Conflicts of Interest

1
Conflicts of Interest

• Brenda Seiton, J.D.
• Assistant Dean for Administration
• Department Administrators Course
• September 1, 2006

2
Presentation Overview

• Individual Conflicts of Interest
• Consulting Agreements
• Start-up Companies
• Use of Emory Resources
• Institutional Conflicts of Interest

3
Individual Conflict of Interest

• Definition A situation that occurs when an
  individual has an outside interest (usually
  financial) that affects or appears to affect the
  individuals professional judgment in carrying
  out university responsibilities
• Interest may influence the universitys business
  and research decisions
• Interest may influence the integrity of the
  employees decisions in teaching, research, and
  service
• Interest may appear to influence individuals
  decisions

4
Conflicts? Which Conflicts?

• Physician/Researcher
• Experiment/Therapy
• Federal Funds/Private Funds
• Consultant, Inventor, Equity Holder,
  Researcher/Teacher
• Time Commitments
• Resource Allocation
• Hiring relatives
• Accepting gifts

5
Why do we care?

• Public Trust
• Maintain integrity credibility for our
  investigators institution
• Role models to our students trainees
• Protecting human subjects

6
A word about money . . .

• In 2004, the median household income in the State
  of Georgia was 49,475
• Average pharmaceutical companys marketing budget
  was 120,700,000
• Of these budgets approximately 30,000,000 was
  spent on Thought Leaders
• These Thought Leaders include our faculty

7
Regulations University Policies

• University Bylaws Article IX
• Research Conflict of Interest Policy
• Policy on Use of Letterhead and Facilities for
  Private Purpose
• Policy on Private Consulting by Faculty
• Employment of Relatives (Nepotism)
• Institutional Conflict of Interest Procedures
• Guidelines for the Responsible Conduct of
  Scholarship and Research
• http//www.or.emory.edu/share/policies/conflict_in
  terest.cfm

• Public Health Service
• National Science Foundation
• Food Drug Administration
• NIH Policies
• Internal Revenue Service
• Securities Exchange Commission

8
Guidance Documents

• AAMC Individual Conflicts of Interest in Human
  Subjects Research - December 2001
• AAMC Institutional Conflicts of Interest in
  Human Subjects Research October 2002
• AAU Report on Individual and Institutional
  Financial Conflict of Interest October 2001
• AMA Code of Medical Ethics, Opinion 8.031,
  March 1992
• Professional Societies and Peer Reviewed Journals

9
Consulting Agreement Basics

• Faculty members may engage in outside consulting
  activities when the activities and the agreements
  have been approved by their Chairs and the Deans
  Office

• Applicable policies from the University and
  School of Medicine may be found on the web
• University Faculty Handbook Chapter 3
  Policies, Reimbursement Compensation
  http//www.emory.edu/PROVOST/
• School of Medicine Faculty Affairs Page
  http//www.emory.edu/WHSC/MED/DEAN/facultyaffairs.
  html

10
Consulting Agreement Basics

• What activities are considered consulting?
• Providing advice to an external company, person,
  or organization
• Serving on an advisory committee
• Serving on a review committee
• Developing products owned by external group as
  long as Emory resources are NOT used and not
  within scope of academic duties
• Speaking to the community or press about a
  companys products, provided that the information
  has already been published

11
Consulting Agreement Requirements

• Agreement must be between faculty member as a
  private individual, i.e. not representing Emory
• Correspondence and payments made directly to the
  faculty member
• Required language (see Consulting Agreement
  Reference Sheet)
• Must be approved by Chair and Deans Office who
  take into consideration
• the academic and clinical needs of the
  Department, the School, Emory Healthcare, and the
  practice plans and
• the benefit of the consulting activity to the
  faculty member and the University

12
Which activities are not permitted in a
Consulting Agreement?

• Faculty may not use any Emory or EmoryHealthcare
  facilities, resources, or personnel for their
  private consulting activities
• This means
• no Emory laboratories or data
• no reagents or equipment ordered by Emory
• no Emory lab techs or assistants
• no Emory conference rooms
• no EmoryHealthcare operating rooms
• no Emory trademarks, tradenames, or logos
• no Emory intellectual property

13
Which activities are not permitted in a
Consulting Agreement?

• Faculty may not engage in the practice of
  medicine
• Providing information or advice about an
  individual patient
• Providing treatment to an individual patient
• Prescribing treatments for individual patients
• Recommending particular physicians in the
  patients geographical area
• Faculty may not perform research or teach classes
  without written approval from Dean

