What is the purpose of this policy?
The Financial Conflicts of Interest Policy protects the objectivity and integrity of the work of Georgetown University and its individual faculty and staff members. The Policy is designed to ensure that faculty and staff members identify, disclose, and appropriately manage or eliminate situations in which their personal or familial interests might otherwise compromise or appear to compromise their objectivity as teachers, researchers or administrators. An effective conflicts of interest policy helps both to safeguard the work and reputations of University faculty and staff members and to ensure the University's compliance with federal and other regulatory requirements relating to conflicts of interest. The Policy—and the system for making the financial disclosures that it requires—can be found here.
To whom does it apply?
It applies to all Georgetown employees—faculty, administration and staff. In addition to the generally applicable requirements, the policy imposes special requirements on “investigators” who are involved in externally sponsored research and educational activities.
What conduct is of concern under the Policy?
In general, the Policy focuses on personal or familial financial interests that could bias or appear to bias the employee's work at Georgetown. The Policy requires faculty and staff members to consider whether they have personal or familial financial interests that intersect significantly with their Georgetown responsibilities and provides a process for disclosing such interests and for dealing with resultant actual or potential conflicts. The Guidelines in Section B of the Policy describe three categories of conduct that are either forbidden (presumptively or in the absence of advance disclosure and approval) or not normally forbidden but nonetheless requiring disclosure.
The first category (Section B-1) includes conduct that is "presumptively prohibited" because it presents a clear conflict of interest. Such conduct includes, for example, a researcher's receiving sponsored program support from an entity in which he or she has a substantial financial interest, an administrator's participating in a University decision that relates to an entity in which that administrator has a substantial financial interest, or any employee's accepting a gift worth more than $100 from an entity that has a business relationship with the University over which the employee has influence or authority.
The second category (Section B-2) includes conduct that has the potential to affect, or appear to affect, one's objectivity and thus is permitted only if it has been disclosed, reviewed and approved in advance. This category has particular application to researchers who hold significant financial interests in, consulting relationships with, or executive positions in business entities that provide sponsored program support or otherwise seek to associate with the University. This category also covers the use of the University's name or facilities by business entities in which individual employees hold significant financial interests and participation in certain government-funded activities.
The third category (Section B-3) includes conduct that is not presumptively prohibited but requires disclosure and in certain situations may be conditioned or prohibited to ensure objectivity and protect against bias or the appearance of bias. Disclosure of financial interests is required for the conduct, publication and presentation of research. Similarly, one who serves in an executive position for an outside entity that has a business relationship with the University or as a consultant to an outside entity that operates in the field of one's University work must disclose these roles and avoid participation in University decisions relating to that entity.
Who is required to make financial disclosures under the Policy?
All employees, with limited exceptions, are being asked to make financial disclosures. The Policy requires that initial, annual and updated disclosure forms be submitted in designated situations by faculty and certain staff. Because of the difficulty of determining up front which faculty and staff are in what situations and the relative simplicity of making financial disclosures, the University Conflict of Interest Committee has determined that it is best to solicit disclosures from all employees with very limited exceptions. All employees should complete an initial form or update their existing form.
In addition, some individuals who are not University employees but are "investigators" on University projects that are externally sponsored, have disclosure obligations.
Who are the Conflict of Interest Officers? To whom are financial disclosures submitted?
The Policy provides for the appointment of a Conflict of Interest Officer by each campus and by University Services. Disclosure forms are submitted to and reviewed by the appropriate Conflict of Interest Officer. The following individuals currently serve as Conflict of Interest Officers: Mary Schmiedel (Main Campus), Thomas Clark (Law Center Campus), John Kotwicki (University Services) and Sheila Zimmet (Medical Center Campus). In addition, Edward Quinn, University Secretary, serves as the Conflict of Interest Officer for Officers and Senior Administrators.
What happens after I submit the financial disclosure?
