Financial Conflicts of
Interest in Research
Sponsored Projects at Penn
Research Integrity Office
February 25, 2014
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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
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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.
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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.

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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
 Consult for research sponsor
o Have stock in company that manufactures experimental
product
o Receive royalties related to IP being tested in the research
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FCOI Concerns
Personal financial ties with industry might distort researcher’s
judgment:
•
•
•
•
•
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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 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
• 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
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 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 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).
•
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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 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
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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.iscseo.upenn.edu
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Investigator Decision Tree: The Who, What, Where, and When
for Disclosure Requirements at Penn
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
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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 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 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 Training
• 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
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Other Policy Elements
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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
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.
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Investigator Maintenance and Reports
Investigator Maintenance Module in PHS-FITS:
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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
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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
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
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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
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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
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