conflict of interest at duke: identification and management joan m. podleski director, duke iecp

Conflict of Interest at Duke:Identification and Management

Joan M. PodleskiDirector, Duke IECP

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Agenda What IS a conflict of interest? Current Climate:

COI in the News Industry Trends & Regulatory Environment

Duke COI Policies Officers & Trustees Faculty/Research Administrative Institutional (NEW)

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Agenda Disclosure Responsibilities Review Processes & Committees Management Plans Related Policies: Nepotism &

Procurement Examples and FAQs Questions

What is all this?????????

Perception is everything Mary Easley’s hiring Halliburton sales to Defense Department TARP relationships Clinton Foundation overseas relationships

Lots of official definitions………..

Institutional Ethics & Compliance Program

What IS a Conflict of Interest?

Conflict of Interest

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

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).


NIH COI Definitions

What financial interests are covered by the regulation? The term does not include: 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.


NIH COI Definitions


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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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’

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’

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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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


University/ Industry Relationships: Why?

Federal programs encourage partnerships between academic research and industry 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)


University/ Industry Relationships: Why?

Why ‘manage’ COIs?

The reasons to manage all COIs, including those of the Institution, include 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

New England Journal of Medicine: Disclosure of Industry Payments to Physicians; 8/08

Wall Street Journal: Pressured, Schools Review Ties to Drug Firms; 9/08

The Chronicle: Conflicts of Interest Concerns Halt NIH Project at Emory; 10/08

The Chronicle: Emory U Scientist Penalized for Hidden Payments from Drug Company; 12/08

The Chronicle: Surgeon’s Royalties Bring Heat to a Medical School with a Strict Ethics Policy, 2/09

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Institute of Medicine COI report April 2009

New York Times: “IOM calls for "far-reaching" changes to prevent industry influence on patient care, research;”

Wall Street Journal: “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."

Associated Press: "the report could give [lawmakers] more 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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New York Times: Doctor Falsified Study on Injured G.I.’s, Army Says; 5/13/09 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 Court documents suggest a broad level of

hidden industry influence on medical literature.

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New York Times: Clinical Trials Rule is Widely Ignored; 9/8/09 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 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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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 off-label purposes.

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COI in the News

The Baylor Story COI Oversight by the NIH - 2010

In the beginning……

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

Vanderbilt and Cornell-Weill had NIH-funded 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

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

Some residual questions, like the fact that Baylor’s declaration of non-overlap sounded appropriate (but maybe not accurate?) 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

Industry sponsors begin to publish payments to clinicians and researchers Merck Eli Lilly Medtronic Cephalon

Some academic medical centers begin to publish disclosed relationships between clinicians and industry

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Regulatory Environment

Regulatory Environment 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

Regulatory Environment 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

Officers & Trustees Faculty/Research (FCOI) Administrative (ACOI) Institutional/Research (ICOI)

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Trustee COI Policy

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 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

Reporting Requirements

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

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

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

Management plans related to FCOIs may include: 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

Committee or decision recusals

Consent documents

Publications Presentations Contracts FDA NIH

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Administrative COI Policy

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

Administrators who: 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

Who makes the ACOI list 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

Potential Conflicts of Interest 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

Conflict of Commitment Membership on boards or advisory boards that

take time away from work to the extent that full-time 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

Clarity of compliance and disclosure responsibilities for those in administrative roles 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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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

How does this affect me as an administrator?

Executive Director of Internal Audits SOM rep: Chair, SOM FCOI

Committee Campus rep: Exec. Vice Provost,

Finance/Administration Representative from Office of Counsel


ACOI Review Committee

Institutional COI in Research Policy

Approved by the Board of Trustees in December 2009

Effective January 1, 2010 Scope includes

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

Definition of “Covered Officials” 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

Scope of ICOI Reviews 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

3 Internal COI Committee Chairs 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?

Product Review Committee members 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

Sign disclosure form

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Vendor Review Meetings 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 COI Policy requires individuals with

administrative responsibilities to exercise their best care, skill, and judgment for the benefit of Duke “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.” 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 Are individuals covered by a COI

Policy permitted to accept any gifts, or are all gifts banned? 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

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 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? 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

What about visiting vendors’ facilities? May vendors pay for site visits? 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

What if I am participating on a vendor-sponsored user group? May a vendor pay my travel expenses? 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

When a vendor sponsors a seminar, may they pay for my time and travel to the seminar? 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 May I attend a seminar which is

sponsored by a vendor that is offered free to all participants? 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

May I provide consulting on my personal time or is this a conflict of commitment or conflict of interest? 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. Next Steps:

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

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?


Examples

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?


Examples

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Duke COI Policies Summary 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


In closing ……….

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QuestionsFor 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.

conflict of interest at duke: identification and management joan m. podleski director, duke iecp

Documents

potential conflict

actual conflict

apparent conflict

duke iecp slide

human services slide

honoraria equity interests

nonprofit entities income

public prices