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Investigator Financial Conflicts Of Interest Policy For Research

Last updated on March 17, 2020 32 min read Investigator Financial Conflicts Of Interest Policy For Research

I. Purpose

Boston University (“BU”) recognizes the importance of collaborations with industry, government, academia and others, and seeks to encourage such relationships. However, it is important that the financial incentives which may accompany such relationships do not create financial conflicts of interest that might undermine the validity of the research or the safety of human research subjects. Such conflicts of interest have the potential to create real or apparent bias in research and may reduce public confidence in the research enterprise.

For these reasons BU has established the following Investigator Financial Conflicts of Interest Policy for Research. The purpose of this policy is to uphold the highest ethical standards of objectivity in research by identifying and evaluating financial conflicts of interest (“FCOI”) that may affect research decisions, transactions and operations at BU and managing them so that important collaborations can be undertaken without compromising integrity. The policy is also intended to be consistent with the Boston Medical Center Significant Financial Conflicts of Interest in the Conduct of Research Policy. Additionally, this policy is intended to comply with the requirements of the federal regulations set forth in 42 CFR Part 50 and 45 CFR Part 94 for research funded through the Public Health Service (PHS). This policy shall be construed in accordance with such regulations and shall be deemed to include any requirements set forth in such regulations that are not expressly set forth below.

II. Covered Parties

This policy applies to all individuals, regardless of title or position, responsible for the design, conduct or reporting of PHS-Funded and Non PHS Research at or under the auspices of BU.

Applicability to PHS-Funded Subrecipients:

For PHS-Funded Research that involves a subrecipient (i.e., subcontractor, subgrantee or subawardee) at other Institutions, BU requires a written agreement from the subrecipient that establishes whether BU’s policy or the subrecipient’s policy shall apply to the subrecipient’s Investigators. In all cases, BU must report to the PHS-Funding agency any subrecipient FCOI (as defined below) prior to the execution of the subcontract or within 60 days of identification of a new FCOI that arises during the term of the subcontract.

If the subrecipient’s policy is used, the subrecipient must certify that its FCOI policy is compliant with 42 CFR Part 50 and 45 CFR Part 94 and that they will be responsible for ensuring that the subrecipient Institution and its Investigators comply with the federal regulations. Subrecipients must report to BU, as the awardee Institution, any identified FCOI within 10 business days of the management plan agreement with the subrecipient’s Investigator, but no later than 45 days after identification of the FCOI by the subrecipient. The details of the FCOI will be reported to the funding agency as required under applicable regulations or policies.

If BU’s policy is used, the subrecipient must ensure that its Investigators disclose to BU all Significant Financial Interests (“SFI”) as defined below) that are directly related to the subrecipient’s work for BU at the time of submission of the application by BU or at the time the subrecipient signs an institutional letter of support if during an on-going award grant or contract.

III. University Policy

Each Investigator responsible for the design, conduct or reporting of research at or under the auspices of BU must disclose all of his or her SFIs, and those of the Investigator’s spouse and dependent children, that reasonably appear to be related to the Investigator’s Institutional Responsibilities. The Investigator is not charged with making a determination as to whether the SFI constitutes a conflict of interest or could affect the design, conduct or reporting of the Research. That determination is made by the Designated Official as further described below.

Significant Financial Interest (“SFI”) Is Defined As

Any financial interests (i.e., anything of monetary value) consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children), within the previous 12 months, that reasonably appears to be related to the Investigator’s Institutional Responsibilities:

  1. For all Publicly Traded Entities
    • Remuneration (e.g., salary, income, consulting fees, honoraria, paid authorship or any other payment) from an Entity that exceeds $5,000;
    • Any equity interest (e.g., stock, stock option, or other ownership interest) in the Entity that exceeds $5,000; or
    • Any remaining remuneration and equity from an Entity that, when added together, exceeds $5,000 in value.
  2. For all Non-Publicly Traded Entities
    • Remuneration (e.g., salary, income, consulting fees, honoraria, paid authorship or any other payment) from an Entity that exceeds $5,000;
    • Any equity interest (e.g., stock, stock option, or other ownership interest) in the Entity regardless of value; or
    • Any remaining remuneration and equity from an Entity that, when added together, exceeds $5,000 in value.
  3. Intellectual Property (IP) Right and Interests
    • Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
  4. For PHS-Funded Research Investigators Only: Reimbursed or Sponsored Travel
    • Travel reimbursed or sponsored by an Entity other than the Investigator’s current institution (i.e., paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), and related to their Institutional Responsibilities that exceeds $5,000 in value (in aggregate for a single Entity).

