Transcript Managing Conflicts of Interest in Large

Does not represent legal advice.
Managing Conflicts of Interest in Large-Scale
Industry Partnerships – June 12, 2012
Jennifer S. Geetter
Robert H. Underwood, Ph.D.
202-756-8205
[email protected]
617-535-4093
[email protected]
www.mwe.com
Boston
Brussels
Chicago
Düsseldorf
Houston
London
Los Angeles
Miami
Milan
Munich
New York
Orange County
Paris
Rome
Silicon Valley
Washington, D.C.
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Does not represent legal advice.
Introduction & Agenda
Agenda: Review illustrative examples in the financial lifecycle
of biomedical innovation in large provider-industry
partnerships to illustrate the multi-dimensional opportunities
and challenges related to these interwoven and overlapping
financial relationships from both the perspective of industry
and institutions
 Current trends in institution-industry partnerships
 Illustrative examples of research collaboration models – mid-size, large and
very large
 Best practices in COI policy and procedure development
 Review of the latest developments regarding the sunshine provisions
 Strategies for going forward using the illustrative case studies
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Current Trends in Institution-Industry Partnerships
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Where We Are…
 Manufacturers are recognized as part of the health care (not just product)
industry by regulators, media and consumers
 Manufacturers will continue to interact closely with customers in leadingedge relationships
 Many new and novel players on the life sciences scene
 Financial relationships between industry and institutions involved
in biomedical research and innovation are both complex and
commonplace.
 Enforcement priority for regulatory bodies, the plaintiffs bar, industry trade
associations and the media.
 Institutions have responded by restructuring and enhancing internal
conflict of interest programs.
 Industry needs to accelerate its response.
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Challenge of Institution - Industry Partnerships
Maximize
Collaboration,
Input & Resources
– Resist
institutions and
innovators from
working in a
vacuum
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Minimize conflicts
of Interest and
Commitment –
Preserve
research/clinical
independence,
and protect
patients, subjects
and the integrity of
the scientific
process
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It takes two to tango
Industry and Providers share a common commitment to innovation
Benefits to Institutions
Access to capital, facilities and resources
Positions the entity to capitalize on intellectual
property
Strengthens and deepens existing research
programs
Accelerates bench to bedside development by
facilitating licensing and other commercializing
deals
Enables serving as an incubator for local, often
physician-led start-ups
Responds to the scientific interests of faculty
and privileged-physicians with institutional
control and buy in
Enables physicians to have input into
biomedical innovation informed by their
experience treating patients
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Benefits to Industry
 Access to scientist/physician talent and insight
– new opportunities
– product experience post market
 Access to physician insight into off-label
treatment experiences and critical demand
therapies
 Access to potential subjects to accelerate
research recruitment
 Access to longitudinal clinical data and
biospecimens
 Creates a steady/steadier pipeline of early-stage
ideas from start-ups through provider incubators
 Provides the “brand” of the participating
institutional provider
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Illustrative Examples of Collaboration Models
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Key Provisions to All Partnerships



Investigator Freedom

To direct research

To publish
No matter the size or complexity of
a collaboration, these terms will
need to be carefully considered.
Research Funding

