Revised: April 2013
As an institution dedicated to excellence in research and education, Tufts University (the University) places a high value on research integrity and academic freedom. Objectivity in the conduct of research, the freedom to disseminate ideas through publication of research results, the protection of the rights and interests of research subjects, maintenance of public trust, and the ability to insure that our responsibility to our students and trainees is not compromised are critical to these institutional values. Relationships with industry and other outside entities, while important to the support and advancement of research, can present special challenges in protecting these institutional values.
In the context of conducting 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 investigator’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 for grants and proposals requires the disclosure of financial interests or associations with other organizations including reimbursed or sponsored travel that could directly and significantly affect the design, conduct, or reporting of the funded research.
The policy is organized into six major sections. The sections are the Preamble, Disclosure, Review, Management, and Reporting of Financial Conflicts of Interest and Other Policy Considerations.
- The Preamble
The Preamble provides the institutional official’s contact information and lays out the authority, applicability and purpose for promoting objectivity in research. Definitions are listed to clarify the meanings of conflict of interest terms and provide examples of reportable activities.
- Disclosing Significant Financial Interests (SFI) and Conflict of Interests
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.
- Review of Conflict of Interests
The third section, explains the review process taken by the Chair of the Committee on Conflicts of Interest in Research (CCIR) when determining whether a disclosure relates to the research and if so whether there is a conflict of interest. It describes the involvement of the department chairs, deans and the Office of the Vice Provost for Research in eliminating, reducing or managing a conflict of interest.
- Management of Financial Conflict of Interests
The section provides examples of when a plan would be imposed and what a plan would entail. It also clarifies the PHS policy on public access to FCOIs that were reported to the PHS.
- Reporting of Financial Conflict of Interests
Reporting FCOIs is specific to PHS sponsors where reporting FCOIs is a federal requirement. This section explains the process and reporting requirements.
- Other Policy Considerations
The last section addresses various items related to the policy. It touches on CCIR Membership, Record Retention, Publication, Students/Trainees, Human Subjects, and Special Considerations for Faculty Start-up Companies.
Summary of Changes
The following is a summary of the changes in the new Financial Conflict of Interest (FCOI) policy. This policy is based on the new Public Health Service (PHS) rule, which includes the National Institutes of Health (NIH), and will be applied to all projects with a few exceptions for non-federal and non-PHS grants.
These policy changes became effective August 24, 2012.
Significant Financial Interest (SFI) Threshold
Minimum threshold, when aggregated exceeds $5,000 applies to payments and equity interests including any equity interest in non-publicly traded entities. This is a change from the previous threshold of $10,000 or a 5% equity interest in a company.
There are different criteria for making disclosures, it depends on whether the sponsor is federal or non-federal. The major change is for federal sponsors where investigators are required to disclose significant financial interests that are related to their institutional responsibilities vs. being related to the research project. A new disclosure requirement for federal sponsors is disclosing travel that is related to an investigator’s institutional responsibilities. There are exceptions but basically the travel disclosed are those times when an investigator is not reimbursed by an entity because the entity paid for the travel and the value is difficult to determine.
- For non-federal sponsors: 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 research project.
- For federal sponsors: 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. This disclosure requirement does not apply to travel that is reimbursed or sponsored by:
- Federal, state, or local government agency;
- Institution of higher education as defined at 20 U.S.C. 1001(a); and
- Academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.
The details of this disclosure will include, at a minimum:
- dollar amount or value,
- purpose of the trip,
- identity of the sponsor/organizer,
- destination, and
Institutional Responsibilities means an Investigator’s professional responsibilities on behalf of Tufts University. That is, all activities that derive or descend from the investigator’s standing or expertise and are tied to those responsibilities and activities the investigator was hired to perform and for which the investigator is paid by the University.
Some examples are, research, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.
Previously, institutional responsibilities did not require a definition, but under the new rule, it is defined because SFIs are disclosed on how they are related to the investigator’s institutional responsibilities.
Special PHS Reporting Requirements to the awarding component such as NIH and possibly to other federal agencies. If a determination is made where there is a FCOI and it could directly and significantly affect the design, conduct, or reporting of the sponsored research, then the following will be reported to the PHS awarding component and in the event of another federal sponsor, then possibly to them.
- Name of PD/PI
- Name of Investigator if different
- Grant Number
- Name of the entity with which the Investigator has a FCOI
- Value of the financial interest
- Nature of FCOI, e.g., equity, consulting fees, honoraria
- A description of how the financial interest relates to PHS-funded research and the basis for the Institution’s determination that the financial interest conflicts with such research
- Key elements of the Institution’s management plan
The major change here is the amount of information to be reported.
Public Accessibility for PHS funded projects only. Before spending funds for PHS-supported research, an Institution shall ensure public accessibility of information on certain SFIs that the Institution has determined are related to the PHS-funded research and are FCOI, by a written response to any requestor within 5 days of the request. This is a new requirement.
Investigator FCOI Training for federal sponsors only, a new requirement. FCOI training is required for Investigators before engaging in federally-funded research, every four years thereafter, and immediately under designated circumstances. There is a training site set up for investigators at the Collaborative Institutional Training Initiative (CITI) where investigators can take the PHS approved mini-course. Click here for instructions on how to register and take the course.
Once the policy becomes effective, investigators have six months to complete the FCOI training. However, the completion of training is required at the JIT stage of NIH potential awards and before a new federal grant is awarded.
This Policy Applies to Federally Funded Projects with Subrecipients
If an Investigator, through the University, carries out federally-funded research through a subrecipient, 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 requirements for disclosure and reporting of FCOI.
FOR PHS FUNDED ONLY, a new requirement (Under the regulation, Tufts does not have the authority to apply the following requirements to non-PHS federally funded projects.)
Tufts will require a 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, if the potential subrecipient is listed on the Federal Demonstration Project (FDP) Institutional Clearinghouse, then this requirement is met and no disclosure form is required.
If the subrecipient does not have a PHS compliant policy, then they will be subject to Tufts’ policy. In the event of a FCOI, Tufts will be the organization that manages, eliminates or reduces the conflict.
Retrospective Review, a new requirement. 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:
- the University fails to review or manage such a financial conflict of interest, or
- the Investigator fails 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 federally-funded research project to determine whether any federally-funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research.