Transcript Update on HIPAA-related work

Conflict of Interest at Duke:
Identification and Management
Joan M. Podleski
Director, Duke IECP
Agenda
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What IS a conflict of interest?
Current Climate:
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COI in the News
Industry Trends & Regulatory Environment
Duke COI Policies
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Officers & Trustees
Faculty/Research
Administrative
Institutional (NEW)
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Agenda
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Disclosure Responsibilities
Review Processes & Committees
Management Plans
Related Policies: Nepotism &
Procurement
Examples and FAQs
Questions
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What is all this?????????
What IS a Conflict of Interest?
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Perception is everything
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Mary Easley’s hiring
Halliburton sales to Defense Department
TARP relationships
Clinton Foundation overseas relationships
Lots of official definitions………..
Institutional Ethics &
Compliance Program
Conflict of Interest
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Defined: A conflict of interest involves the abuse -- actual,
apparent, or potential -- of the trust that people have in
professionals. The simplest working definition states: A conflict
of interest is a situation in which financial or other
personal considerations have the potential to
compromise or bias professional judgment and
objectivity. An apparent conflict of interest is one in which a
reasonable person would think that the professional’s judgment is
likely to be compromised. A potential conflict of interest involves a
situation that may develop into an actual conflict of interest.
*It is important to note that a conflict of interest exists
whether or not decisions are affected by a personal
interest; a conflict of interest implies only the potential
for bias, not a likelihood.
Office of Research Integrity, Health and Human Services
NIH COI Definitions
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What financial interests are covered by the regulation?
All “Significant Financial Interests” (1) that would reasonably appear
to be affected by the research for which funding is sought from the
NIH; and (2) in entities whose financial interests would reasonably
appear to be affected by the research need to be disclosed. A
“Significant Financial Interest” is defined by the regulation as
anything of monetary value, including but not limited to:
 salary or other payments for services (e.g., consulting fees or
honoraria);
 equity interests (e.g., stocks, stock options or other ownership
interests);
 intellectual property rights (e.g., patents, copyrights and royalties
from such rights).
Institutional Ethics &
Compliance Program
NIH COI Definitions
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What financial interests are covered by the regulation?
The term does not include:
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salary, royalties, or other remuneration from the Institution;
any ownership interests in the Institution, if the Institution is an applicant under the
SBIR and STTR programs
income from seminars, lectures, or teaching engagements sponsored by public or
nonprofit entities; income from service on advisory committees or review panels
for public or nonprofit entities;
an equity interest that, when aggregated for the Investigator and the Investigator’s
spouse and dependent children, does not exceed $10,000 in value as
determined through reference to public prices or other reasonable measures of
fair market value, and does not represent more than a five percent ownership
interest in any single entity;
salary, royalties or other payments that when aggregated for the Investigator and
the Investigator’s spouse and dependent children over the next twelve months,
are not expected to exceed $10,000.
Institutional Ethics &
Compliance Program
Conflict of Interest
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Financial conflicts of interest (COI) are those in
which a financial interest has the potential to
influence the impartial business judgment of an
individual.
Areas of consideration include: payments,
honoraria, royalties (even through the
institution), equity, options and warrants, board
of director and management positions, and gifts.
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Conflict of Interest
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An institutional conflict of interest ("Institutional
COI") describes a situation in which the financial
interests of an institution or an institutional
official, acting within his or her authority on
behalf of the institution, may affect or appear to
affect the research, education, clinical care,
business transactions, or other activities of the
institution.
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COI ‘points of intersect’
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A gift to the University by a vendor that
provides services to it
A faculty member with a consulting
relationship with a research sponsor
University owned patents that could increase
in value based on research outcomes
A faculty member with graduate students
working in both their University and private
company labs
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COI ‘points of intersect’
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Research in a University lab that may benefit
a private company
Gifts from a vendor to an administrator who
makes purchasing decisions
Outside responsibilities that conflict with
University responsibilities
Clinicians using products they invented that
are now sold commercially
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University/ Industry
Relationships: Why?
