Logo for Stony Brook University

P209: Investigator Conflict of Interest Policy

Issued by:
Office of the Vice President for Research
Updated:
August 24, 2012

I. Background and Objectives:

Stony Brook University as a community and as a public institution of higher learning is committed to promoting the highest quality research and creative activity. In meeting this commitment, the University encourages interaction of its members (faculty, administrators, students, staff and fellows) with the public and private sectors as an important component of its educational, research and public service missions. External support through grants, contracts and gifts from public and private sources is necessary to provide significant assistance and direction 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. Similarly, technology transfer in the form of patents, licensing agreements, and consulting opportunities for University members are important means of meeting the needs of society and fostering the welfare of the citizens of the State of New York.

The University and its members, in pursuing their teaching, research and public service missions, are committed to meeting the highest ethical standards and to minimizing the risks of conflict of interest or the appearance of conflict of interest between the private and the public interests the University serves. As part of this commitment, the University and its members share an obligation to protect the University's mission and reputation from being compromised by private interests. Furthermore, the University must operate with policies consistent with various federal funding agencies.

To this end, disclosure by Investigators at the University of outside personal interests and obligations, and effective management of actual or apparent conflicts of interest are essential.

II. Statement of Policy:

The responsibilities and obligations of Investigators to the University must be clearly separated from personal financial interests or other obligations. Prudent stewardship of public funds requires protecting University research, education and public service from being compromised by the private interests or obligations of any Investigator.

This policy sets forth requirements and guidelines for:

  • disclosure of outside interests by investigators at Stony Brook University who engage in University activities funded by specified internal and external entities;
  • review of Investigator disclosures by University officials; and
  • identifying, reporting and managing conflicts of interest.

III. Applicability:

This policy applies to Stony Brook University faculty, staff or students who serve as investigators (as defined below) in:

  1. 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 and
  2. 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)

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.

IV. Definitions:

A. Conflict of Interest:

Conflicts of interest in the conduct of externally and applicable internally supported activities, may take various forms, but typically arise when an Investigator at the University is, or may be, in a position to influence activities or University decisions in ways that could lead to personal gain for the Investigator or the Investigator's family, or give an improper advantage to third parties in their dealings with the University. Conflicts may also arise when Investigators have outside obligations of any kind that are in substantial conflict with the Investigator's University responsibilities or the public interest.

  1. The potential for conflicts of interest may arise from Investigators':
    1. specific actions (e.g., consultant arrangements), or
    2. the nature of positions they hold at the University and outside the University (e.g., board positions, paid or unpaid), or
    3. by the financial interests they or their immediate family hold.
  2. A conflict can result when:
    1. The significant financial interests of an investigator could directly and significantly affect the design, conduct, or reporting of his or her externally and applicable internally supported activities
    2. An Investigator has a significant non-University obligation to either:
      1. an individual or a private organization that provides support for a University research, educational or public service activity; or
      2. an organization (or individual) with which (whom) the University has an agreement to provide support for the conduct of a program project, activity or service supervised by the Investigator.
    3. The investigator has a consulting arrangement with a business enterprise that either:
      1. supports, or is supported by, University programs involving the Investigator; or
      2. is licensed to commercialize University technologies invented by the Investigator
    4. The investigator has significant financial interest (see definition) in a business enterprise that either:
      1. supports, or is supported by, the Investigator's SBU research; or
      2. owns, or has applied for the patent, or manufacturing or marketing rights to a drug, device, product, or procedure that either:
        • is a subject of, or will predictably result from, the Investigator's SBU research, or
        • can reasonably be expected to compete with a drug, device, product or procedure that will predictably result from the Investigator's SBU research.
    5. The investigator holds a position as consultant, officer, director, trustee or owner of a non-University business enterprise that supports or is supported by the Investigator's SBU research.

B. Designated Institutional Official: see Vice President for Research (below)

C. Financial Conflict of Interest (FCOI):

A significant financial interest (SFI; see definition 'G' below) that is related to, and that could directly and significantly affect, the design, conduct, or reporting of externally and applicable- internally supported activities. The recommendation that an SFI constitutes a determination of FCOI is made by SBU's COI Committee, with final concurrence by the VPR/designee.

D. Institutional responsibilities:

All professional responsibilities and activities for which the investigator was hired to perform at, and is paid by, this Institution, including but not limited to research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

E. Investigator:

The project director, principal Investigator, co-principal Investigators and all other person(s) who are responsible for the design, conduct, or reporting of externally or internally supported activities as specifically defined in (a) and (b) of the Applicability section above. 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').

