Addressing Conflicts of Interest in PHS-Funded Research

Lynn Zentner, Director
Jon Guden, Assistant Director
Seth Beccard, Program Assistant
Conflict of Interest Program, Office of Institutional Compliance
Lorrie Awoyinka, Sponsored Projects Administration
Gregg Pioske, College of Pharmacy
02.12.2013

Agenda
Individual Conflicts of Interest Policies
Conflict of Interest (COI) Defined
Reporting Interests and COI Review Process
The Public Health Service (PHS) Financial Conflict of Interest
Regulations
What is Different about PHS Funded Research?
Steps to Ensure Compliance
Summary of PHS Requirements
Agencies Using PHS FCOI Regulations
COI Resources
COI Program Staff

Individual Conflicts of Interest:
Administrative Policies

Conflict of Interest (COI) Defined
• Exists when an individual’s* significant financial
interests (SFI) and/or business interests in a business
entity overlap with one of more of their University
responsibilities:
– Teaching
– Research
– Clinical health care
– Outreach activities
– Administrative functions
*This includes the individual’s family members.

Reporting Interests
• Who? Faculty, P&A, those responsible for “design,
conduct, or reporting of research”(investigators, key
personnel)
• What? Financial and Business Interests
• How? Report of External Professional Activities (REPA)
• When?
– Annual reporting spans 2012 and 2013; started Feb 1
– “Change in circumstances” within 30 days of:
• acquisition of a new significant financial interest
(SFI) or business interest; or
• change in responsibilities (e.g., new research) that
overlaps with existing SFI or business interest

Financial Interest Disclosure
Thresholds
Category of Individual*
Involved in Clinical Health
Care
Engaged in Public Health
Service Research (e.g., NIH)
Financial Threshold (royalties,
income, publicly traded
equity)
Any dollar amount
($5000 is SFI threshold)
More than $5,000 income and
equity combined, or $5,000 in
royalties
Equity Interest
(Non Publicly
Traded)
Any equity
Any equity
Everyone Else $10,000 or more 5% or more,
regardless of
value
*This includes the individual’s family members.
NOTE: If the individual is involved in more than one of these categories, he/she must
disclose at the lowest threshold.

Business Interests
• Holding an executive position (e.g., Chief Executive
Officer, Chief Operating Officer, Chief Scientific or
Technical Officer)
• Compensated or uncompensated membership on a
board (e.g., boards of trustees, scientific advisory
boards, medical advisory boards, and boards of
professional societies)

The COI Review Process
Individual
completes a
REPA
Dept/college
reviews
Were
interests
disclosed?
No
REPA is approved
Yes
No
COI program
staff review
Overlap with
U Role?
Yes
Conflict
Review Panel
review
Is there a
COI?
No
Yes
Management
mechanisms
determined
Management
plan created
and accepted.
REPA
approved.
90-day
compliance
review
Annual
compliance
review

The Public Health Service (PHS)
Financial Conflict of Interest Regulations
• Purpose: To promote “…objectivity in research by
establishing standards that provide a reasonable
expectation that the design, conduct, and reporting
of research funded under PHS grants or cooperative
agreements will be free from bias resulting from
investigator financial conflicts of interest.”
• Provisions incorporated into University Conflict of
Interest Policies and REPA in 2012

The Public Health Service (PHS)
Financial Conflict of Interest Regulations
• Apply to domestic, foreign, public and private (not Federal)
entities that apply for or receive PHS funding
• Apply to all individuals who meet the definition of “Investigator”.
That is, any person, regardless of title or position, who is
responsible for the design, conduct, or reporting of research
funded by the PHS or proposed for such funding
• Apply to subrecipients, subgrantees, collaborators and possibly
consultants
• FCOI training required at least every 4 years

What is Different about PHS Funded
Research?
• Can’t spend money until COI training complete and conflicts are
managed
• Ongoing research: Investigator must disclose new SFI within 30
days of acquiring; University has 60 days to review and manage
– Consequences of untimely report and management?
• University must conduct a retrospective review
• Depending on the severity and duration of the noncompliance, Sponsor
could take other actions such as: impose special conditions on the award;
wholly or partially suspend award; or terminate the award (worst case
scenario)
• University may be responsible for subrecipient conflicts
• Investigator reports sponsored/reimbursed travel >$5000
(government agency and higher education exceptions)

Steps to Ensure Compliance
At time of Proposal:
• Communicate with your faculty
• Ensure all UMN personnel identified as “key personnel”
in the proposal have a current REPA on file
• Confirm REPAs are up-to-date
• For proposal that include subs:
• Collect FCOI status for each site:
• Check the FDP Clearinghouse; or
• Obtain completed Form 1 and, if necessary, Form 2

