Guidance on Institutional Conflict of Interest – Human Subjects Research

The University of Pennsylvania, inclusive of the University of Pennsylvania Health System, recognizes the critical importance of close evaluation and management of Financial Conflicts of Interest (FCOI), both individual and institutional, related to human subjects research, in order to ensure ethical research conduct, data integrity and analysis, resource utilization, as well as patient safety and public confidence in the research results.

For purposes of these principles, an Institutional Financial Conflict of Interest (ICOI) related to human subjects research may occur whenever the financial or other interests of the institution, or of an institutional official, might affect—or reasonably appear to affect—institutional processes for the design, conduct, reporting, review, or oversight of the human subjects research.

Potential sources of ICOI include:

  • Gifts1 (or other significant funds not directed to fund identified research) to the University from a potential research sponsor, from a company with products being tested, or from an individual
  • Payments related to University owned intellectual property
  • Financial or other relevant interests of institutional officials who have authority to affect processes in human subjects research

Procedures are in place to identify potential sources of ICOI arising from gifts, payments and the financial interests of institutional officials.  Potential ICOI matters may be referred to the Vice Provost for Research (VPR) by any individual or office. The VPR determines whether the matter may be handled administratively or if it warrants review by the Human Research Advisory Committee (HRAC). Administrative review is appropriate when there is a low risk of impaired objectivity or where there is established precedent for action.2 If it is determined that the ICOI is not manageable, the research will not be conducted at Penn.

Financial conflicts of interest not related to research (e.g., non-research related procurement or medical formulary composition), and non-financial conflicts (e.g., conflict of commitment) are covered in other University, School and/or Health System policies.

For further information:

1 If other types of funds become institutional conflicts, they will be managed in accordance with the procedures implemented under this guidance.
2 See, “Procedures for Identifying, Reviewing and Managing Institutional Financial Conflict of Interest Related to Human Subjects Research.”