Financial Conflict of Interest
Guidance for Investigators
- Who must file disclosures?
- When do I file disclosures?
- How do I file disclosures?
- Where do I file disclosures?
- Does my situation require me to answer "Yes" on my project-specific disclousre?
- Am I properly monitoring my disclosure status?
- What should I expect if I file a "Yes disclosure?
- How should I handle disclosures if my only financial interest is an interest in potential future royalties in intellectual property owned by the institution?
Project-Specific Disclosures are required of all Investigators. Each Investigator (defined below) on each research project at BUMC, CRC, or BMC is required to have submitted an up-to-date Project-Specific Disclosure (PSD) form concerning possible financial conflicts of interest.*
*There is one exception under current policy: if you have filed a Comprehensive Disclosure form indicating “No”, then you are only required to file additional “No” disclosures on projects that are funded externally or that involve human subjects. Projects that are neither externally funded nor human subjects research are covered by a one-time “No” Comprehensive Disclosure under current policy. For further information on Comprehensive Disclosures, see our website at the link above.
The term "investigator" includes all principal investigators and co-investigators, and may include others (e.g., graduate students, post-doctoral fellows, and technicians) who are responsible for designing, conducting or reporting covered research. Individuals whose independent responsibilities will significantly affect the integrity of these functions in Covered Research should be identified by the PI as "investigators" for purposes of the disclosure requirements of the Policy.
Basic Rule for All Project Investigators:
NEW or RENEWAL projects: A Project-Specific Disclosure Form must be submitted as part of the application packages for all investigators on the project, as identified by the Principal Investigator.
HUMAN SUBJECTS projects: A Project-Specific Disclosure Form must be submitted for all investigators on any CRC or BUMC IRB protocol.
Rules for individual investigators where there is a material change in project or individual situation:
MATERIAL CHANGE: At any time during the funded project, a Project-Specific Disclosure form must be submitted by the Investigator in the event of any material change; specifically:
- the investigator is newly added to the project;
- there is a significant increase in the scope of the investigator's work on the project;
- the investigator's answer changes from "NO" to "YES" to a question on the PSD.
To access the Project-Specific Disclosure form, please click here.
- for BMC research projects, use the BMC PSD form; or
- for BU research projects, use the BU PSD form.
For each externally-funded sponsored research project:
| If your research is funded through: | Boston Medical Center Office of Grants Administration |
Boston University Medical Campus Office of Research Administration |
Boston University Charles River Campus Office of Sponsored Programs |
Send this form along with your application package to: |
Ellen Jamieson Office of Grants Administration or fax: (617) 414-2834 |
Boston University
|
Joan Kirkendall Office of Sponsored Programs
|
For other covered research, i.e. all research on the BU Medical campus and on the Charles River campus, all externally-funded research, and all human subject research regardless of funding, please send the PSD to the following office:
Compliance Coordinator
Boston University Office of Research Compliance
85 East Newton Street, M-840A
Boston, MA 02118
Or, fax to (617) 414-4738
DOES MY SITUATION REQUIRE ME TO ANSWER "YES" ON MY PROJECT-SPECIFIC DISCLOSURE?
You should answer “Yes” on your PSD if your answer is Yes to both parts of the question:
“Do you, your spouse, or dependent children have a “significant financial interest” (SFI) that could reasonably appear to be affected by the research?”
Part 1 of the Question: “Do you, your spouse, or dependent children have a significant financial interest (SFI)?”
Answer Yes to Part 1, if the detailed definition of “Significant Financial Interest” contained on the PSD form applies to your situation. Common examples of a SFI:
- You, your spouse or dependent child have certain rights in intellectual property (see part 2 below);
- You, your spouse or dependent child expect to earn consulting income from a related company in excess of $10,000 in the past, present or coming twelve months;
- You, your spouse or dependent child have any equity in a related company.
Important: University base salary and financial interests in mutual funds are not SFI and do not require a Yes answer.
Part 2 of the Question: “…that could reasonably appear to be affected by the research?”
Answer Yes, if the SFI consists of the following:
- Rights in intellectual property being used or studied in the research (see below); or
- A significant financial interest in an Entity that, itself, has a financial interest in the research.
