Financial Conflicts of Interest in Research Sponsored Projects at Penn Joanne Rosenthal, BSN, JD Research Integrity Office May 19, 2015

Does Dr. Heart have a Conflict of Interest? 2

Outline Conflict of Interest Defined The Special Nature of COIs Related to Research (FCOI) PHS Regulations and Penn FCOI Policy 8/24/12 Investigator Disclosure Requirements Disclosure Review and FCOI Determination Other Regulatory Requirements Subawards BA Responsibilities 3

Conflict of Interest Defined 4 May exist when financial or other personal considerations have potential to compromise or bias professional judgment or objectivity Researcher’s primary interests Producing generalizable knowledge Disseminating research results Ensuring the safety of research subjects Secondary or other interests Subjective: o Publications o Promotion o Prestige Objective o Personal financial gain o Funding for research A professional’s judgment does not necessarily have to be biased in order to trigger concerns regarding COI — even the appearance of bias in judgment is ethically worrisome.

Institutional FCOI Conflicts of interest may involve: Individuals and / or Institutions  Institution has a financial interest in the research Equity, royalties etc.  Member of leadership has a financial interest in the research Dean, Department Chair, Trustee IRB members Conflict of Commitment 5

The Special Nature of FCOIs Related to Research 6 COIs are intrinsic to the researcher's enterprise Problem is not just the FCOI but the potential for BIAS Recipe for a FCOI Researcher must have:  A role in the design, conduct, or reporting of research results AND  A personal financial interest / relationship related to the research  Consulting  Stock  Royalties

FCOI Concerns Personal financial ties with industry might distort researcher’s judgment: Validity of study design Subject enrollment Data Collection Data Analysis Data Reporting Publication Researchers don’t think their conflicts affect their research, but that conflicts do affect other people’s decisions. Eric Campbell 7

PHS Regulations and Penn FCOI Policy PHS regulations effective 8/24/12 - Promoting Objectivity in Research, 42 CFR 50, Subpart F and Responsible Prospective Contractors, 45 CFR 94 University of Pennsylvania Policy on Conflicts of Interest related to Research (the FCOI Policy) posted on 8/24/12 Supplement-ConflictsInterest.pdf Supplement-ConflictsInterest.pdf Applicable to all research being conducted under Penn’s auspices, regardless of funding source Applicable to Investigators - any person, regardless of title or position, who is responsible for the design, conduct or reporting of research  Includes Key Personnel, Consultant-Key Personnel and Significant Contributors  May include individuals who are not paid off the award 8

Disclosure Thresholds Significant Financial Interests (SFIs) Investigators must disclose SFIs for any research for past 12 months (includes SFIs of spouse and dependent children) For a public Outside organization: aggregate value of any payments and current equity > $5,000 For a non-publicly traded Outside organization: any equity + payments > $5,000 Income from IP rights not assigned to Penn Any Clinical trial intellectual property, whether or not assigned to Penn – Penn requirement Any Fiduciary Role for an Outside organization – Penn requirement PHS Investigators must also disclose travel reimbursed or paid on the Investigator’s behalf within the most recent 12 months Exclusions to the above Penn salary or research funding received by Penn IP rights assigned to Penn unless used in a clinical trial Payments from a government agency, US academic institutions Retirement accounts 9

Disclosure Requirements - Scope of Disclosure 10 For PHS-funded research Investigator must disclose SFIs in a PHS-Financial Interests and Travel Statement (PHS-FITS) that reasonably appear to be related to the Investigator’s Institutional responsibilities (regardless of whether related to the research). Related if:  SFI arises from extramural activities that derive from the Investigator’s professional standing or are within that Investigator’s professional field(s) of discipline  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 For non-PHS funded research Investigators disclose SFIs (and those of their Family members if such interests could affect or be affected by the research and / or such interests were in / with one or more Outside Organizations whose interests could affect / be affected by the research Disclosure submitted in the Financial Interest Electronic Disclosure System (FIDES)

