University of Pittsburgh Conflict of Interest Committee & Office Partners in Promoting Integrity in Research, Teaching, and Administration

Financial Conflicts of Interest: Why Should You Care? Presentation for the Pitt Research Network March 17, 2009, noon – 1:00 p.m. BST Room S-120 Jerome L. Rosenberg, PhD (Chair/COI Committee & Research Integrity Officer) David T. Wehrle, CPA, CIA, CFE (Director/COI Office)

What is a Conflict of Interest? 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.

Examples of Potential Conflicts  Professor Maureen Belstein, faculty member/researcher  Consultant for Diagnostic Systems, Inc. (earned $35,000 last year)  DSI wants to sponsor university research to evaluate new cancer screening technologies  Professor Belstein wants to be PI on the study

Examples of Potential Conflicts (cont’d) Dr. Maryann Ruecken developed a back brace which was patented by the University; she receives royalties for the device through Pitt The technology is licensed to Strait & Narrow, Inc., a non-publicly held company She holds equity in the company Dr. Ruecken is conducting federally sponsored research to further evaluate the technology.

Importance of COI Management Why is it important to identify and manage conflicts of interests?

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; violation of scientific norms may result; may violate terms of research grants and contracts (including failure to disclose COI) and federal regulations.

Importance of COI Management (cont’d) University may lose public support and funding for academic science; research results may be excessively delayed or not published; students may be negatively impacted: inability to pursue their research interests; University resources may be improperly used; increased government regulations may result; scandals or negative media attention may occur.

Importance of COI Management (cont’d) For FDA-covered clinical studies, FDA may: initiate agency audits of data request additional analyses of data request additional independent studies to confirm results of questioned study refuse to treat covered clinical study as providing data as basis for an agency action

ATLANTA JOURNAL CONSTITUTION Depression expert at Emory pulls out of research projects NIH freezes grant money; Emory to begin monitoring potential conflicts of interest Gayle White, Craig Schneider  Tuesday, October 14, 2008 Emory psychiatry professor D. Charles B. Nemeroff is stepping down from university research projects funded by the National Institutes of Health, as the federal agency cracks down on the school’s handling of potential conflicts of interest, university officials said. The NIH has frozen funds for a $9.3 million project on depression led by Nemeroff, acknowledged Ron Sauder, a university vice president. The project had been under way for two of its proposed five years.

NEW YORK TIMES Researchers Fail to Reveal Full Drug Pay By GARDINER HARRIS and BENEDICT CAREY June 8, 2008 A world-renowned Harvard child psychiatrist whose work has helped fuel an explosion in the use of powerful antipsychotic medicines in children earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but for years did not report much of this income to university officials, according to information given Congressional investigators. By failing to report income, the psychiatrist, Dr. Joseph Biederman, and a colleague in the psychiatry department at Harvard Medical School, Dr. Timothy E. Wilens, may have violated federal and university research rules designed to police potential conflicts of interest, according to Senator Charles E. Grassley, Republican of Iowa. Some of their research is financed by government grants.

T HE C HRONICLE OF H IGHER E DUCATION Senator Grassley Pressures Universities on Conflicts of Interest By JEFFREY BRAINARD August 8, 2008 University scientists should have their grants yanked by the National Institutes of Health if they fail to report financial conflicts of interest, said U.S. Sen. Charles E. Grassley.

Research Coordinators Play a key role in  Assisting investigators in complying with University and federal COI policies and regulations  Facilitating implementation of management plans  Ensuring expeditious approval process

How the University Addresses COIs Disclosure Review Management

How the University Addresses COIs (cont’d) Disclosure on Faculty/Researcher Form  Policy requires disclosure of the outside interests of faculty, investigators, and research administrators (i. e., any staff members who direct or can materially influence research, or who are responsible for the design, conduct, and reporting of research) … upon appointment by April 15 of each year whenever new outside interests are accrued using the Superform system

How the University Addresses COIs (cont’d) Disclosure also must be made/kept current (i.e., whenever new outside interests are accrued) in protocol applications to Institutional Review Board (IRB) Institutional Animal Care and Use Committee (IACUC) Committee for Oversight of Research Involving the Dead (CORID) Institutional Biosafety/rDNA (Recombinant DNA) Committee hSCRO (Human Stem Cell Research Oversight Committee)

How the University Addresses COIs (cont’d) A process should be in place to ensure that all research personnel—i.e., PIs, co- investigators, and research coordinators— respond to COI questions appearing in protocol applications.

How the University Addresses COIs (cont’d) Review and management process  Deans and department chairs review disclosures to identify and manage potential conflicts;  Certain conflicts must be addressed by the Conflict of Interest Committee (COIC) or by its standing subcommittee, the Entrepreneurial Oversight Committee.

Conflict of Interest Policy Conflict of Interest Committee’s Human Subject Research Working COI Policy: Individuals are generally prohibited from serving as principal investigators (PI) of a human subject research study if they have a significant financial interest (SFI) that may be affected, or perceived to be affected, by the outcome of the research study. …

Conflict of Interest Policy (cont’d) Such individuals may be permitted to serve as co-investigators with the implementation of the Standard Conflict of Interest Management Plan for Human Subject Research. …

Standard COI Management Plan (Text ) In view of my Significant Financial Interest (SFI) in ____________________________ (specify name of company and/or technology being evaluated), I agree to the following components of a plan to manage my conflict of interest with respect to Institutional Review Board (IRB) Protocol #________________.

Standard COI Management Plan (cont’d) 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: ________________________________.

Standard COI Management Plan (cont’d) I will not be involved in the recruitment of volunteer subjects, nor will I administer the informed consent. 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.

Standard COI Management Plan (cont’d) 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 (cont’d) The existence of my Significant Financial Interest will be disclosed in the informed consent form using the following language:

Standard COI Management Plan (cont’d) 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). 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 Dr. (Enter the name and telephone number of the PI of the research study) or by the Human Subject Protection Advocate of the University of Pittsburgh ( ).

Standard COI Management Plan (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 a standard notification form. Students will be engaged in the protocol only with the approval of their department chair or dean.

Standard COI Management Plan (cont’d) 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.

Standard COI Management Plan (cont’d) 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 protocol. ###

COI Management Strategies PI exclusion rule: an alternate PI must be selected who can exercise complete scientific independence from the conflicted investigator Characteristics of a suitable alternate PI:  does not have a COI  has supervisory approval as alternate PI  is scientifically qualified  is a tenured faculty member  has no reporting relationship to conflicted investigator  has independent funding  is not a mentee of the conflicted investigator on a training grant  has own lab space

COI Management Strategies (cont’d) Request for exception to PI exclusion rule  May be granted if compelling circumstances exist  For research overseen by the IRB, IACUC, or hSCRO, a written request must be submitted through COI Committee to authorized institutional official (vice chancellor for research conduct and compliance)  For research overseen by the CORID, the COIC and investigator’s dean and department chair must approve request  If granted, would require implementation of a management plan, including the possible establishment of a data stewardship committee

Conflict of Interest Policy (cont’d) All other exceptions to the standard COI management plan (e.g., adding/removing elements to/from the standard plan) must be approved by a subcommittee of the COI Committee. These requests for exceptions should be communicated to the director of the COI Office. A response to the request will be provided within two weeks of receiving the request.

Questions?

Contacts Jerome L. Rosenberg, PhD Chair, COI Committee David T. Wehrle, CPA, CIA, CFE Director, COI Office Khrys X. Myrddin Associate Director, COI Office Hannelore Rogers, MA Coordinator, COI Office COI Web site: