Financial Conflicts of Interest in Research

Sponsored Projects at PennResearch Integrity Office

February 25, 2014

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OutlineOutline

• 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

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Conflict of Interest DefinedConflict of Interest Defined

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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 DefinedInstitutional FCOI

Conflict of Interest DefinedInstitutional 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

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The Special Nature of FCOIs Related to Research

The Special Nature of FCOIs Related to Research

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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 resultsAND

A personal financial interest / relationship related to the research Consult for research sponsoro Have stock in company that manufactures experimental

producto Receive royalties related to IP being tested in the research

FCOI ConcernsFCOI 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

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Major Regulatory and Penn FCOI Policy ChangesMajor 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-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

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New Disclosure Thresholds What to disclose – SFIs

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).

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Prior and NewDisclosure Requirements - Scope of Disclosure

Prior and NewDisclosure Requirements - Scope of Disclosure

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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.

New FCOI Screening Questions PD – PI CertificationNew 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 . 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

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New FCOI Screening Questions PD - PI Certification Cont.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

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Investigator Decision Tree: The Who, What, Where, and When for Disclosure Requirements at Penn

Investigator Decision Tree: The Who, What, Where, and When for Disclosure Requirements at Penn

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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 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).

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FCOI DeterminationFCOI 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

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Management of FCOIsManagement 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

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Mandatory Investigator TrainingMandatory Investigator Training

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• 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 ElementsOther 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

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BA Responsibilities for Triggering EventsBA 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.

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Investigator Maintenance and ReportsInvestigator 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 (3rd 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

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PHS-funded SubawardsPHS-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

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Consulting on PHS AwardsConsulting 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

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Useful LinksUseful 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.FCOI&componentTypeID=COURSE&revisionDate=1349737260000

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