Exclusions: SFIs do not include the following types of financial interests:

  • Salary, royalties, or other remuneration paid by BU to the Investigator if the Investigator is currently employed or otherwise appointed by BU, including intellectual property rights assigned to BU and agreements to share in royalties related to such rights;
  • 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; and
  • Income from seminars, lectures, teaching engagements or service on advisory committees or review panels that are sponsored by a federal, state, or local government agency within the United States, 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 a United States Institution of higher education;

Before disbursing any funds for Research, BU determines whether an Investigator’s SFI disclosure is related to the Research, and if so, whether the SFI constitutes an FCOI. An Investigator’s SFI is related when the Designated Official reasonably determines that the SFI could be affected by the Research or is in an Entity whose financial interests could be affected by the Research.

A FCOI exists when BU reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the Research. If an FCOI is identified, BU will manage the FCOI as needed, including development and implementation of a management plan.

When SFI Disclosures Are Required To Be Filed

All Investigators applying for Research funding or conducting Research must disclose SFIs:

  • Before Application for Funding: Each Investigator who is planning to Participate in Research must disclose SFIs no later than the time of application or submission of a formal proposal, if applicable;
  • When executing a contract with an Entity where no application or proposal is required: Each Investigator planning to Participate in Research must disclose SFIs prior to expending any funds;
  • Upon Discovery or Acquisition of a New SFI: Each Investigator must submit a disclosure within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) all new SFIs; and
  • For Active Awards: Each Investigator who is participating in Research must submit an updated disclosure of SFIs at least annually during the award period. The updated disclosure will include any new information that was not initially disclosed to BU or in any subsequent disclosure of SFIs, and will include updated information regarding any previously disclosed SFI (e.g., the updated value of a previously disclosed equity interest).

What SFI Disclosures Are Required

Investigators must disclose:

  • The person(s) having the interest;
  • The Investigator’s relationship to such person(s);
  • The name of the Entity with which the Investigator has the SFI; and
  • The nature and approximate monetary value of the SFI.

Disclosure Obligations in Publications or Presentations

To promote transparency in scientific discourse, Investigators are expected to disclose their financial interests related to any presentation or publication of research results by the Investigator. Such interests include (i) financial interests in Entities supporting or otherwise connected to the presentation, publication or research, (ii) the Investigator’s provision of legal consulting on the subject of the research, and (iii) any other interests that the Investigator reasonably believes could be material to members of an audience or readers assessing the opinions, advice, or work presented by the Investigator. This includes the disclosure of a financial interest in an Entity which owns or has a contractual relationship to the technology being reported or discussed.

When Training Is Required (PHS-Funded Research ONLY)

Investigators engaging or planning to engage in PHS-Funded Research, at or under the auspices of BU, must complete financial conflict of interest training on Investigator responsibilities prior to engaging in PHS-Funded Research and at least once every four (4) years while they are still engaged in PHS-Funded Research. Investigators must also complete this training immediately in any of the following circumstances:

  • When this policy is revised in any manner that affects the requirements applicable to PHS-Funded Investigators;
  • When an Investigator is new to BU, even if the PHS-Funded Research has already begun; or
  • When BU finds that an Investigator is not in compliance with this policy or an imposed management plan.

How SFI Disclosures Are Reviewed

The Designated Official is responsible for appointing members to the Faculty Review Committee on Research FCOIs (“Review Committee”). The Review Committee consists of no fewer than five (5) voting members from the faculty with relevant research experience. Appointed members of the Review Committee serve three-year renewable terms. Representatives from the Office of Technology Development and the Office of the General Counsel may serve as non-voting consultants. A majority of the voting Review Committee members must be present to constitute a quorum. Members may attend meetings via phone or other electronic means (e.g., Skype) in real time. The Review Committee may act by majority vote of the members present at a meeting with quorum, or by written or electronic consent of a majority of all members.

The Designated Official, through the Office of Research Compliance or the Review Committee, will review all disclosures and any other relevant information (e.g., research proposal, IRB application, etc.) and determine:

  • Whether the Investigator’s SFI is related to the Research; and if so,
  • Whether the SFI constitutes an FCOI.

If an FCOI is identified, the Review Committee will prepare and submit a report to the Designated Official detailing a recommended management plan, including any proposed conditions or restrictions to manage the FCOI. The Designated Official will make a final determination as to how to manage the FCOI and will accept, reject or modify the Review Committee’s recommendation.

The Chair of the Review Committee may elect to conduct an expedited review instead of engaging the full committee for amendments or continuing reviews of SFIs which have been previously reviewed, appear to be related to SFIs covered under an active management plan or can be easily addressed by standard management plan measures. These actions and all SFIs will be reported to the Review Committee at the next scheduled meeting.

The Office of Research Compliance will provide copies of the final determination to the conflicted Investigator (and principal investigator, if different), the Dean at the Investigator’s school or college, the Investigator’s Department Chair, the Charles River Campus or BU Medical Campus Institutional Review Board (if human subjects research is involved), and the BU Office of Sponsored Programs, as applicable.

The Investigator must comply with any management plan imposed by BU and upon receipt of the determination, the Investigator must either accept or submit an appeal. Funding will be held until the Investigator agrees to comply with the final management plan.

How FCOIs Are Managed

When a FCOI has been determined to exist, the management plan will specify the actions that have been, and will be, taken to manage the FCOI. Examples of conditions or restrictions that might be imposed to manage an FCOI include, but are not limited to:

  • Public disclosure of the FCOI (e.g., when presenting or publishing the research);
  • For Research involving human subjects, disclosure of the FCOI directly to the human subjects as approved by the Institutional Review Board;
  • Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the Research against bias resulting from the FCOI;
  • Modification of the research plan or protocol;
  • Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the Research;
  • Reduction or elimination of a financial interest (e.g., sale of an equity interest); and
  • Severance of relationships that create the FCOI.

How to Appeal a Management Plan

The Investigator has ten (10) business days from receipt of the Designated Official’s final decision to submit a written appeal to the University Provost or the Provost of the Medical Campus, as applicable. The appeal should include the specific provisions being challenged, the reason for the appeal, and the justification for a different outcome. The Investigator may also provide an alternative management plan and any supplemental information that might be helpful in reviewing the appeal. After this secondary review, this decision will be final and not further appealable.

How Compliance with the Management Plan Is Monitored

The Office of Research Compliance shall take such actions that it deems reasonable to audit and monitor compliance with the management plan on an ongoing basis until the completion of the Research.

Investigators are required to comply with the final decision of the Designated Official and management plan. If an Investigator fails to comply, the Designated Official, with the aid of the Review Committee, will develop a corrective action plan. The Institution may impose sanctions for non-compliance including suspension, denial of eligibility to engage in Research, or other appropriate penalties. Such sanctions may require giving notice to professional bodies or journals, or the public.

When There Are New SFIs During Ongoing Research

In the event that a new interest is disclosed to BU (e.g., an Investigator new to an ongoing Research project discloses an SFI or an existing Investigator discloses a new SFI during ongoing Research project) or BU identifies a disclosed interest that was not previously reviewed in a timely manner in accordance with this policy, the Designated Official will do the following, acting directly or in conjunction with the Review Committee, within sixty (60) days:

  • Determine whether a FCOI exists; and if it does,
  • Implement a management plan in accordance with this policy that specifies the actions that have been, and will be, taken to manage the FCOI.

What Happens When the FCOI Is Not Identified and Managed

In the event that a FCOI is not identified or managed in a timely manner, including:

  • Failure of an Investigator to timely disclose an SFI that is subsequently determined by the Institution to constitute an FCOI;
  • BU’s failure to review or manage such an FCOI; or
  • Investigator’s failure to comply with a FCOI management plan.