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Decreased Federal funding during the past two
decades has led research institutions to look for
additional sources of funding
As not-for-profit institutions, universities are
encouraged to demonstrate how their activities
lead to improvements to the general public
Industry shift from independent research labs to
funding academic research
Institutional Ethics &
Compliance Program
University/ Industry
Relationships: Why?
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Federal programs encourage partnerships
between academic research and industry
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University-Industry Demonstration Partnership
SBIR and STTR grants
Translational research grants and centers (such as
Duke’s CTSA grant)
Research that leads to new intellectual property
can bring both scientific and financial rewards
(Bayh-Dole Act of 1980)
Institutional Ethics &
Compliance Program
Why ‘manage’ COIs?
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The reasons to manage all COIs, including those
of the Institution, include
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To maintain the highest possible standards of research,
education and clinical care
To protect the health and safety of research participants
To adhere to all applicable federal and state regulations
To maintain the primacy of the University’s educational
mission
To protect the reputation and credibility of the
University, its faculty and staff
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Erosion of the Public Trust
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New England Journal of Medicine: Disclosure of
Industry Payments to Physicians; 8/08
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Wall Street Journal: Pressured, Schools Review
Ties to Drug Firms; 9/08
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The Chronicle: Conflicts of Interest Concerns Halt
NIH Project at Emory; 10/08
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The Chronicle: Emory U Scientist Penalized for
Hidden Payments from Drug Company; 12/08
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The Chronicle: Surgeon’s Royalties Bring Heat to a
Medical School with a Strict Ethics Policy, 2/09
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Erosion of the Public Trust
Institute of Medicine COI report April 2009
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New York Times: “IOM calls for "far-reaching" changes to
prevent industry influence on patient care, research;”
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Wall Street Journal:
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Associated Press: "the report could give [lawmakers] more
“The IOM's recommendations,
contained in a 353-page report, come amid heightened concern and
investigations – often led by Iowa Republican Sen. Charles Grassley
– about the impact that industry gifts and payments have on doctors,
medical schools, professional groups, and journals."
leverage in their push to untangle the knotty relationships between
industry and physicians, which some say drive up the cost of
medicine."
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Erosion of the Public Trust
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New York Times: Doctor Falsified Study on
Injured G.I.’s, Army Says; 5/13/09
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A former Army surgeon who is also a consultant for
a medical company has been accused of
overstating the benefits of a product used in treating
soldiers.
New York Times: Medical Papers by
Ghostwriters Pushed Therapy; 8/5/09
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Court documents suggest a broad level of
hidden industry influence on medical literature.
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Erosion of the Public Trust
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New York Times: Clinical Trials Rule is Widely
Ignored; 9/8/09
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Many researchers are ignoring a requirement that they
register proposed clinical trials in a government
database as a condition for publishing their results.
The Chronicle: Medical Journals See a Cost
to Fighting Industry-Backed Research; 9/13/09
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A journal's tough policy on articles with data paid for
by drug makers pushed more such articles to
competitors, editors hear at a conference.
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Erosion of the Public Trust
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The Chronicle: University Researchers Received
$130,000 Apiece from Drug Maker; 2/3/10
 The pharmaceutical maker Cephalon is the latest
medical company to make public the names of
doctors it has paid for consulting and promotional
services……each of whom collected more than
$130,000 from Cephalon. The company provided the
information as part of a $425-million settlement it
reached with federal prosecutors in 2007 over
allegations it was marketing drugs to patients for offlabel purposes.
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COI in the News
The Baylor Story
COI Oversight by the NIH - 2010
In the beginning……
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Concerns raised after Vytorin (a drug combining
two existing medications) showed limited effect
in a study which had been published only very
slowly
Faculty hired by Merck and Schering-Plough to
speak in favor of Vytorin, even after they knew
of the concerns
Article in the Chronicle of Higher Education
reviewed role of certain well paid faculty
Overview
Baylor’s Position
The Unraveling Begins
Cautionary Notes for All
Francis Collins of NIH to
Senator Grassley
Current Status
Of Note
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Vanderbilt and Cornell-Weill had NIHfunded investigators who received more
than Dr. Ballantyne, and reviewed those
situations.
They were cleared by the institutions, the
NIH and Grassley. Details have not been
released.
Lessons for Duke
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Full and accurate disclosures by each
individual is key
COI is about perception of potential
conflict to the general public, not the
individuals involved
If in doubt, report situations
Manage aggressively
NIH/OIG Enforcement actions can have
real teeth
Questions to Consider
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Some residual questions, like the fact
that Baylor’s declaration of non-overlap
sounded appropriate (but maybe not
accurate?)
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Ballantyne had multiple grants looking at
effects of lipid lowering agents on blood
vessel plaques – while not designed to study
Vytorin specifically, could be considered an
overlap
Current Industry Trends
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Industry sponsors begin to publish payments
to clinicians and researchers
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Merck
Eli Lilly
Medtronic
Cephalon
Some academic medical centers begin to
publish disclosed relationships between
clinicians and industry
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Regulatory Environment
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Regulatory Environment
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OIG audits NIH to assess current management
of conflicts of interest
NIH requesting additional information from
University’s on most reported disclosures,
specifically related to management plans
Congress has pending legislation (Sunshine
Act) requiring industry sponsors to publish all
payments to clinicians and researchers
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Regulatory Environment
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Regulatory Environment
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Fall of 2009 DHHS Office of Inspector General
requires Duke and many other institutions to
complete a “survey regarding financial interests
held by institutions that received National
Institutes of Health grants”
Focus of the survey was “Grantee Institutions’
Policies and Procedures on Institutional
Financial Interests related to Research”
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Duke COI Policies
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Officers & Trustees
Faculty/Research (FCOI)
Administrative (ACOI)
Institutional/Research (ICOI)
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Trustee COI Policy
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In existence since 1987 and updated in
2008
Annual disclosure requirement for all
officers and trustees
Management of COIs typically consists
of recusal from decisions involving any
areas of overlap
Management plans approved by Board
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Reporting for Duke Faculty
and Staff under COI
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Anything on a 1099 or
W2 not from Duke
Direct investments
(not mutual funds)
with vendors &
sponsors
Intellectual Property
Positions with outside
firms
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Gifts related to Duke
business
Family financial
relationships with Duke
vendors or sponsors
Family positions with
firms doing business with
Duke
Others as listed on
individual COI forms
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Reporting Requirements
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Required annually by all Duke faculty,
research staff paid from sponsored projects,
selected administrative staff, officers,
trustees and ICOI Covered Officials
All Duke COI policies includes requirement
that substantial changes be reported within
10 days of change
Currently 8,000+ individuals asked to report
Each responsible for full and accurate
completion of their COI form
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Faculty/Research COI
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Disclosure notice with link to electronic
form sent out February 3, 2010 with
completion due by March 1, 2010
Potential conflicts reviewed by Campus
or SOM FCOI committees
All faculty with protocols reviewed
through the Medical IRB are reviewed by
the SOM FCOI committee
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FCOI Review Committees
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Chairs of Campus and SOM FCOI
Committees sit on both
Voting members of FCOI committees are
faculty members
Ex officio members: counsel
representative; OLV representative;
compliance representative(s); COI staff
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Faculty/Research COI
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Management plans related to FCOIs may include:
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Reassigning the research to a different PI
Establishment of an internal or external Data Safety
Monitoring Board (DSMB or DSMB+)
Supervision of research staff by a non-conflicted
faculty member
Recusal from decisions related to the conduct of the
research
Restricting the research from performance at Duke
Relationship disclosures
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Disclosures as COI Management
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Committee or
decision recusals
Consent
documents
Publications
Presentations
Contracts
FDA
NIH
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Administrative COI Policy
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Approved by Duke Board of Trustees May
2008
Affects officers, directors, and any individual
with administrative responsibilities
Policy addresses: financial conflicts, conflicts
of commitment, and conflicts that may be
presented by the employment of or business
relationship with a relative (nepotism)
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Scope of ACOI Policy
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Administrators who:
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Are involved in decisions or serve in a
position to influence, recommend, or make
purchases
Hire employees
Offer expert advice, or influence or manage
vendor relationships
AND the family of those administrators
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Scope of ACOI Policy
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Who makes the ACOI list
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Administrative staff level 14 and above
Staff with titles of manager or director
All staff in select areas such as compliance,
audit, purchasing
Staff identified by their department or
supervisor as having duties related to
potential COIs
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Issues in ACOI Policy
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Potential Conflicts of Interest
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Ownership or employment by a vendor doing
business with Duke
Acceptance of gifts from vendors or potential
vendors
Consulting relationships with a vendor doing
business with Duke when the administrator can
influence decisions or recommendations related to
that business
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Issues in ACOI Policy
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Conflict of Commitment
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Membership on boards or advisory boards that
take time away from work to the extent that fulltime job obligations are not met
Employment by another entity that is part-time,
but that interferes with meeting the administrator’s
full-time job obligations to Duke
Aggregate time spent in outside activities that
interfere with the performance of Duke obligations
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ACOI Policy Key Points
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Clarity of compliance and disclosure
responsibilities for those in administrative
roles
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COI reporting form: Declaring relationships
Definition and guidance on conflict of interest,
conflict of commitment, nepotism
Definition and clarification on “material
gifts”
Creation of FAQs to provide guidance
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How does this affect me as
an administrator?
