Conflict of Interest Policy: Disclosing
This section explains the process investigators follow to make their disclosures including subrecipient investigators as it relates to the project sponsor, that is, whether it’s a federal or non-federal sponsor. The section also explains the policy for failure to make a disclosure.
This policy requires each Investigator who is planning to participate in sponsored research disclose to the Director of Research Administration annually or via the Financial Interest Disclosure Form, if the investigator did not submit the annual disclosure of the Investigator’s significant financial interests (and those of the Investigator’s spouse and dependent children).
The University is responsible for maintaining an up-to-date, written, enforced policy on financial conflicts of interest that complies with the regulation, and makes such policy available here.
At any time an individual has a potential conflict of interest related to his or her research he or she must disclose it to the Director, Central Pre-Award as the Chair of the CCIR. In addition, with each application for funding (and with each submission of a protocol for human subject research to the Institutional Review Board (IRB)), each Investigator involved in the research have completed an annual disclosure form as indicated in Part IV of the Internal Sponsored Coordination Form (ISCF) or complete and submit a Financial Conflict of Interest Disclosure Form for the specific project. It is the responsibility of each Investigator to update this information at any time that it changes. It is the responsibility of the principal investigator (PI) to ensure that each Investigator working under his or her direction on a research project or receiving support from his or her grant or contract receives a copy of this Policy and submits an annual disclosure forms as required by this Policy.
If there has been a change since the annual disclosure or if an investigator did not submit the annual disclosure form, investigators must submit a Financial Interest Disclosure Form (FIDF) with each proposal submitted for funding. Once the forms are received by Central Pre-Award, they are reviewed by the pertinent member of Central Pre-Award. If there is an indication on the form that a COI is being disclosed, the forms are forwarded to the Director, Central Pre-Award / Chair of the CCIR for review. By submitting the annual disclosure form or signing the hard copy FIDF, investigators acknowledge, among other things, the University’s policy on financial conflicts of interest, the Investigator’s responsibilities regarding disclosure of significant financial interests, and of 42 CFR 50, subpart F, Promoting Objectivity in Research.
The annual disclosure forms are reviewed by the CCIR Chair and when a disclosure is made, will follow up with the investigator for more information. This additional information will assist with determining whether the disclosure relates to the investigator’s institutional responsibilities and if so whether there is a COI.
Before the hard copy disclosure forms are submitted to the Central Pre-Award, they must be reviewed and signed by the investigator’s department chairperson. If the department chairperson is directly involved in the research, the Dean must review and sign the disclosure form. Deans must submit their own disclosure forms to the OVPR. In the event the Investigator indicates has nothing to disclose or there is no COI, then the Chair or Dean’s signature is not required. Disclosure forms that indicate a potential conflict of interest are reviewed by the Director of Central Pre-Award.
In addition to the need to disclose conflicts of interest to the University, it is also important that such conflicts be disclosed to others who might be affected by the research. This includes, for example, human subjects, other researchers who might rely on the research results, and the public. It is expected that all researchers will disclose conflicts of interest related to specific research projects at any time that the results of that research are presented or published.
At the time of the application/proposal submission, Tufts must certify, in each application for funding that it has an up-to-date written, and enforced administrative process to identify and manage, reduce, or eliminate conflicting interests with respect to all research projects for which funding is sought or received. Tufts additionally certifies that it will:
- promote and enforce Investigator compliance with this policy’s requirements including those pertaining to disclosure of significant financial interests;
- manage financial conflicts of interest and provide initial and ongoing FCOI reports to the awarding component (required for all PHS/NIH projects);
- make information available, promptly upon request, to the awarding component relating to any Investigator disclosure of financial interests and Tufts’ review of, and response to, such disclosure, whether or not the disclosure resulted in the University’s determination of a financial conflict of interest; and
- fully comply with the requirements of 42 CFR 50.f, Promoting Objectivity in Research.
Disclosures are made on an annual basis. Investigators receive an email in the February – April time frame with a link to an HTML form.
