Conflicts of interest (COIs) arise where one could financially benefit from research, causing or appearing to cause potential bias in its design, conduct, or reporting.
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 disclose 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.
All individuals responsible for the design, conduct, or reporting of research at Boston University must Complete a Financial Interest Disclosure. Contact the COI Program if you cannot complete the online form.
BMC Investigators working on BMC Research must disclose 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
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.
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.
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).
Individuals identified by the PI, including new investigators during the life of the project, must submit a disclosure.
Who Discloses
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.
What to Disclose
For all PHS-funded BU and BMC research (or agencies 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 Non-PHS funded BU research, investigators are required to disclose any remuneration, related to this research or not, that reasonably appears to be related to institutional responsibilities and are required to disclose equity interests in a publicly or non-publicly traded entity, related to the research or not, that reasonably appears to be related to institutional responsibilities.
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
Below are the forms and policies you will likely need. To quickly find a form or policy in this list please use the Find Function: command+f (mac) or control+f (pc). Or view the full forms and policies libraries under Forms & Policies in the main navigation. Please download and fill out PDFs using Adobe—Acrobat Reader DC is available for free.
If you have questions or need help, please contact one of the specialists. You can email them directly or feel free to call. Office information can be found below.