SUNY Downstate Medical Center
Conflicts of Interest
Financial Conflict of Interest Committee (FCOIC) & Management Plan
The Financial Conflict of Interest Committee (FCOIC) of DMC is an advisory body appointed by the Sr. Vice President for Research (SrVPR), or by the President or Operations Manager (OM) if the SrVPR position is vacant. The main activity of the FCOIC is to identify possible conflicts that arise from financial relationships disclosed by investigators in annual or transactional questionnaires, and then propose individualized Management Plans to minimize/mitigate those real or perceived conflicts. Management Plans are not legal documents per se, but are nevertheless mandatory (e.g., for the NIH) and serve as critical tools that protect and enable investigators and the scientific/educational/commercial activities in which they might be engaged, while at the same time acknowledging the investigator's responsibilities to maintaining the public trust as articulated by Public Officer's Law, the Research Foundation of SUNY, and the NIH. In addition to commercial sponsorship of a research study, conflict management has become more important given that developing and commercializing Intellectual Property (IP) are stated mission priorities of SUNY and the NIH, which reflects the latter's directive to support discoveries that will lead to new ways of improving human health and bringing new health improving inventions to market. Moreover, training in a company/entrepreneurial setting is an established and growing educational priority for our campus and SUNY in general.
The FCOIC understands the natural, expected, and often necessary complex relationships that promote essential scientific synergies between academic and commercial research enterprises and the educational mission. Therefore, the Management Plans, which are developed by the FCOIC in conjunction with the PI, typically include mechanisms of transparency, disclosure and third party oversight of both research operations needed to launch a commercialization process and enable special educational training opportunities in entrepreneurship while mitigating potential conflicts. In acknowledgement of that complexity, the FCOIC is composed of members with diverse practical and professional expertise from our academic medical center who together provide a broad range of perspectives that are essential for comprehensive and in-depth FCOI discussion. Voting members are SUNY faculty who carry out the institute's missions in education, research, and service; as such they are stakeholders who have the essential experience in these areas to identify, evaluate and manage financial conflicts of interests in these settings. Non-voting members provide critical expertise and guidance in each area of compliancy to ensure that the interests of the public, SUNY, SUNY-RF, the Federal government, and DMC are represented and that their respective legal mandates are met. The key distinction is that the voting members actually carry out the activities that would come under regulation by these different regulatory bodies. Voting faculty members are appointed by the SrVPR or the OM for a 3 year term, and ex-officio (non-voting) members represent the Office of Technology Commercialization, the IRB, the RF of SUNY-DMC, and the Office of Compliance & Audit Services, who serve critical advisory roles.
- Operations Manager (OM): Mark Stewart, MD, PhD (Physiology and Pharmacology)
- Senior VPR: Carlos Pato, MD, PhD (Professor of Psychiatry and Dean, College of Medicine)
2017 Voting members
- Eva Cramer, PhD (Cell Biology; VP for Biotechnology and Scientific Affairs, President of the Downstate Incubator and BioBAT)
- Ellen Ginzler, MD, MPH (Medicine/Rheumatology)
- Nira Goldstein, MD, MPH (Otolaryngology)
- Arthur Grant, MD, PhD (Neurology)
- Stephan Kohlhoff, MD (Pediatrics)
- Steven Levine, MD, FAHA, FAAN, FANA (Neurology)
- Kathleen Powderly, CNM, PhD (Medical Ethics/IRB)
- Mark Stewart, MD, PhD (Dean, School of Graduate Studies; Interim Provost)
- Christopher Roman, PhD (Cell Biology) Chair of FCOIC
2017 Non-Voting (ex-officio) members
- Joesph Barabino (AVP for the RF of SUNY-DMC)
- Zhanna Kelley (Senior Compliance Manager, Office of Compliance & Audit Services)
- Sharon Levine-Sealey (Director, RF SUNY-DMC Pre-Award Operations)
- Shoshana Milstein, RHIA, CHP, CCS (AVP, Office of Compliance & Audit Services)
- Kevin Nellis, MS, CIP (IRB Executive Director, Human Research Protection & Quality Assurance)
- David Schoenhaut, Ph. D. (Director, Office of Technology Commercialization)
The FCOIC meets at minimum quarterly and ad hoc as needed. FCOIC members take an oath of confidentiality; meeting minutes are taken and approved, and are also kept confidential. Actions to be taken are based on a simple majority vote of the VOTING members. If the investigator does not agree to a FCOIC-proposed Management Plan, the matter is referred to the OM (or Sr VPR) for resolution. Communications with PIs is primarily conducted via coi-smart.com.
Review Criteria and Management Plans
The Research FCOI Committee will review disclosures based on the criteria and principles they have established (located here). The Committee will determine whether the financial conflict can be managed/ reduced through a management plan, or if in rare cases not, whether it must be discontinued in order to mitigate the conflict.
The Research FCOI Committee shall recommend the actions that have been/ will be taken to manage a financial conflict. Examples include:
- Public disclosures of the financial conflict (e.g., before presenting or publishing the research, and disclosing commercial relationships to trainees such as students, technicians, and post-docs);
- For research projects involving human subject research, disclosure of the financial conflict directly to participants (e.g., in the IRB study Consent Form);
- Appointment of an independent committee to oversee and monitor the educational goals and progress of students performing research at a commercial facility as part of their degree training;
- Appointment of an independent monitor capable of taking measures to protect the design, conduct and reporting of the research against bias resulting from the financial conflict (this is often the Chair);
- Modification of the research plan(s);
- Change of personnel or personnel responsibilities, or disqualification of personnel from participation;
- Review of ongoing/future IP development to identify potential conflicts that may emerge between academic and new IP commercialized entities that come into existence;
- Prohibiting the PI from influencing DMC's purchasing decisions;
- PI's requirement to disclose and receive approval for not-insignificant use of shared resources (for example, lab space, equipment, supplies and staff).
Should the previous actions be insufficient, there will be an evaluation as to whether:
- Reduction or elimination of the financial conflict; or, in rare instances
- Severance of relationships that create the financial conflict are necessary to address the conflict.