Financial Conflict of Interest

Frequently Asked Questions
Who is an Investigator?
Anyone responsible for the design, conduct, or reporting of research, regardless of title or position. This includes:
- Project directors
- Principal investigators
- Co-investigators
- Senior/Key personnel
- Study team members involved in human subjects research
- 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, Julia Zipper or Lila Sisbarro.
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.
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 is a COI or Financial Conflict of Interest (FCOI)?
Generally speaking, a Conflict of Interest (COI) exists if a COI Officer determines that an individual’s outside financial interests or relationships intersect with and could impact or bias (or appear to impact or bias) the objectivity of an individual’s University activities.
A Financial Conflict of Interest (FCOI) exists when the institution’s designated official(s) reasonably determines that an investigator’s significant financial interests could directly and significantly affect the design, conduct, or reporting of research. The institution is required to review each Investigator SFI disclosure to determine if a SFI: could directly and significantly affect the design, conduct, or reporting of the research. Georgetown’s Senior Director, ORO is the designated institutional official for COI determinations related to research.
Where Do I File a 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 complete a conflict of interest disclosure in MedStar’s COI-Smart system. ORO has access to applicable disclosures in COI-Smart to perform required COI reviews.
What Happens After I File a Disclosure Form?
The University is responsible for reviewing disclosures and managing, reducing, or eliminating identified conflicts. Disclosures are reviewed by the Conflict of Interest Officer, 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. The University is responsible for reviewing disclosures and managing, reducing, or eliminating identified conflicts. In the context of research, the University must meet applicable sponsor COI requirements and COI reporting obligations where applicable. Georgetown’s Senior Director, ORO is the designated institutional official for COI determinations related to research.
How Do I Complete COI Training?
Investigators who receive Public Health Service (PHS) funding (and funding from other agencies that abide by PHS COI regulations) must undergo conflict of interest (FCOI) training before engaging in the funded research. To complete the training, visit our FCOI training page for instructions.
What Agencies are Part of the Public Health Service (PHS)?
PHS includes the federal agencies and cooperative groups listed below:
| Cooperative Groups | ALLIANCE, ACRIN, ACSOG CALGB, COG ECOG, EORTC GOG NCICA, NCCTG, NSABP RTOG SWOG |
|---|---|
| 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) |
Questions or Concerns?
For questions about policies, procedures, or training, please contact:
- Julia Zipper, MPPA (202) 687-3911, julia.zipper@georgetown.edu
- Nabeel Qureshi, MBBS, MPH, nabeel.qureshi@georgetown.edu
- Lila Sisbarro, BS, lila.sisbarro@georgetown.edu