1. Financial Conflicts of Interest in Research Sponsored Projects at Penn Research Integrity Office February 25, 2014

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

4. 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.

5. 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

6. 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

7. 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

8. Major Regulatory and Penn FCOI Policy Changes New 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 http://www.upenn.edu/almanac/volumes/v59/n02/pdf_n02/09041 2-Supplement-ConflictsInterest.pdf http://www.upenn.edu/almanac/volumes/v59/n02/pdf_n02/09041 2-Supplement-ConflictsInterest.pdf Applicable to all research being conducted under Penn’s auspices, regardless of funding source  Implementation will be in stages  Initial emphasis will be to first assure compliance with the PHS regulations (transition period)  For Investigators – biggest change is in the disclosure process 8

9. New 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

10. Prior and New Disclosure Requirements - Scope of Disclosure 10 Past (and still 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 Now for PHS 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, such as consulting or serving on a scientific advisory board 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. 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.

11. New 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 https://medley.isc-seo.upenn.edu/phsFits/jsp/fast2.do?fastStart=investigator. https://medley.isc-seo.upenn.edu/phsFits/jsp/fast2.do?fastStart=investigator 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, http://www.upenn.edu/research/pdf/policy_on_conflicts_of_interest_related_to_research. pdf Yes No 11

12. New 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 https://fides.isc- seo.upenn.eduhttps://fides.isc- seo.upenn.edu 12

13. 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

14. Assessment of PHS-FITS Disclosures School COI Office / Officer will review 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

15. 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

16. 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

17. 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

18. 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 Management of subawards  Subaward agreement must specify the applicable FCOI policy and timeframes for reporting to Penn 18

19. BA Responsibilities for Triggering Events When? New and competing awards - at JIT or other indication of funding Noncompeting Continuations - when submitting progress reports for NCCs For subawards – prior to execution What? BA for the proposal responsible org must: 1. Confirm with the PI an accurate list of Investigators. Edit / update list in “Investigator Maintenance” portal in PHS-FITS and certify that list. 2. Confirm in PHS-FITS that all Penn Investigators have completed FCOI training in Knowledge Link 3. Confirm in PHS-FITS that all Penn Investigators have a complete PHS-FITS (SFIs, Travel and Relatedness Assessment) and that their final FCOI status is either:  a) FIDES not required, school concurs;  b) FIDES required by system, school concurs; or  c) School requested additional disclosure in FIDES 4. When steps 1 to 3 are complete, E-mail ORS advising that the proposal is ready for review / account set-up. 19

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 7/1/13 Investigators are required to complete Relatedness Assessments for new or competing awards and update existing Relatedness Assessments when adding new SFIs Investigators do not need to update Relatedness for each noncompeting segment 20

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 Penn will require Investigator to eliminate any FCOIs 21

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 22

23. Useful Links PHS-FITS Investigator Disclosure Link: https://phsfits.apps.upenn.edu/phsFits/jsp/fast2.do?fastStart= investigator PHS-FITS Administrator Disclosure Link: https://phsfits.apps.upenn.edu/ Access the FCOI training in KnowledgeLink at: https://upenn.plateau.com/learning/user/deeplink_redirect.jsp ?linkId=ITEM_DETAILS&componentID=UP.91028.ITEM.FC OI&componentTypeID=COURSE&revisionDate=1349737260 000 23