Not tied to results

Not fee for service
Intellectual Property
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Intellectual Property
 Ownership of Research Results and IP
– Sole and joint IP may result from partnership
– Provide a framework to obtain exclusive rights in all partnership IP
• Must work with Institution’s goals to commercialize
• First option to license
– Time limit on option
– Fixed period of time for license negotiations after option is exercised
– Framework to resolve disputed terms
• Right of first refusal
• Any Rights not licensed by Industry become sole property of Institution
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Intellectual Property
 Licenses
– Scope of license and filed of use
• Exclusive, nonexclusive, sublicense
• Limited to particular indications, geographic limitations
• Reservations
– Who controls patent prosecution
– Up front fees
– Milestones
– Royalties
– Rights/obligations to enforce patents and division of any damages recovered
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Collaboration Models
“Small(er) Scale” Partnership
 Prototype
– One Principal Investigator and one Industry funder
– Usually with focused objectives but multiple trials
• Particular area of basis or clinical research
– May involve both industry-sponsored and industry-granted research
– May incorporate translational research initiatives
 Principal Investigator may or may not have financial
relationship with funder or funder’s competitors
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“Small Scale” Partnership
Institution
Faculty
Researchers
For Profit
Development Company
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Collaboration Models
Large Scale Partnership: Consortiums
 Institution-Industry Research Consortium
– Several Institutions and several funders
– Jointly administered with priorities adjusted from time to time
• Usually fund a set number of projects per year
– Usually focused on pre-competitive technology development
– Industry members may obtain non-exclusive (royalty free) rights to IP
– Projects may graduate to targeted research partnerships funding by
individual industry members
– Lower cost way for industry to collaborate with Institutions
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Consortium
Technology
Infrastructure
Financing
Innovations
Multiple Institutions
Jointly Administered
Collaboration
Multiple For Profit
Development Companies
Research funding
Technical support
Non-exclusive license
Results/IP for research
Publication rights
Possible sole ownership of Results/IP
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Results/IP
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Collaboration Models
Large(r) Scale Partnerships
 Key Feature is the scope of Institutional involvement
– One to multiple Institutions
– Multiple departments, Principal Investigators
 Objectives may be defined, semi-defined or undefined
– diseases or disease areas
– “Open innovation”
 Jointly Administered
 Often resemble aspects of venture capital
– Usually funder makes a substantial financial commitment for period of years
– Funder seeks to be able to obtain exclusive IP rights
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Large(r) Scale Partnership
Technology
Infrastructure
Financing
For Profit
Development Company
Innovations
Institution(s)
Jointly Administered
Collaboration
First option to
Results/IP
Research funding
Technical support
Results/IP for research
Publication rights
Possible sole ownership of Results/IP
Royalties, Milestones
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Results/IP
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Best practices in Conflicts of Interest Policy and
Procedure Development
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Sources of Common Conflicts of Interest Involving
Research
Credit for published works
Start-up Board Membership*
Sales and marketing
Payments to consultants*
Intellectual Property
Charitable Donations
Recruitment Bonuses
Off label promotion
Pricing practices
Speakers Bureaus*
Tenure
Equity in Biomedical
Companies
CME funding
Research grants
arrangements
Business entertainment, gifts,
and travel reimbursement
Scientific advisory
board participation*
* May also present Conflict of Commitment considerations
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Laws and Standards
 Laws:
–
Federal and state sunshine laws
–
Public Health Service COI Regulations
–
FDA Financial Disclosure Regulations
–
Anti-Kickback Law
–
Stark Law (not directly relevant to manufacturers, but important to know)
–
False Claims Act
–
Other Health Care Related and General Federal Criminal Laws
–
Federal Food, Drug and Cosmetic Act and FDA regulations concerning labeling, promotion and advertising
– State law versions of the false claims, anti-kickback and self-referral law
–
Medicare Marketing Guidelines
–
Foreign Corrupt Practices Act
–
Case Law
 Standards
–
OIG Compliance Program Guidance for Pharmaceutical Manufacturers
–
Professional Codes (PhRMA, AdvaMed Code)
–
Media Scrutiny
–
AAMC/AAU Conflict of Interest Guidance
–
Emerging Best Practices From Experience
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Law or Benchmark?
 Certain laws apply in some but not all cases
 State law may be contradictory, unclear and more stringent
 Where two or more regulations apply, care must be taken to meet the requirements of both
 Even when the regulations do not apply to one party, they may apply to the other party – for
example, the research sites and investigators, but not the industry entities
 Even when the regulations do not apply, a party may have policies and procedures that
incorporate similar standards
 Even when the regulations do not apply, they can be useful as a set of widely accepted norms
 Even when the regulations do not apply, participants should be careful about departures since the
public and courts may consider these regulations minimum standards
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Conflicts of Interest: New PHS Guidance
 Responsibility of Applicants for Promoting Objectivity in Research for which Public Health
Service Funding is Sought and Responsible Prospective Contractors
– August 25, 2011: Public Health Service (PHS) released a Final Rule substantially changing the
