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P209: Investigator Conflict of Interest Policy

Issued by:
Office of Vice President for Research
Revised:
April 2017
Effective:
April 11, 2017

Background:

Stony Brook University* (University) encourages interaction of its members (i.e., faculty, administrators, students, staff and fellows) with the public and private sectors as serving an important component of its educational, research and public service mission. Examples of such interactions include:

  • External support through grants, contracts and gifts from public and private sources provides significant assistance for University activities.
  • Professional interactions with public agencies, private businesses, non-profit organizations and individuals advance the University's ability to provide research and educational experience for our students, contribute to the economic well-being of our community, and add to our store of knowledge and understanding.
  • Technology transfer in the form of patents, licensing agreements, and consulting opportunities are important means of meeting the needs of society and fostering the welfare of the citizens of the State of New York.

*All Schools, Centers, and Institutes within the State University of New York at Stony Brook, the Research Foundation for the State University of New York as it relates to the Stony Brook University, the Stony Brook Foundation, Stony Brook Medicine (including University Hospital), and the Long Island State Veterans Home.

Policy:

It is the policy of the University to maintain the highest ethical standards in its efforts to promote and achieve the highest quality research and creative activity. As part of this commitment, the University and its members: (1) share an obligation to protect the University's mission and reputation from being compromised by real and potential conflicts of interest or obligations and (2) operate with policies consistent with various federal funding agencies. To manage compliance with this Policy: (1) Investigators must report outside personal interests and obligations in accordance with this Policy and (2) the University must effectively manage reported actual or apparent conflicts of interest.

Applicability of Policy:

This Policy applies to:

A. University faculty, staff or students who are responsible for the design, conduct, or reporting of activities** and any University faculty who are identified in a budget or who are acting as a consultant or collaborator in any and all:

  • Externally supported activities for University programs, projects, activities and services, solicited and unsolicited, including gifts and donations specifically made to support the activities of identified individuals;
  • Internally supported activities, where support is granted following formal application to a University program in response to a request for proposals (e.g., Targeted Research Opportunity 'TRO' Grants); and
  • Internally supported research activities for the benefit of an external entity (e.g., non-funded research projects where deliverables such as reports/data are provided to an external entity)

**Exceptions:

Not included: Individuals who do not make independent decisions regarding the design, conduct, or reporting of the activity in question, and only work on or are engaged in the activity (for example, in most cases research assistants, undergraduates and secretaries will not be considered responsible for the design, conduct, or reporting of activities of a research project). However, for PHS-funded activities, only collaborators or consultants are considered responsible for the design, conduct, or reporting of activities of a research project.

B. University faculty, staff or students who are named as study personnel on any externally funded research studies involving human subjects.

C. University faculty, staff or students who hold a financial interest or obligation in a company that is negotiating an agreement with the Office of Technology Licensing and Industry Relations (OTLIR) for technology developed by the respective faculty, staff or student.

Note: Phase I Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR) applications are exempt from the additional specific requirements referenced in this policy pertaining to PHS/NIH activities. SBU investigators on such applications are NOT exempt, however, from any other requirements (e.g., disclosure, need to comply with management plans, etc.) set forth in this policy.

Conduct of Research

No research activity may commence until review of the Investigator's certification is completed, and, if necessary, the Investigator agrees to and endorses the management plan.

Training:

Each Investigator must complete University's FCOI training requirement:

  • Prior to engaging in research related to any grant and at least every four years, and
  • Immediately under the designated circumstances:
    • University COI policies change in a manner that affects Investigator requirements
    • An Investigator is new to the University
    • University finds an Investigator to be noncompliant with University's COI policy or management plan.

The Vice President for Research (VPR) will:

  • Appoint the Designated Institutional Official; and
  • Serve as the final arbiter in any appeals process.

The Designated Institutional Official will:

  • Develop standard operating procedures for this policy;
  • Solicit and review certifications from each Investigator required to submit such disclosures;
  • Provide guidelines to identify conflicting interests and obligations; and
  • Develop management plans that specify the actions that have been, and shall be, taken to manage a Financial Conflict of Interest or Conflict of Obligation.

Standard Operating Procedures for P209 Investigator Conflict of Interest Policy set forth requirements and guidelines for:

  • Definition of key terms, including definitions of Investigator and Immediate Family Member;
  • Training requirements;
  • Method and timing for reporting of outside interests and obligations by Investigators at the University who engage in University activities supported by specified internal and external entities;
  • Process for review of Investigator certifications by University designees;
  • Processes for identifying, reporting, and managing conflicts of interest;
  • Processes for appeals, retrospective review (for PHS/NIH), and non-compliance; and
  • Processes for the review of COI compliance for sub-recipients for PHS/NIH proposals/awards only.

Documentation:

The Office of the Vice-President for Research will maintain records of all Investigator certifications and the Institution's review of, and response to, any disclosures (whether or not a disclosure resulted in the Institution's determination of Financial Conflict of Interest or Conflict of Obligation) and all actions under the University's policy or retrospective review (in the case of PHS/NIH funds) for at least three years from the date of submission of the final expenditures report or, in the case of PHS/NIH, from other dates specified in 45 C.F.R. 74.53(b) and 92.42 (b) for different situations.

Forms:

None

Policy Cross Reference:

None

Related Documents:

Inquiries / Requests:

Office of Research Compliance
W5530 Frank J. Melville, Jr. Library
Zip: 3368
Phone: (631) 632-9036
Fax: (631) 632-9839


Created by Application Support for Administration
University Policy Manual @ Stony Brook University