TERM

 DEFINITION

For COIs in Research and Sponsored Programs  

Those facts that convince the Senior Vice President and Vice Dean for Science and the Research Conflict of Interest Committee (RCOIC) that an Investigator may participate in a Sponsored Project despite the existence of a Significant Financial Interest.  Factors that may be evaluated by the RCOIC in determining whether Compelling Circumstances are present are listed in the Research Conflict of Interest Committee - Operating Guidelines.

For Institutional COIs in Human Subjects Research 

Those facts that convince the Senior Vice President and Vice Dean for Science and the Research Conflict of Interest Committee (RCOIC) that the Medical Center may participate in a human subjects' research project despite the existence of an Institutional Financial Interest.  Factors that may be evaluated by the RCOIC in determining whether Compelling Circumstances are present are listed in the Research Conflict of Interest Committee - Operating Guidelines.

When a Faculty Member's commitment to external activities- such as consulting, lecturing, acting as an expert witness, public service, or service on a professional board or commmittee, or pro bono work- compromises his or her obligations to NYU and the Medical Center.    

In Business Affairs

When an NYU Langone Medical Center Member's personal interests or activities within or outside the Medical Center influence or appear to influence an NYU Langone Medical Center Member's ability to promote objectively the best interests of the Medical Center. See Business COI Examples

For Trustees

When a Trustee's personal interests or activities within or outside of the Medical Center influence or appear to influence a Trustee's ability to promote objectively the best interest of the Medical Center.  Any business transaction which involves the Medical Center and the Trustee, a member of his or her Immediate Family, or an entity in which he or she has a Material Interest gives rise to a Conflict of Interest.    

In Research and Sponsored Programs

When an Investigator's Financial Interest might reasonably appear to affect or be affected by the design, conduct or reporting of a Sponsored Project (* See Insitutional Conflict of Interest below ).  See Research COI Examples

For Faculty Members

When external activities influence or appear to influence a Faculty Member's ability to promote objectively the best interests of the Medical Center.  A consulting or other external activity which does not comply with our Policy on Faculty Consulting results in a Conflict of Commitment or Conflict of Interest. See Faculty Conflict Examples

Refers to consulting fees, honoraria, lecture fees, other emoluments, stock, stock options, royalties or "in kind" compensation directly or indirectly received from an entity (or entitlement ot the same), whether for consulting, lecturing, or service on a scientific advisory board, data saftey monitoring board, steering committee for a clinical trial, executive committee for a clinical trial, or other committee for an outside entity, or for any other purpose, that have been received in the past calendar year or are expected to be received in the next calendar year.    

Senior leadership of the Medical Center as defined by the Dean and CEO.

Financial Interest

A financial interest is held in an outside entity by an NYU Langone Medical Center Member when he or she or a member of his or her Immediate Family has a personal financial interest in the outside entity. Examples of Financial Interests are an Outside Position, Ownership Interests, Consulting Compensation or Royalty Income. 

Financially-Interested Company 

An outside entity which would reasonably appear to affect or be affected by the conduct or outcome of a Sponsored Project at the Medical Center.  This term includes: (1) the manufacturer or distributor (including business partners and affiliates) of any drug, device or other process being used in the Sponsored Project; (2) any entity acting as the agent of the Research Sponsor or other Financially-Interested Company (e.g. a contracted research organization); and (3) a company that provides direct or primary competition for the invetigational product if the Investigator actually knows the financial interests of the company would reasonably appear to affect or be affected by the Sponsored Project.  

Human Subjects Research

A systematic investigation performed with human subjects (including development, testing, and evaluation) designed to develop or contribute generalized knowledge, regardless of the source of funding. 

IACUC

The Medical Center's Institutional Animal Care and Use Committee. 

Immediate Family

A person's spouse, domestic partner, children, parents, siblings, equivalents by marriage, or other individuals residing in the person's household.  

Institutional Conflict of Interest

Occurs in human subjects' research when a financial interest of NYU or the Medical Center may affect or appear to affect the design, conduct, reporting, review, or oversight of the human subjects' research.  

Exists when either (i) NYU or the Medical Center receives or might resonably be expected to receive royalty income for the sale of a product covered by any patent, license or copyright, whether issued or pending, held by NYU or the Medical Center and proposed to be used in a human subjects' research project; and/or (ii) NYU or the Medical Center holds or proposes to hold, directly or indirectly, any equity interests of any amount (or entitlement to the same), in a research sponsor for a human subjects' research project, whether such research sponsor is public or non-public, through NYU's or the Medical Center's technology licensing actvities or investments.