reporting requirements for PHS-supported research
 Broadens the definition of individuals who must disclose Interests
– Institutions must provide access on a publicly available website for certain disclosed interests of
Key Personnel and Senior/Key Personnel
Investigator
 Principal Investigator
 Project Director
 Any other individual responsible
for the design, conduct or
reporting of research funded by
PHS
Key Personnel
 Principal Investigator
 Project Director
 Any other personnel considered to be
essential to work performance
Senior/Key Personnel
 Principal Investigator
 Project Director
 Any other individual responsible for the
design, conduct or reporting of research
funded by PHS
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Investigator
Key Personnel
and Senior/Key
Personnel
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Conflicts of Interest: New FDA Guidance
 Guidance for Clinical Investigators, Industry, and FDA Staff: Financial
Disclosure by Clinical Investigators
– May 25, 2011: FDA released draft guidance on financial disclosures and
conflicts of interest for studies submitted in marketing applications
 FDA requires certain financial disclosures by Clinical Investigators (21
C.F.R. Part 54)
– Draft Guidance clarifies the significant role of Sponsors and Applicants in
ensuring sufficient disclosure of interests held by Clinical Investigators
 Why is this important?
– FDA may refuse to file a marketing application that does not contain the
required financial disclosure information (21 C.F.R. § 54.4(c)).
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Conflicts of Interest: New PHS Guidance, Continued
 Lowers the threshold reporting requirements for disclosing Significant Financial
Interests in publicly traded entities
Now: $10,000
when aggregated
No later than August 24, 2012:
$5,000 when aggregated
 Calculating Interests Held in Publicly Traded Entities
– What: Remuneration or equity value, when aggregated, exceeds $5,000
– How: Calculate all remuneration or equity value received from the publicly held
company
– When: Measure all remuneration or equity retroactively for the 12 months preceding the
disclosure
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FDA Conflicts of Interest Guidance
Requirements under FDA Regulations
and Draft Guidance
 Sponsor/Applicant must collect information
regarding certain financial interests or
arrangements held by Clinical Investigators
 Sponsor/Applicant must submit financial
disclosure statements (FORMS FDA 3454
and 3455)
 Sponsor/Applicant must describe steps taken
to minimize any bias from the financial
arrangements or relationships of the
Investigator
 Sponsors/Applicants must have procedures
in place to confirm financial disclosures and
management strategies
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Implications for Sponsor/Applicants
 Sponsors/Applicants are responsible for
collecting financial information from Clinical
Investigators involved in the studies
submitted in any marketing application
 Sponsor/Applicants should have conflict of
interest policies in place that contain
strategies to manage interests held by
Clinical Investigators
 Sponsor/Applicants should have procedures
in place to review and confirm the conflict of
interest programs at Institutions conducting
the studies
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Important Takeaways from Draft FDA Guidance
 Draft FDA Guidance reiterates the importance of conflicts of
interest for pharmaceutical companies
– Sponsors/Applicants must work closely with FDA to minimize the bias
from a conflict of interest so that a clinical trial may be used in a
marketing application
– Raises the bar for Sponsor/Applicants to ensure that institutions
conducting clinical studies have proper conflict of interest disclosure
procedures in place
 Create conflict of interest policies and procedures to
minimize the risk that FDA will refuse to file a marketing
application
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Definitions
Individual Interest – An interest held by an
individual or that individual’s immediate family.
COI Component – An Interest or
Commitment that is part of a Match.
Institutional Interest – An interest held by
the institution directly or indirectly.
Match – Two or more Interests or
Commitments with the same third-party that
need to undergo Conflict of Interest review.
Imputed Interest – An interest held by an
individual that is imputed to the organization
by virtue of that individual’s authority and
decision-making capacity within the
organization
Commitment – An Interest that involves an
activity outside of the individual’s main
institution – for example, serving on a board
of directors or working as a consultant.
√ Practice Tip : A conflict of interest can exist when there is no allegation
that a researcher actually acted improperly. The threshold is about
appearances and possibilities.
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Conflict of Interest - An Interest that has the
potential to compromise or bias the
professional judgment or objectivity of the
holder of the Interest, or has the appearance
of having the potential to compromise or bias
the professional judgment of the objectivity of
the holder of the Interest
√ Practice Tip: Conflicts of Interest always involve the appearance/actual
use of a person's authority for personal and/or financial gain.
√ Practice Tip: Conflicts may involve both individuals and institutions
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Four Steps to Identifying, Assessing and Managing
Conflicts of Interest
 Competent Conflicts of Interest Committee oversees management
 All Interests must be reported by Covered Persons
Reporting
Assessment
Management
 All Interests must be assessed to determine if they are Conflicts of Interest.
The assessment must follow pre-set criteria and must take into account
whether the Holder is a key decision-maker or a member of the Research Team
 Identified Conflicts of Interest must be reviewed by the appropriate Conflicts of
Interest Committee to determine an effective management strategy or to
determine that there is no effective management strategy available and the
Conflict of Interest bars the holder from proceeding:

