Conflict of Interest Policy

The following examples are intended to illustrate principles that underlie the Policy. Some of the activities in these examples may also represent conflicts of commitment. Individuals who have questions about how this Policy applies to a particular activity should seek advice from the Office of the Vice Provost, Paul Murphy, JD, Director, Research Administration at (617) 363-3819.

Activities Not Ordinarily Reportable
Except as otherwise indicated in this Policy, activities of the following types generally need not be disclosed:

• An individual receives royalties for published scholarly works and other writings.
  
• An individual accepts customary honoraria for commissioned papers and occasional lectures
  
• An individual receives payments under the University's intellectual property policy.
  
• In situations, such as investment funds, where the holder's equity is managed by someone else without the holder knowing or being able to influence the identity of companies in the portfolio at any given time, no disclosure is required.

Reportable Activities
Activities of the types described in the following examples must be disclosed, and in most circumstances will be subject to oversight as a potential conflict of interest:

• An individual participates in clinical research on a technology that was developed by the individual or his or her spouse or dependent child, but which is owned by or licensed to a business in which neither the individual, nor the spouse or dependent child, has a consulting relationship, a management position or a significant financial interest.

• An individual or his or her spouse or dependent child serves on the board of directors or scientific advisory board of a business from which the individual receives sponsored research support or with which Tufts has a contractual relationship known to the individual.

• An individual publishes the results of research which could have an impact on a significant financial interest of his or hers, provided that the individual discloses his or her significant financial interest in the publication.

The following examples represent types of activities presumed to constitute major conflicts of interest. Such activities must be disclosed, are not permitted without express authorization of the University, and usually will be prohibited, or permitted only with continuing oversight:

• An individual receives sponsored research support (whether in dollars or in kind) for research from a business in which he or she or his or her spouse or dependent child holds a significant financial interest (equity interest exceeding $10,000 in value and/or representing more than 5% ownership).

• An individual participates in clinical research on a technology owned by or licensed to a business in which the individual, or his/her spouse or dependent child, has a significant financial interest.

• An individual makes patient referrals to a diagnostic company in which he or she or his or her spouse or dependent child has a significant financial interest.

• An individual directs the purchase of supplies for Tufts to a business in which he or she or his or her spouse or dependent child has a significant financial interest.

• An individual conducts research externally that could be conducted within the University.

• An individual assigns a student, fellow or other trainee to a project in which the individual has a significant financial interest.

• An individual assumes an executive position in an outside entity engaged in commercial or research activities related to the individual's field.
  

Disclosing Conflicts of Interest

At any time that an individual has a potential conflict of interest related to his or her research he or she must disclose it to the Office of the Vice Provost (see contact information). 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 must complete and submit a Financial 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 disclosure forms as required by this Policy.

Before the disclosure forms are submitted to the Office of Research Administration (ORA), Office of the Vice Provost (OVP), 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 OVP. In the event the Investigator indicates 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, Research Administration, who is also the Chair of Tufts University Committee on Conflicts of Interest in Research (CCIR).

In addition to the need to disclose conflicts of interest to the University and to funding agencies, 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.

Those required to disclose financial interests
Under the regulation through its implementation by Tufts, Investigators are required to disclose to the Office of the Vice Provost, a listing of Significant Financial Interests (and those of his/her spouse and dependent children) that (1) would reasonably appear to be affected by the research for which NIH, NSF, or other external funding is sought, and (2) in entities whose financial interests would reasonably appear to be affected by the research.

An “Investigator” for this purpose
An “Investigator” is defined as the Principal Investigator and any other person who is responsible for the design, conduct, or reporting of research funded by the NIH, NSF, or other external funding agency, or proposed for such funding, including subgrantees, contractors, or collaborators. The definition of Investigator’s financial interests includes the interests of the Investigator’s spouse and dependent children.

Regulations apply to subgrantees, collaborators of grantees (e.g. consortia) or subcontractors
The regulation is applicable to each Institution that applies for NIH grants or cooperative agreements for research or submits a proposal for a research contract whether in response to a solicitation or otherwise and, through the implementation of the regulation by each Institution, to each Investigator participating in such research. Accordingly, Institutions carrying out NIH-funded research through subrecipients (e.g., contractors, collaborators) or subcontractors must take reasonable steps to ensure that Investigators working for such entities comply with the regulation, either by requiring the Investigators to comply with the prime-recipient/awardee Institution's policy or by requiring the entities to provide appropriate assurances to the prime-recipient/awardee Institution. Subrecipients/subcontractors must report identified FCOIs to the prime-recipient/awardee Institution; that Institution must report to the NIH the existence of any conflicting interests arising from subrecipients/subcontractors and assure that the interest has been managed, reduced, or eliminated in accordance with the regulation. These terms are included in all subcontracts where Tufts is the prime-recipient from a federal source and issues a contract to the subrecipient.

