Financial Conflict of Interest

FAQs by Investigators

Do my activities require that I file a "yes" disclosure?

You may be required to file a "Yes" disclosure if you propose, conduct, or report any research supported by funds administered by Boston University or Boston Medical Center and you, your spouse, or dependent children have any financial interest that could reasonably appear to be affected by your research.

If so, you must determine whether it is a "Significant Financial Interest," and if so you should file a "Yes" disclosure using the Project Specific Disclosure Form.

A "Significant Financial Interest" refers to:

  • anything of monetary value, including a salary, consulting fee, honorarium or other payment for service;
  • equity interests, including stocks, stock options or other ownership interests;
  • intellectual property rights, including patent rights owned by the investigator or on which a clinical investigator is named inventor (whether licensed or not), copyrights and royalties.

This Conflict of Interest Policy, however, excludes from consideration the following items:

  • salary, or other remuneration (not including royalties) from Boston University;
  • income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities;
  • income from service on advisory committees or review panels sponsored by public or non-profit entities;
  • salary, royalties or other payments from a single entity (or group of affiliated entities) that, when aggregated for the investigator and members of his immediate family over the next twelve months, are not expected to exceed $10,000

For more information you may refer to the Boston University Policy on Investigators'Conflicts of Interest or the Boston Medical Center Policy on Investigators'Conflicts of Interest and other materials on this website. For advice and assistance, contact the CRC Advisory Committee on Investigators' Conflicts of Interest or the BUMC Advisory Committee on Investigators' Conflicts of Interest.

When and where do I file disclosures?

Comprehensive Disclosures: When and where do BUMC investigators file?

BUMC requires all faculty investigators to file a one-time, baseline Comprehensive Disclosure Form (PDF). This requirement went into effect on December 31, 2003.  CDs were filed by then current faculty investigators at that time.  Thereafter, new faculty investigators must file a CD on or before December 31 of their first year at BUMC.  The CD relates to all covered research, whether or not funded.  To find out whether you have a CD on file, contact the Office of Research Compliance & Health Information Privacy.

Project-Specific Disclosures: When and where do all investigators file?

When to file PSD? Where to file PSD?
Whenever a new or renewal application for funding is filed on a research project for which you are the Principal Investigator or Co-Principal Investigator.  The PI must attach a PSD for any other investigator on the project who would answer "Yes" to the question on the PSD. The PSD should be filed with your research administration office and will be forwarded to the Office of Research Compliance
Whenever a protocol for human subjects research is filed with the Institutional Review Board on your campus for a project on which you are the Principal Investigator and you have not already filed a PSD. The PI must attach a PSD for any other investigator on the project whose answer to the question on the PSD is "Yes."
Whenever the information contained in your previously filed PSD, or your BUMC Comprehensive Disclosure Form, has "materially changed."* A PSD reporting "material change" should be filed directly with the Office of Research Compliance & Health Information Privacy (Link to Committees and Offices)

What is a material change that must be disclosed when it occurs?

"Material change" includes, for example:

  • Change from "No" to "Yes"
  • Any change that would require you to answer "Yes" on a previously filed "No" disclosure.  This applies to any previously-filed and still active Project Specific Disclosures on which you answered "No" and to any previously-filed BUMC Comprehensive Disclosure on which you answered "No".
  • Change in "Yes" Disclosure that is still active
  • Any order of magnitude change (e.g. $10,000 to $100,000) in the financial interest previously disclosed in any "Yes" disclosure that is still active.  A "Yes" disclosure remains active after the Provost has determined that a conflict of interest exists until all activity required to be carried out under the Provost's decision has been done.  For example, if you are still publishing results from a project that was affected by a conflict of interest and you have been required by the conflict of interest decision to disclose your significant financial interest in your publications, then the "Yes" disclosure is still active.

Am I properly monitoring my disclosure status?

You are properly monitoring your disclosure status if you regularly review your financial interests and your research to determine (a) whether any of your financial interests could reasonably be affected by your CRC or BUMC research and (b) whether there has been a material change in the information previously disclosed.  Such "material change" (see above) is required to be disclosed by filing a supplemental disclosure. 

If you have any questions about your responsibilities, contact the CRC Advisory Committee on Investigators'Conflicts of Interest or the BUMC Advisory Committee on Investigators' Conflicts of Interest.

Am I complying with my conflict of interest management plan?

Advisory Notice on Management Plans November 8, 2007: "Publication disclosures; Deviations from Management Plans; Supplemental and Annual Reporting"