Financial Conflicts of Interest in Research Sponsored Programs at Penn Research Integrity Office Domenick Klein, Regulatory Compliance Officer April 8, 2013 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 Conflict of Interest Defined 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 The Special Nature of FCOIs Related to Research 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 • Equity • Inventor’s right to / receipt of • royalties Service as officer , or in any fiduciary role for company • With research sponsor • With company that manufactures product being tested, evaluated or developed in the research (including competitive products) 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 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_n02/090412-SupplementConflictsInterest.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 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 and 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). Prior and New Disclosure Requirements - Scope of Disclosure Past (and still applicable for non-PHS research) • Investigators disclosed SFIs (and those of their Family members), based on their own selfassessment, 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. 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 senior / key personnel and other individuals responsible for the design, conduct and reporting of PHS-funded research (Investigators) must submit a PHS Financial Interest and Travel Statement (PHS-FITS). Investigators must also complete FCOI training prior to participating in PHS funded research and then every 4 years. Please contact the Office of the Vice Provost for Research at 215-898-3603 or email [email protected] regarding how to submit a PHS-FITS and how to comply with FCOI training requirements. 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 disclosure 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 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.edu Investigator Decision Tree: The Who, What, Where, and When for Disclosure Requirements at Penn 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). FCOI Determination CISC advisory to SVPR • 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 SVPR makes final determination regarding FCOI and management 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 Mandatory Investigator Training • Investigators must receive FCOI training in KnowledgeLink prior to participating in PHS-funded research and every 4 years • Commenced training this summer in Blackboard. • Training records have been migrated to KnowledgeLink. • Investigators are prompted in PHS-FITS to take training • Investigators should 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 – Must report details of FCOI and management prior to expenditure of funds, within 60 days of identifying a new FCOI, and at least annually – OVPR will handle for if NOA after 8/24/12 Response to Noncompliance Management of subawards – Subaward agreement must specify the applicable FCOI policy and timeframes for reporting to Penn 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: • Confirm with the PI a complete list of Investigators • 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 • Confirm that all Penn Investigators have completed FCOI training in KnowledgeLink (may obtain through Data Warehouse report) • Complete the PHS-FITS Confirmation Form and submit to ORS 19 PHS-FITS Confirmation Form PHS-FITS Confirmation Form Date: Award Title: Institution Number: Award Number: Investigators participating in this research I have confirmed with the Principal Investigator that the below is a complete list of Investigators (individuals responsible for the design, conduct or reporting of this research), including but not limited to key personnel, consultants and collaborators (you may enter multiple names in each text box below.): Penn Investigators: Non-Penn Subaward Investigators: Other Non-Penn Investigators (e.g., consultants and collaborators): O I confirm that all Penn Investigators have submitted a current PHS-FITS, including a Relatedness Assessment for this research. O I confirm that all Penn Investigators have completed the Financial Conflicts of Interest in Research Investigator Training Course – OVPR. Business Administrator Certification I certify that the above information is complete and accurate to the best of my knowledge. Type Name Business Administrator Signature: School: Department: 20 Useful Links • PHS-FITS Investigator Disclosure Link: https://medley.iscseo.upenn.edu/phsFits/jsp/fast2.do?fastStart=investigator • PHS-FITS Administrator Disclosure Link: https://medley.isc-seo.upenn.edu/phsFits/jsp/fast2.do • Access the FCOI training in KnowledgeLink at: https://upenn.plateau.com/learning/user/deeplink_redirect.jsp?linkId =ITEM_DETAILS&componentID=UP.91028.ITEM.FCOI&componentType ID=COURSE&revisionDate=1349737260000 Export Controls – What They Are and What You Should Know • U.S. laws and regulations that restrict, limit, curtail, or prevent the distribution of strategically important products, services, and information to foreign nationals and foreign countries for reason of foreign policy and national security. – Export Administration Regulations (EAR) Department of Commerce, Bureau of Industry and Security (BIS) – International Traffic in Arms Regulations (ITAR) Department of State, Directorate of Defense Trade Control (DDTC) – Office of Foreign Asset Controls (OFAC) Department of Treasury – Other Departments and Agencies –NRC, DEA, EPA, FDA, etc. Export Controls – So What? Export Control Laws prohibit the unlicensed “export” of certain controlled technologies for reasons related to national security, treaty compliance, and trade agreement. If Penn research involves these controlled technologies, Penn may be required to get U.S. government approvals (licenses) before allowing: • Foreign researchers and students in the U.S. (including at Penn!) or anyone outside the U.S. to participate in such research • The sharing of research materials or results with persons who are not U.S. citizens or permanent residents • “Export” is defined very broadly as any oral, written, electronic or visual disclosure, shipment, transfer or transmission of a commodity, technology or software/codes. Note: Server access could be an export! Export Control Laws and Research at Penn General Rule: Penn, its faculty, and employees may not export to some foreign entities certain materials and information without a license from the U.S. Government, unless an exception applies ORS and OGC will determine whether an exception applies. Researchers are the first line of defense and need to make ORS aware of any potential Export Control issues with a particular study or agreement. So, what do you need to look out for? Export Control Laws and Research at Penn What to look for in your study/agreement: International Component • Are there foreign entities, researchers, or students involved? • Will information be shared with persons who are not U.S. citizens or permanent residents? • Is there international travel or field research where Penn owned equipment may be shipped outside the U.S.? Agreement terms • References to U.S. export regulations • Restrictions or approvals of who may participate • Receipt of and/or restricted use of proprietary information • Restrictions on the dissemination of research results Purchase of Equipment that is Controlled • Non-export certifications Any study/agreement that has an international component may be subject to Export Control Laws and should be reviewed by ORS to ensure compliance. Export Control Laws and Research at Penn Important: Most research studies will pass Export Control review without any further action (90%+) because of the Fundamental Research Exclusion. Fundamental Research: basic and applied research in science and engineering, the results of which are ordinarily published and shared broadly within the scientific community, as distinguished from proprietary research and from industrial development, design, production, and product utilization, the results of which ordinarily are restricted for proprietary or national security reasons. Consequences of Non-Compliance: 1) Loss of exporting privileges of the University 2) Place Federal funding at risk for both University and individual PIs 3) Criminal and Civil penalties for both the University and individuals Any questions? Please contact ORS at anytime. Reporting Non-Compliance • Responsible Offices – ORS – IRB – IACUC • Office of General Counsel • 215-P-Comply Questions???