Affiliations
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.

Review and Management of Conflicts of Interest

Review

Investigators submit a Financial Interest Disclosure Form with each proposal submitted for funding. Once the forms are received by the Office of Research Administration, they are reviewed by the pertinent Associate Director, Research Administration. If there is an indication on the form that a COI is being disclosed, the forms are forwarded to the Director, Research Administration/Chair of the CCIR for review.

In instances where the disclosed financial interest is minimal (less than $10,000 per year and less than 5% equity ownership) and/or only requires a straight-forward and modest plan to reduce, eliminate or manage the potential conflict, the Chair of the CCIR may elect to conduct an expedited review and approval. These actions are reported to the entire CCIR on a quarterly basis by the Chair so that all disclosures are shared with the membership of the committee.

Where there are questions or the COI is not determined to be minimal, the CCIR Chair will contact the PI and Department Chair in order to review the COI. The CCIR Chair and Department chair will prepare an information packet for the Dean’s review.

The information packet will be reviewed by the Dean of the involved school. Based on the information provided by the CCIR Chair, the Dean may require the conflict be eliminated, may decline to allow the research to take place, or may recommend a management plan.

If the Dean recommends that the research proceed, a plan for management or elimination of any conflicts shall be prepared by the Dean in collaboration with the CCIR Chair. The plan recommended by the Dean and the review packet are then sent to the CCIR for review and recommendation. The CCIR’s comments and disposition are sent to the Vice Provost who will make the final decision on behalf of the University as to whether or not any conflict of interest can be appropriately managed or eliminated.

In cases where the University determines that it cannot manage the conflict, it may require that the conflicted be eliminated or that the research not proceed. Factors in this decision might include such considerations as the involvement of human subjects in the research, the level of risk involved, the nature and significance of the conflict, the potential for having a serious adverse impact on the scientific field or on the reputation of the University, and the level of difficulty involved in managing the conflict relative to the benefit of doing the research.

Decisions of the Vice Provost may be appealed to the Provost, whose decision on these matters will be final. Deans must submit their own disclosure forms to the OVP, which may, if there is a potential conflict, forward them to the CCIR. The Vice Provost may report the existence of the conflict to funding agencies.

An approved plan for management or elimination of the conflict of interest must be in place before the research begins. Federal grant applications may be submitted while the University is considering a possible conflict of interest with the understanding that the University will not accept the funds unless the conflict can be managed or eliminated. Agreements with non-federal research sponsors will not be signed until completion of the CCIR's review unless the agreement can be made contingent on the University's ability to resolve the conflict of interest concerns.

Managing Conflicts

The regulations require the designated official, at Tufts, the Director of Research Administration, to review all financial disclosures made and to follow the process described above by making a determination with respect to managing, reducing, or eliminating any conflict identified. The PHS regulations specifically state "a conflict of interest exists when the designated official(s) reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the funded research." The following are examples of conditions or restrictions that can be put into place to either manage or eliminate conflict:

• Public disclosures of significant financial interest;
• Monitoring of research by independent reviewers;
• Disqualification from participation in all or a portion of the research funded by the agency;
• Divestiture of significant financial interests; or
• Severance of relationships that create actual or potential 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.

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.

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Tufts' Requirement to Report to the NIH

At the time of the application/proposal submission: Tufts must certify that it has a 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 from the NIH and other federal and non-federal sponsors. By the time an application/proposal submission is submitted to the NIH, each Investigator who is planning to participate in the research must have submitted to Tufts Office of Research Administration, a listing of her/her known Significant Financial Interests (and those of his/her spouse and dependent children) (1) that would reasonably appear to be affected by the research for which funding is sought from the sponsor; and (2) in entities whose financial interests would reasonably appear to be affected by the research need to be disclosed.

