A BMC Health System Researcher’s Guide to Conflicts of Interest Disclosure, Review and Management

September 2026 Issue

Author(s):

  • Jami Wood, MBA, CHC, CCRP, Research Compliance Officer, Boston Medical Center Health System
  • Jacqueline Presedo, Research Compliance Manager, Boston Medical Center Health System

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Introduction

Financial conflict of interest disclosure, review, and management is a key component of BMC Health System’s research compliance program. Researchers must disclose their relevant outside relationships and interests to the BMCHS Compliance Office in order to help protect the research from bias; and to preserve the public trust in BMCHS, the research, and you!  Both BMCHS and research sponsor policies require BMCHS to evaluate researchers’ significant financial interests to determine if they pose a financial conflict of interest with their BMCHS research--and if a conflict is identified, to take steps to manage that conflict. In this month’s Feature Article, you’ll find a summary of BMCHS’s process for reviewing and managing research COIs, and the steps researchers need to take to facilitate this review.

Please note that this Feature Article describes BMC Health System’s disclosure process for BMCHS investigators working on BMCHS research. For researchers at Boston University (BU) conducting BU research, please review the information related to the BU financial conflict of interest process, found here.

 

Submitting Your Disclosure

How to disclose?

BMCHS uses COI-Smart to collect COI disclosure surveys.  If you do not have a BMC email address, use this link to access COI-Smart.

Who must disclose and when?

All Investigators identified by the Principal Investigator/Project Director (PI/PD) as responsible for the design, conduct, or reporting of research must disclose their outside relationships and financial interests related to their BMCHS role:

  • At the time of a grant proposal or protocol submission;
  • Annually; and
  • Anytime there is a change in your outside interests or relationships; e.g., acquiring new interests.

 

The Compliance Office Disclosure Review Process

How are disclosures reviewed?

Upon notice of award or notice of IRB protocol submission, BMC Health System’s Compliance Office reviews the COI disclosures of each Investigator listed on the project to determine if they reported any Significant Financial Interests (SFIs).

Is the amount significant?

SFIs include any of the following in the previous 12 months:

  • Income >$5,000 or income plus equity >$5,000;
  • Public equity >$5,000 (including stock options);
  • Any amount of private equity (including stock options);
  • Any income from intellectual property (if rights not assigned to BMCHS or BU); or
  • Travel worth >$5,000 (for Public Health Service-funded Investigators only).

Is the SFI related to research?

If an Investigator has reported an SFI, Compliance determines if it is related to the investigator’s research. Circumstances where the SFI is considered related to the research include, but are not limited to, when the outside entity makes or owns a drug, device, technology, or intellectual property used in the research; the entity is the sponsor of the research; or the value of the interest may be impacted by the outcome of the research. 

If the SFI is related to the research, the next step is to initiate a review by the Boston University/Boston Medical Center Faculty Review Committee on Research Financial Conflicts of Interest.

 

Review by the Boston University/Boston Medical Center Faculty Review Committee on Research Financial Conflicts of Interest

Is the SFI a research financial conflict of interest (FCOI)?

If the SFI is related to research, then the Boston University/Boston Medical Center Faculty Review Committee on Research Financial Conflicts of Interest reviews it, determines if a conflict exists, and if so, decides how to manage the conflict. The Committee meets monthly and consists of BU Faculty members from the Medical and Charles River Campuses, and BMCHS and BU compliance staff members.

To prepare for the Committee review, the researcher will often meet with Compliance staff and will complete a Compelling Circumstances Questionnaire; and provide such information as the researcher’s unique qualifications for the project, their role in the proposed research, and how the financial interest could influence or be influenced by the proposed research.

The Committee applies a “Rebuttable Presumption,” where the default position is that a conflicted investigator cannot participate in research for which they have a conflict unless they can demonstrate compelling circumstances.  Every decision by the BU/BMC Faculty Review Committee on Research Financial Conflicts of Interest is based on the particular set of facts of each case.

Factors the Committee considers in its evaluation include:

  • nature and value of the financial interest/activity;
  • ability of the research to impact the value of the financial interest;
  • actual ability for the interest to bias the investigator’s work or the data integrity of the project;
  • potential for the appearance of bias or negative impact on the public’s trust in research;
  • if the investigator is uniquely qualified to conduct the research.

If the Committee finds that compelling circumstances exist and that the COI can be managed, the next step is for the Committee to design a management plan.

 

Managing Conflicts of Interest

How is the conflict managed?

If the Committee finds that compelling circumstances exist and that the COI can be managed, the Committee designs a COI management plan–-a set of requirements that a conflicted investigator must carry out which are intended to protect the research from bias.

Management strategies may include:

  • disclosure of the financial interest to department chair and dean, as well as colleagues, mentees, & students involved in the research;
  • disclosure of the financial interest to the IRB & research subjects;
  • disclosure of the financial interest in relevant publications and presentations;
  • use of an independent scientific reviewer;
  • use of a safe haven monitor if trainees are involved;
  • recusal from research or modifications to the conflicted investigator’s role in the research.

Once the COI management plan has been signed by the investigator and reported to the sponsor, IRB, or others as necessary, then the research can proceed.

 

Key Things to Remember

Below is a list of important points to keep in mind related to the BMC Health System process for conflicts of interest disclosure, review and management.

  • Researchers must keep their BMCHS Disclosure of Outside Relationships up to date! Complete annually and update timely when you have a change.
  • The BMCHS Compliance Office facilitates the review of the research and financial interests by the BU/BMC Faculty Review Committee on Research Financial Conflicts of Interest.
  • Research COI management plans are required by BMCHS and research sponsor policy when a conflict of interest is identified to help protect the research from bias; and to preserve the public trust in BMCHS, the research, and you!

The full policy on Significant Financial Conflicts of Interest in the Conduct of Research is available on Policy Tech.

 

Conclusion

The COI disclosure process is an important component of research compliance at BMC Health System. Researchers need to disclose relevant outside relationships and interests because BMCHS and research sponsor policies require BMC to evaluate researchers’ significant financial interests to determine if they pose a financial conflict of interest with their BMCHS research; and to take steps to manage conflicts that are identified.

Please remember that if you ever have questions about this process, you may reach out to the following contacts who will be glad to assist you:

COI-Compliance@bmc.org, Adrien Crete at Adrien-James.Crete@bmc.org, or Jami Wood at Jami.Wood@bmc.org

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