Financial Conflict of Interest

Overview

The Georgetown University Financial Conflicts of Interest (FCOI) 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 conflict 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 requires all faculty and most staff to file disclosure forms annually and to update their disclosures when circumstances change. All “Investigators” must update their forms within 30 days of discovering or acquiring a new financial interest related to their university responsibilities.

In addition, the FCOI Policy requires ALL investigators of sponsored research to report financial interests related to their university responsibilities BEFORE filing applications or proposals for external funding (see Appendix B and Appendix C).

Requirements for PHS Investigators

All investigators on research proposals and projects funded by the Public Health Service (NIH, etc.)

• must undergo conflict of interest (COI) training every 4 years.
• must have filed an annual disclosure form within the past 12 months.
• Investigators with financial conflicts of interest must enter into a conflict management plan before expenditures can begin.

View list of Public Health Service agencies.

View financial conflict of interest training.

Frequently Asked Questions

Who is an Investigator?

Anyone responsible for the design, conduct, or reporting of funded or proposed research, regardless of title or position. This includes:

• Project directors
• Principal investigators
• Co-investigators
• Key personnel
• May include research assistants, postdocs, collaborators or consultants.

If you have any doubts about whether you could be classified as an “investigator,” please contact Nabeel Qureshi, Mary Schmiedel or Lila Sisbarro

What is a Financial Conflict of Interest (FCOI)?

Financial conflict of interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of research.

What is a Financial Interest?

A financial interest is anything of monetary value, related to an investigator’s University Responsibilities, whether or not the value is readily ascertainable, in any of these categories:

• remuneration or compensation (e.g., salary, consulting fees, honoraria,etc.) from a public or private company;
• equity (e.g., stock, stock options or other ownership interest) in a public or private company;
• intellectual property rights (e.g., patents, copyrights), and any royalties and licensing income from such rights;
• a position in an outside entity that gives rise to a fiduciary duty, such as director, officer, partner, trustee, employee or any position of management,
• and, for investigators with PHS funding, also any reimbursed or sponsored travel.

For the full definition of a “significant financial interest,” visit Appendix B and Appendix C of the Georgetown University Financial Conflicts of Interest (FCOI) Policy.

A financial interest DOES NOT include:

• salary, royalties or other remuneration from Georgetown University;
• income or travel from seminars, lectures or teaching engagements sponsored or paid by a public 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;
• income or travel from service on advisory committees or review panels sponsored or paid by a public 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;
• income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles (e.g. 403b plan or target date retirement fund);

What are “University Responsibilities”?

“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.

Where Do I File a General Conflict of Interest Disclosure Form?

Georgetown University Employees (All Campuses)

All full-time faculty, many full-time staff, investigators on sponsored research projects and IRB protocols (including study team members) employed by Georgetown University, regardless of campus, must complete a conflict of interest disclosure in GU-PASS (or update their GU-PASS disclosure if their circumstances have changed since the disclosure was last completed).

MedStar Health Physicians and Employees

MedStar employed physicians with a Georgetown University faculty appointment conducting research at MedStar Georgetown University Hospital will not be required to complete a GU-PASS conflict of interest disclosure. Instead, all study team members employed by MedStar Health must complete a conflict of interest disclosure in COI-Smart (or update their COI-Smart disclosure if their circumstances have changed since it was last completed).

What Happens After I File a Disclosure Form?

The form is reviewed by the Conflict of Interest Officers, who will determine whether or not it includes 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 member or staff member to create an appropriate conflict management plan. An employee who disagrees with the decision of the Conflict of Interest Officer may seek review by the Provost or campus Executive Vice President.

How Do I Complete COI Training?

Investigators who receive Public Health Service (PHS) funding must undergo conflict of interest (FCOI) training before engaging in the funded research. To complete the training, visit our FCOI training page for instructions.

Trainees who are the recipients of NIH F or K Series awards can fulfill their responsible conduct of research requirements by enrolling in NSCI-532/TBIO-562, a course that is required for PhD students in Pharm, Immunology, IPN, TBIO, Microbio, and also taken by Psychology students and other postdocs). Students in the Department of Biochemistry and Molecular and Cellular Biology should contact Prof. Jessica Jones to determine whether they must take this course or whether other previous courses may fulfill the requirement. For additional information, please contact Prof. Patrick Forcelli at paf22@georgetown.edu

What Agencies are Part of the Public Health Service (PHS)?

PHS includes the federal agencies and cooperative groups listed below:

NASA Conflict of Interest Policy

Please click here to view the NASA Conflict of Interest Policy

Questions or Concerns?

For questions about policies, procedures, or training, please contact:

• Mary E. Schmiedel, JD, (202) 687-3911, mary.schmiedel@georgetown.edu
• Nabeel Qureshi, MBBS, MPH, nabeel.qureshi@georgetown.edu
• Lila Sisbarro, BS, LS1302@georgetown.edu