Other Regulatory Requirements FCOI training required prior to participating in PHS-funded research and every 4 years Public Accessibility  Must respond within 5 business days to written requests for information regarding FCOIs of Senior/key personnel Reporting to NIH o Prior to spending of funds o Within 60 days for any FCOI identified subsequent to initial report o Annual status updates for each FCOI reported  Must provide: o Investigator identifying information o Name of entity with which the Investigator has a FCOI o Nature of FCOI, how it relates to research, and why SFI = FCOI o Value of SFI with specified increments to $100,000 and above o Key elements of management plan, including how plan is designed to safeguard objectivity and monitoring If an FCOI is not timely identified or managed, must complete a retrospective review to determine whether the research was biased

Assessment of Relatedness of SFIs to Research SFIs are related to the research if: SFI could be affected by the research; or SFI is in an entity whose financial interests could be affected by the research Penn is responsible for assessing relatedness but may obtain Investigator’s input PHS-FITS Grant Relatedness Tab - 5 screening questions Example – Disclosed SFI with Merck What role does Merck have in this research (sponsor, provides study drug)? Will Investigator acknowledge or give attribution to Merck in any publication or presentation related to the research? Other questions not specific to any company Any fiduciary role for Merck or any other entity whose financial interests could be affected by this research? Any IP being tested, evaluated, developed in, or will its commercial value be affected by, the research? 12

FCOI Screening Questions PD – PI Certification This project, if awarded, will be funded either directly or indirectly, by the Public Health Service (PHS) or one of its agencies (e.g. NIH) If Yes Research to be funded by the Public Health Service - Financial Conflict of Interest (FCOI) Disclosure and Training Requirements for Investigators. At the time of proposal submission, all Investigators (senior/key personnel and any other individuals responsible for the design, conduct and reporting of PHS-funded research) must submit a "PHS Financial Interests and Travel Statement" (PHS-FITS) at Investigators must also complete FCOI training prior to participating in PHS-funded research and then every 4 years in KnowledgeLink. I understand that I am responsible for identifying all Investigators (as defined in the paragraph above) on this proposal and advising them of their obligation to complete all FCOI disclosures and training requirements as more fully set forth in the University of Pennsylvania Policy on Conflicts of Interest Related to Research, pdf Yes No 13

FCOI Screening Questions PD - PI Certification Cont. This project, if awarded, will be funded either directly or indirectly, by the Public Health Service (PHS) or one of its agencies (e.g. NIH) If No Does any person who is responsible for the design, conduct, or reporting of the proposed research (or his/her spouse or dependent children) have a Significant Financial Interest* that may affect or be affected by this research, including Significant Financial Interests related to any entity whose interests may affect or be affected by this research? If YES to the above, any person identified with such Significant Financial Interests must submit a financial disclosure via Penn's Financial Interest Disclosure Electronic System (FIDES). FIDES may be accessed at seo.upenn.eduhttps://fides.isc- seo.upenn.edu 14

Investigator Decision Tree: The Who, What, Where, and When for Disclosure Requirements at Penn 15 When do I complete a Grant Relatedness Assessment in PHS-FITS? For new proposals At Just-in-Time (but no later than at the time the NOA is issued) For awarded grants When NOA is received (if I have not submitted a Relatedness Assessment at Just-in-Time) When I report a new SFI in PHS-FITS (but not a change in a previously reported SFI) If there is a change in the relatedness of a previously reported SFI to a specific grant A separate Grant Relatedness Assessment must be submitted for EACH grant

Assessment of PHS-FITS Disclosures School FCOI Office / Officer reviews SFI disclosures and the Investigator’s input on their relatedness If the School determines that any SFIs are related to the research, the School shall direct the Investigator to submit a more detailed disclosure to the RIO in FIDES FIDES disclosures may be referred to the CISC for review or handled administratively 16

FCOI Determination CISC advisory to the Vice Provost for Research (VPR) Will generally review SFIs involving:  Any equity in a private company or equity > $50,000 in a public company  Payments > $25,000  Fiduciary roles  IP Interests and Clinical Trial IP related to the research  Multiple SFIs for same company CISC’s Role: Makes recommendations regarding whether a related SFI = an FCOI and its management FCOI = if the SFI could directly and significantly affect the design, conduct and reporting of the research) VPR makes final determination regarding FCOI and management 17

Management of FCOIs Factors considered for management include: Nature and design of the research Magnitude and nature of the SFI Investigator’s role in the research Other For Clinical Trials No presumption against participation based on having an FCOI FCOIs still may not be amenable to management Must consider degree of risk to human subjects, degree of the Investigator’s influence upon the recruitment/ enrollment of subjects and/or the results of the study, and other factors 18

