Stony Brook University Office of Research Services

Conflict of Interest

Effective August 24, 2012 In Response To Revised PHS Regulations

The U.S. Public Health Service (PHS), which includes the National Institutes of Health (NIH) has revised their Financial Conflict of Interest Regulations: http://grants.nih.gov/grants/policy/coi/fcoi_final_rule.pdf

Here are some helpful FAQ’s from PHS: http://grants.nih.gov/grants/policy/coi/coi_faqs.htm

For Existing CITI Users

  1. Visit: https://www.citiprogram.org/
  2. Log in with your CITI username and password.
  3. Under my courses:  Click on add a course or update your learner groups for SUNY-Stony Brook University.
  4. Click the box and choose the last option, Conflict of Interest Course. Click the next button
  5. Main Menu will appear:  -Under my courses- you will see the Conflict of Interest Course- status: "Not started and enter".  Click on the red "Enter" word and you will be directed to the module.   

For New CITI Users

  1. Visit: https://www.citiprogram.org/
  2. Register as a new user and follow the prompts.  ** (Note you do not need a SB ID number- put any numbers here)
  3. Click the box and choose the last option, Conflict of Interest Course. Click the next button
  4. Site will ask you if you want to affiliate with another institution. If yes, provide the information. If no, then click the "NO" button.
  5. Main Menu will appear:  -Under my courses- you will see the Conflict of Interest Course- status: "Not started and enter".  Click on the red "Enter" word and you will be directed to the module.   

Since Stony Brook receives NIH or other PHS funding from a grant, cooperative agreement, or contract that is covered by the final rule, we must be in full compliance with all of the revised regulatory requirements beginning August 24, 2012.

Consistent with SBU’s prior handling of this regulatory requirement, some of these changes will impact all investigators, and others will be specific to investigators submitting to, or awarded funds from, PHS (including NIH). 

The new regulations maintain the general framework of the 1995 regulations, but make some significant changes.

In particular, the new regulations:

  • Broaden who must comply. The definition of ‘investigator’ has been revised to: The project director, principal Investigator, co-principal Investigators and all other person(s) who are responsible for the design, conduct, or reporting of the activity in question. For PHS funded activities, the definition includes collaborators and consultants.
  • Require investigators to disclose to their institutions all of their significant financial interests related to their institutional responsibilities (as opposed to related to a particular funding entity).
  • Lower the monetary threshold at which certain significant financial interests require disclosure, from $10,000 to $5,000.
  • Require investigators to complete training related to the regulations and their institution’s financial conflict of interest policy. We will be using a short web-based course for this purpose, developed by the Collaborative Institutional Training Initiative (CITI).
  • Requires disclosure by Investigators of the occurrence of certain travel that is related to their institutional responsibilities.
  • Require institutions to report to the PHS Awarding Component additional information on identified financial conflicts of interest and how they are being managed.
  • Where the proposal involves sub-recipients, requires that the written agreement with the sub-recipient establish terms regarding compliance with PHS disclosure requirements.
  • Require institutions to make certain information accessible to the public concerning identified financial conflicts of interest specifically held by senior/key personnel.

We will not post our policy (which signals to PHS that we are following the new federal regulations) until the effective date of August 24, 2012. In the interim, please continue to follow the current version of P209, available at http://www.stonybrook.edu/policy/policies.shtml?ID=209

We are working diligently to ensure that the transition will be as effortless and facilitative as possible for you, and will keep you updated throughout the summer regarding SBU’s implementation of this new regulation.

If you have any questions, or require additional information, please contact:

Judy Matuk, Assistant Vice President for Research Compliance
Judy.matuk@stonybrook.edu
(631)-632-9036

 

Frequently Asked Questions for SBU Investigators

Who has to comply with the new FCOI regulation?

Investigators must comply with the regulation, and an "investigator" is now defined as: The project director, principal Investigator, co-principal Investigators and all other person(s) who are responsible for the design, conduct, or reporting of:

  • externally supported activities, or
  • internally supported activities where support is granted following formal application to an SBU program in response to a request for proposals (for example, Targeted Research Opportunity ‘TRO’ Grants).

For PHS/NIH funded activities, this definition includes collaborators and consultants.

Important clarification concerning who must comply: 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 do not meet SBU’s definition of an investigator (for example, in most cases research assistants, undergraduates and secretaries will not be considered ‘investigators’).

Does the new FCOI regulation include a requirement for investigator training?

Yes. Investigators who are awarded funds beginning on August 24, 2012 must complete FCOI training at least once every 4 years.

