Presentation Title Author Conflict of Interest management & the responsible conduct of research Khrys X. Myrddin, MPPM Associate Director COI Office A partner in promoting integrity in research, teaching, and administration

Presentation Title Author Today’s agenda A general overview of conflicts of interest (COI). Discuss why properly identifying and managing COIs is important. Management of research-related COIs NEW review requirements for PHS-funded research Implications of COI management

Presentation Title Author Scenario 1 Professor A. E. Moniz is a consultant for e-SCOPE (his contract is for $35,000 in this current year); e-SCOPE wants to sponsor human subject research at the University to evaluate new technologies for measuring the architecture of the brain

Presentation Title Author Scenario 1 - Questions Do you have any concerns with Dr. Moniz being the PI of the clinical trial sponsored by e-SCOPE? What kind of information, if any, would you want as a potential research subject in the study? What kind of information would you want as a co- investigator on the study?

Presentation Title Author Myth/fact? You can’t have a financial conflict of interest with federal research.

Presentation Title Author Scenario 2 Dr. Ivette Semmelweiss developed a new method for treating OCD, which was patented by the University and licensed to Rehab, Inc., she receives royalties for the IP through Pitt; Dr. Semmelweiss is conducting federally sponsored research to further evaluate the technology.

Presentation Title Author Scenario 2 - Questions Do you think Dr. Semmelweis has a conflict of interest? If so, would the type of research being conducted influence how you think it should be managed? What kind of information would you want as a co- investigator on the study?

Presentation Title Author 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.

Presentation Title Author Why should you care about COI? Conflicts of interest can affect… An investigator’s role in studies; The willingness of potential research subjects to participate in research; How the research results are viewed by the scientific community and the general public; The reputation of individual researchers and research institutions.

Presentation Title Author Importance of COI management If conflicts of interest are 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; University may lose public support and funding for research; the investigator/faculty member may lose the respect of the academic community;

Presentation Title Author Importance of COI management violation of scientific norms may result; research results may be excessively delayed or not published; there may be a negative impact on students, trainees, and/or junior faculty; University resources may be improperly used; increased government regulations may result; scandals or negative media attention may occur….

Presentation Title Author From the headlines The Chronicle of Higher Education NIH Halts Study at Emory Over Concerns About Drug Company’s Payments The National Institutes of Health has halted a $9.3- million five-year research project at Emory University, pending an investigation into potential conflicts of interest by the project’s former leader…

Presentation Title Author From the headlines Researchers Fail to Reveal Full Drug Pay By GARDINER HARRIS and BENEDICT CAREY PUBLISHED: JUNE 8, 2008 in The New York Times [Dr. Joseph Biederman], a Harvard child psychiatrist whose work has helped fuel an explosion in the use of antipsychotics in children earned at least $1.6 million in consulting fees from drugmakers from 2000 to 2007 but for years did not report much of the income to university officials, according to information given to Congressional investigators…

Presentation Title Author Ban or manage? “The University recognizes the obligation to make the special knowledge and intellectual competence of its faculty members available to government, business, labor, and civic organizations; as well as the potential value to the faculty member and the University.” (Policy )

Presentation Title Author Manage! – University policies : Outside Employment: This policy establishes the conditions under which faculty members may perform professional services outside the University.

Presentation Title Author Manage! – University Policies ( ) Permission from the department chairman, dean or campus president No use of University name, property, or facilities Time given to outside activities is not to exceed one day per week on average Fees for outside work are commensurate with services provided and the faculty member's professional standing

Presentation Title Author Manage! – University Policies Conflict of Interest Policy for Faculty, Scholars, Researchers, Research Staff/Coordinators The opportunity for University personnel to receive financial…rewards from [relationships with industry] …is not intrinsically unacceptable, as long as they do not adversely affect the objectivity, integrity, or professional commitment of investigators and scholars.