PHS-FITS Overview Required only for Investigators participating in any PHS funded research Must submit SFIs and Travel  Not related to any specific grant  Must add new SFIs within 30 days  Must certify SFIs and Travel annually in July o For remainder of this FY, if new or competing award, SFIs must have been submitted on or after 7/1/14 Must submit a Relatedness Assessment for each new or competing award or subaward  Only one per grant  Only updated for new SFI or if a previously reported SFI that was unrelated becomes related  New Relatedness Assessment not required at time of NCC 19

Investigator Maintenance and Reports Investigator Maintenance Module in PHS-FITS:  Populates initially from PD  Enables BA to add / remove Investigators for life of award, including non-Penn Investigators  Requires certification as to accuracy  FCOI training completion data is available Reports available in PHS-FITS:  Investigators who submitted SFIs and Travel  Investigators who submitted Grant Relatedness Assessments  Grant Relatedness Overdue (3 rd report) should not be used 20

BA Responsibilities Related to PHS Triggering Events Triggering events are: New and competing awards - at JIT or other indication of funding but no later than NOA Noncompeting Continuations - when submitting progress reports For subawards – prior to execution each year BA for the proposal responsible org must:  Confirm Investigators for that award with the PI.  In the PHS-FITS Investigator Maintenance module o Add any Investigators who were not previously listed. –Make sure each Investigator is assigned a role. –For any Non-Penn Investigator not on a subaward / subcontract, select “Other” and then in the text box add “Consultant No Subaward” o End any Investigators who are no longer participating. o Certify the list of Investigators. 21

BA Responsibilities Related to PHS Triggering Events Run the Financial/Travel Report and confirm that each Penn Investigator has completed his/her SFIs and Travel after July 1 of each year Run the Grant Relatedness Status Report and confirm that each Penn Investigator has a Relatedness Assessment for that award with a final status of “FIDES required; school concurs" or "FIDES not required; school concurs" (regardless of the date submitted). Confirm that each Penn Investigator has completed FCOI Training. Confirm that each Non-Penn Investigator not covered under a subaward has a Relatedness Status of “Non PHS-FITS Disclosure Received.” If this status is blank, please contact the RIO. When all the above steps are complete, ORS advising that the proposal is ready for review / account set-up. 22

FCOI Procedures - PHS Subawards from Penn to Other Institutions Subaward agreement must state whether Penn’s or the subrecipient’s FCOI policy will apply to the subrecipient’s Investigators Penn will require subrecipients to have their own FCOI policies Only in exceptional circumstances will Penn assume primary FCOI responsibility  Foreign subawards  Community Investigators For Subrecipient’s covered under Penn’s FCOI Policy: o Investigators must disclose SFIs that are directly related to the subrecipient’s work for Penn and complete Penn’s FCOI Training o Will not manage any FCOIs BAs responsible for: o Adding Investigators in PHS-FITS if notified by RIO o Interfacing with subrecipient if issues arise 23

Consulting on PHS Awards 1) Penn personnel consulting on another institution’s grant No subaward or other agreement with Penn Penn will not be responsible for FCOI compliance obligations related to an individual’s private, extramural consulting activities Disclosure requests from other institutions should be routed to ORS 2) Penn engages non-Penn personnel as independent contractors to consult on Penn award (and no subaward with other institution) If consultant has an academic affiliation and qualifies as an Investigator: o Home institution with compliant FCOI compliant policy may accept FCOI compliance responsibilities for the Investigator Otherwise, Penn will assume primary responsibility  Investigator must complete disclosure and Penn’s FCOI Training Consultants affiliated with industry or startup – Work should be done under subaward / subcontract 24

Useful Links PHS-FITS Investigator Disclosure Link: nvestigator PHS-FITS Administrator Disclosure Link: Access the FCOI training in KnowledgeLink at: inkId=ITEM_DETAILS&componentID=UP ITEM.FCOI&co mponentTypeID=COURSE&revisionDate=

Coming Soon In contract negotiations regarding purchase of new web-based disclosure application Will combine into one system School-based annual extramural reporting Travel disclosures for PHS investigators Research disclosures  Including non-Penn Investigators Will require significant customization 26