14
Potential Conflicts of Interest Created Due to
Consulting Relationships

• Consulting activities research or academic
  activities overlap
• Inappropriate use of Emory facilities or
  resources
• Most editors require disclosure of any consulting
  relationships
• Consulting fees greater than 10k may trigger COI
  Research policy and review is required by the COI
  Committee

15
Start-up Companies

• Faculty owned companies
• Purpose is to develop and/or commercialize
  intellectual property that faculty developed at
  Emory or other institution
• Outcomes include commercial sales by start-up or
  sale to larger corporation

16
SOM Procedures for Start-up Companies

• Faculty are required to submit to Chair and Dean
  a report outlining the business plan
• Appropriate time for faculty member to start a
  company?
• Time commitments?
• Competitive with Emory?
• Report must be reviewed by SOM Conflict of
  Interest Committee
• Review by Office of Technology Transfer is
  required if plans include use of Emory
  Intellectual Property
• If Emory technology is licensed to the start-up
  company, Emory may request an equity share in the
  company if cash is not available
• http//www.emory.edu/WHSC/MED/DEAN/facultyaffairs.
  html

17
Potential Conflicts with Start-up Companies

• Use of Emory technology by business prior to
  license
• Negotiating with Emory on behalf of company
• Use of Emory resources
• Co-mingling of assets with Emory
• Inappropriate transfer of data/information/technol
  ogy to company
• Fiduciary duty to company

18
Conflict Management University Federal
Requirements

• Conflicts must be
• Disclosed in writing (annually and as
  circumstances change)
• Reviewed by designated officials
• Properly managed, reduced, or eliminated
• Consistent monitoring and oversight
• Sanctions employed for non-compliance

19
Process for Disclosure Review

• Disclosures obtained annually from faculty
• Annual Disclosure Form available on-line
  http//med.emory.edu/administration/faculty_affair
  s/profile_coi_links.cfm
• Disclosure statements included on Sponsored
  Projects Approval Form, IRB forms, IACUC
  applications, Appointment Promotions Committee
• Disclosures reviewed to determine whether a
  conflict of interest or commitment exists
• If a potential conflict is found, more
  information from individual is requested

20
Types of Information Requested for Review by COI
Committee

• Faculty Status
• Research Proposal/Business Plan
• Equity Interest/Financial Interest
• Corporate Information
• Consulting/Advisory Agreements
• License Agreements
• Report from Individual(s)

21
What are the Goals?

• To protect the integrity of data against bias,
  and thereby the reputation of the institution and
  the individual faculty member
• To protect the safety of human subjects in
  research
• To carry out the missions of the institution in
  accordance with the highest ethical standards

22
Considerations for Management Tools

• Is the research clinical or non-clinical?
• Is this a pilot study?
• Does the investigator have unique expertise?
• What protections are built into the study design?
• Is the study design reviewed by peers through a
  grant review panel?
• How will data be used, i.e. is this the pivotal
  study for approval by the FDA?
• From where does the investigator receive the
  majority of his/her funding?
• What would be the publics perception of the
  conflict?
• Would this activity expose the University or the
  investigator to scrutiny by the IRS, SEC, or
  other federal agency?

23
Individual Conflicts That Are Not Permitted

• Purchasing equipment/materials used in research
  from a private firm in which the investigator has
  a significant financial interest or other direct
  relationship (consultant)
• Using SOM facilities/resources by an entity when
  the investigator is a consultant or has equity
  ownership
• Using students/trainees on research projects
  directed by a conflicted investigator in a way
  that restricts
• Freedom to discuss findings
• Seeking training and advice from others
• Conducting job searches freely
• Publishing freely (confidentiality agreements)

24
Managing Conflicts General Principles

• Emory owns all the intellectual property
  generated by its employees and students (with
  some exceptions)
• External activities cannot compromise the
  employees ability to perform his/her full-time
  Emory job
• Emory business (scholarship, teaching service) is
  conducted in a manner that is above inferences
  that the activity could be compromised by the
  employees expectation of financial gain, direct
  or indirect
• Students, trainees, and employees must be
  assigned duties consistent with their status and
  position. Their work should not be compromised
  by agreements with external sponsors or by a
  faculty members financial interests.
• The University must authorize any use of Emorys
  research facilities, personnel, and intellectual
  property for use by anyone other than Emory

25
Management Plans

• Disclosure
• Re-design of research project
• Appointment of independent reviewer(s)
• Limitation of corporate responsibilities
• Leave of absence from faculty duties
• Prohibition of certain responsibilities
  associated with research or Emory activities
• Divestment of corporate interest
• Prohibition of corporate relationship
• Annual reports on compliance with management plans