Common examples of an Entity that has a financial interest in research include:
- Company sponsors the research;
- Company will have access to pre-publication results of the research;
- Company markets or has rights in product, invention, device, drug, program, etc. used or studied in the research;
- Company could otherwise directly and significantly benefit from the research.
HOW SHOULD I HANDLE DISCLOSURE IF MY ONLY FINANCIAL INTEREST RELATED TO THE RESEARCH IS AN INTEREST IN POTENTIAL FUTURE ROYALTIES IN INTELLECTUAL PROPERTY OWNED BY THE INSTITUTION?
Your interest in potential future royalties in institutionally-owned intellectual property does not currently constitute a “significant financial interest” as defined under current federal regulations or under Boston University and Boston Medical Center Policies on Investigators’ Conflicts of Interest. Actual receipt of royalties in excess of $10,000 in a 12 month period does constitute a “significant financial interest” under current policies.
PLEASE NOTE, however, that if your related research involves human subjects and is not IRB-exempt, you should consult the Administrative Process and Guidance indicating how you should handle this situation.
IF YOU ANSWER YES TO BOTH PARTS 1 AND 2, THEN YOU SHOULD ANSWER “YES” ON YOUR PROJECT-SPECIFIC DISCLOSURE. OTHERWISE, YOU SHOULD ANSWER “NO.”
You may consult the Office of Research Compliance at any time for advice on how to answer the questions.
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 the following: 1. whether any of your financial interests could reasonably be affected by your institutional research and 2. whether there has been a material change in the information you previously disclosed. Such "material change" (see above) is required to be disclosed by filing a supplemental Project-Specific Disclosure.
WHAT SHOULD I EXPECT IF I FILE A YES DISCLOSURE?
A “Yes” PSD will be reviewed by the Office of Research Compliance or by the BUMC or CRCAdvisory Committee on Investigators’ Conflicts of Interest to determine whether, indeed, you have a “Significant Financial Interest,” whether a conflict of interest exists affecting the project of research, and, if so, whether the conflict of interest should be eliminated, reduced or managed under a written, Committee-monitored management plan.
In basic science research, typically, a management plan is imposed requiring further disclosure of your financial interest to colleagues and in publications of the research results and requiring monitoring of involvement of trainees, and academic appropriateness determinations for involvement of students.
In human subjects research, particularly when not IRB-exempt, if management is permitted, the plan is usually more robust. The Committee is required by policy to presume that the conflict of interest should be eliminated and not managed. Elimination means divestiture or recusal from participation in the project. However, this presumption may be rebutted by a showing of “compelling circumstances” to allow management of the conflict.
Compelling circumstances are generally based upon findings of both 1. low risk to human subjects and 2. unique qualifications, knowledge or resources of the disclosing investigator that necessitate his or her having a role in a valuable early-stage research project. In several cases, compelling circumstances have been found to warrant that an investigator may play a continuing, but limited, role in a project, subject to involvement of an additional or substitute independent investigator who will fulfill specifically defined duties. The compelling circumstances analysis enables the institution to balance the competing goals of avoiding risks to research integrity and credibility from conflicts of interests while facilitating technology transfer in its very early stages. Federal policies and regulations support both of these competing goals.
HOW SHOULD I HANDLE DISCLOSURE IF MY ONLY FINANCIAL INTEREST RELATED TO THE RESEARCH IS AN INTEREST IN POTENTIAL FUTURE ROYALTIES IN INTELLECTUAL PROPERTY OWNED BY THE UNIVERSITY?
Your interest in potential future royalties in institutionally-owned intellectual property does not currently constitute a “significant financial interest” as defined under current federal regulations or under Boston University and Boston Medical Center Policies on Investigators’ Conflicts of Interest. (Note: Actual receipt of royalties in excess of $10,000 in a 12 month period does constitute a “significant financial interest” under current policies.)
PLEASE NOTE, however, that if your related research involves human subjects and is not IRB-exempt, you should consult the Administrative Process and Guidance(indicating how you should handle this situation.
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.