Prior to spending any funds under an award: Prior to spending any funds under an award, Tufts must report to the NIH the existence of a conflicting financial interests that is reasonably determined to be a COI that is significant to the point that it could directly and significantly affect the design, conduct and reporting of the funded research. In these cases, Tufts will ensure the interest has been managed, reduced, or eliminated in accordance with the regulation. The regulation does not require Tufts to report to NIH officials the nature or other details of a reported FCOI; however, Tufts is required to make information available, upon request, to the NIH regarding all Financial Conflicts of Interest (FCOI) identified by Tufts and how those interests have been managed, reduced, or eliminated to protect the research from bias.

Subsequent to the initial report: For any interest that Tufts identifies as conflicting subsequent to the Institution's initial report under the award, a report should be made and the conflicting interest managed, reduced, or eliminated, at least on an interim basis, within sixty (60) days of that identification.

Disclosures deemed minimal: Such disclosures are reported to the entire CCIR on a quarterly basis by the CCIR Chair so that all disclosures are shared with the membership of the committee.

NIH Reporting of a financial conflict of interest: Until June 30, 2009, FCOI reports are sent to the appropriate Chief Grants Management Officer (http://grants.nih.gov/grants/stafflist_gmos.htm) of the NIH funding Institute/Center. For contracts, reports should be sent to the appropriate Director, Office of Acquisitions. (http://oamp.od.nih.gov/AcquisitionOffices/chief_cos1.asp). Beginning July 1, 2009, the NIH will require all FCOI reports for grants and cooperative agreements to be submitted using the new electronic Research Administration (eRA) Commons FCOI Module. NIH encourages Institutions to begin using the FCOI Module now; however, Institutions may continue to submit FCOI reports directly to the Chief Grants Management Officer of the NIH awarding component through June 30, 2009.

The University’s report will include the following information:

• Grant or Contract number, as appropriate;
  
• Principal Investigator (PI) or contact PI if the grant/contract is awarded under the multiple PI model;
  
• Name of the Investigator (if different from the PI) with the FCOI; and
  
• Description of which method was used to protect the involved NIH-funded research from bias (e.g., managed, reduced, or eliminated).

The NIH or other federal agency may at any time inquire into the University’s procedures and actions regarding conflicting financial interests in research funded by the NIH, including a requirement for submission, or review on site, of all records pertinent to compliance with the regulation.

Additionally, a federal agency may decide that a particular conflict of interest will bias the objectivity of the research it funds to such an extent that further corrective action is needed or that the Institution has not managed, reduced, or eliminated the conflict of interest in accordance with the regulation. The federal agency may determine that suspension of funding is necessary until the matter is resolved.

Failure to Disclose a Conflict of Interest
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.

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CCIR Membership

The CCIR is comprised of one faculty member from each school, the Director of Research Administration, the Director of Technology Transfer and Licensing and one person who is not otherwise affiliated with the University. Faculty members are appointed by their deans, normally to three-year terms. The Vice Provost has the discretion to allow a member to serve for a shorter or longer term.

The CCIR Chair submits a quarterly report to the CCIR detailing the actions taken during the quarter. Additionally, the CCIR Chair will bring to the attention any items requiring the CCIR’s review and actionable recommendations.

In the event the CCIR requires a meeting, it can be accomplished by means of being physically present or on a teleconference. A quorum is 51% of the committee.

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Record Retention

The OVP will retain records of all financial disclosures and all actions taken by the University with respect to conflicts of interest.

The University is required to keep all records as follows:

• For grants or cooperative agreements – for at least three years from the date of submission of the final expenditures report or, where applicable, from other dates specified in 45 C.F.R. 74.53(b) for different situations

• For research contracts – for three years after final payment or, where applicable, for the other time periods specified in 48 CFR part 4, subpart 4.7.

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Publication

The University requires in all its contracts for support of research or education that the researchers be free to objectively analyze and publish all results of their work. The University may accept reasonable delays on publication (normally not to exceed 90 days) that allow for the protection of intellectual property, the deletion of confidential information provided by a research sponsor or for the completion of a multi-site clinical trial.

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Students/Trainees

An important part of the training of graduate students and postdoctoral fellows is mentored research. The University and the faculty who oversee student research must insure that the educational interests of these trainees are not compromised by institutional or individual conflicts of interest. Care must be taken to insure that the source of research funding does not cause a change in the training experience. Students and fellows should not be placed in a situation where publication will be unduly restricted or excessively delayed (any delay greater than 90 days will be considered excessive) or where the financial interests of the company or the mentor will influence the direction of the research project. Students must be able to publicly present dissertations and theses and to publish their research.

