Whenever the University implements a management plan it will monitor Investigator compliance with the management plan on an ongoing basis until the completion of the federally-funded research project.
Prior to the expenditure of any funds for a research project, the Director of Central Pre-Award will, as the process above describes, review all Investigator disclosures of significant financial interests; determine whether any significant financial interests relate to the research; determine whether a financial conflict of interest exists; and, if so, develop and implement a management plan that shall specify the actions that have been, and shall be, taken to manage such financial conflict of interest. Examples of conditions or restrictions that might be imposed to manage a financial conflict of interest include, but are not limited to:
Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research);
For research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants and whether the investigator should be allowed to participate in subject recruitment; pre-screening for inclusion/exclusion criteria; the consent process; the clinical treatment of subjects, separate from the research interventions or procedure or the clinical evaluation of subjects during the research, separate from the research interventions or procedures, including advers event evaluation and reporting
Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the financial conflict of interest;
Modification of the research plan;
Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;
Reduction or elimination of the financial interest (e.g., sale of an equity interest); or
Severance of relationships that create financial conflicts.
An example of a plan could entail the following:
Disclose the support the Investigator received from the company or other sponsor.
Disclose the Investigator’s financial relationship with company.
Describe the steps taken to inform current or new students and other trainees of the conflict of interest.
Determine whether student projects are different in any way from those of other members of the group with respect to the way they interface with company’s goals.
Determine whether a student thesis project has been altered in direction because of a change in those goals.
Demonstrate how publications and meeting presentations (within Tufts and external) are handled to allow the co-existence of the company’s and academic goals.
State whether students or other trainees were included in patents obtained by the group.
State whether students were compensated beyond the student stipend for work performed under the sponsoring company.
Ensure that all COI’s are disclosed.
PI acknowledges Tufts FCOI policy and agrees to abide by it and the plan and makes assurances that the PI will disclose any new SFI.
For Management Plans where human subjects are involved, the following additional options can be considered:
Public disclosure of the financial interests.
Disclosure of the financial interests to subjects.
Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the financial conflict of interest.
Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research.
Reduction or elimination of the financial interest (e.g., sale of an equity interest).
Severance of relationships that create financial conflicts.
Modification of the research plan.
Involvement of external individuals in key portions of the protocol
Use of an external IRB.
A retrospective review.
A mitigation report.
A plan to monitor and enforce the implementation of the management plan.
Once a management plan is in place it is reviewed annually, and the Investigator is required to inform the CCIR of any changes in the COI.
Public Accessibility to the FCOI Policy and Disclosed Significant Financial Interests on PHS Funded Projects
Prior to the University’s expenditure of any funds under a PHS-funded research project, the University will ensure public accessibility, via a written response to any requestor within five business days of a request, of information concerning any significant financial interest disclosed to the University that meets the following three criteria:
The significant financial interest was disclosed and is still held by the senior/key personnel;
The University determines that the significant financial interest is related to the PHS-funded research; and
The University determines that the significant financial interest is a financial conflict of interest.
The information that the University makes available via a written response to any requestor within five business days of a request, will include, at a minimum, the following:
Investigator’s title and role with respect to the research project;
name of the entity in which the significant financial interest is held;
nature of the significant financial interest; and the approximate dollar value of the significant financial interest (dollar ranges are: $0–$4,999; $5,000–$9,999; $10,000–$19,999; amounts between $20,000–$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), or
statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.
The information the University keeps will be updated at least annually. In addition, the University will update its files within sixty days of the receipt or identification of information concerning any additional significant financial interest of the senior/key personnel for the PHS-funded research project that was not previously disclosed, or upon the disclosure of a significant financial interest of senior/key personnel new to the PHS-funded research project, if the University determines that the significant financial interest is related to the PHS-funded research and is a financial conflict of interest. If the University responds to written requests for the purposes of this subsection, the University will note in its written response that the information provided is current as of the date of the correspondence and is subject to updates, on at least an annual basis and within 60 days of the University’s identification of a new financial conflict of interest, which should be requested subsequently by the requestor.
Information concerning the significant financial interests of an individual subject to this policy shall remain available, for responses to written requests for at least three years from the date that the information was most recently updated.
Written request should be mailed to:
Heather J. Cosier, JD, MA
Associate Vice Provost for Research Compliance | Office of the Vice Provost for Research
136 Harrison Ave.
Boston, MA 02111