To whom should the Conflict of Interest be disclosed?

What information regarding the Conflict of Interest should be disclosed?

Are changes in personnel or participation necessary? Chinese Wall?

Does the make-up or nature of the Financial Interest need to change
 The Conflicts of Interest Committee must maintain oversight of the Conflict of
Interest to verify that the management strategy is implemented and remains
sufficient to manage the Conflict of Interest
Oversight
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Emerging Best Practice Considerations
 The AAMC-AAU Reports, experiences of institutions under enforcement and media scrutiny, and evolving
reactions and approaches to conflicts of interest suggest consensus on certain elements and on-going
debate on others.
Consensus Standards:
On-going Consideration:
1.
2.
1.
3.
4.
5.
6.
7.
8.
9.
10.
Potentiality-based definition of conflicts of interest
Detailed disclosure/Elimination of discretion of the
disclosing party
Focus on Institutional & Imputed Conflicts
Broad-based disclosures to human subjects
Consistent rules across funding sources
SOPs that cover disclosure, assessment,
management and oversight
Initial and on-going training standards
Development of Conflict Management Plans & Ongoing Oversight
Moving beyond legal standards to best practices
IRB is not enough!
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2.
3.
4.
5.
Functionality of a Rebuttable Presumption Standard
with Compelling Circumstances Exception
Approach for the integration of conflicts program into
related compliance functions
Abandon thresholds
Universal Watch List Mechanisms
Composition of COI committee
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Overview of Sunshine Provisions
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What are the Federal “Sunshine Provisions”?
 Section 6002 of the Patient Protection and Affordable Care
Act
– Seeks to increase transparency in the financial relationships
between (1) industry and group purchasing organizations
(GPOs) and (2) physicians and hospitals
– Balances two goals: (1) discouraging relationships that
undermine scientific integrity, and (2) allowing beneficial
collaborations
– Requires certain entities to report to the Secretary of the
Department of Health and Human Services (HHS) certain
financial relationships
 GPOs and life sciences industry entities – even those with
robust fraud and abuse compliance programs – will need to
make significant operational changes to comply with these
requirements
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The Proposed Rule: The Basic Requirements

Issued by the Centers for Medicare & Medicaid Services (CMS) on December
19, 2011, to implement the Sunshine Provisions (comment period closed
February 17, 2012)
The Proposed Rule tracks many of the statute’s requirements, but also proposes to
refine the statute in important ways that are not necessarily intuitive
–

