1. Sponsored Projects at Penn
Financial Conflicts of Interest in Research
Sponsored Projects at Penn
Diane Wender, JD
Research Integrity Office
February 20, 20-18

2. Conflict of Interest Defined
May exist when financial or other personal considerations have potential to compromise or bias professional judgment or objectivity
Conflict of Interest vs. Financial Conflict of Interest (FCOI)
Subjective factors
Publications
Promotion
Prestige
Objective factors
Funding for research
Personal financial gain
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.

3. The Special Nature of FCOIs Related to Research
FCOIs are intrinsic to the researcher's enterprise
Problem is not just the FCOI but the potential for BIAS
Recipe for an 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
Stock
Royalties

4. 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
Researchers don’t think their conflicts affect their research, but that conflicts do affect other people’s decisions. Eric Campbell

5. 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 8/24/12
Applicable to all research being conducted under Penn’s auspices, regardless of funding source
Applicable to Investigators - any person, regardless of title or position, who is responsible for the design, conduct or reporting of research
Includes Key Personnel, Consultant-Key Personnel and Significant Contributors
May include individuals who are not paid off the award

6. Disclosure Thresholds Significant Financial Interests (SFIs)
Investigators must disclose SFIs for any research for past 12 months (includes SFIs of spouse and dependent children)
For a public company: aggregate value of any payments and current equity > $5,000
For a non-publicly traded company: any equity + payments > $5,000
Income from IP rights not assigned to Penn
Any Clinical trial intellectual property, whether or not assigned to Penn – Penn requirement
Any Fiduciary Role for a company – Penn requirement
PHS Investigators must also disclose travel reimbursed or paid on the Investigator’s behalf within the most recent 12 months
Exclusions to the above
Penn salary or research funding received by Penn
IP rights assigned to Penn unless used in a clinical trial
Payments from a government agency, US academic institutions
Retirement accounts

7. Current Disclosure Requirements – Scope of Disclosure
For PHS-funded research
Investigator must disclose SFIs in a PHS-Financial Interests and Travel Statement (PHS-FITS) that reasonably appear to be related to his/her Institutional responsibilities (even if not related to the research).
Related if:
SFI arises from extramural activities that derive from the Investigator’s professional standing or are within that Investigator’s professional field(s) of discipline
Equity in, or serving in a fiduciary role for, a company that, to the best of the Investigator’s knowledge, conducts or seeks to conduct business related to the Investigator’s field of discipline
For non-PHS funded research
Investigators disclose SFIs (and those of their Family members if such interests could affect or be affected by the research and / or such interests were in / with one or more companies whose interests could affect / be affected by the research
Disclosure submitted in the Financial Interest Electronic Disclosure System (FIDES)

8. Other Regulatory Requirements
FCOI training required prior to participating in PHS-funded research and every 4 years
Public Accessibility
Must respond within 5 business days to written requests for information regarding FCOIs of Senior/Key Personnel
Reporting to NIH
Prior to spending of funds
Within 60 days for any new FCOI
Annual status updates for each FCOI reported
Must provide:
Investigator identifying information
Name of entity with which the Investigator has a FCOI
Nature of FCOI, how it relates to research, and why SFI = FCOI
Value of SFI with specified increments to $100,000 and above
Key elements of management plan, including how plan is designed to safeguard objectivity and monitoring
If an FCOI is not timely identified or managed, must complete a retrospective review to determine whether the research was biased

9. Assessment of Relatedness of SFIs to Research
SFIs are related to the research if:
SFI could be affected by the research; or
SFI is in an entity whose financial interests could be affected by the research
Penn is responsible for assessing relatedness but may obtain Investigator’s input
PHS-FITS Grant Relatedness Tab - 5 screening questions
Example – Disclosed SFI with Merck
What role does Merck have in this research (sponsor, provides study drug)?
Will Investigator acknowledge or give attribution to Merck in any publication or presentation related to the research?
Other questions not specific to any company
Any fiduciary role for Merck or any other entity whose financial interests could be affected by this research?
Any IP being tested, evaluated, developed in, or will its commercial value be affected by, the research?

10. 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

11. Assessment of PHS-FITS Disclosures
School Review
School FCOI Office / Officer reviews SFI disclosures and the Investigator’s input on their relatedness
If SFIs are related to the research, additional disclosure in FIDES may be required
FIDES disclosures may be referred to the CISC for review or handled administratively
CISC Review
Advisory to the Vice Provost for Research (VPR)
Review SFIs based on type and/or on $ value
Makes recommendations regarding whether a related SFI = an FCOI and its management
FCOI = if the SFI could directly and significantly affect the design, conduct and reporting of the research)
VPR makes final determination regarding FCOI and management

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

13. PHS-FITS Overview
Required only for Investigators participating in any PHS funded research
Also now required for Penn Investigators on PCORI awards
Must submit SFIs and Travel
Not related to any specific grant
Must add new SFIs within 30 days
Must certify SFIs and Travel annually in July
For remainder of this FY, if new or competing award, SFIs must have been submitted on or after 7/1/16
Must submit a Relatedness Assessment for each new or competing award or subaward
Only one per grant
Only updated for new SFI or if a previously reported SFI that was unrelated becomes related
New Relatedness Assessment not required at time of NCC

14. 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
Reports 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

15. BA Responsibilities Related to PHS Triggering Events
Triggering events are:
New and competing awards - at JIT but no later than NOA
Noncompeting Continuations - when submitting progress reports
For subawards – prior to execution each year
BA for the proposal responsible org must:
Confirm Investigators for that award with the PI.
In the PHS-FITS Investigator Maintenance module
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”
For PCORI awards, BA does not need to list non-Penn Investigators
End any Investigators who are no longer participating.
Certify the list of Investigators.

16. BA Responsibilities Related to PHS Triggering Events, Cont.
Run the Financial/Travel Report and confirm that each Penn Investigator has completed his/her SFIs and Travel after July 1 of each year
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 on or after 7/1/13
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.
Does not apply for PCORI awards
When all the above steps are complete, ORS advising that the proposal is ready for review / account set-up.

17. FCOI Procedures - PHS Subawards from Penn to Other Institutions
Subaward agreement must state whether Penn’s or the subrecipient’s FCOI policy will apply to the subrecipient’s Investigators
Penn will require subrecipients to have their own FCOI policies
Only in exceptional circumstances will Penn assume primary FCOI responsibility
Foreign subawards
Community Investigators
For Subrecipient’s covered under Penn’s FCOI Policy:
Investigators must disclose SFIs that are directly related to the subrecipient’s work for Penn and complete Penn’s FCOI Training
Penn will not manage any FCOIs
BAs responsible for:
Adding Investigators in PHS-FITS if notified by RIO
Interfacing with subrecipient if issues arise

18. Consulting on PHS Awards
1) Penn personnel consulting on another institution’s grant
No subaward or other agreement with Penn
Penn 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
2) Penn engages non-Penn personnel as independent contractors to consult on Penn award (and no subaward with other institution)
If consultant has an academic affiliation and qualifies as an Investigator:
Home institution with compliant FCOI compliant policy may accept FCOI compliance responsibilities for the Investigator
Otherwise, Penn will assume primary responsibility
Investigator must complete paper disclosure and Penn’s FCOI Training
Consultants affiliated with industry or startup
Work should be done under subaward / subcontract

19. Useful Links PHS-FITS Investigator Disclosure Link:
PHS-FITS Administrator Disclosure Link:
Access the FCOI training in KnowledgeLink at: