Conflict of Interest Albert Einstein College of Medicine strives to ensure objectivity, balance, transparency, and scientific rigor in all academic activities, free of Conflict of Interest. As such, the college has a comprehensive set of Conflict of Interest policies to ensure compliance, has established a Conflict of Interest Office and appointed a Conflict-of-Interest Chair (Victor L. Schuster, MD) who oversees the Conflict-of-Interest Committee. Albert Einstein College of Medicine requires disclosure of financial interests (FI) of any value, including salary or any remuneration for services. Additionally, the disclosure must include FI of a related party (spouse, domestic partner, or dependent child). All disclosures must be complete, timely and truthful. After review of these disclosures, the Conflict-of-Interest Chair establishes a plan to mitigate identified conflicts of interest. What is a Conflict of Interest? Conflict of Interest can occur when individuals involved in academic activities (research or teaching) have financial or other secondary interests from which they might personally benefit depending on the results of the research, or which might bias educational presentations. COI also may occur in clinical or administrative situations. How Do I Report a Conflict of Interest? The Conflict of Interest (COI) Office has initiated a new Conflict of Interest Disclosure System, the COI Risk Manager System, https://einstein.coiriskmanager.com. You must be a registered user to gain access to the system and complete a COI Disclosure Form. If you are not a registered user, i.e., there is a blank screen when you attempt to access the system, please contact the COI office at coi@einsteinmed.edu to establish your account. Who Must Submit a Conflict of Interest Disclosure? Investigators are required to disclose all financial interest (FI) and relationships to external entities that may be pertinent to their Einstein related research. Additionally, the financial interest of a related party (spouse, domestic partner, or dependent child) must also be disclosed. An Investigator is defined as an individual who is independently responsible for the design, conduct, outcome, or reporting of research, regardless of title, position, or salary support. Only those individuals who are listed as an “Investigator” on an IRB (Institutional Review Board) application need to complete and update COI Disclosure Forms. Please use the following guidance document to determine which research team members meet the definition of an “Investigator.” Is There a Timeline for Submitting a Conflict of Interest Disclosure? Einstein faculty appointees are required to submit a COI disclosure at the time of appointment. Thereafter, investigators engaged in human subjects or any PHS-funded research must submit updated COI disclosures at least annually. However, a COI disclosure is considered up to date if it is submitted within six (6) months of the COI review date. Faculty and investigators must also update their COI disclosures within thirty (30) days of acquiring any new remuneration, establishment of a new role, or acquisition of any new Intellectual Property. What “Events” Require Disclosure Updating and Review? Investigators must update their COI disclosures within thirty (30) days of acquiring any new remuneration, establishment of a new role, or acquisition of any new Intellectual Property. Other events which require updated disclosures include: Submission of a grant application to the Office of Grant Support (COI review must be completed before the expenditure of any grant funds); Submission of a human subjects’ research protocol; Filing for a patent or clinical trial agreement; Establishment of a contract with a commercial entity as detailed by Einstein’s Office of Biotechnology and Business Development. What External Relationships Require Disclosure? Any role/relationship or remuneration received from a company or organization external to Albert Einstein College of Medicine should be disclosed, including: Honoraria and fees for participating in meetings or conferences by industry or commercial entities; Ownership interest, whether private or listed, i.e. stock(s), stock options or other forms of equity; Patent or Intellectual Property Interest, i.e. copyrights, trademarks, patents, industrial design rights or trade secrets; Reimbursed or sponsored travel; Foreign activities, i.e. funding from foreign sources, foreign academic appointments, etc. What Are Significant Financial Interests (SFI)? Significant financial interest means: (1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator's spouse and dependent children) that reasonably appears to be related to the Investigator's institutional responsibilities: (i) With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value; (ii) With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator's spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); (iii) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests. (2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their institutional responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education. Are There Any Exclusions for FI and SFIs? Per the Code of Federal Regulations, 42 CFS 50.603, the term significant financial interest does not include the following types of financial interests: Salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights; Any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization; 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; Income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; Income from service on advisory committees or review panels for a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education. Do I Have To Report Travel? Travel As required by federal regulation, Investigators must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid for on behalf of the individual but not reimbursed so that the exact monetary value is not readily available). Disclosure must be made within 30 days of the travel event. Pre-planned or anticipated travel may be disclosed up to one year in advance. I Need More Information. Who Can I Contact? Please reach out to our office if you have questions or concerns about a potential COI: Christopher Eichstedt, PhD, CIP Assistant Director, Policy and Regulatory Compliance christopher.eichstedt@einsteinmed.edu Mia Brisbane, MPH Research Compliance Manager mia.brisbane@einsteinmed.edu Nilsa E. Laboy Research Compliance Analyst nilsa.laboy@einsteinmed.edu General contact: Phone: 718.430.2237 Fax: 718.430.8705 COI@einsteinmed.edu Institutional Policies All key personnel should review the Institution’s policies ensure they are familiar with, and understand their responsibility; the IRB will not review submissions without a COI review. Comprehensive Conflict of Interest Policy Outside Professional Income Policy Policy on Disclosing Financial Conflicts of Interest to the IRB Guidelines for Conflict of Interest Disclosure Outside Professional income Policy Conflict of Interest Policy for Trustees, Officers, and Key Employees Montefiore Vendor Policy Federal Laws and Regulations Title 21, Part 54, subpart A Financial Disclosure by Clinical Investigators Title 42, Part 50, subpart F Section 50.604, Institutional Responsibility Regarding Conflicting Interests of Investigators Title 45, Part 94 Responsible Prospective Contractors