Note:

  • For the purposes of this policy, "Investigator" shall include the Investigator's spouse and all dependent children.
  • PHS/NIH only: this definition includes collaborators or consultants.

F. Senior/key personnel (PHS/NIH Only):

The PD/PI and any other person identified as senior/key personnel in the grant application or contract, progress report, or any other report submitted to PHS/NIH (including those required by this policy) are considered investigators.

Note: this subgroup is specifically defined as these are the individuals for whom the public disclosure requirement addressed below pertains.

G. Significant Financial Interest (SFI):

  1. A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator's spouse and dependent children) that reasonably appears to be related to the Investigator's institutional responsibilities, i.e., If either the investigator's interests, or the entity in which the investigator has interests, relies upon the same expertise utilized to carry out the investigator's Institutional responsibilities as defined above, it is considered an SFI:
    1. With regard to any publicly traded entity, a significant financial interest exists if:
      1. the value of any remuneration* received from the entity in the twelve months preceding the disclosure
      2. and/or

      3. the value of any equity interest** in the entity as of the date of disclosure,

      when aggregated, exceeds $5,000.

      *Remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship);

      **equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;

    2. With regard to any non-publicly traded entity, a significant financial interest exists if:
      1. the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000,
      2. or

      3. the Investigator (or the Investigator's spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest);
    3. Intellectual property rights and interests (e.g., patents, copyrights), royalties from such rights, and agreements to share in royalties related to such rights, upon receipt of income related to such rights and interests. At SBU, all royalties are to be disclosed, including those received by the Investigator from this institution
  2. PHS/NIH only: Investigators also must disclose the occurrence (over the preceding 12 months) of any reimbursed travel or sponsored travel (i.e., that which is paid on behalf of the Investigator) that is related to their institutional responsibilities (* in other words, the purpose of the travel relies upon the same expertise used to carry out the investigator's Institutional responsibilities as defined in section IV). The disclosure must include the sponsor, destination, duration, and purpose of the travel. Excluded from this requirement is travel that is reimbursed or sponsored by federal, state or local government agency, 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,

H. Significant Financial Interest (SFI) Exclusions

  • 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, 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; or
  • Income from service on advisory committees or review panels for a federal, state or local government agency, a (United States) Institution of higher education as defied 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.

I. Significant Obligations (SO):

Significant obligations include unpaid positions held as an officer, trustee, director, employee or consultant of 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 funded or proposed by the University for external and selected internal funding.

J. Stony Brook University (SBU):

In this policy, the term Stony Brook University includes all Schools and Centers 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.

K. Vice President for Research (VPR) serves as the Designated Institutional Official for this policy and shall be taken to include his/her appointed designee(s)*. The VPR will:

  • solicit & review disclosure statements from each Investigator required to submit such disclosures,
  • Provide guidelines to identify conflicting interests (e.g., see 'Conflict of Interest' definition, above)
  • develop management plans that specify the actions that have been, and shall be, taken to manage FCOI

*Designees to the VPR may include:

  • Assistant Vice President for Research Compliance,
  • Assistant Vice President for Research Operations,
  • COI Committee (appointed by the VPR).

These individuals/this committee will be advisory to the VPR and act on his/her behalf on delegated responsibilities pertaining to this policy.

V. Timing of Disclosures:

Disclosures required by this policy are to be made:

  • At the time of submission to the Office of Sponsored Program (OSP) of an applicable proposal for funding
  • and

  • Within 30 days of discovering or acquiring (e.g., through purchase, marriage, inheritance etc.) a new SFI. (A new SFI is a different type or nature of SFI [e.g., royalty payment versus consulting fees] than what had previously been disclosed from the same source that meets or exceeds the threshold. In addition, a "new" SFI is also considered to be the same type or nature of SFI [e.g., royalty payment] from a different source [e.g., company A versus company B]). For PHS/NIH funded investigators, applicable travel must be disclosed within 30 days of said travel. Alternatively, travel that is anticipated can be disclosed anytime in advance and would satisfy the 30 day requirement.
  • and (PHS/NIH Only):

  • At least annually, commencing with, and on the anniversary of, the date of award, during the period of award (including notices of awards for continuations or competitive renewals).

VI. Procedure for Disclosure Submission:

A. Investigator Disclosure Forms Part I and Part II

The process described below requires the utmost discretion by all participants. To the maximum extent permitted by federal and state law, and by University policy, all elements of this process are to be treated as strictly confidential. The purpose of confidentiality is to assure that the integrity of the research and the Investigator, as well as the interests of the University, are protected at all times. It is for this reason that the disclosure procedure is a two-step process via use of Investigator Disclosure Form (IDF) Part I and Investigator Disclosure Form (IDF) Part II.