BU will, within 120 days of the determination of noncompliance, complete a retrospective review of the Investigator’s activities on the project(s) to determine whether there was any bias in the design, conduct, or reporting of the Research during the period of noncompliance.

BU will document the following key elements of the review:

  • Project number and title;
  • Principal investigators or project directors (or if multiple, the contact PI/PD);
  • Investigator and entity resulting in the FCOI;
  • Reason the retrospective review was completed;
  • Detailed description of methodology used to conduct the retrospective review; and
  • Findings and conclusions.

For PHS-Funded Research only, BU will submit FCOI reports to the PHS awarding agency annually until the completion of the project, specifying the actions that will be taken to manage the financial conflict of interest going forward. If the retrospective review finds bias in the design, conduct, or reporting of PHS-funded Research, BU will notify the PHS awarding agency promptly and submit a mitigation report, as required, which will include at minimum:

  • The key elements documented in the retrospective review;
  • A description of the impact of the bias on the research project; and
  • BU’s plan of action or actions taken to eliminate or mitigate the effect of the bias.

For PHS-Funded Clinical Research only, in any case where the Department of Health and Human Services determines that a 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 and was not managed or reported by the Institution as policies require, BU will require the Investigator involved to disclose the FCOI in each public presentation of the results of the Clinical Research and to request an addendum to previously published presentations.

For NSF-Sponsored Research only, the Designated Official will provide notice to the NSF Office of General Counsel if the Institution finds that it is unable to satisfactorily manage a FCOI.

At any time, the Designated Official may determine that interim measures are necessary regarding the Investigator’s participation in the affected PHS or NSF-Funded Research.

How Records Will be Maintained

BU will maintain records relating to all Investigator SFI disclosures, including the review of and response to the disclosures (whether or not resulting in an FCOI finding), and any other action under this policy, for at least three (3) years for Non-PHS-Funded Research and for PHS or NSF-funded Research, from the date the final expenditures report is submitted to the PHS, NSF, or, where applicable, from other dates specified in 45 CFR 74.53(b), 92.42(b), or National Science Foundation, Grant Policy Manual, Ch. 510, Conflict of Interests Policy (“NSF 510” ) relating to records retention.

Where to Find the Policy (Public Accessibility)

This policy and all related forms will be made publicly available on the Boston University Research website.

For PHS-Funded Research: The Office of Research Compliance will make available, upon written request, SFIs disclosed to BU that meet the following criteria: the SFI was disclosed and is still held by the Senior/Key Personnel; the Institution has determined that the SFI is related to the PHS-Funded Research; and the Institution has determined that the SFI is an FCOI. Responses will be returned within five (5) business days from when the Office of Research Compliance receives the request and shall include, at a minimum, the following: the Investigator’s name; the Investigator’s title and role with respect to the Research; the name of the Entity in which the SFI is held; the nature of the SFI; and the approximate dollar value of the significant financial interest, or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.

Information concerning the SFIs of Senior/Key Personnel will remain available for responses to written requests for at least three (3) years from the date that the information was most recently updated. When the PHS-Funded Research is conducted by a subrecipient Investigator, and under their written agreement the subrecipient is required to comply with the subrecipient’s FCOI policy, the subrecipient will have the responsibility of making such information publicly accessible.

IV. Responsible Parties

Investigators are responsible for compliance with this policy. The Designated Official is responsible for ensuring implementation and compliance with this policy. The Office of Research Compliance and Review Committee also support implementation and compliance of this policy. More information about the Office of Research Compliance, including contact information, can be found online at http://www.bu.edu/research/ethics-compliance/conflicts-of-interest/.

V. Defined Terms:

Designated Official: An institutional official designated to solicit and review disclosures of Significant Financial Interests from Investigators. The Designated Official shall be the Boston University Associate Vice President for Research Compliance and or such other individual(s) as the Institution may designate in writing.

Entity: Any business or legal entity, including a corporation (profit or non-profit), partnership, limited partnership, joint ventures, voluntary association, sole-proprietorship, or trust.

Equity Interest: Any type of ownership interest in an Entity such as owning stock or stock options (vested and unvested) but excluding interests from investments such as mutual funds and retirement accounts if the Investigator does not directly control investment decisions.

Financial Conflict of Interest (“FCOI”): A Significant Financial Interest that could directly and significantly affect the design, conduct or reporting of the Research.

Independent Monitor: An individual who is proficient in the area research, holds no SFI or role in the Research, and does not report to the conflicted investigator.

Institutional Responsibilities: An Investigator’s professional responsibilities on behalf of BU, including, but not limited to, research, teaching, professional practice, and administration (e.g. service on committees, boards and panels, etc.) if they have such responsibilities.

Investigator: The Project director or principal investigator or any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of the Research, taking into account the degree of independence with which the person works, which may include, but is not limited to, graduate students, post-doctoral fellows, technicians, collaborators or consultants.

Non-PHS Research: A systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research, which is not funded by a PHS awarding component or other entity or organization that has incorporated the PHS rules with regard to FCOIs. The term encompasses educational activities funded or proposed for funding by NSF.Phase I and II Small Business Innovative Research (“SBIR”) or Small Business Technology Transfer (“STTR”) applications and awards are subject to the same COI disclosure requirements and reviews as all other Non-PHS-Funded Research.

Participate: To be responsible for the design, conduct or reporting of Research regardless of title or position.

PHS-Funded Research: Research funded or proposed to be funded by the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the NIH, and any entity or organization that has incorporated the PHS rules with regard to FCOIs. The term includes but is not limited to research grants, career development awards, center grants, individual fellowship awards, infrastructure awards, institutional training grants, program projects, and research resources awards. Although the PHS regulations exclude Phase I Small Business Innovative Research (“SBIR”) or Small Business Technology Transfer (“STTR”) research from COI requirements, under this policy Phase I and II SBIR and STTR applications or awards are subject to the same COI disclosure requirements and review as all other PHS-Funded Research, including PHS-required COI training.

Research: A systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research, regardless of funding source. The term encompasses basic, sponsored, and clinical research, including applied research and product development.

Senior/Key Personnel: The project director or principal investigator and any other person identified as senior/key personnel in the grant application, contract proposal, contract, progress report, or any other report submitted to the sponsor for the PHS-Funded or Non PHS-Funded Research.

Significant Financial Interest (“SFI”): Any financial interests (i.e., anything of monetary value) consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children), within the previous 12 months, that reasonably appears to be related to the Investigator’s Institutional Responsibilities:

  1. For all Publicly Traded Entities
    • Remuneration (e.g., salary, income, consulting fees, honoraria, paid authorship or any other payment) from an Entity that exceeds $5,000;
    • Any equity interest (e.g., stock, stock option, or other ownership interest) in the Entity that exceeds $5,000; or
    • Any remaining remuneration and equity from an Entity that, when added together, exceeds $5,000 in value.
  2. For all Non-Publicly Traded Entities
    • Remuneration (e.g., salary, income, consulting fees, honoraria, paid authorship or any other payment) from an Entity that exceeds $5,000;
    • Any equity interest (e.g., stock, stock option, or other ownership interest) in the Entity regardless of value; or
    • Any remaining remuneration and equity from an Entity that, when added together, exceeds $5,000 in value.
  3. Intellectual Property (IP) Right and Interests
    • Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
  4. For PHS-Funded Research Investigators Only: Reimbursed or Sponsored Travel
    • Travel reimbursed or sponsored by an Entity other than the Investigator’s current institution (i.e., paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), and related to their Institutional Responsibilities that exceeds $5,000 in value (in aggregate for a single Entity).

Exclusions: SFIs do not include the following types of financial interests:

  • Salary, royalties, or other remuneration paid by BU to the Investigator if the Investigator is currently employed or otherwise appointed by BU, including intellectual property rights assigned to BU and agreements to share in royalties related to such rights;
  • 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; and
  • Income from seminars, lectures, teaching engagements or service on advisory committees or review panels that are sponsored by a federal, state, or local government agency, a United Stated 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 a United States Institution of higher education;

United States Institution of Higher Education: The term “institution of higher education” means educational institutions located in any State of the United States, the Commonwealth of Puerto Rico, the District of Columbia, Guam, American Samoa, the United States Virgin Islands, the Commonwealth of the Northern Mariana Islands, and the Freely Associated States.

  1. Boston University Institutional Conflicts of Interest in Research Policy.
  2. Policy for Interactions with Industry by Faculty/Clinicians at the Boston University School of Medicine (08/20/2014)
  3. Boston University Policy on External Compensated Activity.
  4. Boston University Patent Policy (Boston University Medical Center).
  5. Boston University Patent Policy (Charles River Campus).
  6. Boston University Conflict of Interest Policy
  7. Boston Medical Center Significant Financial Conflicts of Interest in the Conduct of Research Policy

VII. History

Original Date Approved: June 1997
Revised: 10/31/2003, 8/24/2012, 7/1/2017, 3/17/2020
Next Review Date: March 2023

VIII. BU DOE Interim Requirements

Addendum to the Boston University Investigator Financial Conflicts of Interest in Research Policy: Department of Energy Interim Conflict of Interest Policy Requirements for Financial Assistance

Boston University complies with the Department of Energy’s (DOE) Interim Conflict of Interest Policy Requirements for Financial Assistance, which went into effect June 18, 2022. The Interim Policy is enforceable through the Special Terms and Conditions for DOE financial assistance awards (FAS), including grants, cooperative agreements, and technology investment agreements. DOE FAS’ include the National Nuclear Security Administration (NNSA). The Interim Policy does not apply to Office of Indian Energy or Phase I Small Business Innovation Research (SBIR) / Small Business Technology Transfer (STTR) applications and awards.

The DOE Interim Policy aligns, to a large extent, with the existing Public Health Service (PHS) Conflicts of Interest regulations at 42 CFR Part 50 and 45 CFR Part 94 and the BU Investigator Financial Conflicts of Interest Policy for Research. The BU FCOI Policy has been expanded to include the relevant DOE FAS’ with some minor but important differences in the DOE requirements outlined below. Please note that because the DOE COI policy is ‘Interim,’ it is subject to change with the final version. BU investigators applying for or receiving new DOE funding after June 18, 2022, will follow the BU FCOI Policy for compliance with the DOE Interim COI Policy.

Under the DOE Interim Policy

  • Financial conflict of interest (FCOI) means a situation in which an investigator or the investigator’s spouse or dependent children has a significant financial interest or financial relationship that could directly and significantly affect the design, conduct, reporting or funding of a project.
  • Organizational conflict of interest means a situation where because of relationships with a parent company, affiliate, or subsidiary organization, the non-federal entity is unable or appears to be unable to be impartial in conducting a procurement action involving a related organization.
  • Investigator means the principal investigator (PI) and any other person, regardless of title or position, who is responsible for the purpose, design, conduct, or reporting of a project funded by DOE or proposed for funding by DOE.

Investigator Requirements:

The Interim Policy requires each investigator who will be, or is, participating in a project funded wholly or in part under a DOE FAS and responsible for the design, conduct and/or reporting (and in some cases, the purpose) of the research:

  • Requirement: Disclose their significant financial interests (and those of their spouse and dependent children) no later than the time of proposal for the DOE award. Disclosures must be made at least annually within the period of the award, and within 30 days of discovering or acquiring a new significant financial interest (SFI).

Process: Investigator disclosures at BU are made via instructions on the BU FCOI website. Disclosures are reviewed by the FCOI program and Committee review processes outlined in the Investigator FCOI Policy for Research.

  • Requirement: Disclose any unmanaged or unmanageable FCOIs.

Process: When BU FCOI processes determine that a conflict is or may be unmanageable, a meeting will be held with the PI, their Department Chair, Sponsored Programs representative (SP), FCOI Assistant Director and other participants as appropriate, to discuss the determination and any possible options for management. If no feasible options are identified at the meeting, it will be confirmed that the conflict is unmanageable and a determination letter will be reported to DOE by the FCOI department with a copy to the PI, their Department Chair, SP and the FCOI Designated Official (DO), ordinarily within five days of the determination. If a new management strategy is identified, it will go back to the FCOI committee for further review and determination; the resulting determination letter or management plan will be sent to the PI with a copy to their Department Chair, SP, the FCOI Designated Official (DO), and other appropriate offices (e.g. Institutional Review Board) and will be sent to the DOE if unmanageable or if manageable, as requested by the DOE.