 When should you, as an investigator, complete SBU's FCOI training?

  • If you are currently supported by PHS/NIH funds, you should complete training as soon as possible, but no later than the issue date of your next annual Notice of Award for continuation or for your competitive renewal.  
  • If you have applied for PHS/NIH funds you should complete training by the issue date of your Notice of Award received on August 24th or thereafter.
  • All other investigators must complete the FCOI training prior to establishment of an account for a grant or contract awarded on August 24th or after.


How does an investigator satisfy SBU's FCOI training requirement?
  

SBU is using the Collaborative Institutional Training Initiative (CITI) web-based program to meet our training needs. It is a short tutorial and shouldn't take up too much of your time. It's live and ready to go for SBU, so if you would like to get a jump start on the training requirement, please feel free to do so!

When does an investigator have to file a disclosure?

Disclosures must be filed:

At the time of submission to the Office of Sponsored Program (OSP) of a proposal for funding

and

Within 30 days of discovering or acquiring a new Significant Financial Interest (SFI; defined below)

and (PHS/NIH Only)

At least annually, commencing with, and on the anniversary of, the date of award, during the period of award. This is important because it means that if you are an investigator on a submission that is currently being considered for funding by PHS, you will need to file a disclosure as soon as you are aware that an award is forthcoming, and no later than the issue date of the award, if that date is after the effective date of the new PHS policy, i.e., August 24th. 

What information does an investigator have to disclose?

You have to disclose

  1. Significant Obligations, and
  2. Significant Financial Interests

What are significant obligations?

Significant obligations are unpaid positions held as an officer, trustee, director, employee or consultant for a for-profit or not-for-profit entity, .that would reasonably appear to directly and significantly affect (i.e., have a relevant and consequential effect on)  the work proposed for funding external and selected internal funding.

What are significant financial interests?

A Significant Financial Interest (SFI) is one or more of the following interests 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 SBU, 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 SBU. 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 SBU), but what the company's business is that must be considered in determining relatedness.  

  1. Financial interest in any publicly traded entity where the value of any remuneration (including salary and any payment for services not otherwise identified as salary, e.g., consulting fees, honoraria, paid authorship) received from the entity in the twelve months preceding this disclosure and the value of any equity interest (including stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value)  in the entity as of the date of disclosure, when added together, exceeds $5,000.  

  2. Financial interest in any non-publicly traded entity where the value of any remuneration (including salary and any payment for services not otherwise identified as salary, e.g., consulting fees, honoraria, paid authorship) received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000.

  3. Any equity interest (e.g., stock, stock option, or other ownership interest) in any non-publicly traded entity.

  4. Receipt of income over the past 12 months from royalty and other forms of payments in excess of (when aggregated) $5,000 resulting from successful commercialization of intellectual property rights and interests (e.g., patents, copyrights) licensed to any commercial entity or to the Research Foundation of SBU

  5. Travel (PHS Only)   You must disclose any reimbursed travel or sponsored travel (i.e., that which is paid on your behalf) that occurred in the twelve months preceding this disclosure, if it was related to your institutional responsibilities (i.e., the purpose of the travel relies upon the same expertise used to carry out your institutional responsibilities). You may also disclose the anticipated occurrence of such travel (up to in advance of one year). Excluded from this 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.

Are there any exceptions to what constitutes a significant financial interest? 

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.

What forms do I use to file the required disclosures?

Given the importance of respecting investigator confidentiality, we are employing a two-step process (as we have in the past with the ‘CID’ and the ‘IDF’ forms). The two forms are called

  • Investigator Disclosure Form (IDF) Part I and
  • Investigator Disclosure Form (IDF) Part II.

These forms will be available online by August 24th at http://www.stonybrook.edu/research/orc/coi-new-regulations.shtml

IDF Part I is a yes/no SFI survey. If the investigator answers ‘yes’ to any of the questions regarding whether or not he or she has a SFI, an IDF Part II is completed which asks for specific details concerning the identified SFI(s). This IDF Part II is always sent directly to the COI Office so that the details concerning SFI’s are available only to that office, the COI Committee, the Vice President for Research, as select others on a ‘need to know’ basis.

Where do I submit the required disclosure forms?

When you are an investigator on a proposal that is being submitted for funding, you upload into COEUS the IDF Part I, along with all other required proposal documents for submission to the Office of Sponsored Programs. If you check ‘yes’ to any of the questions in Section B of that form, you will then, within 7 working days, submit a completed IDF Part II directly to the COI Office within the Office of Research Compliance (z=3368, or aimee.minton@stonybrook.edu).