These forms are available online at: http://www.stonybrook.edu/research/orc/coi-new-regulations.shtml

IDF Part I is a yes/no survey the investigator completes to simply assess if s/he has significant financial interests (SFI's). The presence of this general assessment for all investigators named on a grant proposal is confirmed by the Office of Sponsored Programs (OSP) at the time of submission of the proposal in COEUS. No other review takes place by OSP. The answers provided in IDF Part I are reviewed by the COI Administrator within the COI division of the Office of Research Compliance ("COI Office") for the presence of SFI's. If SFI's are identified, the administrator waits for the submission by the investigators of the IDF Part II.

If the investigator answers 'yes' to any of the SFI questions on IDF Part 1, s/he then completes IDF Part II within seven (7) working days. This document asks for the specific information concerning the identified SFI(s) that, along with the grant proposal, will allow the COI Office and COI Committee to determine if the SFI is an FCOI, requiring review, and development (if possible) of a conflict management plan. This IDF Part II is sent directly to the COI Office so that the details concerning SFI's are available only to that office, the COI Committee, and others on a 'need to know' basis.

B. Procedure for disclosures to be made at the time of submission to the Office of Sponsored Program (OSP) of an applicable proposal for funding for processing (or transfer of funds from Stony Brook Foundation to Research Foundation for research activities) via COEUS:

  1. All individuals named on a grant who meet this policy's definition of 'investigator' must complete an IDF Part I and upload it into COEUS with the rest of the proposal documents.
  2. Any investigator answering 'yes' to one or more of the questions asked in Section B of that document must complete an IDF Part II and submit it to the COI Office within seven working days.
  3. Upon receipt of the proposal, the Office of Sponsored Programs (OSP) will confirm that Part I of the Investigator Disclosure Form has been uploaded into COEUS for all investigators named in the proposal and others as applicable.
  4. PHS/NIH Only: Where the proposal involves sub-recipients, OSP will, as part of the written agreement with the sub-recipient, establish terms regarding whether the FCOI policy of SBU or the sub-recipient's institution will apply to the sub-recipient's Investigators.
    1. If sub-recipient's institutional FCOI policy will apply to the sub-recipient investigators, the agreement will include a requirement that the sub-recipient's institution must:
      1. provide certification that its FCOI policy complies with PHS regulation.
      2. Report to SBU identified FCOI's for its Investigators in a time frame that allows SBU to report said FCOI's to the NIH as detailed below (Reporting to External Sponsors, 'for PHS/NIH only').
    2. If SBU's FCOI policy will apply to sub-recipient investigators, the agreement will include a requirement that said investigators will submit disclosures to SBU for review, identification, and handling of FCOI's as required by this policy (including those required only for PHS/NIH activities)

C. Procedures for disclosures to be made within 30 days of discovering or acquiring (e.g., through purchase, marriage, inheritance etc.) a new SFI.

A new SFI is a different type or nature of SFI [e.g., royalty payment versus consulting fees] than what had previously been disclosed from the same source that meets or exceeds the threshold. In addition, a "new" SFI is also considered to be the same type or nature of SFI [e.g., royalty payment] from a different source [e.g., company A versus company B]). For PHS/NIH funded investigators, the occurrence of new applicable travel constitutes a new SFI.

If information in the IDF's Part 1 or Part 2 last provided by an investigator has changed due to the acquisition of a new SFI, s/he has 30 days from discovery/acquisition to file the revised Form I and Form II to the COI Office within the Office of Research Compliance. The investigator should consider all his or her funded activities when providing opinion in Part II regarding whether or not the new SFI would directly and significantly affect, the design, conduct, or reporting of externally and applicable- internally supported activities.

For PHS/NIH funded investigators, although applicable travel not previously disclosed must be disclosed within 30 days of said travel, it should be noted that travel that is anticipated can be disclosed anytime up to one year in advance and would satisfy the 30 day requirement.

D. Procedures for disclosures required at least annually, commencing with, and on the anniversary of, the date of award, during the period of award (PHS/NIH Only)

PHS awards (including notices of awards for continuations or competitive renewals) with issuance dates on August 24, 2012 or later require that updated IDF's Part I and Part II (if required) be submitted by all investigators named on the applicable grant at the time of the award. This must be done on the initial issuance date, and on the anniversary of that date thereafter for the life of the award. Submissions are made to the COI Office within the ORC.