In a situation where a student is to work on a corporate sponsored research project in which his or her advisor has a financial interest, prior approval from the student's Department Chair is required. The financial interest must be disclosed to both the Chair and the student prior to beginning the research project. If the Chair approves of the involvement of the trainee in that research and the trainee is a graduate student, the Chair will inform the student's thesis committee. If the individual is a fellow or a student who does not have a thesis committee, the Chair will work with the CCIR in developing a management plan that will ensure the PI informs, in writing, students and postdoctoral trainees funded from this source about the conflict of interest, and in doing so inform the trainees that should they have concerns, they should contact their Dept Chair or the Director of the graduate program in which they are enrolled.

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Human Subjects

In situations where research could involve risk to human subjects, the protection of those subjects must be of paramount concern. With each protocol involving human subject research each Investigator must submit to the IRB a conflict of interest disclosure. Forms that indicate a possible conflict of interest will be forwarded by the IRB to the Office of the Vice Provost and will be subject to the review and management procedure described under "Review and Management of Conflicts of Interest" above. IRB approval will not be granted until the conflict of interest oversight or management plan has been set up and approved by the pertinent Dean, the CCIR, and the Vice Provost. The University may prohibit research that involves a conflict of interest even if the IRB approves the research.

In accordance with federal regulations governing human subject research, a study participant is to be fully informed of research related risks before he or she consents to participate in the research. Informed consent forms and procedures should include the disclosure of any conflict of interest that could reasonably appear to influence an investigator's judgment in conducting the research.

Additionally, no IRB may have a member participate in the IRB’s initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB (45 CFR 46.107(e)).

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Special Considerations for Faculty Start-up Companies

In situations where a faculty member obtains or owns equity in a company that relates to his or her research, it is especially important to be mindful of conflicts of interest and conflicts of commitment. Care should be taken to keep sight of what is the property of the University versus what belongs to the company. The faculty member should assure that time invested in the company does not exceed the amount of time allowed for outside activities under the conflict of commitment policy and does not compromise his or her ability to perform his or her regular duties and obligations to the University, to funding agencies or to students. University facilities and resources may not be used for the benefit of the company without a written agreement authorizing the use approved by the dean and the vice provost.

Faculty members and staff who own equity in a company should not personally negotiate or attempt to influence the licensing terms that the University offers to that company. An attorney or executive of the company with no connection to the University should be used for that purpose. The needs and interests of students and fellows must be carefully considered. The Office of the Vice Provost will work closely with faculty members who are starting companies and the faculty members’ deans. Normally, a special conflict of interest oversight committee may be convened and meet at least annually as long as the faculty member remains involved with the company. This committee will be a subcommittee of the CCIR and should consist of one member of the CCIR and two individuals who are familiar with the area of research. The subcommittee will report annually to the CCIR. Alternatively, in lieu of the subcommittee, the CCIR Chair can work with the Investigator and submit the plan to the CCIR committee for review. Once the plan is approved and in place, the Chair may ensure annual reports are conducted and submitted to the CCIR.

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Use of the University's Name and Resources

The University's name, facilities, and equipment are to be used solely for furtherance of University goals and not for the benefit of, or to imply the University's support of, non-University activities. Employees, including faculty and research staff, may not use University resources, including facilities, equipment or confidential information, for non-University purposes. The University may grant permission to a member of the faculty or research staff to use University facilities in pursuit of outside activities or interests, but will usually do so only where there is evidence that the work of the employee will be of significant benefit to the University. Confidential information acquired through conduct of University business or research activities may not be used for personal gain, and unauthorized access to such information may not be granted. Unless specifically authorized by the University, an individual may not use the name of the University or its letterhead in sponsoring or recommending any commercial service or product, regardless of whether the individual has any interest in the promotion, or in connection with an outside organization unless the individual's participation in the organization is at the request of the University or part of the individual's normal University duties. More detailed information on the use of the Tufts University name and registered trademarks can be found in a separate University Policy on Name Use.

Conflict of Interest Websites:

• NIH
  http://grants.nih.gov/grants/policy/coi

• FAQ
  http://grants.nih.gov/grants/policy/coifaq.htm

• NIH COI Tutorial
  http://grants.nih.gov/grants/policy/coi/index.htm