When you have a new SFI to disclose, and you need to update your disclosures currently on file (note: you must do so within 30 days of obtaining or acquiring that new SFI), you will submit the revised IDF Part I and Part II, as necessary, directly to the COI Office within the Office of Research Compliance (z=3368, or aimee.minton@stonybrook.edu).

When you are supported by a PHS grant with award notices (including notices of awards for continuations or competitive renewals) issued after August 24, 2012, and you need to submit disclosures on the issuance date, and anniversary dates thereafter, you will submit your IDF forms directly to the COI Office within the Office of Research Compliance (z=3368, or aimee.minton@stonybrook.edu).

What is the review process that takes place after I submit my disclosure forms?

In the case where a IDF Part I is submitted to OSP as part of a proposal going to a potential funding agency, OSP simply checks to make sure that IDF Part I’s are present for all individuals who meet the definition of ‘investigator’ on the proposal. The COI Office will then conduct a review of all submitted Part I’s to see if any investigators indicated that they had an SFI. Those are flagged, waiting for the investigator to follow-up, within 7 working days, with submission of a completed IDF Part II. Once Part II is received, the COI Office will put together a complete disclosure review package, including all disclosure forms and the grant proposal, and the case will be placed on a meeting agenda for review by the COI Committee. The COI Committee will then review the case to determine if the SFI constitutes a FCOI, i.e., the SFI could directly and significantly affect, the design, conduct, or reporting of the externally and applicable- internally supported activity.

 In all other cases, where disclosures are required (new SFI, anniversary of PHS award issuance), and are submitted directly to the COI Office, the same review process is followed where SFI’s are identified (Part I) and detailed (Part II) by the investigator.

What happens if the COI Committee finds that one or more of my SFI’s constitute a FCOI?

For all identified FCOIs, the COI Committee 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 COI Committee.

Recommendations for management plans proposed by the COI Committee will be conveyed by the COI Administrator to the Vice President for Research or his/her designee. Once approval is provided by the VPR/designee, the COI Committee will convey the notice of FCOI and associated management plan to the 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). The investigator must provide concurrence and certification for compliance with the management plan in order for the award in question to be established.

Policy

Stony Brook University’s Policy at P209 addresses the policy and procedure for SBU investigator financial disclosure and conflict of interest management.

Procedure

WHAT FORMS DO I USE TO FILE THE REQUIRED DISCLOSURES?

Given the importance of respecting investigator confidentiality, we are employing a two-step process (as we have in the past with the ‘CID’ and the ‘IDF’ forms). The two forms are called

IDF Part I is a yes/no SFI survey. If the investigator answers ‘yes’ to any of the questions regarding whether or not he or she has a SFI, an IDF Part II is completed which asks for specific details concerning the identified SFI(s). ThisIDF Part II is always sent directly to the COI Office so that the details concerning SFI’s are available only to that office, the COI Committee, the Vice President for Research, as select others on a ‘need to know’ basis.

WHERE DO I SUBMIT THE REQUIRED DISCLOSURE FORMS?

When you are an investigator on a proposal that is being submitted for funding, you upload into COEUS the IDF Part I, along with all other required proposal documents for submission to the Office of Sponsored Programs. If you check ‘yes’ to any of the questions in Section B of that form, you will then, within 7 working days, submit a completed IDF Part II directly to the COI Office within the Office of Research Compliance (z=3368, oraimee.minton@stonybrook.edu).

When you have a new SFI to disclose, and you need to update your disclosures currently on file (note: you must do so within 30 days of obtaining or acquiring that new SFI), you will submit the revised IDF Part I and Part II, as necessary, directly to the COI Office within the Office of Research Compliance (z=3368, oraimee.minton@stonybrook.edu).

When you are supported by a PHS grant with award notices (including notices of awards for continuations or competitive renewals) issued after August 24, 2012, and you need to submit disclosures on the issuance date, and anniversary dates thereafter, you will submit your IDF forms directly to the COI Office within the Office of Research Compliance (z=3368, or aimee.minton@stonybrook.edu).

Committee Members

Faculty Members Ex-Officio Members
Chair, Arthur Stone, Psychiatry Judy Matuk, Research Compliance
Co-Chair, Carlos Simmerling, Chemistry Susan Blum, Attorney's Office
Clive Clayton, Material Science and Engineering
Arnold Katz, Surgery  
Imin Kao, Mechanical Engineering  
David W. Paquette, Dental Medicine  
Larry Swanson, Waste Management Institute  

The Committee meets monthly.