Friday, February 1, 2013 9 a.m. Herberman Auditorium UPMC Cancer Pavilion Presented by the University of Pittsburgh COI Office: Jerome L. Rosenberg, PhD.

Conflict of Interest Management

Friday, February 1, 2013 9 a.m.Herberman AuditoriumUPMC 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.

What is a Conflict of Interest?

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.

Example of a COI

Rationale for a Conflict of Interest (COI) Policy 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 https://myhub.upmc.com University of Pittsburgh Superform system https://

coi.hs.pitt.edu◦ Faculty/Researcher Form (F/R)◦ Faculty/Researcher (Public Health Service-funded)

Form (PHS F/R)◦ Designated Administrator/Staff Form

Disclosure of Financial Interests…

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 11-01-03 Conflict of Interest Policy

for Faculty, Scholars, Researchers, Research Staff/Coordinators

Disclosure of Financial Interests cont’d

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.

Disclosure of Financial Interests cont’d

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.

Disclosure of Financial Interests cont’d

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)

Operating Divisions of the PHS

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.

Disclosure of Financial Interests cont’d

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.

Disclosure of Financial Interests cont’d

“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

Disclosure of Financial Interests cont’d

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.

Review & Management: COI Management Techniques

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;

Examples related to the application of the PI exclusion rule

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.

Examples related to the application of the PI exclusion rule, cont’d

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).

Standard COI Management Plan for Human Subject Research

◦ 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.

Standard COI Management Plan for Human Subject Researchcont’d

◦ 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 (866-212-2668).

Standard COI Management Plan for Human Subject Research, cont’d

◦ 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.

◦ 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; [email protected]) of the titles and numbers of any present or future federal research grants supporting this protocol.

Standard COI Management Plan for Human Subject Research, cont’d

Questions?

COI Office StaffDavid T. Wehrle, CPA, CFE, CIA

Director/COI Office

412-383-1774 [email protected]

Khrys X. Myrddin, MPPM

Associate Director/COI Office

412-383-2828 [email protected]

Benjamin T. West, BA

Compliance Coordinator/COI Office

412-383-1735 [email protected]

Hannelore N. Rogers, MA

Coordinator/COI Office

412-383-1968 [email protected]

COI CommitteeJerome L. Rosenberg, PhD

Chair

412-624-3007 [email protected]

COI Web sitewww.coi.pitt.edu

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