Financial Conflicts of Interest (FCOI) in research may occur when outside financial interests compromise, or have the appearance of compromising, the professional judgment of a researcher when designing, conducting, or reporting research. FCOIs are not inherently bad and do not always lead to biased behavior.

BU has two policies that address conflicts of interest in research:

Members of the research community should review these policies so they understand their responsibilities as they pertain to federal requirements and university policy.

Effective 8/7/17, Boston Medical Center (BMC) Investigators working on BMC Research must disclosure their Significant Financial Interests, or SFIs, through the BMC Compliance Department’s web based system, COI-Smart.

Please contact BMC’s Compliance Department at COI-Compliance@bmc.org if you require access and provide your name, email address, department and section (e.g., Pediatrics/Pediatric Infection Diseases; Medicine/General Internal Medicine; Medicine/Cardiology).

After 8/7/2017, any BMC Investigator that inadvertently receives an annual disclosure request from BU for a BMC Research project should notify BMC’s Compliance Department at COI-Compliance@bmc.org to have BU remove the BMC Research project from BU’s system.

BU Investigators working on BU Research Projects should continue to follow the Disclosure Procedures below.

Disclosure Procedures

Step One: Complete a Financial Interest Disclosure

  • BMC Investigators working on BMC Research must disclosure their SFIs through the BMC Compliance Department’s web based system, COI-Smart.  Please contact BMC’s Compliance Department at COI-Compliance@bmc.org if you require access

Step Two: Complete Financial Interest Disclosure Training

  • Investigators engaging or planning to engage in Public Health Service (PHS) Funded Research 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.

Step Three: FCOI Committee Review

  • When the Committee identifies a financial conflict of interest, it will submit a proposed management plan to the Associate Vice President for Research Compliance (AVPRC). The investigator will have an opportunity to review and comment on the management plan before it is sent to the AVPRC.

Step Four: Management Plans

  • The AVPRC will make the final determination on how to manage the FCOI and will accept, reject, or modify the Review Committee’s recommendation.
  • The COI Program will send the final decision to the investigator for review and signature.

Guidance

You may disclose in one of two ways:

To access the Online Financial Interest Disclosure Module:

  1. You will need a BU account and Kerberos password. You may check the BU Directory to see if you are listed or you may contact the COI Program for assistance. If you need to create an account, go to https://www.bu.edu/link/bin/uiscgi_research_compliance.pl to set up a BU account and password.
  2. Grant administrators may assist PIs in completing the disclosure form by:
    • Going to https://share.bu.edu/sites/fcoi/Pages/Default.aspx
    • Clicking on “Manage Projects”
    • Clicking on “+Add Project”, in the top left corner
    • After submitting, the grant admininstrator will need to click the “Send Invitation to PI” link, in the right most column of the “Manage Projects” page
    • When the investigator signs in, they will see the project with an “INVITED to disclose” status.
    • When the PIPrincipal Investigator View Boston University's policy on... clicks on “Start Form” under “Actions”, the pre-filled form will appear.
  3. PIs may submit a new form without an adminstrator’s assistance by:
  4. Once the PI has submitted a disclosure, all individuals listed on the project that have been checked to receive an email will automatically be invited to disclose (If there are Co-PIs on a project, only one should disclose as the PI of the project).
  5. Individuals identified by the PI, including new investigators during the life of the project, must submit a disclosure.
Anyone who is responsible for the design, conduct, or reporting of research activities at Boston University or Boston Medical Center must disclose, regardless of title.
For all PHS-funded BU and BMC research, (or an organization following PHS FCOI rules), investigators are required to disclose financial interests (and those of the investigator’s spouse and dependent children) that reasonably appear to be related to the investigator’s institutional responsibilities, regardless of whether they are related to a specific research project or not. This includes outside remuneration, equity, and royalties related to intellectual property.

For BU research not funded by PHS, investigators disclose only those financial interests that could be affected by the research.

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 or updated SFIs.
    • Protect research integrity
    • Protect taxpayer money
    • Protect researcher and institutional reputations
    • Protect population safety
    • Federal law: 42 CFR Part 50, Subpart F

    Conflicts of Interest Policies

    Boston University Policy on External Compensated Activity

    Regulatory Framework