  • Requirement: Disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the investigator and not reimbursed to the investigator so that the exact monetary value may not be readily available) related to their institutional responsibilities that is not otherwise disclosed in current and pending or other support disclosures, provided that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a Federal, state, or local government agency of the United States; a domestic Institution of Higher Education; or a domestic research institute that is affiliated with a domestic Institution of Higher Education.

Process: Investigators submit reimbursed or sponsored travel via disclosure instructions on the BU FCOI website. Disclosures will be reviewed by the FCOI program and Committee review processes outlined in the Investigator FCOI Policy for Research.

  • Requirement: Each disclosure must include the following certification: I understand that this Disclosure is required to obtain funding from the U.S. Government. I, [Full Name and Title], certify to the best of my knowledge and belief that the information contained in this Disclosure Statement is true, complete, and accurate. I understand that any false, fictitious, or fraudulent information, misrepresentations, half-truths, or omissions of any material fact, may subject me to criminal, civil or administrative penalties for fraud, false statements, false claims, or otherwise. (18 U.S.C. §§ 1001 and 287, and 31 U.S.C. 3729-3730 and 3801-3812). I further understand and agree that (1) the statements and representations made herein are material to U.S. Government’s funding decision, and (2) I have a responsibility to update the disclosures during the period of performance of the award should circumstances change which impact the responses provided above.

Process: Investigators make the above certification with disclosures related to DOE-awards in the FCOI submission system.

  • Requirement: Investigators must complete FCOI training prior to engaging DOE FAS funded research, and thereafter every four years.

Process: Investigators complete training requirements via the CITI Program. The FCOI program will track CITI training completion. Investigators should maintain copies of their training records.

Boston University, through its Investigator Financial Conflicts of Interest Policy for Research and procedures and Sponsored Programs policies and procedures, meet the DOE standards.

Organizational Requirements

The Interim Policy establishes standards that research funded (wholly or in-part) by DOE will be free from bias resulting in Organizational Conflicts of Interest, as such:

  1. Organizations must have and/or follow policies and procedures for identifying, mitigating and managing organizational conflicts of interest.
  2. Organizations must report actual or potential Organizational conflicts to DOE.
  3. Organizations must follow procurement standards at 2 CFR 200.318 and .319.

Boston University Conflicts of Interest Policy, Competition and Supplier Selection for Products and Services Policy and Institutional Conflicts of Interest policy meet the DOE standards. Organizational Conflicts of Interest identified by Procurement, Technology Development, Sponsored Programs, Compliance Services, Research Compliance, or any other office at BU will be reviewed in accordance with established policies and procedures.

Actual or potential organizational conflicts of interest may be identified by one of several offices at BU, including (but not limited to): SP, the PI, Department administration, FCOI, Procurement Services, Compliance Services, Technology Development. The applicable Office/Department representatives will work together to confirm a conflict, mitigate the conflict, and develop a management plan (if appropriate/applicable). Actual or potential conflicts of interest will be reported to the DOE by the FCOI program with a copy to the PI, their Department Chair, SP and the FCOI Designated Official (DO), and other relevant BU offices, ordinarily within 5 days of the determination and/or signed management plan.

Approved by the BU Faculty Review Committee on Research FCOIs on February 16, 2023.

IX. BU NASA Revised Requirements

Addendum to the Boston University Investigator Financial Conflicts of Interest in Research Policy: National Aeronautics and Space Administration Conflicts of Interest Policy Requirements, effective December 1, 2023.

Boston University complies with the National Aeronautics and Space Administration (NASA) revised Conflicts of Interest Policy Requirements set forth in section 3.3 of NASA’s Grant and Cooperative Agreement Manual (GCAM section 3.3). GCAM section 3.3 is enforceable through Grant Information Circular 23-07 and applies to all new and amended NASA grants and cooperative agreements as of December 1, 2023.

