FAQ

Conflict of Interest

As of April 17, 2017

  • Annual Certifications are due annually by May 1st
  • For new Investigators an initial Annual Certification should be submitted prior to the submission of any proposals

 

When Is It Required to Report a Change in External Interests?

  • Within thirty (30) days of discovering or acquiring a new FI or Obligation.
  • At the time of establishing a faculty owned company.
  • At the request of the DIO, where new FIs have come to the attention of the DIO.
  • For PHS/NIH funded investigators, applicable travel must be disclosed within thirty (30) days of said travel. Alternatively, travel that is anticipated can be disclosed anytime in advance and would satisfy the thirty (30) day requirement.

The University uses the Collaborative Institutional Training Initiative (CITI) web-based program to meet our training needs.

Select "SUNY - University at Stony Brook" as your institution and then use your NetID and password.

The Policy applies to:

A. Stony Brook University (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: 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: If any provision in this document is in conflict with the governing legal and policy requirements for review and management of conflicts, the governing legal and policy requirements shall prevail 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. University 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.

Of course, please refer to Definitions

If there are any terms that you still need defined more clearly, please contact the Office of Research Compliance.

 

Disclosure is another term for an outside financial interest that is entered into the COI Module in myResearch (Huron Click)

Certification is the activity of reporting whether or not you hold any outside financial interests or obligations in the COI Module in myResearch (Huron Click)

There are two types of Certifications:

  • Annual -  Annual Certifications are non-project specific.
  • Research -  Research Certifications may be requested by the Office of Research Compliance if additional information is needed to clarify if there is any relationship between a disclosed outside financial interest or obligation and a specific project.

A Financial Interest is:

1. Any remuneration to the Investigator (and/or those of the Investigator’s Immediate Family Member) from outside the University, and/or

2. Any equity holdings or ownerships of the Investigator (and/or those of the Investigator’s Immediate Family Member), and/or

3. Intellectual property rights and interests (e.g., new technology disclosures, patents, copyrights) where a company has entered into an option to license, or license, such rights and interests from the University, and/or

4. Intellectual property rights and interests upon receipt of income related to such rights and interests and/or

5. PHS/NIH Only - sponsored travel

 

Note: At this University, all royalties, including those received by the Investigator from this University, are to be disclosed.

You should: 

(1)  Make sure your disclosures are up to date; and

(2)  Contact the Conflict of Interest Administrator in the Office of Research Compliance if you have any questions.

Yes. All investigators must complete COI training in CITI at least once every 4 years.

Investigators with PHS/NIH funding are required to complete the module for PHS/NIH investigators, all others can complete the shortened module.

 

 

Management Plan

For all identified FCOI’s and CO's, the DIO will develop and implement a Management Plan. If the University is unable to resolve a real or potential conflict of interest or the appearance of same, it will decline to perform the activity in question. Where human subjects are involved, the IRB may modify and/or add to the Management Plan. Where there is discrepancy or disagreement, the IRB's decision will supersede that of the DIO. The DIO sends the Management Plan to the Investigator. The Investigator must then provide concurrence and certification for compliance (signature) with the Management Plan in order for the award to be established or the unfunded agreement to be institutionally endorsed. The DIO will convey the notice of FCOI and/or CO and associated signed Management Plan to the Chair of the COI Committee, Assistant Vice-President of Research Compliance, Investigator, associated Chair, and associated Dean (the VPR will serve in this capacity when the investigator is a dean or vice president, or is otherwise conflicted).

Management Plan Compliance

The Investigator is required to comply with all terms of a Management Plan, including the submission of any resulting Publications via Huron Click.

Management Plan Monitoring

For all identified FCOI's and CO's, the DIO will monitor compliance with the Management Plan. Such monitoring will be documented.

Standard Operating Procedures - Effective April 17, 2017

Disclosures and Certifications

Yes! The following do NOT have to be disclosed:

  • 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 in 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, or 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;
  • Excluded from the travel disclosure requirement is travel that is reimbursed or sponsored by federal, state or local government agency, a (United States) 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.
     

A Significant Financial Interest (SFI) is a Financial Interest (FI) that you (or your spouse or dependent children) hold that reasonably appears to be related to your institutional responsibilities.

Institutional Responsibilities are those duties you have and activities you do as part of your professional responsibilities at the University, including, e.g., research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.) 

…reasonably appears to be related to your institutional responsibilities…” means that if either your identified interests below, or the entity in which you have those interests, relies upon the same expertise utilized to carry out your Institutional responsibilities, it is considered an SFI. So, let's say you on a speaker's bureau for a company and present on topics related to the expertise you need to do your job at SBU. That would be a related interest. What if you were a paid board trustee for a religious organization? No, not related if you are an endocrinologist at the University. Yes, related if you are a faculty member in Religious Studies. Now let's say you are a paid member on a company's board. In this situation, it's not what you do for the company (serve as a board member, which may not be something you do at the University), but what the company's business is that must be considered in determining relatedness.  

What External Interests Must be Reported?

  • Obligations
  • Financial Interests, where when aggregated for any one entity is greater than $5,000
  • Equity interests
  • Intellectual Property Rights and Interests, where royalty and other forms of payment are in excess of $5,000
  • Travel (for PHS/NIH only)

Note: The above include obligations and financial interest for both you and any Immediate Family Members.

Review the Definitions section of the Standard Operating Procedures for additional information and exclusions to what is considered a Financial Interest 

 

 

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