Overview of Policy on Conflicts of Interest Related to Research

Description

See bottom for definitions of italicized terms.

For several years, the University had two relevant policies pertaining to disclosure, assessment and management of Investigators’ personal financial interests related to research. In 2011, federal regulation mandated significant changes to those policies. The University has recently developed a single uniform policy which not only reflects the new regulatory requirements, but also seeks to integrate and simplify certain aspects of the two previous policies. This unified policy – which supersedes the prior policies – defines the obligations of Investigators in Penn’s research community and governs Investigators’ financial interests / relationships related to their research, regardless of funding source. A summary of key policy provisions follows; however, Investigators engaged in research are responsible for reviewing the complete policy referenced above prior to participating in research at Penn.

Purpose

The purpose of this policy is to set forth the framework for identifying, evaluating, and managing financial conflicts of interest related to University research activities in order to minimize the risk of bias and to maintain integrity, credibility and respect for the work of Penn researchers.

Applicability

This policy is applicable to all research being conducted under the University’s auspices, regardless of whether the research is externally or internally funded.

Disclosure Requirements

Each Investigator must disclose the following Significant financial interests (SFIs) (and those of his/her Family members) that reasonably appear to be related to the Investigator’s Institutional responsibilities:

• For a public Outside organization: remuneration for the 12 months preceding the date of the disclosure plus the value of current equity that when aggregated exceed $5,000
• For a non-publicly traded Outside organization: any equity (regardless of value) and remuneration for the 12 months preceding the date of the disclosure exceeding $5,000
• Income from intellectual property rights not assigned to Penn
• Any Clinical trial intellectual property, whether or not assigned to Penn
• Any Fiduciary Role

Investigators must disclose their SFIs at the time of proposal submission, annually, when added as an Investigator to an ongoing Public Health Service (PHS) or Patient-Centered Outcomes Research Institute (PCORI) project, and prior to participation in any PHS-/PCORI-funded research. Investigators are also required to timely update (within 30 days) their disclosures in the event of acquiring new SFIs or changes in their previously reported SFIs.

Investigators participating in research funded by the PHS or PCORI must also disclose travel reimbursed or paid on the Investigator’s behalf within the most recent 12 months, other than by an Excluded Payer.

A financial interest is related to an Investigator’s Institutional responsibilities if, for example, it arises from extramural activities that derive from the Investigator’s professional standing or are within that Investigator’s expertise in his or her professional field(s) of discipline, such as consulting, serving on a scientific advisory board, providing continuing professional education services, or serving as an expert witness for an Outside organization that, to the best of the Investigator’s knowledge, conducts or seeks to conduct business related to the Investigator’s field of discipline. In addition, equity in, or serving in a fiduciary role for, an Outside organization that, to the best of the Investigator’s knowledge, conducts or seeks to conduct business related to the Investigator’s field of discipline, is related to the Investigator’s Institutional responsibilities.

Assessment of Disclosures

Investigators are directed to submit information regarding Financial Interests to the University’s Office of the Vice Provost for Research (OVPR) using such means of disclosure as prescribed by the OVPR (presently, the Research, Interests, and Activities system, or RIA). For additional information on RIA, please go to

https://portal.research.upenn.edu/conflict-of-interest/

Each School will appoint an FCOI Office / Officer to review SFI disclosures and an Investigator’s assessment of the relationship of the SFIs to the Investigator’s research to determine which SFIs (if any) are related to the research. A determination of relatedness will be made based on the Investigator’s assessment and/or on other facts deemed relevant by the School.

Determination of a Financial Conflict of Interest (FCOI).

A Financial Conflict of Interest (FCOI) is an SFI that could directly and significantly affect the design, conduct, or reporting of the research. The University may utilize several forms of review to reasonably determine whether an SFI related to the research is an FCOI, including review by the Conflict of Interest Standing Committee (CISC), depending on the nature and value of the disclosed financial interests, as well as other factors. 

Management of FCOIs, including FCOIs Involving Clinical Trials. An SFI found to constitute an FCOI may be subject to a management plan as a condition to the Investigator’s participation in the research. The determination of whether an FCOI is manageable, including an FCOI involving a Clinical Trial, should take into account relevant factors, including but not limited to, the uniqueness of the Investigator’s position with respect to the study, the nature and design of the research and the magnitude and nature of the financial interest. With respect to Clinical Trials, other relevant factors include the degree of risk to human subjects, the role of the Investigator in the study, the study’s design, and the degree of the Investigator’s influence upon the recruitment/ enrollment of subjects and/or the results of the study. 

Training

Investigators must receive training from the University related to research-related FCOI prior to engaging in research at the University, and at least every four years thereafter.

Requests from the Public Regarding FCOI Information

To the extent required by law (e.g., PHS regulations) or otherwise by the terms and conditions of a research award, in response to a written request for information related to FCOIs held by senior/key personnel of the particular research project specified in the request, the University will provide required information to the requestor.

Other Policy Provisions

In addition to the foregoing, the FCOI Policy includes other provisions as required by law, research sponsors and/or the University. These include FCOI disclosure and reporting requirements for sub-awards, the reporting of FCOIs to research sponsors (e.g., PHS agencies), as well as provisions to address noncompliance with the FCOI Policy.

Selected Definitions

Clinical trial shall have the same meaning as prescribed from time to time by the World Health Organization.

Clinical trial intellectual property means an Investigator’s interest in intellectual property that is the subject of a copyright, issued patent, or a patent application (regardless of whether the intellectual property has been patented, licensed, or assigned to the University) if such intellectual property is being tested, evaluated, or developed in, or if its commercial value could be affected by, the Clinical trial in which the Investigator is engaged or proposes to engage

Excluded payer means a Federal, state, or local government agency, a United States institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. By way of example, Children’s Hospital of Philadelphia, the Philadelphia Veterans Affairs Medical Center, the Howard Hughes Medical Institute, and Wistar Institute are Excluded payers.

Family member means an Investigator’s spouse or dependent child. From time to time, the Institutional official may amend the definition of Family member and notify the University research community prior to the effective date of such change.

Fiduciary role means membership on the governing board of an entity, including service on its board of directors, or having a position of authority or responsibility to act in the best interest of the entity, including being an officer, manager, partner, or limited liability company member with management responsibility.

Institutional official means the Vice Provost for Research or such other person as the Provost appoints from time as the individual within the University responsible to oversee the University’s compliance with conflict of interest regulations and policies.

Institutional responsibilities means an Investigator’s professional or employment-related responsibilities on behalf of the University or any of its Schools, which may include research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

Investigator means the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research, whether externally or internally funded, or proposed for such funding, which may include, for example, collaborators or consultants.

Outside organization means any organization other than the University or University of Pennsylvania Health System or its corporately-owned entities (e.g., Clinical Care Associates and Clinical Practices of the University of Pennsylvania), and other than an Excluded payer.