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Financial Conflict of Interest Policy

 

Summary

This policy describes the University’s commitment to manage conflicts of interest in sponsored projects supporting research, scholarly and creative activities, where the sponsor may be any external sponsor or the University itself. This policy supplements the University’s General Policy on Conflicts of Interest.

Context

The mission of Drexel University (the “University”) is to promote public good by creating, sharing and applying knowledge in the public interest. This mission is accomplished in many ways, including but not limited to, conducting inquiry-based and use-inspired research and engaging in creative and scholarly activities.

The University, which includes its faculty, staff and administrators, incentivizes its community members to participate in research, creative and scholarly projects via progressive policies that, for example, encourage and reward research and scholarship in tenure and promotion policies, reward translational research activities through royalty revenue sharing, and allow time away from the campus for consulting.

It is widely recognized, however, that these policies create the possibility that an individual's actions or decisions made in the course of conducting or supporting research, creative and scholarly activities might be motivated by considerations of professional, reputational or financial gain that may conflict with either the University’s mission to promote knowledge creation and sharing in the public interest or with the University’s commitment to conduct research, creative, and scholarly activities to the highest ethical standards.

Thus, the University community has adopted the Policy on Managing Conflicts of Interest in Sponsored Projects (“Policy”) to identify and manage such conflicts of interests effectively.

Definitions

For the purposes of this Policy, the following definitions apply.

Sponsored Projects are projects that support research, creative, and scholarly activities funded by sponsors whose funds are administered by the University, or are projects that support research involving humans or animals as research subjects regardless of the source of sponsor support.

University Personnel include all individuals engaged in sponsored projects, and all individuals responsible for overseeing or managing sponsored projects at the University, with the exception of students and post-doctoral fellows and scholars unless they contribute to the development or execution of a sponsored project. University Personnel may include members of the Board of Trustees; all University officers; senior (“cabinet-level”) officials of the University and any other individual that the President designates; all University faculty, staff, and administrators; IRB chairs and members overseeing sponsored project protocols; IACUC chairs and members; emeritus faculty; and members of the Outside Interest Committee. “University faculty” are those individuals defined as University faculty in the Faculty Handbook.

Conflicts of Interest in Sponsored Projects are defined in two major categories.

An Individual Conflict of Interest in a Sponsored Project occurs when a person engaged in the project has a professional or financial interest that might adversely affect, or appear to a reasonable person to adversely affect, the University’s responsibility to the public, to the safety of human subjects participating in the sponsored project, to the sponsor, or to the integrity of research, creative, and scholarly activities.

Some, but by no means all, examples of situations that may create an individual conflict of interest in a sponsored project include:

  • Serving as an investigator on a sponsored project that is either sponsored by a company or related to the company’s products where the investigator is receiving royalties, consulting fees, or has equity (or stock options or a future “inventor’s share”) in the same company.
  • Ghostwriting or having an investigator’s name attached to a paper written by another individual consulting for or directly employed by industry, including papers featuring research data that were simply presented to the individual without the opportunity to analyze directly, perform calculations, review and/or question the research data.
  • A faculty member acting as a thesis or dissertation advisor to a graduate student in a sponsored project where the research outcomes generated are likely to substantially enhance the value of a company in which the faculty member has a significant ownership interest.
  • A faculty member requiring students currently enrolled in his or her class to participate as a human subject in his or her or another faculty member’s sponsored project.
  • Issuing a University subcontract for work to an outside entity in which the investigator on the sponsored project has a financial interest.
  • Receiving project support for human subjects research from a private sector organization without a contract, or for more than the reasonable costs of conducting the sponsored project.
  • Receiving personal payments conditioned upon a particular sponsored project result or tied to successful project outcome.
  • While serving on a board of directors, participating in sponsored projects involving human subjects on a technology owned by or obligated to the business.

An Institutional Conflict of Interest in a Sponsored Project arises when the reputational or financial interests of the University, or a University official acting within his/her authority on behalf of the University, may influence or appear to influence processes for the conduct, review, or oversight of the sponsored project, possibly affecting the University’s responsibility to the public, to the safety of human subjects participating in the sponsored project, to the sponsor, or to the integrity of research, creative, and scholarly activities.  Examples of activities in which an institutional conflict of interest may arise include:

  • Situations in which the University has an equity stake in an organization seeking to support a sponsored project.
  • Situations in which the University, its President, or members of the Board of Trustees have a considerable financial stake in the outcome of a sponsored project.

Policy Statement

The University is committed to managing Conflicts of Interests in Sponsored Projects in ways that hold the University’s mission first and foremost, and in ways that ensure that the conduct of research, creative, and scholarly activities undertaken on the University’s behalf is of the highest ethical standards.

The Policy requires that University Personnel make financial interest disclosures at the time a proposal for sponsored project support is developed for submission to a sponsor, or at the time a sponsored project involving human or animal subjects is designed for implementation. Furthermore,University Personnel engaged in or responsible for overseeing sponsored  projects are required to make ad-hoc conflict of interest disclosures at the time they arise during the period in which a sponsored project is active.  Following disclosure, if a bona fide conflict of interest is determined to exist, a management plan will be developed to manage the conflict. University Personnel must comply with the management strategies developed to manage or mitigate conflicts of interest in sponsored projects.

Finally, University Personnel engaged in or managing sponsored projects are required to take conflicts of interest training prior to engaging in research and at least once every four years, and immediately when any of the following circumstances apply: the University revises this Policy and related procedures in ways that affect the requirements of University Personnel or that the University finds an individual is not in compliance with this Policy. This Policy applies regardless of where the sponsored project activities are conducted.

Policy Implementation

The Senior Associate Vice Provost for Research Administration administers this policy, ensuring it remains consistent with federal regulations. The Senior Associate Vice Provost for Research Administration has primary responsibility for overseeing the process for managing conflicts of interest in sponsored projects. Details can be found within the Policy Implementation document.

Effective Date

This Policy on Managing Conflicts of Interest in Sponsored Projects shall be effective August 24, 2012.