Friday, February 1, a.m. Herberman Auditorium UPMC Cancer Pavilion Presented by the University of Pittsburgh COI Office: Jerome L. Rosenberg, PhD COI Committee Chair David T. Wehrle, CPA, CIA, CFE Director Khrys X. Myrddin, MPPM Associate Director

 A potential Conflict of Interest (COI) may exist if an individual’s outside interests (especially financial) may affect, or perceive to affect, his/her research, teaching, or administrative activities at the University.

 Professor F.L. Wright is a consultant for e- SCAN (his contract is for $35,000 in this current year);  e-SCAN wants to sponsor human subject research at the University to evaluate new technologies for measuring the architecture of the brain.  Professor Wright would like to serve as an investigator on this study.

 Our COI Policy reaffirms the value of faculty members’ interactions with the commercial sector and provides guidelines for maintaining integrity in research in the course of such interactions.

Importance of COI Management If COI is not managed…  protection of human subjects may be compromised;  integrity of research may be at risk;  the public may lose trust in the University and its research findings;  the investigator/faculty member may lose the respect of the academic community;

Importance of COI Management cont’d  violation of scientific norms may result;  the University may lose public support and funding for academic science;  may violate terms of research grants and contracts (including failure to disclose COI) and federal regulations;  research results may be excessively delayed or not published;

Importance of COI Management cont’d  there may be a negative impact on students;  University resources may be improperly used;  increased government regulations may result;  scandals or negative media attention may occur.

 To your institution(s) ◦ Upon appointment ◦ Annually by April 15 ◦ Whenever outside interests change  UPMC COI form  University of Pittsburgh Superform system ◦ Faculty/Researcher Form (F/R) ◦ Faculty/Researcher (Public Health Service-funded) Form (PHS F/R) ◦ Designated Administrator/Staff Form

 Questions on COI disclosure forms capture relationships defined by University policy and federal regulation to be Significant Financial Interests (SFIs) that are related to an individual’s Institutional Responsibilities. ◦ See Policy Conflict of Interest Policy for Faculty, Scholars, Researchers, Research Staff/Coordinators

 Institutional responsibilities – an Investigator’s professional responsibilities on behalf of the University, including: ◦ research ◦ teaching ◦ professional practice ◦ institutional committee memberships ◦ service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards, and other administrative activities.

 Faculty members and those engaged in research will complete either a PHS F/R or a “regular” F/R Form, based on whether or not they are engaged in PHS-funded research. They should not complete both forms.

 Administration for Children and Families (ACF) ◦ Administration on Children, Youth and Families (ACYF)  Administration for Community Living (ACL)  Agency for Healthcare Research and Quality (AHRQ)  Centers for Disease Control and Prevention (CDC)  Centers for Medicare & Medicaid Services  Food and Drug Administration (FDA)  Health Resources and Services Administration (HRSA)  Indian Health Service (IHS)  National Institutes of Health (NIH) ◦ National Cancer Institute (NCI)  Substance Abuse and Mental Health Services Administration (SAMHSA)

 Who should file a PHS F/R Form? ◦ All individuals, regardless of title or position, who participate in the design, conduct, or reporting of research funded by a PHS operating division.  Including those not listed on PHS grants or contracts, but who are serving as investigators on research protocols funded by a PHS operating division.

 In research protocols overseen by a regulatory committee (i.e., IRB, IACUC, rDNA/IBC, hSCRO & CORID)  COI Declaration form applies to ALL study personnel, not just the PI  PI is responsible for ensuring that all study personnel review SFIs on Declaration form  If study personnel accrue new outside interests during the course of the study, they must inform the appropriate regulatory committee and the COI Office.

 “Regular” COI Declaration form – for all studies not funded by PHS ◦ asks for SFIs related to the research, e.g., financial interest in study sponsor or in entity that owns IP being evaluated  PHS COI Declaration form – for all studies with PHS funding ◦ requires disclosure of all SFIs related to Institutional Responsibilities ◦ Institution (Department/COI Committee) determines if they are related to the research

 The management plan implemented (including the application of the automatic PI exclusion rule) depends on factors such as ◦ the amount & type of outside financial interest; ◦ the type of research being conducted (i.e., human, animal, or bench); ◦ whether or not the research is funded by the PHS.

 An investigator conducting bench research sponsored by Newtek, Inc., from which she receives annual consulting income of $25,000, can serve as PI if acceptable to her department chair with the implementation of a conflict management plan (CMP);  An investigator conducting PHS-funded animal research evaluating a cancer vaccine owned by a publicly traded company from which he receives annual consulting income of $7,500 can serve as PI if acceptable to his department chair with the implementation of a CMP;

 An investigator conducting PHS-funded animal research evaluating an experimental drug owned by a non-publicly traded company in which he has an ownership interest can serve as a CO-I, but not as PI, with implementation of a CMP;  An investigator conducting human subject research evaluating patented IP she invented can serve as a Co-I, but not as PI with the implementation of the University’s Standard Conflict of Interest Management Plan for Human Subject Research.

 In view of my Significant Financial Interest (SFI) in (specify name of company and/or describe technology being evaluated), I agree to the following components of a plan to manage my conflict of interest with respect to the above- named protocol. ◦ I will not serve as Principal Investigator (PI) on this protocol, although I may serve as a co-investigator. The PI selected must be approved by the IRB. As a co-investigator, I will be responsible for: (describe role on study).

◦ I will not be involved in the recruitment of subjects, nor will I obtain subjects' informed consent at any time. ◦ I will not engage in the recording of research data. ◦ I will not be involved in clinical assessments of study eligibility criteria and intervention outcomes. ◦ I will not participate in data and safety monitoring activities. ◦ I will not solely be involved in the interpretation of study results, although I may be involved as part of a committee that evaluates study results. Final decisions about the appropriate interpretation and presentation of research results shall be the responsibility of the PI.

◦ The existence of my Significant Financial Interest will be disclosed in the informed consent form using the following language:  One or more of the investigators conducting this research has a financial interest in or a patent for the development of this (add study specific information, i.e., description of what is being evaluated). This means that it is possible that the results of this study could lead to personal profit for the individual investigator(s) and/or the University of Pittsburgh. This project has been carefully reviewed to ensure that your well-being holds more importance than any study results. Any questions you might have about this will be answered fully by the Principal Investigator, Dr. (enter the name and telephone number of the PI of the research study), who has no financial conflict of interest with this research, or by the Human Subject Protection Advocate of the University of Pittsburgh ( ).

◦ If other individuals (such as students, staff or other faculty members) will be involved in research under this protocol, I will notify them of the existence of my Significant Financial Interest through the use of the Notification of Investigator's research- related SFI form. Students will be engaged in the protocol only with the approval of their department chair or dean.Notification of Investigator's research- related SFI ◦ I will disclose the existence of my Significant Financial Interest in any abstracts, presentations, press releases, or publications and in any proposals or applications for research funding related to the nature of that interest. ◦ I will notify the chair of the Conflict of Interest Committee (Dr. Jerome Rosenberg; of the titles and numbers of any present or future federal research grants supporting this

COI Office Staff David T. Wehrle, CPA, CFE, CIA Director/COI Office Khrys X. Myrddin, MPPM Associate Director/COI Office Benjamin T. West, BA Compliance Coordinator/COI Office Hannelore N. Rogers, MA Coordinator/COI Office COI Committee Jerome L. Rosenberg, PhD Chair COI Web site