The disclosure is reviewed by the appropriate Conflict of Interest Officer, who will determine whether or not it identifies an actual or potential conflict of interest and, if so, what action is required to manage the situation appropriately. The Conflict of Interest Officer may request additional information from an employee in order to make these determinations. In the case of an identified conflict, the Conflict of Interest Officer may work with the faculty or staff member to put in place and to document an appropriate conflict management plan. An employee who disagrees with the decision of the Conflict of Interest Officer may seek review by the University Conflict of Interest Committee.
Is the information that I disclose confidential?
Yes. The Policy provides that financial disclosures will be considered confidential and that the information on the disclosure forms will be shared only with those who have a need to know under the Policy and/or applicable law. The disclosures are intended to elicit information that is necessary to determine whether a financial conflict of interest exists and do not require the disclosure of financial or other information that is not relevant for that purpose. Additional information provided to the Conflict of Interest Officer (if required) will be considered confidential to the same extent as that provided in the disclosure.
Do I have any continuing obligations?
Yes. All Georgetown faculty and staff members are required on an ongoing basis to comply with the provisions of the Policy and the terms of any existing conflict management plan, to identify situations that could create the appearance of a conflict of interest, and to submit annual and updated disclosures as required. If your financial interests or University role(s) change in any significant way, you must update your disclosure.
What if I have questions about the Policy?
When in doubt, disclose. You may also consult your campus Conflict of Interest Officer, who plays a critical role in enforcing the Policy and providing guidance on its obligations and procedures. Alternatively, you can seek guidance from the Office of Compliance and Ethics.
I have heard that the Policy includes additional disclosure and reporting requirements for PHS and other externally-funded researchers ("investigators"). Is this correct?
Yes. The Department of Health and Human Services has rules that impose additional requirements relating to financial disclosures and reporting for those who are involved with Public Health Service funded research. The Policy reflects those requirements, and “investigators” should review Appendix B (applicable to those involved in externally sponsored research or educational activities funded by Non-PHS sponsors) and/or Appendix C (applicable to those involved in research or educational activities funded by PHS). In general, prior to engaging in work on sponsored projects, investigators are required to make disclosures of financial interests and relationships at a lower dollar threshold and covering a broader range of activities than non-investigators. In addition, investigators are required to submit “study specific” disclosure forms for each individual sponsored project. The University is required to identify, evaluate and manage or eliminate investigator financial conflicts of interest and, in some instances, to make information about them public and provide reports to government agencies.
How do I know if I am an “Investigator?”
Under the Policy, you are an “investigator” if you are the principal investigator, co-principal investigator, co-investigator, project director or any other person, regardless of your 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. This is a broad definition, and if you have any doubts about whether you could be classified as in “investigator,” you should contact your Campus Conflict of Interest Officer.
What if I have technical problems?
If you have difficulty accessing the disclosure system or other problems completing or submitting a disclosure, you should contact your campus Conflict of Interest Officer, who can help you determine the appropriate steps to resolve the problem.
I am a member of the public and would like to request information about conflicts on a particular PHS-grant. To whom should such a request be directed and what information must a request contain?
Requests must be submitted in writing to the appropriate Conflicts of Interest officer (whose information is below) with a copy to email@example.com and should contain the heading "REQUEST FOR FCOI INFORMATION." To allow the Conflicts of Interest officer to identify the requested information, requests should contain the name of the senior/key personnel and the grant/contract title or number.
John Kotwicki----University Services (COIUS@georgetown.edu)
Mary Schmiedel----Main Campus (COIMAIN@georgetown.edu)
Sheila Zimmet----Medical Center (COIGUMC@georgetown.edu)
Thomas Clark----Law Center (COILAW@law.georgetown.edu)
Within five business days of receipt of a request, the Conflicts of Interest officer will provide information on significant financial interests (SFIs), held by the key/senior personnel, that the University has determined to be related to the research and to constitute financial conflicts of interest. This information will include the following:
--Name of the Investigator
--Investigator's title and role with respect to the research project
--Name of the entity in which the SFI is held
--Nature of the SFI
--Approximate dollar value of the SFI or statement that the interest is one whose value is not readily ascertainable.