Financial Conflicts of Interest in Research Sponsored Projects at Penn Joanne Rosenthal, BSN, JD Research Integrity Office December 2, 2014

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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 Training 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 Tangible:  Personal financial gain  Funding for research Intangible  Publications  Promotion  Prestige 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.

Conflict of Interest Defined 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 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  Consult for research sponsor o Have stock in company that manufactures experimental product o Receive royalties related to IP being tested in the research

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  Secrecy  Subject safety 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/ Supplement-ConflictsInterest.pdf 2-Supplement-ConflictsInterest.pdf Applicable to all research being conducted under Penn’s auspices, regardless of funding source  Implementation being done in stages  Initial emphasis is to first assure compliance with the PHS regulations (transition period) 8

Disclosure Thresholds What to disclose – SFIs Investigators must disclose SFIs for any research. If PHS-funded research, Investigator must disclose SFIs to his / her School in PHS-FITS For a public Outside organization: remuneration for the 12 months plus the value of current equity that when aggregated exceeds $5,000 For a non-publicly traded Outside organization: any equity or remuneration for the 12 months exceeding $5,000 Income from intellectual property rights not assigned to Penn Any Clinical trial intellectual property, whether or not assigned to Penn Any Fiduciary Role for an Outside organization PHS Investigators must also disclose travel reimbursed or paid on the Investigator’s behalf within the most recent 12 months, other than by certain entities (Excluded Payers). 9

Disclosure Requirements - Scope of Disclosure 10 For PHS-funded research Each Investigator must disclose SFIs (and those of his/her Family members) 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). An SFI is related to an Investigator’s institutional responsibilities if it arises from extramural activities that derive from the Investigator’s professional standing or are within that Investigator’s expertise in his or her 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, is related to the Investigator’s Institutional responsibilities. Applicable for non-PHS research Investigators disclosed SFIs (and those of their Family members), based on their own self-assessment, 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

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 11

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 12

Investigator Decision Tree: The Who, What, Where, and When for Disclosure Requirements at Penn 13 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 COI Office / Officer reviews SFI disclosures and the Investigator’s input on their relatedness to determine which (if any) SFIs are related to specific PHS research. 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 OVPR (presently, in the Financial Interest Disclosure Electronic System or FIDES). 14

FCOI Determination CISC advisory to VPR Makes recommendations regarding whether a related SFI = an FCOI (SFI could directly and significantly affect the design, conduct and reporting of the research) and its management CISC 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 Other types of SFIs may be handled administratively VPR makes final determination regarding FCOI and management 15

Management of FCOIs Factors considered for management include: Nature and design of the research Magnitude and nature of the SFI 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, the Investigator role, study’s design, degree of the Investigator’s influence upon the recruitment/ enrollment of subjects and/or the results of the study, and other factors 16

Mandatory Investigator Training 17 Investigators must receive FCOI training in KnowledgeLink prior to participating in PHS-funded research and every 4 years Investigators are prompted in PHS-FITS to take training Investigators can print and save Certificate of Completion

Other Policy Elements Public Accessibility  Must respond within 5 business days to written requests for information regarding FCOIs of Senior/key personnel Reporting  RIO must report details of FCOI and management prior to expenditure of funds, within 60 days of identifying a new FCOI, and at least annually Response to Noncompliance Subawards 18

BA Responsibilities related to 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 NCCs For subawards – prior to execution 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. 19

BA Responsibilities related to Triggering Events Run the Financial/Travel Report and confirm that each Penn Investigator has completed his/her SFIs and Travel after 7/1/14. 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. 20

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 in this portal Reports: The following reports are 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 Other: Investigators are required to certify SFIs and Travel every July  For remainder of this FY, SFIs must have been submitted on or after 7/1/14 Investigators are required to complete Relatedness Assessments for new or competing awards Investigators must update existing Relatedness Assessments when adding new SFIs or if a previously reported SFI that was unrelated becomes related Investigators do not need to update Relatedness for each noncompeting segment 21

PHS-funded Subawards Subaward agreement must state whether Penn’s or the subrecipient’s FCOI policy will apply to the subrecipient’s Investigators If Penn’s FCOI policy applies, Penn must obtain disclosures from subrecipient’s Investigators and determine if any FCOIs exist As a rule, Penn will require subrecipients to have their own FCOI policies or adopt FDP model policy Only in exceptional circumstances will Penn assume primary responsibility for obtaining and reviewing subrecipient personnel disclosures  Foreign subawards  Community Investigators Investigators must disclose SFIs that are directly related to the subrecipient’s work for Penn on Financial Interests Disclosure Form for Investigators Not Affiliated with the University of Pennsylvania and complete Penn’s FCOI Training o Penn will require Investigator to eliminate any FCOIs Detailed process has been developed to handle these situations o BAs responsible for adding Investigators in PHS-FITS once RIO receives list o BAs also responsible for interfacing with subrecipient if issues arise 22

Consulting on PHS Awards Other institution engages Penn personnel as independent contractors to consult on grant No subaward or other agreement with Penn School and University 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 Penn engages non-Penn personnel as independent contractors to consult on Penn award (and no subaward with other institution) If consultant with an academic affiliation qualifies as an Investigator: o Home institution with compliant FCOI compliant policy may accept FCOI compliance responsibilities for the Investigator (e.g., obtain disclosure, report FCOIs to Penn) o Otherwise, Penn will assume primary responsibility for obtaining and reviewing disclosures o Investigator must complete Financial Interests Disclosure Form for Investigators Not Affiliated with the University of Pennsylvania and Penn’s FCOI Training o Consultants affiliated with industry or startup – Work should be done under subaward / subcontract 23

Useful Links PHS-FITS Investigator Disclosure Link: investigator PHS-FITS Administrator Disclosure Link: Access the FCOI training in KnowledgeLink at: ?linkId=ITEM_DETAILS&componentID=UP ITEM.FC OI&componentTypeID=COURSE&revisionDate=

Coming Soon Taskforce convened in October to make recommendations regarding a web-based disclosure application Will combine into one system School-based annual extramural reporting Research disclosures Including non-Penn Investigators Final recommendations being presented to VPR this month 25