Three key requirements (tracks the statute):
1.
“Applicable Manufacturers” of covered drugs, devices, biologicals, and medical
supplies must annually report to HHS:
•
2.
“Applicable Manufacturers” and “Applicable GPOs” must annually report to HHS:
•
3.
Payments or other transfers of value to physicians and teaching hospitals
(“Covered Recipients”)
Ownership or investment interests held by physicians or their immediate family
members
HHS must publish this information on a website (data must be searchable, clear and
understandable, and easily aggregated and downloaded)
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Who Must Report?
 Applicable Manufacturer: An entity:
–
–
(1) “Engaged in the production, preparation,
propagation, compounding, or conversion of a covered
drug, device, biological, or medical supply for sale or
distribution in the United States [or a territory,
possession, or commonwealth thereof],” OR
(2) “Under common ownership with an entity in
paragraph (1) of this definition, which provides
assistance or support to such entity with respect to the
[activities described in paragraph (1)].”
Note:
 Applicable GPO: An entity:

(1) Operating in the U.S. (or a territory, possession or
commonwealth thereof), AND

(2) that “[p]urchases, arranges for or negotiates the
purchase of a covered drug, device, biological, or medical
supply for a group of individuals or entities, and not solely
for use by the entity itself.”
Note:
 Includes physician owned distributors (PODs) that
purchase covered products for resale or distribution
 “All or nothing” definition (one covered product renders
a manufacturer an Applicable Manufacturer, including
start-up companies with most products still in
development stage)
 Includes companies that operate globally but
sell/distribute covered products domestically
 Includes companies that hold FDA approval of a
covered product but outsource manufacturing
“Covered drug, device, biological, or medical supply” means “[a]ny drug, device, biological, or medical
supply for which payment is available under [Medicare, Medicaid, or CHIP], either separately, as part of a
fee schedule payment, or as part of a composite payment rate ….”
 Excludes: Certain exclusions, for example, over-the-counter (OTC) products
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Who Are the Targeted Receivers of Value?
 Covered Recipients of Payments or Transfers of Value
From an Applicable Manufacturer:
– Means a physician (other than a physician who is an
employee of an Applicable Manufacturer); OR
– A teaching hospital
 Physicians and Their Immediate Family Members
Who Hold Ownership or Investment Interests in an
Applicable Manufacturer or Applicable GPO:
– “Physician” includes “doctors of medicine and osteopathy,
dentists, podiatrists, optometrists, and licensed
chiropractors”
 Note: Unlike Covered Recipients, this category includes
physicians employed by the Applicable Manufacturer or
Applicable GPO
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What are the Covered Financial Relationships?
 Payments or other transfers of value: Must be reported unless explicitly excluded
– Examples of exclusions:
•
Transfers of less than $10 (unless aggregate amount to a Covered Recipient exceeds $100 in a calendar year)
•
Product samples
•
Manufacturer discounts, including rebates
•
Dividend, profit distribution from, or ownership/investment interest in publicly traded securities or mutual funds
•
Indirect transfers through a third party where Applicable Manufacturer is “unaware” of the identity of the Covered
Recipient
 Ownership and investment interests
– E.g., stock; partnership shares; LLC membership; loans, bonds, or other financial instruments
secured with property or revenue
– May be direct or indirect, and through debt, equity, or other means
– Excludes:
•
Interests in a publicly traded security or mutual fund
•
Retirement plan interests held by a physician (or immediate family member) by virtue of employment with the
Applicable Manufacturer or Applicable GPO
•
Stock options and convertible securities received as compensation, unless excercised or converted to equity
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Reporting Payments and Other Transfers of Value
 Each Applicable Manufacturer must timely file an annual report of all payments or other transfers of
value
 For each payment or other transfer of value, the report must include the:
 Name, business address, specialty, and NPI of Covered Recipient
 Date and amount of payment or other transfer of value
 Associated covered drug, device, biological, or medical supply (if applicable)
 Form of payment or other transfer of value (cash or cash equivalent; in-kind items or services; or stock,
stock option, or any other ownership interest, dividend, profit, or return on investment)
 Nature of payment (each payment or other transfer of value must be categorized in one of 14 specified
categories, such as consulting fee, gift, entertainment, food and beverage, research, or “other”)
Special Rules for Research Payments
–
Limited to “bona fide” research, including clinical investigations subject to both a written agreement and research protocol
–
Report must indicate whether it is a direct research payment (provided directly to the physician or teaching hospital Covered
Recipient) or indirect research payment (provided to research institution which in turn pays the physician Covered
Recipient(s) serving as principal investigator(s))
–
For indirect research payments or other transfers of value, the report must include the Covered Recipient principal
investigator’s name and NPI
 Note: The Proposed Rule requires Applicable Manufacturers to report the entire payment amount for each research-related
payment, rather than the specific amount provided to the Covered Recipient, even if the research budget itemizes the