Presentation Title Author Manage! – University Policies ( ) It is the potential for conflicts of interest that must be addressed to ensure that they do not threaten the integrity of the university’s scholarship, research, instruction, evaluation, and administration.

Presentation Title Author Manage! – University Policies ( ) Purpose – to assure that: – the advantages of interactions w/industry are realized without the loss of the fundamental values of objectivity and freedom of inquiry in research and scholarship; – University’s research programs and reputation are not compromised; and – no one unfairly benefits from the University’s public trust or reputation

Presentation Title Author Manage! – University Policies ( ) Requires disclosure of financial relationships to the University using the Superform system – Everyone files between Jan 1st – April 15th – Disclosures must be kept up-to-date throughout the year Separate UPMC & Pitt COI systems – University: Superform – UPMC: My Hub > Human Resources tab > COI

Presentation Title Author Annual COI filing – Faculty/Researcher forms All regular full-time faculty Anyone, regardless of title or position, who engages in research at the University of Pittsburgh Anyone who is or expects to be an investigator on a PHS-funded project must complete the PHS Faculty/Researcher form, instead of the regular form – Only complete the Faculty/Researcher form that applies to you, not both

Presentation Title Author Manage! – University Policies ( ) Outlines COI management of regulated research Outlines restrictions on faculty interaction with Licensed Start-up Companies – Not publicly-traded – Option or license to University intellectual property – University or one or more of its employees have ownership interest

Presentation Title Author 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 (CMS) Food and Drug Administration (FDA) Health Resources and Services Administration (HRSA) Indian Health Service (IHS) National Institutes of Health (NIH) – National Cancer Institute Substance Abuse and Mental Health Services Administration (SAMHSA) Agencies of the Public Health Service (PHS)

Presentation Title Author PHS COI regulations New regulations for “promoting objectivity in research”– 42 CFR Part 50, subpart F (grants) & 45 CFR Part 94 (contracts) – Lowered reporting thresholds – Placed responsibility for determining if financial interests constitute Financial Conflicts of Interest w/PHS-funded research w/institution – Requires reporting of sponsored & reimbursed travel related to institutional responsibilities – Additional training requirements – Managed FCOIs with PHS-funded research to be disclosed on publicly-accessible website

Presentation Title Author PHS COI regulations Policy revised August 24, 2012 to reflect new PHS COI regulations See COI website for summary of changes and information regarding new requirements –

Presentation Title Author Submissions: the Office of Research will check that PI/PD and all Senior/Key personnel have PHS Faculty/Researcher forms on file & have completed the CITI PHS COI Training module. Awards: the Office of Research will refer to the COI Office awards on which Investigators have reported outside financial interests on PHS Faculty/Researcher forms. PHS COI review – grants & contracts

Presentation Title Author Manage! – Industry Relationships Policy Ended participation in Speaker’s Bureaus Limits site access for Industry and banned the provision of gifts and meals by Industry Outlines criteria for faculty participation in Industry- sponsored events Explicitly bans sales, marketing, and promotional activities, and otherwise proscribes faculty interactions with Industry AKA: Policy on Conflicts of Interest and Interactions between representatives of Certain Industries and Faculty, Staff and Students of the Schools of the Health Sciences and Personnel Employed by UPMC at all Domestic Locations

Presentation Title Author Not me! Yes, YOU (and everyone else). Daylain Cain, PhD and Allan S. Detsky, MD, PhD. “Everyone’s a Little Biased (Even Physicians),” JAMA, June 25, 2008—Vol. 299, No. 24 – “Conflicts of interest are problematic, not only because they are widespread, but also because most people incorrectly think that succumbing to them is due to intentional corruption, a problem for only a few bad apples.”

Presentation Title Author Not me! Yes, YOU (and everyone else). The Ethical Brain, Post Hoc – People think they have good reasons for their beliefs, but these reasons are often made up after the fact. Subconscious Conflicts – ‘Motivated reasoning’ – individuals use different strategies to evaluate propositions depending on whether the hypothesis is desirable or threatening/disagreeable to them. – Many of these processes have been shown to be unintentional, difficult to control, and resistant to incentives for accuracy.