An issued or pending patent, license or copyright covering products or processes being used in a Sponsored Project and includes, for the purpose of this Policy, the right to income from NYU in connection with a patent, license or copyright held by NYU (for further information, see the NYU Statement of Policy on Intellectual Property.

Investigator

Any person doing any of the following in connection with a Sponsored Project at or under the auspices of the Medical Center, whether conducted at an NYU-owned or Medical Center-owned facilty, Bellevue Medical Center, Mahattan Harbor Veteran's Administration Medical Center or any other affiliated facility anywhere in the world): 

• Designing, conducting or directing the Sponsored Project;
• Applying, on behalf of the Medical Center, for grants or awards to perform  the Sponsored Project;
• Serving as the principal investigator/program director, co-investigator, or sub-investigator;
• Enrolling subjects (including obtaining informedconsent, if applicable) or making decisions related to eligibility for enrollment; or
• Analyzing, reporting presenting or publishing research data 

All key personnel listed on a submission for the Sponsored Project to the IRB, the IACUC or the applicable Sponsored Research Office are Investigators. 

The Medical Center's Institutional Review Board.  The term also refers to any other Institutional Review Board for Human Subjects Research conducted at or under the auspcies of the Medical Center.  

Material Interest

When a Trustee and/or a member of his or her Immediate Family (a) is a director, trustee, partner, officer or senior executive in the entity or (b) has a financial interest of any kind in the entity which, in view of all the circumstances, is substantial enough that it might affect, or reasonably be perceived to affect, the Trustee's judgment with respect to transactions between the Medical Center and the entity.  A "financial interest" includes all forms of direct and indirect compensation, remuneration, ownership or control of the entity.

Non-Human Subjects Research                

Basic research, animal research, and other research that is not Human Subjects Research, regardless of the source of funding.

NYU Langone Medical Center Member

Refers to employees, faculty, staff, residents, trainees, students, volunteers and officers of the Medical Center.  This term does not include Trustees.

A position or appoinment to serve, in either a personal or representative capacity, as a director, trustee, partner, senior executive officer, or employee, whether paid or unpaid, at an outside entity. 

Equity interests held, either directly or indirectly, including stock and stock options (or entitlement to the same), of any amount in either a pubicly-traded or non-publicly-traded entity. (Exception: Mutual Funds- Interests of any amount in publicly-traded, diversified mutual funds are not Ownership Interests.)

Pre-Clinical Research 

Non-Human Subjects Research which is reasonably anticipated to be (1) a component of a submissionto the FDA related to aproduct or process to be tested in human subjects (including IND nad IDE submission) or (2) to progress the research involving human subjects within the coming twelve (12) months.   

Research Sponsor

Any government (federal, state, or municipal), foundation, not-for-profit entity providing either monetary or material support for a Sponsored Project.

Royalty Income

Payments linked to product sales or the written contractual right to receive future royalties, directly or indirectly, under an issued or pending patent, license or copyright, that has been received in the past calendar year or is expected to be received in the next calendar year.  Royalty income includes all income received by an NYU Langone Medical Center Member from NYU in accordance with the NYU Statement of Policy on Intellectual Property.

Significant Financial Interest  

In Human Subjects Research and Pre-Clinical Research:

• Any Outside Position (i.e. director, trustee, partner, senior executive, officer or employee);
• Ownership Interests (i.e. stocks, options and warrants) of any amount;
• Consulting  Compensation (including consulting income and honoraria) of greater than $10,000 in any relevant year;
• Royalty Income of greater than $10,000 in any relevant year; or
• Any Intellectual Property Right (Exception: Pre-Clinical Research)      

In all Non-Human Subjects Research (other than Pre-Clinical Research) or Sponsored Programs):

• Any Outside Position (i.e. director, trustee, partner, senior executive, officer or employee);
• Ownership Interests (i.e. stocks, options and warrants) of greaterthan $25,000 in a publicly-held company;
• Consulting Compensation (i.e. consulting income and honoraria) of greater than $25,000 in any relevant year; or
• Royalty Income of greater than $25,000 in any relevant year   

Sponsored Program

Any activity that receives funding from outside the Medical Center other than a Human Subjects Research project and a Non-Human Subjects Research project, including education and service activities. (Exception: CME Activities- Commercial support of any certified-CME-activity is not a Sponsored Program.) 

Sponsored Project

Any Human Subjects Research project, any Non-Human Subjects Research project, or any Sponsored Project. 

Sponsored Research Office

The Medical Center Office responsible for the review and administration of a Sponsored Project proposal. These consist of the Office of Sponsored Programs Administration (SPA), the Office of Clinical Trials (OCT) and the Office of Industrial Liaison (OIL).