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Compliance and disclosure for those
in administrative roles
Guidance to review staff disclosures
of relationships
Oversight of any COI management
plans put in place
Reinforces confidentiality obligations
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ACOI Review Committee
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Executive Director of Internal Audits
SOM rep: Chair, SOM FCOI
Committee
Campus rep: Exec. Vice Provost,
Finance/Administration
Representative from Office of Counsel
Institutional Ethics &
Compliance Program
Institutional COI in Research
Policy
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Approved by the Board of Trustees in
December 2009
Effective January 1, 2010
Scope includes
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Financial interests of “covered officials” that
overlap with Duke research
Ownership of Intellectual Property or Equity that
overlaps with Duke research
Gifts to Duke from sponsors of research
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Institutional COI Policy
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Definition of “Covered Officials”
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Board of Trustees, the President and vice presidents, the
Chancellor for Health Affairs and vice chancellors, the
Provost and vice-provosts, other senior officials, Deans and
vice-deans, associate deans and other institutional
administrators with responsibility for the supervision of faculty
and staff participating in research conducted at or under the
auspices of the institution. The policy specifically covers
department chairs, division chiefs, institute and center
directors, and the chairs of the Institutional Review Boards,
Conflict of Interest Committees, the Institutional Biosafety
Committee, the Stem Cell Review committee and chairs of
similar committees that might be created in the future.
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Institutional COI Policy
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Scope of ICOI Reviews
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Individual financial relationships of Covered
Officials that might overlap with University
oversight of research or researchers
Duke’s financial holdings that overlap with
University research
Gifts to Duke from vendors of materials being
studied or sponsors of research
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ICOI Review Committee
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3 Internal COI Committee Chairs
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SOM FCOI
Campus FCOI
ACOI
2 at-large faculty (1 SOM, 1 Campus)
2 external members (can not be Duke
faculty, staff or Board members)
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Procurement
Issues
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Responsibilities: How will this
affect me?
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Product Review Committee members
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Sign disclosure form
Reaffirm COI status at each meeting
Disclosure responsibilities
If COI exists, participant not involved in
decision making
Strict confidentiality regarding information
discussed in meetings
Product Requesters
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Sign disclosure form
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Vendor Review Meetings
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Codicil to meeting documents:
“As part of the work of this team, you will have
access to pricing and other vendor information.
Materials and pricing provided by vendors should
not be shared outside the team nor should such
information be made available or communicated in
any way to anyone outside Duke. It is important
that you maintain the highest level of
confidentiality regarding this process and any
information you receive. Disclosure of information
outside the team may result in disciplinary action,
up to and including termination of your
employment at Duke.”
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ACOI Policy Summary
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COI Policy requires individuals with
administrative responsibilities to exercise their
best care, skill, and judgment for the benefit of
Duke
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“Individuals shall not accept any material gifts,
favors, or hospitality that might influence their
decision making or compromise their judgment in
actions affecting the University.”
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If an employee has a relationship with a vendor
representative, it could be interpreted as a conflict of
interest in influencing product decision making or it may
be seen as Duke sponsoring a particular product.
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Examples
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Examples
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Are individuals covered by a COI
Policy permitted to accept any gifts, or
are all gifts banned?
