BU’s research conflict of interest disclosure process has transitioned to Huron COI as of March 2023.
Find tutorials and updated procedures for the new system below. Please watch our overview video, review FAQs, or email coi@bu.edu with any questions or issues.
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.
Review the policies and information below to become familiar with federal requirements, university policy, and actions required from BU investigators.
Are you an investigator at Boston Medical Center (BMC)? The information below is for researchers at Boston University. BMC investigators working on BMC research must disclose through the BMC Compliance Department’s web-based system, COI-Smart. Please contact BMC’s Compliance Department at COI-Compliance@bmc.org to gain access.
Disclosure Procedures
- Have questions? Review FAQs about the Huron system or contact the COI Program if you have trouble accessing or completing your disclosure profile.
- Investigators engaging or planning to engage in Public Health Service (PHS) and/or Department of Energy (DOE) funded research must complete financial conflict of interest training on investigator responsibilities prior to engaging in PHS- and/or DOE-funded research and at least once every four (4) years.
Step Three: FCOI Committee Review
- When a significant financial interest may be related to the research, the Faculty Review Committee on Research FCOIs will review the research project.
- 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).
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 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.
Guidance
How to Disclose
With Huron COI, investigators must disclose online. If you have trouble logging in, contact the
COI Program.
To access Huron COI:
Huron uses single sign-on (SSO), so you will need a BU account and Kerberos password. Check the BU Directory to see if you are listed. If you are not listed and need an account, your PI will need to sponsor an affiliate account for you. They can request an affiliate account through BU TechWeb. To do so, they will need the following information from you:
- Legal Name
- Date of Birth
- Personal Email
- Contact Telephone Number
More information on affiliate accounts and the request process is available on BU TechWeb.
Once your affiliate account is created, you will be able to use your credentials to log into Huron.
Disclosing Entities
- Log into Huron using your BU Kerberos username and password.
- Navigate to COI, then Disclosures. You should be on a page that says “Disclosure profile for [your name].”
- Click Edit Disclosure Profile (blue button)
- In the Entity Disclosure Information section, review any entity disclosures previously entered.
- Update and/or add any entity disclosures for yourself, your spouse, and any dependent children as necessary.
- Once you have finished reviewing and completed disclosure of all entities, click Complete Disclosure Profile Update to certify that the disclosure is complete and accurate.
Projects
In Huron COI, a project is called a Triggering Event because being included on a project triggers a required action.
If your PI or Grants/Departmental Administrator submitted a Proposal Summary Form to Sponsored Programs for your project, that project will be imported into Huron COI as a Triggering Event.
However, for industry partnerships, IRB protocols, and other projects that require COI disclosure, the PI or primary contact will manually create a triggering event in Huron.
Whether the project is manually created or imported into Huron, the PI and/or primary contact will Edit the Triggering Event to manage the list of research personnel associated with the project, determining who will be required to disclose.
Once all current research personnel are listed on a triggering event, the PI or primary contact will Manage Certifications from the Triggering Event workspace to create a research certification for each individual associated with the project. Research personnel will receive an email notification prompting them to log into Huron COI and disclose if necessary.
Who Discloses
Anyone who is responsible for the design, conduct, or reporting of research activities at Boston University must disclose, regardless of title or position.
What to Disclose
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.
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:
- 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.
- 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.
- 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.
- For PHS- or DOE-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 of any dollar amount must be disclosed.
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;
When to Disclose
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.
Why Disclose
- Protect research integrity
- Protect taxpayer money
- Protect researcher and institutional reputations
- Protect population safety
- Federal law: 42 CFR Part 50, Subpart F
Related Policies
Key Contacts