NASA’s GCAM section 3.3 aligns, to a large extent, with the existing Public Health Service (PHS) Conflicts of Interest regulations at 42 CFR Part 50 and 45 CFR Part 94 and the BU Investigator Financial Conflicts of Interest Policy for Research. The BU FCOI Policy has been expanded to include the relevant NASA section 3.3 with some minor but important differences in the NASA requirements outlined below. BU investigators applying for or receiving new NASA or amended funding after December 1, 2023, will follow the BU FCOI Policy for compliance with the NASA COI policy requirements. 

Under the revised GCAM section 3.3 (changes are bolded):

The term “significant financial interest” means anything of monetary value, including, but not limited to, salary and any payment for services not otherwise identified as salary (e.g., consulting fees or honoraria), equity interest (e.g., stock, stock options, private equity, or other ownership interests), venture or other capital financing, and intellectual property rights (e.g., patents, copyrights, and royalties from such rights). The term does not include the following:

i. Salaries, royalties, or other remuneration paid by the proposing institution to the investigator if the investigator is currently employed or otherwise appointed by the institution;

ii. Any ownership interests in the proposing institution if the institution is a commercial or for-profit organization;

iii. 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;

iv. Income from seminars, lectures, or teaching engagements sponsored by a public or nonprofit entity;

v. Income from service on advisory committees or review panels for a public or nonprofit entity;

vi. An equity interest that, when aggregated for the investigator and the investigator’s spouse and dependent children, meets both of the following tests: (1) does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value and (2) does not represent more than a 5 percent ownership interest in any single entity; or

vii. Salaries, royalties, or other payments that, when aggregated for the investigator and the investigator’s spouse and dependent children, are not expected to exceed $10,000 during the prior twelve-month period.

Investigator Requirement:

GCAM section 3.3 requires each investigator who will be, or is, participating in a NASA- funded research project and responsible for the design, conduct and/or reporting of the research:

Requirement: Disclose their significant financial interests (SFI) (and those of their spouse and dependent children) no later than the time of application for the NASA-funded award, including “venture and other capital financing.”

Process: Investigator disclosures at BU are made via instructions on the BU FCOI website. The Huron disclosure system includes “venture and other capital financing” in its definition of SFI. Disclosures are reviewed by the FCOI program and Committee review processes outlined in the Investigator FCOI Policy for Research.

Requirement: Not disclose certain remuneration and/or equity excluded from the definition of Significant Financial interest in section 1(b) (i-vii). However, with regard to section 1(b)(vi and vii), consistent with the PHS regulations 42 CFR Part 50 and 45 CFR Part 94 and the BU Investigator Financial Conflicts of Interest Policy for Research, and as authorized by GCAM section 3.e., which permits institutions to apply disclosure standards that are more stringent than section 3.3 of the GCAM, the BU threshold for remuneration and equity in a publicly-held company remains $5,000. Any amount of equity in a privately-held company must be disclosed.

Process: Investigator disclosures at BU are made via instructions on the BU FCOI website. The Huron disclosure system sets a $5000 threshold for remuneration and for equity in a publicly-held company and a $0 threshold for equity in a privately-held company in its definition of SFI. Disclosures are reviewed by the FCOI program and Committee review processes outlined in the Investigator FCOI Policy for Research

Institutional Requirements:

Requirement: Disclose any unmanaged or unmanageable FCOIs.

Process: BU shall adhere to the following notification requirements:

a. Prior to the expenditure of any funds under a NASA-funded research award, BU shall notify the NASA Grant Officer(s) listed on the related award(s) in writing of any COI that cannot be satisfactorily managed, reduced, or eliminated in accordance with the BU policy. In cases in which an institution identifies a COI and manages, reduces, or eliminates it prior to the expenditure of NASA-awarded funds, BU shall not submit a COI notification to NASA.

b. After the expenditure of award funds, BU shall notify NASA within 60 days of any subsequently identified COI that cannot be managed, reduced, or eliminated.

c. Notifications shall include sufficient information to enable NASA to understand the nature and extent of the COI (e.g., award number, name of investigator with the COI, nature of the significant financial interest, etc.).

Approved by the BU Faculty Review Committee on Research FCOIs on November 13, 2023.

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