Faculty Handbook : Financial Conflicts of Interest Policy

Financial Conflicts of Interest Policy

A. 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, [19] 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 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 [20] (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. [21] 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 Appendix B. 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.

B. 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.

1. 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 the effective oversight and management. Section D of the Policy sets forth the applicable process for review and approval in such cases.

a. 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.

b. 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 from any participation in such a decision.

c. 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.

2. 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 D of the Policy. The factors specified in Section B. 1 above maybe also be considered in addressing requests under this section.

a. 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 D of the Policy, the person may not

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;
assign students, post-graduate students, fellows or other trainees to projects listed in Section B.2.a(1) above; or,
make clinical referrals to such a BUSINESS.

b. 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 D 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 D of the Policy, to make such assignments.

c. 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 D of the Policy.

d. 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 D of the Policy. In addition, the person must comply with any other applicable University requirements.

e. 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 D of the Policy. This procedure supplements and does not supersede space allocation procedures utilized by the University and its campuses.

f. 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 D of the Policy:

be responsible for the design, conduct or reporting of or otherwise participate in government-funded research, educational or clinical care activities that would reasonably appear to be directly and significantly affected by such BUSINESS interest: or
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.

3. 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 C of the Policy. Conduct requiring disclosure is subject to review in accordance with Section D 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 B. 1 above may also be considered in addressing matters disclosed under this section.

a. 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 C 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.

b. 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.

c. 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 C 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.

C. 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 B 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.

1. INITIAL DISCLOSURE

All (1) FACULTY, and (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.

2. 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 C.1 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 D.2 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 (insert link)

3. 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 C.1 and C.2 of this Policy to disclose any activities or relationships described in Section B of the Policy. INVESTIGATORs must additionally report any SIGNIFICANT FINANCIAL INTEREST: (1) that would reasonably appear to be affected by research or educational activities for which external funding is sought or has been awarded; or (2) in entities whose financial interests would reasonably appear to be affected by such research or educational activities.

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 D.1 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 D.1 or 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").

a. 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:

the name and address of the BUSINESS and a general description of the BUSINESS;
a statement of the fair market value of the investment or interest held described in broad categories similar to that on Federal disclosure forms (for instance, the investment is worth $10,000 or less; more than $10,000 but less than $50,000; more than $50,000 but less $100,000; $100,000 or more; all values given shall be the aggregate for all holdings of the person and the person's FAMILY);
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
the position held in the BUSINESS by the person.

b. DISCLOSURE OF INCOME, FEES, LOANS OR OTHER SIGNIFICANT FINANCIAL INTEREST

When the disclosure required to be given is of income, fees, loans or other sums, the disclosure shall include the following information, when applicable:

the name and address of the BUSINESS and a general description of the BUSINESS activity;
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 (for instance, income/ compensation is $10,000 or less; more than $10,000 but less than $50,000; more than than $50,000 but less than $100,000; $100,000 or more; all values given shall be the aggregate for the person and the person's FAMILY);
in the case of a loan, the annual interest rate, the security, the terms for repayment and the names of any guarantors.

D. IMPLEMENTATION OF THE CONFLICT OF INTEREST POLICY

1. INITIAL CAMPUS REVIEW

A. As detailed in Section D.1.b below, each campus and each University Services area shall appoint an individual (the "Conflict of Interest Officer") who shall be responsible for:

distributing, collecting and reviewing the disclosure forms required by Section C of the Policy;
determining if conduct governed by Sections B.1 and B.2 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;
determining whether alleged noncompliance or breach of the Policy has occurred;
transmitting appeals of his or her determinations under Section D.1.a(2) above to the appropriate individual referenced in Section D.2.c.(1) of the Policy;
transmitting his or her determinations under Section D. 1.a(3) above, and any appeal of such determinations, to the University Conflict of Interest Committee for action in accordance with Section D.2.c.(2) of the Policy.

All determinations made under Sections D.1.a(2) and D.1.a(3) above shall be communicated to the affected party in the form of a written statement that sets forth the basis for the decision.

b. 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 D.1.a above. In the case of the University Services areas, the Senior Vice President and Chief Administrative Officer shall appoint the individual referenced in D.1.a above. Specific information regarding individual appointments for each campus and University Services area may be accessed at (insert link)

Conflict of Interest Officers shall submit their disclosure forms, and any request to engage in conduct covered by Section B.1 or Section B.2 of the Policy, to the Executive Vice President or Senior Vice president responsible for their appointment, who shall discharge the review functions referenced in D.1.a 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 he 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.