Steps to Ensure Compliance
At time of Proposal (continued):
• Consultants can be included in the Key/Senior Personnel
section under two circumstances:
• If consultant meets definition of Senior/Key Personnel (as
defined by NIH Grants Policy) but does not meet the
definition of Investigator (FCOI Policy), the PI should provide
an explanation in writing (e.g. email)
• If consultant meets definition of Senior/Key Personnel (as
defined by NIH Grants Policy) and also meets the definition
of Investigator, then the consultant must complete Form 2

Steps to Ensure Compliance
At time of Award and Post-Award:
• Anytime SPA generates a NOGA, the GA must verify
the University PI and other University personnel
identified as key have completed their FCOI training
• Department must provide FCOI verification
information for all subrecipients prior to issuance of
the sub agreement
• FCOI training must also be verified for changes to
existing awards (i.e. change in PI and no cost
extensions)

Summary of PHS Requirements
• At proposal time:
• Current year REPA must have been completed by PIs, Co-Is
and all others identified as key personnel on PRF before
proposal can be submitted.
• If including subs, SPA must be provided with documentation
that each: 1) Subrecipient has its own FCOI policy in place
(FDP Clearinghouse or Form 1); or 2) Subrecipient will use
UMN FCOI policy AND Forms 1 and 2.*
• If Consultant included in Senior/Key Personnel section,
provide appropriate documentation
*NOTE: If subrecipient documentation is not provided, all references to sub
(personnel, budget and scientific) must be removed from the proposal.

Summary of PHS Requirements
• At Award time and Post Award:
• Current year REPA must be on file for PIs, Co-Is and all others
identified as key personnel on PRF and each must have
completed their FCOI training.
• NOTE: Any person with a positive disclosure must have completed review by the COI
Program, have management plan in place (if needed), and PHS notified
• Before a sub can be issued, GA must receive documentation that:
1) Subrecipient has its own FCOI policy in place; or 2) if using
UMN FCOI policy. When using UMN Policy:
• Form 1 and Form 2 and online FCOI training must have been
completed.
• NOTE: If positive disclosure on Form 2, COI Program must have completed its
review, a management plan must be in place (if needed) and PHS notified

Agencies Using these Regulations
Public Health Service (PHS) Agencies
• Office of Global Affairs (OG)
• Office of the Assistant Secretary for Health (OASH)
• Office of the Assistant Secretary for Preparedness and Response (ASPR)
• Agency for Health Care Research & Quality (AHRQ)
• Agency for Toxic Substances and Disease Registry (ATSDR)
• Centers for Disease Control and Prevention (CDC)
• Food and Drug Administration (FDA)
• Health Resources and Services Administration (HRSA)
• Indian Health Service (IHS)
• National Institutes of Health (NIH)
• Substance Abuse and Mental Health Services Administration (SAMHSA)

Additional Agencies Identified as
Using These Regulations
Non-PHS Agencies*
• Administration for Children and Families (ACF)
• Alliance for Lupus Research (ALR)
• American Cancer Society (ACS)
• American Heart Association (AHA)
• American Lung Association (ALA)
• Arthritis Foundation (AF)
• California Breast Cancer Research Program (CBCRP)
• California HIV/AIDS Research Program (CHRP)
• Juvenile Diabetes Research Foundation (JDRF)
• Lupus Foundation of America (LFA)
• Susan G. Komen for the Cure
*It is anticipated that SPA will treat proposal submissions and awards under these agencies
the same as those under PHS

COI Resources
• COI Program Webpage (access to COI policies, COI training
module, and REPA):
http://www.compliance.umn.edu/conflictHome.htm
• NIH FCOI Frequently Asked Questions:
http://grants.nih.gov/grants/policy/coi/coi_faqs.htm
• Public Health Service (PHS) Agencies:
http://www.policy.umn.edu/Policies/Operations/Compliance/CONFLICTINTEREST_APPI.html
• FDP Clearinghouse:
http://sites.nationalacademies.org/PGA/fdp/PGA_070596
• SPA Subrecipient FCOI Resource page:
http://www.ospa.umn.edu/PHSFCOIT.html

COI Program Staff
• Lynn Zentner, Director, Office of Institutional
Compliance, 612/626-7852, lzentner@umn.edu.
• Jon Guden, Assistant Director, Conflict of Interest
Program, 612/626-4727, jguden@umn.edu.
• Seth Beccard, Program Assistant, Conflict of
Interest Program, 612/625-2210
becca002@umn.edu
• Teja Kelley, Coordinator, tjcrane@umn.edu
• repamail@umn.edu; Helpline 626-1462

QUESTIONS?

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