Conflict of Interest Policy (revised: 2/8/07)

In the context of doing research, the primary interest of a researcher should be the objective conduct of the research. Coupled with this, the researcher, the University, and the public share an interest in the complete, objective and timely communication of research results. While the University expects that all of its faculty and other research staff should carry out their professional responsibilities with the highest standards of personal integrity, it is necessary to acknowledge and to avoid or manage situations where a secondary interest could reasonably be expected by others to influence decision-making.

To say that one has a conflict of interest does not necessarily mean that the individual involved acted or is expected to act inappropriately. It is the existence of the competing interests that creates the initial conflict of interest concern.

Conflict of interest can be defined as a situation in which an individual's external interests undermine, appear to undermine, or have the potential to undermine the investigator's ability to perform his or her ethical, legal, or professional duties. The potential for personal gain or the existence of competing interests must not jeopardize or appear to jeopardize the integrity of the research, its design, or the interpretation or reporting of research results.

The University Policy on Conflict of Interest in Research requires the disclosure of financial interests or associations with other organizations that could affect, appear to affect, or be affected by the conduct of research.

This Policy applies to all Tufts faculty members and other individuals -- such as medical staff, researchers, students, postdoctoral fellows and visiting researchers -- who are responsible for the design, conduct or reporting of research at Tufts. "Investigator" in this Policy refers to such faculty members and other individuals. This Policy also applies to any individual at Tufts who is responsible for educational activities funded or proposed for funding by the National Science Foundation, the National Institutes of Health, or other external funding agencies.

Conflict of Commitment
A conflict of commitment occurs when the commitment to an individual's external activities may adversely affect his or her capacity to meet University responsibilities. This form of conflict involves a perceptible reduction of the individual's time and energy devoted to University activities. The University recognizes, however, that the contributions and activities of an individual to the University may extend beyond the work done directly for the University. The University also understands the desire of an individual, within the constraints set forth below, to earn and accept outside income for activities that do not create a conflict of interest. Under University policy, a full-time faculty member may spend up to one day in a calendar week (20% of his or her full-time weekly effort) on consulting or other external activities, subject to individual School policies on outside activities. No individual, including faculty members and other employees, may accept salaried employment at another institution while employed full-time by the University. Part-time faculty and staff may not engage in consulting or other external activities during the time they have committed to the University.

It is important to recognize that each individual's obligations move beyond the letter of these requirements to their spirit. The University requires that its faculty meet their teaching, administrative and clinical obligations, and remain productively involved in their research and other scholarly pursuits. External activities that compromise or diminish an individual's capacity to meet these obligations represent a conflict of commitment, regardless of how much time an individual devotes to these activities.

Categories of Conflict of Interest
Because the appropriate approach to each situation depends on its specific facts, this Policy does not contain an exhaustive list of fixed rules regarding conflicts of interest. For example, several external interests taken together, any one of which might be permitted, could amount to a conflict of interest. Further, individuals who seek funding from or who work on a project funded by an external sponsor must comply not only with this Policy but also with that sponsor's requirements, if any, related to disclosure, management, and avoidance of conflicts of interest.

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 Vice Provost for Research or her designee(s).

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.

Reportable Activities
Activities of the types described in the following examples must be disclosed, and in some circumstances may 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 hers, provided that the individual discloses 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 she 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. In addition, with each application for funding (and with each submission of a protocol for human subject research to the IRB), each Investigator involved in the research must complete and submit a 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 disclosure forms as required by this Policy.

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.

Review and Management of Conflicts of Interest
Before they are submitted to the Office of the Vice Provost (OVP), disclosure forms must be reviewed and signed by the appropriate department chairperson. If the department chairperson is directly involved in the research, the dean must review and sign the disclosure form. Disclosure forms that indicate a potential conflict of interest may be forwarded by the OVP to the appropriate dean. The dean may require that the conflict be eliminated, may decline to allow the research to take place, or may recommend a management plan to the Tufts University Committee on Conflicts of Interest in Research (CCIR). If the dean decides to permit the research to take place, a plan for management or elimination of any conflicts shall be submitted to the CCIR. The CCIR will review the plan and make a recommendation to the Vice Provost who will make a decision on behalf of the University as to whether or not any conflict of interest can be appropriately managed or eliminated. The Vice Provost may report the existence of the conflict to funding agencies. Decisions of the Vice Provost for Research 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.

In instances whereby 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.

The OVP will retain records of all financial disclosures and all actions taken by the University with respect to conflicts of interest for at least three years from the date of submission of the final expenditures report.

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.

In some instances, the University may decide to allow the research to proceed, in spite of a conflict of interest, with disclosure and oversight. In other cases, the University may develop a formal management plan to deal with the situation. In cases where the University determines that it cannot manage the conflict, it may require that the conflict 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.

The CCIR shall be comprised of one faculty member from each school, the director of research administration, the director of technology transfer and one person who is not otherwise affiliated with the University. Faculty members will be appointed by their deans to three-year terms. Initial faculty appointments will be for one, two or three years so that terms will be staggered, with one third of the committee membership rotating each year.

In situations, such as investment funds, where the holder's equity is managed by someone else without the holder knowing or being able to ascertain or influence the identity of companies in the portfolio at any given time, no disclosure is required.

Publication
The University will require 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.

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 dean is required. The financial interest must be disclosed to both the dean and the student prior to beginning the research project. If the dean approves of the involvement of the trainee in that research and the trainee is a graduate student, the dean will inform the student's thesis committee and will ask that annual reports from the thesis committee concerning the impact of the conflict on the student be submitted to the CCIR. If the individual is a fellow or a student who does not have a thesis committee, the dean will appoint a committee of three faculty members to oversee the situation and make annual reports to the CCIR. It will be the responsibility of the school representative to the CCIR to meet periodically with students who are sponsored by corporate funds to assure that the committee process is working and to resolve any problems that arise.

Human Subjects
In situations where research could involve risk to human subjects, the protection of those subjects must be of paramount concern. Investigators must submit a conflict of interest disclosure form with each protocol for human subject research that is submitted to the IRB. 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" above. IRB approval will not be granted until the conflict of interest oversight or management plan has been set up and approved by the 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.

Human research subjects should be fully informed of research risks before they consent 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.

Special Considerations for Faculty Start-up Companies
In situations where a faculty member obtains 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 their deans. Normally, a special conflict of interest oversight committee will be convened and will 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 will 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.

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.

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 here.

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.