardees and Collaborators
If the University carries out PHS-funded research through a subrecipient (e.g., subgrantees, contractors, or collaborators), the University will include in its written agreement with the subrecipient a statement as to whether the financial conflicts of interest policy of the University or that of the subrecipient applies to the subrecipient’s Investigators.If the subrecipient’s financial conflicts of interest policy applies to subrecipient Investigators, the subrecipient shall certify as part of the agreement that its policy complies with the PHS regulations. If the subrecipient cannot make such a certification, the University’s policy and this Appendix C as applied to University Investigators will apply to subrecipient Investigators.

If the subrecipient’s financial conflict of interest policy applies, the University will include in the subrecipient agreement time periods for the subrecipient to report all identified financial conflicts of interests to the University. Such time periods must provide the University with sufficient time to review the reports and make timely reports to PHS, as necessary.

If subrecipient Investigators are subject to the University’s policy, the subrecipient agreement will specify time periods for the subrecipient Investigators to submit Investigator disclosures of Significant Financial Interests to the University so that the University has sufficient time to review the disclosures and comply timely with its review, management, and reporting obligations under this Policy.
Public Disclosure of Information
The University shall make this Financial Conflicts of Interest Policy available via a publicly accessible website. In addition, prior to the expenditure of any funds under a PHS-funded research project, the University will make available, either via a publicly accessible website or by responding within five (5) days to any written request, information concerning any Significant Financial Interest determined by the University to be a Financial Conflict of Interest held by a principal investigator or project director or any other individual who has been identified by the University as key personnel on the PHS-funded project.In situations where the Department of Health and Human Services determines that a PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device or treatment has been designed, conducted, or reported by an Investigator with a Financial Conflict of Interest that was not managed or reported by the University as required by this Policy, the University will require that the Investigator disclose the Financial Conflict of Interest in each public presentation of the results of the research and to request an addendum to previously published presentations.
Notification to PHS
The University will promptly notify the PHS Awarding Component if failure of an Investigator to comply with this Policy or a management plan provided for hereunder has biased the design, conduct or reporting of PHS-funded research.
Training
Prior to engaging in PHS-funded research, Investigators will be required to complete training regarding the requirements set forth in this Policy. Training shall be updated every four (4) years, and immediately when any of the following circumstances apply: (i) the University revises its policy in a manner that affects the requirements for Investigators with regard to financial interests; (ii) an Investigator is new to the University; or (iii) the University finds that an Investigator is not in compliance with the Policy on Financial Conflicts of Interest or management plan implemented thereunder.
Record Retention
Records relating to all Investigator disclosures of financial interests related to PHS-funded research and the University’s review of, and response to, such disclosures will be maintained for at least three years from the date of submission of the final expenditures report under the PHS-funded research or, where applicable, for such longer periods as specified in 45 CFR 74.53(b).