Covered Recipient principal investigator’s compensation. However, on its public website, CMS would publish the separate
research payment amount for physician Covered Recipients rather than aggregate the information. (For teaching hospital
Covered Recipients, however, the entire amount would still be aggregated.)
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Reporting Physician Ownership or Investment Interests
 Each Applicable Manufacturer and Applicable GPO must timely
file an annual report of ownership or investment interests held
by a physician or an immediate family member thereof
 The report must include:
 Whether the ownership or investment interest is held by a
physician’s immediate family member
 Name, business address, specialty, and NPI of physician
 Dollar amount of investment and the value and terms of each
ownership or investment interest
 The data required for payments and other transfers of value if any
payment or other transfer of value was made to a physician holding
an ownership or investment interest
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Penalties
 Potential civil monetary penalties for noncompliance
– $1,000 - $10,000 for each payment or other transfer of value or
ownership/investment interest not reported as required
•
$150,000 maximum annual penalty
– $10,000 - $100,000 for each payment or other transfer of value or
ownership/investment interest) in case of knowing failure to report
•
$1,000,000 maximum annual penalty
 Factors to be considered in setting penalty include:
– Length of time of failure to report, including the length of time the Applicable
Manufacturer and Applicable GPO knew of the payment or other transfer of
value or ownership/investment interest
– Amount of unreported payment or transfer of value or ownership/investment
interest
– Level of culpability
– Nature and amount of information reported incorrectly
– Degree of diligence in correcting the error
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Implementation Delays
Statutory Timeline: Initial reports due by March 31, 2013 (for data from CY 2012). Subsequent reports due by the
90th day of each calendar year. The Secretary of HHS was to establish procedures for implementing these
requirements by October 1, 2011.
However, CMS did not issue a Proposed Rule until December 19, 2011. As
a result, CMS proposed to not require data collection until after it issued a
final rule, and that it was considering requiring the reporting of some CY
2012 data by March 31, 2013.
CMS Announces Additional Delay: Then, on May 3, 2012,
CMS announces it will not require Applicable Manufacturers
and Applicable GPOs to begin collecting data before January
1, 2013. The agency notes it received over 300 comments to
the Proposed Rule and that it “intends to release the final rule
later this year.”
Sens. Chuck Grassley and Herb Kohl,
authors of the Sunshine Provisions,
expressed disappointment, noting that,
“[g]iven all of the extra time, CMS will have
no further excuses for not [properly
implementing the statutory requirements].”
With a final rule to be issued in late 2012 and data collection to possibly begin
January 2013, regulated entities will have a compressed timeframe in which to
build compliance programs. Consider beginning the development process
based on the statutory provisions, using the Proposed Rule as a guidepost.
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The Devil is in the Details
 The Proposed Rule contains several important ambiguities, including:
– the difference between research, development, and clinical investigations for
purposes of determining eligibility for delayed publication of research
payments
– how to categorize compensation for physicians serving in roles other than
principal investigator in connection with research
– what types of entities may fall within the definition of “teaching hospital” in light
of various complicated corporate structures
– the specific parameters regarding when multiple entities under common
ownership have the option to submit a collective report
 Given the breadth of the Proposed Rule and the extensive comments
CMS received, some of these finer details may get lost
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Research Contracting: What’s in a Name?
Sponsor ≠ Funder
 Common Mistake: Equating “sponsor” with “funder” – sponsor is a term of art
under the FDA regulations
 Critical to clearly establish in a research agreement if there is a sponsor (and if
so, whom) and if not, at whose behest the trial is being conducted
 Minimizing Risks:
 Distinguish between grantor and sponsor
 No obligation for 100% funding by a non-sponsor funder
 Clearly document the grantor’s reason for providing funding and in what amount
 Demonstrate the research study’s scientific bona fides
 Consider requiring a DSMB or other independent reviewers of scientific merit and ongoing safety
 Coordinate decision to seek and receive grant funding with COI programs
 Monitor extent, frequency, types of financial relationships between grantee and grantor
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Does not represent legal advice.
Strategies for Going Forward
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41
Does not represent legal advice.
Lifecycle of Financial Considerations In Biomedical
Innovation
Institutional Provider-Industry Partnerships Occur Against a Backdrop of Other Financial Relationships that Must
be Considered as Part of Conflict of Interest Management
Individual & Institutional
Provider/Industry Collaborations
Vendor
Contracts
Research
Funding
Research
Studies
CME and
Publications
Intellectual
Property
Protections
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Conflict of
Interest
Management
Clinical
Trial Billing/Financial
Management
42
Does not represent legal advice.
Management in Motion – Useful baseline