For each proposal investigators note on Part IV of the ISCF whether they completed the annual disclosure form. If yes, they are asked whether there are any changes to disclosure since the annual form. If so, they need to fill out a hard copy FDIF and submit it with their proposal. If they note that they did not complete the annual form, then they also need to submit the hard copy FDIF with their proposal.
- Investigators are required to disclose to the Office of the Vice Provost for Research, a listing of Significant Financial Interests (and those of his/her spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities. Investigators also must disclose the occurrence of any reimbursed or sponsored travel related to their institutional responsibilities. For example, costs that were paid on your behalf and not reimbursed to you so that the exact monetary value may not be readily available. However there are exceptions for travel disclosures, see the definition of SFI on the preamble page.
- An “Investigator” is defined as the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants. The definition of Investigator’s financial interests includes the interests of the Investigator’s spouse and dependent children.
If an Investigator through the University carries out sponsored research through a subrecipient (e.g., subcontractors or consortium members), the University as the awardee Institution will take reasonable steps to ensure that any subrecipient Investigator complies with this policy:
Tufts will incorporate as part of a written agreement with the subrecipient, terms that certify the subrecipient has a financial conflicts of interest policy that meets the PHS (or other federal sponsors such as NSF) requirements for disclosure and reporting of FCOI. If not, the subrecipient should follow Tufts Financial Conflict of Interest Policy. Such assurance enables Tufts to comply with the sponsors requirements. Subrecipient will report to Tufts all significant financial conflict of interest as defined by the federal sponsor and will provide assurance that the interest has been managed, reduced or eliminated in accordance with the sponsor requirements.
FOR PHS/NIH FUNDED PROJECTS ONLY (Under the regulation, Tufts does not have the authority to apply the following requirements to non-PHS federally funded projects.). As part of a written agreement:
- Requiring a Non-Tufts Investigator Financial Disclosure Form to be filled out at the proposal stage, which will provide certification that the potential subrecipient has a FCOI policy in place that meets the PHS requirements. Alternatively, this requirement can be met by checking the Federal Demonstration Partnership’s (FDP) Institutional Clearinghouse website to see whether the subrecipient is listed as being in compliance. If so, then a notation should be made on the internal coordination form when the proposal is submitted.
- If the subrecipient’s Investigators must comply with the subrecipient’s financial conflicts of interest policy, the subrecipient shall certify as part of the agreement that its policy complies with 42 CFR 50 Subpart F. If the subrecipient cannot provide such certification, the agreement shall state that subrecipient Investigators are subject to the financial conflicts of interest policy of Tufts University for disclosing significant financial interests that are directly related to the subrecipient’s work for the University;
- Additionally, if the subrecipient’s Investigators must comply with the subrecipient’s financial conflicts of interest policy, the agreement shall specify time period(s) for the subrecipient to report all identified financial conflicts of interest to the University. Such time period(s) shall be sufficient to enable the University to provide timely FCOI reports, as necessary, to the PHS as required by Tufts’ policy;
- Alternatively, if the subrecipient’s Investigators must comply with the Tufts University’s financial conflicts of interest policy, the agreement referenced above shall specify time period(s) for the subrecipient to submit all Investigator disclosures of significant financial interests to the University. Such time period(s) shall be sufficient to enable the University to comply timely with its review, management, and reporting obligations under Tufts’ policy.
When a person employed by Tufts accepts a position as an officer or a board member of another company or organization, he or she may be taking on a fiduciary duty to act in the best interests of that organization. In situations where that company or organization is doing business with, sponsoring research at, or licensing intellectual property from Tufts, a conflict of interest exists. Such a conflict of interest must be disclosed and either managed or eliminated.
