FAQ

 

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Conflict of Interest

How does an investigator satisfy the COI training 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.

When does an investigator have to file a certification?

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.
What information does an investigator have to disclose?

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 

 

 

What is a significant financial interest?

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.  

Are there any exceptions to what Financial Interests need to be disclosed?

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.
     
How are Disclosures and Certifications reviewed?

Standard Operating Procedures - Effective April 17, 2017

Disclosures and Certifications

What happens if one or more of my Significant Financial Interests constitute a Finanical Conflict of Interest?

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.

Does the Investigator COI Policy include a requirement for training?

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.

 

 

Where do I find the policies that govern research at Stony Brook University?

There are many policies in place relevant to the research community at Stony Brook. They can be found at this site.

Who should I contact if I need assistance in compliance matters?

The Office of Research Compliance staff directory outlines the various individuals and their respective positions/roles. 

What commitments does the IACUC promote for animal use?

The Institutional Animal Care and Use Committee works to ensure that research is conducted in a way that

  1. avoids or minimizes discomfort, distress, and pain in experimental animals consistent with sound scientific practices
  2. uses the minimum number of animals necessary to obtain valid results, and
  3. considers non-animal models wherever possible
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