2. THE UNIVERSITY CONFLICT OF INTEREST COMMITTEE

a. 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 Administrative Officer, as detailed below.

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.
The Executive Vice Presidents of the three campuses shall each appoint one (1) non-FACULTY member from their respective campuses.
The Senior Vice President and Chief Financial Officer shall appoint one (1) individual from a University Services area.
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 Administrative 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.

b. DUTIES OF THE COMMITTEE

The Committee shall:

set policies for conflict of interest consistent with this document;
conduct annual reviews of the past year's decisions to allow conduct covered by Section B.1 and Section B.2;
establish specific requirements for the disclosure forms described in Section C of the Policy;
develop and publish procedures supplemental to those set forth in the Policy for implementing the disclosure and approval process; and
make final determinations in matters appealed to the Committee in accordance with Section D.2.c.(1) or Section D.2.c.(2) of the Policy.

c. 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 D.1 of the Policy to disallow or restrict conduct covered by Section B.1 or B.2 of the Policy where such a decision has in turn been upheld by the relevant official described in Section D.2.c.(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 the a Conflict of Interest Officer to disallow or restrict conduct covered by Section B.1 or B.2 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 D.1.b above to allow such conduct shall be final and not subject to appearl. Decisions by these reviewers or by the University Secretary pursuant to Section D.1.b 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 interest 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. [22] 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 D.1(a)(5) 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.

E. WAIVER

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.

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 for profit 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.
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) and any other person 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, and includes the Investigator's spouse and dependent children.
"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 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.
4. a loan from, or other indebtedness to, a BUSINESS, regardless of the amount.
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. 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. 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.

Appendix B-Additional Provisions Applicable to Certain Federally Sponsored Research and Educational Activities

Research and eductiaonal activites funded by or proposed for funding by PHS or NSF are subject to certain requirements imposed by PHS regulations and NSF's Award Administration Guide, as ameded from time to time (include links to the PHS regulations(42 C.F.R. Part 50, Subpart F.) and the Guide). As of (September 17th, 2008), the University implements those requirements as follows.

Subawardees and Collaborators

If the University carries out federally-funded research or educational activities through subgrantees, contractors, or collaborators, the University will take reasonable steps to ensure that INVESTIGATORs working for such entities comply with applicable federal requirements regarding conflicts of interest, either by requiring those INVESTIGATORS to comply with this Policy or by requiring the entity to provide assurance to the University that will enable the University to comply with federal requirements.

2. Recordkeeping

a. PHS-funded Research

The University shall maintain records of all financial disclosures and of all actions taken by the University with respect to each conflict of interest in connection with PHS-funded research for at least three years from the date of submission of the final expenditures report or, where applicable, as provided in 45 C.F.R. § 74.53(b) for different situations.

b. NSF-funded Research and Educational Activities

The University shall maintain records of all financial disclosures and of all actions taken to resolve conflicts of interest in all NSF-funded research and educational activities for at least three years beyond the termination or completion of the grant to which they relate, or until the resolution of any NSF action involving those records, whichever is longer.

3. Access to Records

Pursuant to PHS regulations, the University will make information available, upon request, to the U.S. Department of Health and Human Services regarding all conflicting interests that have been identified by the University and how those interests have been managed, reduced or eliminated to protect PHS-funded research from bias.

4. Conflict-of-Interest Reports

a. PHS-funded Research

(1) Prior to the University’s expenditure of any funds under a PHS award, the University will report to the PHS AWARDING COMPONENT the existence of a conflicting interest (but generally not the nature of the interest or other details) found by the University and assure that the interest has been managed, reduced or eliminated in accordance with federal regulations.

(2) If the University identifies any conflicting interest following the University’s initial report under a PHS award, the University will report to the PHS AWARDING COMPONENT the existence of the conflicting interest (but generally not the nature of the interest or other details) and manage, reduce, or eliminate the interest, at least on an interim basis, within sixty days of that identification.

(3) If the failure of an INVESTIGATOR to comply with this Policy has biased the design, conduct, or reporting of PHS-funded research, the University will promptly notify the PHS AWARDING COMPONENT of the corrective action taken or to be taken.

(4) If the U.S. Department of Health and Human Services concludes that a clinical research project funded by PHS for purposes of evaluating the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted or reported by an INVESTIGATOR with a conflicting interest that was not disclosed or managed as required under this Policy, the INVESTIGATOR must disclose the conflicting interest in each public presentation of the results of the research.