A cardiologist on the ABC Hospital medical staff is a nationally recognized leader in her field. As a result of her reputation and
expertise, she is approached by DEF company to sit on the DEF scientific advisory board, which advises DEF on product
development. The cardiologist holds DEF’s products in high regard, so she accepts the offer and is paid and accepts
$5,000.00 for each all-day scientific advisory board meeting she attends, usually 3-4/year. Over time, she becomes very
familiar with DEF’s products and is instrumental in identifying potential improvements. She also routinely prescribes DEF’s
products to her patients but her patients are not aware of her compensation relationship with DEF. As a result of the
cardiologist’s expertise and familiarity with DEF’s products, DEF asks if she will conduct a Phase III clinical research study at
ABC hospital to test the safety and efficacy of DEF’s product. She remains a paid member of the scientific advisory board.
First: Cardiologist discloses
the SAB compensation
Interest on her Annual COI
Dislcosure Statement to
Corporate Compliance
Later: Cardiologist
submits a Research
Application to the
Research Support
Office, including her
Research Protocol
Disclosure Statement
disclosing the SAB
compensation Interest
COI Committee determines whether the Interest
poses an Individual Conflict of Interest in the
cardiologist’s clinical practice. If so, the COI
Committee determines if a management
strategy is necessary.
Corporate
Compliance
Corporate Compliance
updates Universal Watch
List
Research
Support
Office
COI Committee
Universal
Watch
List
Research Support Office confirms that there
are no additional interests in or adverse to
DEF registered in the Universal Watch List
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COI Committee reviews the cardiologist’s Protocol
Disclosure Form, Annual COI Disclosure Form, and
the absence of any hits on the Universal Watch
List to identify the Individual Conflict of Interest
held by the cardiologist and whether a
management strategy is necessary, for example,
disclosure in the informed-consent authorization
form.
COI Committee
communicates with IRB
to implement
management strategy
IRB
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Does not represent legal advice.
Management in Motion – Unintended Effects of Large
Scale Partnerships on Existing Research