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The policy prohibits the acceptance of
material gifts, favors, or hospitality that
might influence or appear to influence
their decision making or compromise their
judgment in actions. “Material” is defined
to be anything having a fair market value
of $25 or more. For DUHS, it is $0.
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Examples
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An example of a prohibited gift is
accepting tickets to sporting events,
concerts, plays, and similar events;
accepting merchandise of greater than
$25 in value.
For DUHS, it includes the prohibition of
all “branded” materials
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Examples
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Are vendors still able to provide lunch during
a lunch and learn session when they are
providing training on a new product that is
being implemented?
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Vendors may provide nominal lunches such as
pizza or sandwiches for Campus areas. The
DUHS Policy on Gifts specifically precludes
acceptance of lunches from vendors.
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Examples
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What about visiting vendors’ facilities?
May vendors pay for site visits?
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No. With regard to visits to vendor facilities, if
the department administrator in consultation
with Procurement determines that it is in the
best interest of Duke, then Duke will pay the
travel expenses.
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Examples
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What if I am participating on a vendorsponsored user group? May a vendor
pay my travel expenses?
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No. If your participation on a user group has
been approved by your immediate supervisor
as being in the best interest of Duke, then
Duke will pay the expenses.
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Examples
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When a vendor sponsors a seminar, may
they pay for my time and travel to the
seminar?
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If you will be presenting on a topic unrelated to
the vendor’s product or service, the vendor
may pay for your expenses but not your time.
If the presentation is related to the vendor’s
product or service, the vendor may NOT pay
any of the expenses.
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Examples
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May I attend a seminar which is
sponsored by a vendor that is offered
free to all participants?
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Yes. Because the vendor is paying for all
participants, this would not be a violation of
the Conflict of Interest policy.
On-site meals that are part of the event
may be included.
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Examples
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May I provide consulting on my
personal time or is this a conflict of
commitment or conflict of interest?
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This situation could be a conflict of interest
or commitment. In order to comply with the
Policy, you should take the following steps:
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Examples, cont.
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Next Steps:
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Notify your manager
Complete a revised Disclosure Form for review
Manager must consider if responsibility conflicts with Duke
position and propose a management plan if appropriate
Employee cannot use Duke’s name, materials or other Duke
staff members to perform outside responsibilities
Employee must perform Duke obligations, e.g., be available
for coverage or overtime requirements with no special
considerations
Employee cannot use information gained at Duke
Employee should identify any vendor funding for supervisor
to consider in management process
Manager must oversee the management plan agreed upon
by the COI review committee and the employee
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Examples

Dr. Johnson created a new assessment scale
for evaluating bi-polar disorder and is listed
on the copyright for the scale. The scale has
been licensed to Feel Good Pharma. Feel
Good pays Dr. Johnson royalties as a result
of the license. What type of role can Dr.
Johnson have in ongoing research related to
the scale?
Institutional Ethics &
Compliance Program
Examples
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Dr. Happy serves on the advisory board for
Miller Medical Devices and is paid $30,000.
Dr. Happy has an NIH-funded study that
includes comparing three medical devices,
one of which is manufactured by Miller.
Review Questions: can he be the PI on the
study? Can he take part in the study? Are
there any notifications or disclosures
required?
Institutional Ethics &
Compliance Program
Duke COI Policies Summary
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All Policies cover financial & fiduciary conflicts
ACOI also covers conflicts of commitment and
nepotism
Policies require reporting of all outside
relationships as defined in the policy and complete
answers to all questions on the COI Disclosure
Form
Disclosures will be reviewed to determine if there
is a conflict that needs to be managed or
eliminated
Compliance is required with all Duke COI policies
and management plans
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In closing ……….
Institutional Ethics &
Compliance Program
Questions
For questions regarding Conflict of
Interest, please contact:
 [email protected]
 Office of Internal Audits at 613-7630
 Duke Procurement at 681-5900
Compliance concerns can be reported to the Duke Institutional
Ethics & Compliance Office at 919-613-7691 or to [email protected].
Issues can be reported anonymously to the Duke Compliance &
Fraud Hotline at 1-800-849-9793.
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