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

Export Controls

What is Fundamental Research?

The regulations distinguish between Fundamental and Proprietary Research.

The distinction is important as there are different rules for different types of research.

Do you receive proprietary information from a third party?
Proprietary Information is not publicly available and is subject to the export regulations. If you received Proprietary Information and wanted to share it with a research team member that was a foreign national, a deemed export license may be required. Research Agreements (RA), Material Transfer Agreements (MTA) and Non-Disclosure Agreements (NDA) can be structured to mandate that a party notify the Research Foundation and the principal investigator that Proprietary Information is export controlled prior to releasing it in order to allow for the proper sharing of the information.
Will you be sharing information and/or materials with an international collaborator?

The fundamental research exclusion does not apply to shipping information and/or materials off campus, a license may be required to share this information with an international collaborator - even under a fundamental research project.

The fundamental research exclusion applies to INFORMATION that is made public; while the actual “item” that is the result of the research may require a license.

Key considerations when you have international collaborations - what are you sharing, who are you sharing with, why are you sharing.

Who is a foreign person under the federal export regulations?

A person who is NOT:

  • Granted permanent U.S. residence, as demonstrated by the issuance of a permanent residence card, i.e., a "Green Card"
  • Granted U.S. citizenship
  • Granted status as a "protected person" under 8 U.S.C. 1324b(a)(3), e.g., political refugees, political asylum holders, etc.
  • It also means any foreign corporation, business association, partnership, trust, society or any other entity or group that is not incorporated or organized to do business in the United States, as well as international organizations, foreign governments and any agency or subdivision of foreign governments (e.g., diplomatic missions)
What is the I129 Deemed Export Attestation?

U.S. Citizenship and Immigration Services' I129 form requires an Export Attestation for a foreign person petitioning for a H-1B, H-1B1 Chile, Singapore, L-1 or O-1A visa.

What is a Deemed Export?

The release of technology or software subject to the Export Administration Regulations to a foreign national in the U.S. (although this term in not expressly stated in the International Traffic in Arms Regulations the same principles apply).

Deemed exports can be conveyed through visual inspection, oral exchange, electronic/digital exchange, made available by practice/application (e.g. training).

When receiving third party proprietary information and before sharing the information with a foreign national (even a fellow SBU employee or student) a deemed export review should be completed.

Are you traveling to an international off site location and taking field equipment with you?

Prior to taking any field equipment with you to an international research location, you must first stop and review whether or not these items export controlled under either the Export Administration Regulations (EAR) or the International Traffic in Arms Regulations (ITAR)? If they are controlled under the International Traffic in Arms Regulations, the items will need a license. If they are controlled under the Export Administration Regulations, the applicability of a license exception or need for a license will depend upon the destination. If they are controlled under the EAR and there is an applicable license exception, this exception needs to be properly documented.

Remember: Just because you can purchase an item overseas does not mean that a license is not required to take the item overseas.

You are taking your laptop overseas under the TMP license exception, what are your obligations?

The TMP license exception, applies to the Export Administration Regulations and not the International Traffic in Arms Regulations.  A laptop must be “clean” - may not contain any export controlled technical data - to be eligible for the TMP license exception. In addition, the following must be followed: 

  • you MUST retain exclusive control of the equipment at all times
  • you MUST not let the equipment be used by anyone in the foreign country
  • you MUST not intend to keep these items in these countries for longer than one year
  • you MUST verify that no government licenses are required

Go to International Travel for additional consideration for traveling.

What is considered an open conference?

Under the EAR a "conference or gathering is considered “open” if all technically qualified members of the public are eligible to attend and attendees are permitted to take notes or otherwise make a personal record (but not necessarily a recording) of the proceedings and presentations." In all cases, access to the information must be free or for a fee that does not exceed the cost to produce and distribute the material or hold the conference (including a reasonable profit).

Individuals should be cognizant of whether or not the conference or workshop they are attending, hosting, or presenting at is open.

Open conferences will not ask that attendees complete forms confirming their nationality status or sign non-disclosure agreements.

If you are attending a conference/workshop that is not open, a license may be required to share the information from that conference/workshop with foreign persons (even within the U.S.).

What do I need to consider before shipping equipment, biologics, chemicals or any other item off campus?

Before Shipping Checklist for Export Compliance

Is the item or technical information controlled under the export control regulations?

  • Yes and it is controlled under the International Traffic in Arms Regulations (ITAR) – STOP - an export license is required
  • Yes and it is controlled under the Export Administration Regulations (EAR) – STOP – an export license or a license exception may be required
  • It is EAR99 - STOP - EAR99 items cannot be shipped to most restricted parties or to embargoed countries

Are you sending the item to an embargoed or sanctioned country?

Does the person or entity that you are sending the item to appear on any restricted parties lists?

Is it a legitimate end purpose?

What should I consider before sharing information with collaborators whether in the US or abroad?

Before sharing information with collaborators, please consider these important points

What do I need to consider before traveling?

International travel considerations include: country you are going to (is it a sanctioned/embargoed country), person/business/university you are visiting (are they a restricted entity), what you are taking (is a license needed or is there a license exception), and what you will be doing there (do you need a license).

Example - standard laptops qualify for license exception TMP. Although no license is required, there are requirements to be in compliance with the license exception: you MUST retain exclusive control of the equipment at all times, you MUST not let the equipment be used by anyone in the foreign country, you MUST not intend to keep these items in these countries for longer than one year, you MUST verify that no government licenses are required.

Example - even if you are conducting fundamental research, a license may still be required to bring field equipment. This is especially true for any military controlled items.

Example - travel to Cuba has recently opened up but travel is not completely open and not all activities are permitted.

Why have a campus export compliance policy?

The purpose of the campus policy is to inform and educate the University community of their responsibilities to comply with federal export control regulations.

Although many of the campus activities are not subject to the export regulations, most notably educational activities, fundamental research, there are still many activities that are subject to the export regulations.

Penalties and sanctions can be applied to either or both the university and the person and can include significant fines and jail time.

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