Whenever, in the course of an ongoing sponsored research project, an Investigator who is new to participating in the research project discloses a significant financial interest or an existing Investigator discloses a new significant financial interest to the University, the designated official(s) of the University will, within thirty (30) days:
- review the disclosure of the significant financial interest;
- determine whether it is related to federally-funded research;
- determine whether a financial conflict of interest exists; and, if so,
- implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such financial conflict of interest going forward;
In addition, whenever a financial conflict of interest is not identified or managed in a timely manner including failure by the Investigator to disclose a significant financial interest that is determined by the University to constitute a financial conflict of interest; failure by the University to review or manage such a financial conflict of interest; or failure by the Investigator to comply with a financial conflict of interest management plan, the University will, within 120 days of its determination of noncompliance, complete a retrospective review of the Investigator’s activities and the sponsored research project to determine whether any research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research.
The University is required to document the retrospective review; such documentation shall include, but not necessarily be limited to, all of the following key elements:
- Project number;
- Project title;
- PD/PI or contact PD/PI if a multiple PD/PI model is used;
- Name of the Investigator with the FCOI;
- Name of the entity with which the Investigator has a financial conflict of interest;
- Reason(s) for the retrospective review;
- Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed);
- Findings of the review; and
- Conclusions of the review.
Whenever Tufts identifies a significant financial interest that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed by the University during an ongoing sponsored research project (e.g., was not timely reviewed or reported by a subrecipient), the designated official(s) shall, within sixty days:
- review the significant financial interest;
- determine whether it is related to federally-funded research; determine whether a financial conflict of interest exists; and, if so:
- Implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such financial conflict of interest going forward;
- In addition, whenever a financial conflict of interest is not identified or managed in a timely manner including failure by the Investigator to disclose a significant financial interest that is determined by the University to constitute a financial conflict of interest; failure by the University to review or manage such a financial conflict of interest; or failure by the Investigator to comply with a financial conflict of interest management plan, the University will, within 120 days of its determination of noncompliance, complete a retrospective review of the Investigator’s activities and the sponsored research project to determine whether any research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research.
The University has established adequate enforcement mechanisms and provides for employee sanctions or other administrative actions to ensure Investigator compliance as appropriate.
Failure to disclose the existence of a financial conflict of interest can result in disciplinary action or sanctions at the institutional level and involve restitution, criminal prosecution, or corrective action by the funding agency or the University. Allowing a conflict of interest to influence one’s judgment in the context of research may also constitute or lead to scientific misconduct, which may result in disciplinary action under the University Policy on Misconduct in Research.
In the event that an Investigator’ failure to comply with this policy or a financial conflict of interest management plan appears to have biased the design, conduct, or reporting of the sponsored research, Tufts will promptly notify the sponsor of the corrective action taken or to be taken. The sponsor will consider the situation and, as necessary, take appropriate action, or refer the matter back to Tufts for further action, which may include directions on how to maintain appropriate objectivity in the funded research project. The sponsor may for example, require employing such an Investigator to enforce any applicable corrective actions prior to an award or when the transfer of a grant(s) involves such an Investigator.
For Federal Sponsors
The federal sponsor may inquire at any time before, during, or after award into any Investigator disclosure of financial interests and the University’s review (including any retrospective review) of, and response to, such disclosure, regardless of whether the disclosure resulted in the determination of a financial conflict of interest. Tufts will submit, or permit on site review of, all records pertinent to compliance with the regulation. To the extent permitted by law, the federal sponsor will maintain the confidentiality of all records of financial interests. On the basis of its review of records or other information that may be available, the federal awarding component may decide that a particular financial conflict of interest will bias the objectivity of the federally-funded research to such an extent that further corrective action is needed or that the University has not managed the financial conflict of interest in accordance with this policy. The federal sponsor may determine that imposition of special award conditions under 45 CFR 74.14 and 92.12, or suspension of funding or other enforcement action under 45 CFR 74.62 and 92.43, is necessary until the matter is resolved.
In any case in which the federal sponsor determines that a federally-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a financial conflict of interest that was not managed or reported by the University as required by the US Code of Federal Regulations, the University shall require the Investigator involved to disclose the financial conflict of interest in each public presentation of the results of the research and to request an addendum to previously published presentations.