VII. Procedure for Disclosure Review:

  1. All IDF Part I forms are reviewed by the COI Office for identification of disclosed SFI's. No action is taken on IDF Part I forms where no SFI's are identified. The COI Office will follow up with investigators who submitted IDF Part I's with disclosure of SFI's, and who and have not additionally submitted the IDF Part II within the required 7 working days.
  2. Where the disclosure process identifies one or more SFI's for a given investigator, the COI Office will create a complete disclosure review package, including all disclosure forms and the grant proposal and place the case on a meeting agenda for review by the COI Committee.
  3. The convened COI committee will review the SFI's and to determine if an FCOI or (confirm that an) SO exists (i.e., the SFI or SO could directly and significantly affect the design, conduct, or reporting of applicable activities covered under this policy).
    • Note: In any such case where human subjects research is involved, the COI Administrator will work with the Office of Research Compliance to ensure that the IRBs are aware of the case being reviewed. The fully convened IRB will conduct independent review of the potential conflict in compliance with its own COI policy, and to ensure the protection of human subjects.
  4. For all identified FCOIs and SO's, 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.
    1. Possible Management plans include but are not limited to:
      1. Public disclosure of significant financial interests;
      2. Monitoring of research by independent reviewers;
      3. Modification of the research plan;
      4. Disqualification from participation in the portion of the externally funded research that would be affected by the significant financial interests;
      5. Divesture of significant financial interests;
      6. Severance of relationships that create actual or potential conflicts
      7. Removal of investigator as Principal Investigator/Project Director.
      8. Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the Financial Conflict of Interest;
      9. Additional remedies specific to the conduct of research involving human subjects, including but not limited to, disclosure in the consent process of the identified investigator and identified conflict, the removal of the investigator's ability to recruit and/or consent research subjects.
    2. Documentation of the management plan will include:
      1. The role and principal duties of the conflicted Investigator in the research project;
      2. Conditions of the management plan;
      3. How the management plan is designed to safeguard objectivity in the research project;
      4. Confirmation of the Investigator's agreement to the management plan;
      5. How the management plan will be monitored to ensure Investigator compliance; and
      6. Other information as needed
  5. 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.
  6. For all identified FCOI's and SO's, the COI Committee will monitor compliance with the above referenced plan. Such monitoring will be documented.

VIII. Reporting to External Sponsors

  1. For PHS/NIH only:
    1. Where an FCOI is found by the COI Committee, details concerning the FCOI (including management plan) will be reported to NIH via the eRA Commons FCOI Module (see appendix 1 for content of report):
      1. prior to expenditure of any funds under the award,
      2. within 60 days of identifying a new FCOI for an existing investigator, during the period of the award (FCOI must be determined, and management plan implemented within those 60 days)
      3. within 60 days of identifying an FCOI for an investigator who is newly participating in the project
      4. annually report on the status of FCOI and any changes in management plan (Due at same time as annual progress report is submitted, including multi-year progress report, or at time of extension-with or without funds)
      5. These reports are accessible under FOIL.

    2. If upon receipt of the FCOI report, NIH decides that the FCOI will bias the objectivity of research, NIH may impose special award conditions, suspend funding or impose other enforcement mechanisms until the matter is resolved.
    3. In any case in which NIH determines that an PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with an FCOI that was not managed or reported by SBU as required by regulation, SBU will require the Investigator involved to disclose the FCOI in each public presentation of the results of the research and to request an addendum to previously published presentations,
  2. All other external funding agencies with reporting requirements
    1. The VPR/designee will report to the external funding agency/agencies:
      1. Any instances in which the institution finds it is unable to satisfactorily manage an actual or potential conflict of interest,
      2. and

      3. Any instances where an Investigator participating in externally or selected internally funded research has not complied with this policy, and the specific corrective measures taken by the University.

IX. Appeals

Should an Investigator fail to concur with the management plan recommended by the COI committee, he/she may transmit comments to the VPR within ten working days from receipt of the committee's recommendation. In such a case, the VPR will review the case (which may include seeking the advice of appropriate impartial experts and holding discussions with the investigator and/or the COI committee) and will render a judgment within twenty working days of the time that the committee's initial recommendation is made known to the investigator. Awards for external and selected internal support of a program, project, activity or service may not be activated by the University unless a management plan is in place or the issue is otherwise resolved.

When the Vice President for Research serves as the reviewer of a disclosure statement (for Deans/VPs) the appeal shall be to the President.