An oncologist on the ABC Hospital medical staff is conducting an investigator-sponsored research study. The goal of
the research study is to determine whether a drug manufactured by DEF that is effective in fighting lung cancer in
adults also may be effective in children. Although DEF is not interested in sponsoring the study, it recognizes its
important public health benefits and has provided a grant to the oncologist in the form of the drug at no cost and
$25,000. Without this grant, the oncologist could not have conducted the research. When she began the study, the
ABC Hospital Conflict of Interest Committee informed her that there were no Individual, Institution or Imputed Conflicts
of Interest. Six months later, DEF awarded ABC Hospital a $100,000 grant to support ABC Hospital’s building a new
heart center. The ABC officials who awarded the grant were not aware of the study and the oncologist had no part in
seeking the grant. The study is on-going.
Research
Support
Office
Later: CFO discloses
Institution's Interest on
Institution's Continuing
COI Disclosure Statement
to Corporate Compliance
Universal
Watch
List
Corporate
Compliance
COI Committee reviews the investigator’s
Protocol Disclosure Form, Annual COI
Disclosure Form, and the absence of a hit
on the Universal Watch List and
determines there are no Conflicts of
Interests.
COI Committee
COI Committee determines
whether the Interest poses a Direct
Institution Conflict of Interest
because of Institution's updated
COI disclosure, and if so, whether
a management strategy is now
necessary, for example, additional
oversight by a DSMB and possible
forfeiture of the subsidy.
Oversight
DSMB
Corporate Compliance
updates Universal Watch
List
Research Support Office
confirms no Universal
Watch List Hits
First: Oncologist submits a
Research Application to the
Research Support Office,
including her Research
Protocol Disclosure Statement
disclosing he has no Interests
DSMB
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44
Does not represent legal advice.
Management in Motion – Management Beyond
Research

DEF Company believes it manufacturers a superior anti-nausea drug to the drug that ABC Hospital currently has on its
inpatient formulary purchase list. Therefore, the marketing/sales division of DEF Company is currently working with
ABC its oncologists to present the clinical data that demonstrates that ABC Hospital should add DEF product to its
inpatient formulary. At the same time, the research and development division of DEF is entering into a collaboration
arrangement ABC Hospital to conduct DEF-sponsored research.
First: Material management
discloses ABC’s formulary
negotiations on Institution's
Annual COI Dislcosure
Statement to Corporate
Compliance
Corporate
Compliance
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Corporate
Compliance
updates Universal
Watch List
Later: Institution
works through the
RSO to enter into a
multi-study
collaboration with
DEF (through an
“update” to its Annual
COI Disclosure
Statement) and
submits this pending
Institutional Interest
as well as notice of
multiple, pending
studies with DEF.
Research
Support
Office
Research Support Office Identifies
Institution's Interest using the Universal
Watch List
COI
Committee
Universal
Watch
List
COI Committee reviews the Annual COI
Disclosure Forms and the Universal
Watch List’s hit of Institution's Interest to
identify the Institutional Conflict of
Interest and whether it can be managed.
45
Does not represent legal advice.
Universal Watch List – Institutional Providers
Functional Areas Across an Institutional Provider Need to Report Interests to
Common, Integrated Databank
Board of Directors or Trustees
Research Sponsors &
Funders
COI Reporting
Forms
Vendors
Universal Database of
Interests
Pharmacy and
Therapeutics
Committee
Formulary Drug
Manufacturers
Research Support
Office/Division
All Purchasing Officials
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46
Does not represent legal advice.
Universal Watch List -- Industry
Functional Areas Across an Industry Entity Need to Report Interests to Common,
Integrated Databank while Maintaining Firewalls
Grant Applications
Grant Agreements
Sales
Speaker Bureaus
Research
Sponsorship
Agreements
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Universal Database of
Interests
Institutional
Relationships
Advisory Boards
47
Does not represent legal advice.
Approaches for Large-Scale Collaborations
 Have a robust conflict of interest program in place – lends credibility to
the collaboration process
 Distinguish between basic and clinical research
 Assess the relative IP rights of investigators versus home institutions
 Balance subject safety concerns – especially relevant for Phase I trials
 Look for opportunities for upfront, project-wide (not study-specific)
management approaches
 Vet conflicts in advance – do not safe this for closing time
 Have multi-party buy-in to the conflict of interest process and
management plan
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48
Does not represent legal advice.
Thank you
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49