Presentation Title Author Not me! Yes, YOU (and everyone else). Is disclosure the answer? – Not quite – disclosure can actually “have the perverse effect of making professionals more biased rather than less.” Disclosure (alone) is not the solution. – “Transparency is well and good, but accuracy and objectivity are even better. [The profession] does not have to keep confessing its sins. It just has to stop committing them.”

Presentation Title Author Not me! Yes, YOU (and everyone else). “Researchers and clinicians have been taught that scientific experiments that involve observations or judgments must be protected from the unintentional influences of bias.” – E.g., double-blinded studies “Bias is not a crime, is not necessarily intentional, and is not a sign of lack of integrity; rather it is a natural human phenomenon.”

Presentation Title Author Managing COIs with research The COI Committee is responsible for managing potential conflicts related to Human subject research (IRB) and Animal research (IACUC) No longer ask COI questions on protocols for – CORID (Research and Clinical Training on Decedents) – IBC (Institutional Biosafety Committee/rDNA) – hSCRO (Human stem cell research)

Presentation Title Author Managing COIs with research COI questions that appear on protocol applications apply to all investigators and research personnel – There are NEW questions for PHS-funded studies Questions reflect SFI categories & thresholds PI is responsible for ensuring that all investigators and study personnel review these questions

Presentation Title Author Managing COIs with research 'Investigator' means any member of the study team who participates in the design, conduct, or reporting of this research, as well as his/her spouse, registered domestic partner, dependents, or other members of his/her household.

Presentation Title Author Managing COIs with research Reporting must be kept current – Whenever new outside interests are accrued, investigators should notify the COI Office and the appropriate regulatory committee (e.g., IRB, IACUC), and update their Faculty/Researcher COI forms

Presentation Title Author Human subject research (IRB) NB: Protocols that are “exempt” or receive a “not human subjects research” designation are treated like bench research (i.e., not subject to regulated research section of COI policy) Non-PHS funded protocols – Answering “yes” to any of the COI questions in section 7.3 requires invocation of Standard COI Management Plan (SMP) for Human Subject Research

Presentation Title Author Human Subject Research (IRB) PHS funded protocols – CMP for “yes” answers to COI questions will depend on nature/value of SFI – SFIs with value > $5,000, but < $10,000 and those arising from reimbursed or sponsored travel, COI Office will work with department chair to develop CMP

Presentation Title Author Animal research (IACUC) Non PHS-funded – “PI-exclusion rule” applies to equity, remuneration, and Licensed Start-up companies. Management plan similar to SMP, less the items specific to human subject research – Financial interest only in the IP being evaluated are reviewed on a case-by-case basis.

Presentation Title Author Animal research (IACUC) PHS-funded – “PI-exclusion rule” applies to SFIs in publicly-held entities (> $10K); any equity in nonpublic entities, remuneration from nonpublic entities (> $10K), and Licensed Start-up companies. Management plan similar to SMP, less the items specific to human subject research – Financial interest only in the IP being evaluated are reviewed on a case-by-case basis. – COI Office works with dept. chair to develop CMPs for travel FCOIs and SFIs < $10K

Presentation Title Author Managing COIs with research The “minimum required CMP” for PHS-funded research – The investigator will disclose the existence of his/her SFI in any abstracts, presentations, press releases, or publications resulting from the PHS-funded research, and in any proposals or applications for research funding of commercial interest to the company. – Other individuals (students, staff, or other faculty members) engaged in the PHS-funded research project with the investigator, should be notified of the existence of his/her SFI through the use of the standard Notification form – Students will be engaged in the project only with the approval of their department chair or dean.

