Financial Conflict of Interest (FCOI)
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 InvestigatorsView Requirements
Frequently Asked Questions About FCOIRead FAQs
Questions or Concerns?
For questions about policies, procedures or training, please contact:
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.
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
- Key personnel
- May include research assistants, postdocs, collaborators or consultants.
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.
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
- 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
Effective July 1, 2020, 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, IPN, TBIO, Microbio, soon Biochem, and also taken by Psychology students and TBIO and other postdocs). For additional information, please contact Dr. Patrick Forcelli at firstname.lastname@example.org.
What Agencies are Part of the Public Health Service (PHS)?
PHS includes the federal agencies and cooperative groups listed below:
|ALLIANCE, ACRIN, ACSOG
NCICA, NCCTG, NSABP
|Dept. of Health & Human Services (HHS)
|Agency for Healthcare Research and Quality (AHRQ)
Agency for Toxic Substances and Disease Registry (ATSDR)
Centers for Disease Control (CDC)
Food and Drug Administration (FDA)
Health Resources and Services Administration (HRSA)
Indian Health Services (IHS)
Office of Global Affairs (OGA)
Office of the Assistant Secretary for Health (ASH)
Office of the Assistant Secretary for Preparedness and Response (ASPR)
Substance Abuse and Mental Health Services Administration (SAMHSA)
|National Institutes of Health (NIH)
|NIH Office of the Director (OD)
National Cancer Institute (NCI)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)
National Institute on Minority Health and Health Disparities (NIMHD)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Library of Medicine (NLM)
Center for Information Technology (CIT)
Center for Scientific Review (CSR)
Fogarty International Center (FIC)
National Center for Complementary and Alternative Medicine (NCCAM)
National Center for Advancing Translational Sciences (NCATS)