Investigator Financial Disclosure and Conflict of Interest Policy

Revised Supplemental Guidelines

I. Introduction

New York University has a strong commitment to the principle of open and objective inquiry in the conduct of its education, research, and service missions. To promote and protect this objectivity, the University has long-standing policies concerning conflict of interest and faculty responsibility to the University. (1) Additional conflict of interest guidelines for Medical Center researchers were announced in 1992 by Saul J. Farber, M.D., Provost and Dean of the Medical Center. (2)

On July 11, 1995, the Public Health Service (PHS) and the National Science Foundation (NSF) published final rules on financial disclosure and conflict of interest (Federal Register, Volume 60, Number 132, pp. 35810-35823). The purpose of these policies is to ensure that the design, conduct, and reporting of research will not be biased by any conflicting financial interest of an investigator. Other federal agencies that provide funding to universities are expected to adopt these rules.

New York University Medical Center's policy concerning conflict of interest is consistent with the principles of the PHS and NSF rules. The Medical Center's Supplemental Guidelines have been revised, as presented below, to comply with standards and regulations that are specified in the PHS and NSF policies.

II. Effective Date

October 1, 1995.

III. Definitions

"Investigator," as defined by federal rules, means: the principal investigator/program director, co-principal investigator(s), co-investigator(s), and any other person who is or will be responsible for the design, conduct, or reporting of research, including clinical trials, education, or service activities funded, or proposed for funding, by any external or internal sponsor. At NYUSM, this means all faculty and employees, including research associates, technicians, postdoctoral fellows, and any other persons who, on behalf of the Medical Center, apply for or receive Federal or other funds or awards through a grant, subgrant, contract, subcontract, or cooperative agreement for any research, including clinical trials, education, or service activities from any potential sponsor, including Federal and other governmental agencies, foundations, and other not-for-profit and for-profit entities or who has any responsibility for the design, conduct, or reporting of such research, including clinical trials, education or service activities.

"Immediate Family" means the Investigator's spouse, children, siblings, parents, or equivalents by marriage, or other individuals residing in the Investigator's household.

"Financial Interest" means:

• anything of monetary value including, but not limited to, salary, royalties, or other payments for services, including payments for consulting services and services on advisory committees;
  
  
• holding intellectual property rights, including patents, patent applications, copyrights, and royalties from such rights;
  
  
• equity interests; e.g., owning or having the right or obligation to acquire stocks or stock options or other securities in a for-profit entity.
  
  
• a position as consultant, employee, director or manager of an entity.

The term "Financial Interest" does not include:

• salary, share in royalties, or other remuneration from New York University (NYU);
  
  
• intellectual property rights developed in the course of employment at NYU and assigned to NYU.

"Subject Entity" means a for-profit, not-for-profit or governmental entity which, with respect to an individual Investigator's proposed research, would reasonably appear to be financially affected by the research, including clinical trials, education or services funded, or proposed for funding. This includes any for profit, not-for-profit or governmental entity except agencies of the federal government which:

• sponsors basic research, clinical trials, or other studies;
  
  
• supplies drugs or devices for research, clinical trials, or other studies;
  
  
• may in any way derive benefits or be competitively advantaged or disadvantaged from results of clinical trials, or other studies;
  
  
• engages in licensing discussions with New York University with respect to inventions in which a property right may be claimed by the investigator;
  
  
• any affiliate or subsidiary of such entity.

"Clinical Trials" means studies in which a drug, therapeutic or diagnostic agent, or device is evaluated in human subjects.

"Project Period" means the period from the time that the Investigator's active and personal involvement in the study begins until:

1. the Investigator's active and personal involvement in the study ends; or
   
   
2. the Medical Center's involvement in the study ends;
   
   
3. or, in the case of clinical trials, funding for the clinical trials ends and the results are made public through scientific publications or presentation at a scientific gathering, whichever is latest.

IV. Applicability

This policy shall apply to all New York University Medical Center Investigators, as defined above.

If sponsored projects are carried out on behalf of the Medical Center through subgrantees, contractors, subcontractors, or collaborators, those institutions must ensure that Investigators comply with the Medical Center's policy or provide assurance to the Medical Center that the other institution is in compliance with the Federal regulations.

V. Policy

A. Background

Collaboration of academic researchers and educators with industry and private entrepreneurial ventures is encouraged. Such relationships, however, may present an increased risk of potential or actual conflict between the interests of individuals or the entities with which they are involved, and the public interest that Federal and other sponsored funding should serve. To ensure that the design, conduct, and reporting of all sponsored project activity will not be biased by such conflicts, this policy restates existing New York University and New York University Medical Center policies and implements the Federal regulations for investigator financial disclosure and the determination and management of financial conflicts of interests.

B. Disclosure

1. Each Investigator planning to apply for or receiving funds or other support for research, including clinical trials, education, or service activities shall disclose the following Financial Interests:
   
   
   • any Financial Interest of the Investigator and/or the Investigator's Immediate Family that would reasonably appear to be affected by the research, education, or service activities funded, or proposed for funding;
     
     
   • any Financial Interest of the Investigator and/or Investigator's Immediate Family in a Subject Entity.
     