Presentation Title Author Managing COIs with research All managed FCOIs will be reported to the appropriate funding source In the case of PHS-funded research, this information will also be posted on the University’s COI website, as required by federal regulation –

Presentation Title Author Examples & discussion In the following scenarios, think about what issues might arise as a result of the investigator’s financial interest. Think about yourself as the person with the financial relationship and as someone working with that person.

Presentation Title Author Examples of research COIs Professor A. E. Moniz is a consultant for e-SCOPE (his contract is for $35,000 in this current year); e-SCOPE wants to sponsor human subject research at the University to evaluate new technologies for measuring the architecture of the brain

Presentation Title Author Examples of research coiS What management plan would be implemented? Why do you think certain elements are required? How do you think potential research participants would feel about reading the COI disclosure language in the informed consent document?

Presentation Title Author Examples of research COIs Dr. Ivette Semmelweiss developed a new method for treating OCD, which was patented by the University and licensed to Rehab, Inc.,; she receives royalties for the IP through Pitt; Dr. Semmelweiss is conducting federally sponsored research to further evaluate the technology.

Presentation Title Author Examples of research COIs Do you think Dr. Semmelweiss has a COI? What are the potential benefits of COI management in this scenario? What would you think if you received a form notifying you that one of the investigators on a study you are working on has a financial interest in the research?

Presentation Title Author Questions?

Presentation Title Author Resources & assistance COI website: – For information about the Pitt/UPMC combined disclosure form, see COI Filing Process > Pitt & UPMC Electronic COI Filing Systems – For information on engaging in consulting activities, see Industry Relationships Policy > Policy Compliance Tools, as well as the IRP FAQ page NIH FCOI website: – Links to new regulations – Educational tutorial & FAQs

Presentation Title Author Resources & assistance COI Office Staff David T. Wehrle, CPA, CFE, CIA Director/COI Office Khrys X. Myrddin, MPPM Associate Director/COI Office Benjamin T. West Compliance Coordinator/COI Office COI Committee Jerome L. Rosenberg, PhD Chair

Presentation Title Author RCR Training Evaluation Questions Thank you for your participation CTSI Responsible Conduct of Research Training Center

Presentation Title Author This program enabled me to feel more confident in my knowledge and understanding of this topic. A.Strongly Disagree B.Disagree C.Somewhat Disagree D.Neither Agree nor Disagree E.Somewhat Agree F.Agree G.Strongly Agree Response Counter

Presentation Title Author Through this program I have gained practical tools or skills that I can apply to my research. A.Strongly Disagree B.Disagree C.Somewhat Disagree D.Neither Agree nor Disagree E.Somewhat Agree F.Agree G.Strongly Agree Response Counter

Presentation Title Author After attending this program I feel that I am better able to access resources at Pitt for my research. A.Strongly Disagree B.Disagree C.Somewhat Disagree D.Neither Agree nor Disagree E.Somewhat Agree F.Agree G.Strongly Agree Response Counter

Presentation Title Author After attending this program, I feel more confident to advance the progress of my research. A.Strongly Disagree B.Disagree C.Somewhat Disagree D.Neither Agree nor Disagree E.Somewhat Agree F.Agree G.Strongly Agree Response Counter

Presentation Title Author Overall, my evaluation of this program is: A.Poor B.Fair C.Neutral D.Good E.Excellent Response Counter

Presentation Title Author What is your role in research ? (choose all that apply) A.Department chair or senior faculty B.Assistant or Associate Professor C.Postdoctoral fellow D.Medical fellow E.Medical resident F.Medical student G.Graduate student H.Research coordinator I.Research staff J.other

Presentation Title Author In general, where in the research process do you encounter the biggest barriers? A.Designing the study (protocol development, statistics, collaborations, grant writing, etc.) B.Launching the study (regulatory, contracts, personnel, equipment, etc) C.Conducting the study (recruitment, data collection and analysis, publication, etc.) Response Counter

Presentation Title Author How many years have you been involved in research? A.<1 B.1-5 C.6-10 D E.>15 Response Counter