X. Compliance with this Policy

General:

In addition to reporting requirements outlined above, if an investigator is found to have failed to comply with this policy or the means determined to resolve a conflict of interest, the VPR shall report promptly in writing to the:

  • President, to initiate disciplinary proceedings against said investigator, and
  • Assistant Vice President for Research Compliance who will:
    • initiate investigation into matters concerning human subject safety and welfare, and potential regulatory violations, in accordance with federal law governing human subject protections and, if appropriate
    • initiate the processes associated the University's Research Misconduct policy, if applicable and, if appropriate
    • initiate procedures associated with other relevant University policies, as applicable.

Disciplinary sanctions may include termination or alteration of the employment or academic status of persons against whom charges have been substantiated, and must be consistent with established University and Board of Trustees policies, and applicable collective bargaining agreements. Article 19 of the UUP Agreement shall be the sole source of University discipline for members of the UUP-represented unit. Additional sanctions may be rendered in accordance with applicable University policies (e.g., governing human subject protections, University research misconduct etc).

Upon completion of disciplinary proceedings, the President shall report to the appropriate University officers or bodies, to cognizant federal agencies when federal funds are involved, and to all other parties as necessary.

Additional Actions Required for PHS/NIH Activities:

Retrospective Review:

Whenever an FCOI is not identified or managed in a timely manner, including failure by the investigator to disclose an SFI or comply with a management plan, or failure by SBU to review or manage an FCOI, SBU will, within 120 days of a determination of non- compliance, complete a retrospective review of the investigator's activities and the NIH-funded research project to determine if there was bias in the design, conduct, or reporting of such research. The following will be documented in the retrospective review:

  • Project number;
  • Project title;
  • PD/PI or contact PD/PI if a multiple PD/PI model is used;
  • Name of the Investigator with the FCOI;
  • Name of the entity with which the Investigator has an FCOI;
  • Reason(s) for the retrospective review;
  • Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed);
  • Findings and conclusions of the review.
  • If results of the retrospective review warrant, update previously submitted FCOI report

Mitigation Report:

If bias is found through retrospective review, The Designated Official (VPR) will notify the NIH Awarding Component promptly (through the eRA Commons) and submit a Mitigation Report. The following will be documented in the Mitigation Report:

  • Key elements documented in retrospective review
  • Description of the impact of the bias on the research project
  • Plan of action(s) to eliminate or mitigate the effect of the bias

Thereafter, SBU will submit FCOI reports annually as described above in the Procedures section.

XI. Training

Each Investigator must complete SBU'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:
    • SBU COI policies change in a manner that affects Investigator requirements
    • An Investigator is new to SBU
    • SBU finds an Investigator noncompliant with Institution's COI policy or management plan.

XII. Documentation

SBU will maintain records of all Investigator disclosures and the Institution's review of, and response to, such disclosures (whether or not a disclosure resulted in the Institution's determination of FCOI or SO) and all actions under the Institution'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.

XIII. Public Disclosure of FCOI's (PHS/NIH Only)

Stony Brook University will make certain information concerning FCOIs held by senior/key personnel available via a written response to any requestor within five business days of a request, and update such information as specified in the regulation. In response to such request, the Institution will provide:

  • Investigator's name;
  • Investigator's title and role with respect to the research project;
  • Name of the entity in which the SFI is held;
  • Nature of the SFI; and
  • Approximate dollar value of the SFI (dollar ranges will be provided, e.g., $0-$4,999; $5,000-$9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily determined through references to public prices or other reasonable measures of fair market value.

Questions may be directed to:

Assistant Vice President for Research Compliance
Office of Research Compliance

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

Appendix 1:

FCOI Reports to NIH will consist of:

  • Grant number;
  • PD/PI or contact PD/PI;
  • Name of Investigator with the FCOI;
  • Name of the entity with which the Investigator has an FCOI;
  • Nature of FCOI (e.g., equity, consulting fees, travel reimbursement, honoraria);
  • Value of the financial interest $0-4,999; $5K-9,999; $10K-19,999; amts between $20K-100K by increments of $20K; amts above $100K by increments of $50K or a statement that a value cannot be readily determined;
  • A description how the financial interest relates to NIH-funded research and the basis for the Institution's determination that the financial interest conflicts with such research; and
  • Key elements of the Institution's management plan, including:
    • Role and principal duties of the conflicted Investigator in the research project;
    • Conditions of the management plan;
    • How the management plan is designed to safeguard objectivity in the research project;
    • Confirmation of the Investigator's agreement to the management plan;
    • How the management plan will be monitored to ensure Investigator compliance; and
    • Other information as needed.

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