     
2. Each Investigator shall complete a Financial Disclosure Form that must be submitted with the proposal and the Medical Center's Transmittal Form to the Office of Sponsored Programs Administration. When a Financial Interest must be disclosed, supporting documentation that identifies the entity involved and the nature and amount of the interest should be submitted in a sealed envelope marked "confidential" and should accompany the Financial Disclosure Form and Transmittal Form. The Office of Sponsored Programs Administration will transmit the Disclosure packet to the Associate Dean for Science and Technology (the office designated for this purpose by the Dean) for review.
   
   
3. All Financial Interests must be disclosed at the time the proposal is submitted to a sponsoring agency or entity. No proposal may be submitted without such disclosure.
   
   
4. Investigators who wish to conduct clinical trials and who have (or whose Immediate Family has) a Financial Interest in a Subject Entity will ordinarily not be permitted to conduct the research unless approved on an exceptional basis by the Dean after consultation with the Faculty Committee on Conflict of Interest.
   
   
5. Review of Financial Disclosures, determination of whether a conflict of interest exists, and the management, reduction, or elimination of any conflicts must be completed prior to the expenditure of any awarded funds.
   
   
6. Investigators shall not, during the course of any research, including clinical trials, education or service activities, acquire any Financial Interest in a Subject Entity unless the Investigator has previously disclosed such Financial Interest and submitted it for review and a decision has been rendered pursuant to these guidelines.

C. Resolution of Conflicts

1. The Associate Dean for Science and Technology Administration shall conduct an initial review of all Financial Disclosures to determine whether any Financial Interest disclosed could affect the design, conduct, or reporting of the Investigator's research, education or service activities.
   
   
2. If the Associate Dean for Science and Technology Administration determines that the Financial Interest disclosed could affect the design, conduct or reporting of the Investigator's research, the Disclosure packet will be referred to the Medical Center's Faculty Committee on Conflict of Interest. If the Associate Dean for Science and Technology Administration determines that no potential or perceived conflict of interest exists, the Associate Dean for Science and Technology Administration shall so advise the Office of Sponsored Programs Administration and Research Services in writing and no further review shall be required.
   
   
3. The Faculty Committee on Conflict of Interest, consists of five faculty members, each appointed by the Dean, for a three-year term.
   
   
4. The Committee shall review Financial Disclosures and supporting documentation referred by the Associate Dean for Science and Technology Administration and determine whether or not a potential conflict of interest exists.
   
   
5. The Committee shall recommend conditions or restrictions, if any, which should be imposed upon the Investigator to manage, reduce, or eliminate actual or potential conflicts of interest. Examples of such conditions include, but are not limited to:
   
   
   • public disclosure of Financial Interests;
     
     
   • monitoring of research, education, or service plan and/or activities by independent reviewers;
     
     
   • modification of the proposed plan or activities;
     
     
   • disqualification from participation in all or a portion of the sponsored activity;
     
     
   • divestiture of Financial Interests; or
     
     
   • severance of relationships that create conflict of interests.
     
     
6. The Committee shall forward its recommendations to the Dean.
   
   
7. The Dean shall decide and transmit the final decision to the Investigator, the Committee, the Associate Dean for Science and Technology Administration, and the Office of Sponsored Programs Administration.
   
   
8. The Office of Sponsored Programs Administration shall inform the sponsor, prior to the expenditure of any funds, that a conflict of interest has been managed, reduced, or eliminated.
   
   
9. If application for annual renewal funding is made, the procedures described above shall be followed.

D. Enforcement

1. Failure to submit the required Investigator Financial Disclosure Form shall delay submission of the proposal to funding agency or sponsor until after such Form is submitted to the Office of Sponsored Programs Administration and Research Studies.
   
   
2. If an investigator fails to comply with the conditions imposed by decision of the Dean, or has otherwise violated this policy, the Dean shall notify the Faculty Committee on Conflict of Interest. The Committee shall review the matter and recommend corrective and/or disciplinary action, pursuant to existing New York University Medical Center procedures.

E. Remedies

If there is a determination by the Dean, after review by a duly charged Medical Center Committee that the failure of an Investigator to comply with this policy has biased the design, conduct, or reporting of the sponsored activity, the Medical Center shall promptly notify the funding agency

F. Record Keeping and Reporting

The Dean, or his designee, shall maintain records of all financial disclosures, Committee determinations and recommendations, final decisions, and actions taken to resolve conflicts of interest for at least three (3) years from the date of submission of the final expenditure report for the project, or until the resolution of any action involving those records, whichever is longer.

Footnotes

(1) New York University Faculty Handbook: Conflict of Interest Statement, pp. 112-115; and Statement of Policy on Faculty Responsibility to the University, pp. 115.a-115.b. Return to the text (2) Memorandum to Medical Center Researchers from Saul J. Farber, M.D., "Conflict of Interest in Research Situations," dated April 20, 1992. Return to the text