26
Questionable Uses of Emory Resources

• Press releases or marketing campaigns by outside
  companies
• Provision of facilities or resources to outside
  companies
• Filming at Emory
• Training Programs
• Endorsements
• Testimonials

27
Things to remember

• All interactions with the press or public
  relations firm must be cleared with the Office of
  Communications
• Emory facilities and resources cannot be used for
  commercial, political, or private financial gain
  or commercial advertising by third parties
• Endorsements are not permitted and testimonials
  are rarely permitted (must be cleared through
  General Counsel and Communications)

28
Institutional Conflicts of Interest

• When the financial or personal interests of the
  institution, or of an institutional official
  acting in his/her official capacity, might affect
  or appear to affect
• Any phase of its research mission -- conduct,
  review, oversight and compliance, outcome
• Finances and economic status of the
  institution/school/department
• Missions of the institution/school/department
• Appropriate vendor relationships
• Employment practices (oversight of faculty,
  staff, students)

29
To Maintain the Public Trust . . .

• Institutional officials must
• Make decisions and policies for the institution
  that are free from improper bias or conflict of
  interest
• Be able to document that they have done so

30
The Institution has Competing Interests in . . .

• Its reputation
• Its research integrity
• The safety and welfare of its human subjects

• Its financial gain from external entities
  donors, research sponsors, companies, investments
• Its own academic and clinical missions and the
  policies that support them
• Allocations of space, money, people
• Review and approval processes
• Monitoring, auditing, compliance
• Discipline
• Purchasing for Departments, School, Hospitals,
  Clinic, Grady

Decisions are made by Chairs Deans at SOM level
31
Potential ICOI in Research

• Exist when the institution or institutional
  officials who manage or oversee research also
• Might get royalties from the sale of the product
  that is to be investigated
• Hold any equity through licensing its technology
  to a non-publicly traded research sponsor (e.g.,
  startup company)
• Hold ownership interests through licensing its
  technology to a publicly-traded research sponsor
  (gt100K ?)
• Receives a significant gift from a potential
  research sponsor

32
Potential ICOI in Research

• When an institutional official who has research
  responsibility has a
• Significant financial interest in the research
  sponsor or the product to be investigated
• Equity interest
• Consulting relationship
• Honoraria, gifts
• Service as officer, board member
• Purchasing relationship with the research sponsor
  (vendor)

33
Rules and Regulationson ICOI

• Various regulations and statutes govern ICOI in
  finance, employment, Board duties, etc. (IRS,
  SEC, corporate law . . . )
• No federal regulations on ICOI in research
• Excellent guidance for institutions engaged in
  human subject research, adaptable to broader
  application
• Protecting Subjects, Preserving Trust, Promoting
  Progress II Principles Recommendations for
  Oversight of an Institutions Financial Interests
  in Human Subjects Research
• AAMC Task Force on Financial Conflicts of
  Interest in Clinical Research, October 2002

34
A Few SIMPLE Rules For Chairs Administrators

• Carefully weigh the competing interests
• Need for money, but does the end justify the
  means?
• Think about how the arrangement would be seen in
  view of an adverse event involving a patient
• Think about your own and the institutions
  reputation (with colleagues and the public) if
  the arrangement is published in the newspaper
• Ask yourself whether the arrangement passes the
  smell test
• Think about ways to manage the potential COI
  disclose or modify the arrangement for better
  management of the COI

35
A Few SIMPLE Rules for The Institution

• Separate the roles of administrators who oversee
  and make institutional decisions about research
  and administration from those who oversee
  investments and technology transfer
• Have established policies and procedures for the
  identification, disclosure, review, and
  management or elimination of potential ICOI
• Have an ICOI Committee with some external
  members, and high-ranking independent internal
  members (not COI Committee)
• Make use of external committees, ad hoc or
  standing, routinely or in certain cases, if
  feasible

36
A Few SIMPLE Rules . . .

• Have good communication among the ICOI Committee,
  COI Committee(s), Tech Transfer Office, and IRB
• Disclose, disclose, disclose
• Require IRB members to disclose potential
  conflicts of interest and recuse or divest if
  appropriate

37
School of Medicine Conflict of Interest Committee
Members Tristram Parslow, M.D., Ph.D., Chair
Pathology
Laboratory Medicine Edmund E. Waller, M.D., Ph.D.
, Vice-Chair Hematology/Oncology, WCI Greg
Berns, M.D., Ph.D.
Psychiatry Behavioral Sciences Victoria Greene,
J.D., M.D. Gynecology/Obstetrics Jay Justice,
Ph.D. Chemistry, Emory College Jeff Lessesne,
M.D. Geriatric Medicine Rebecca Pentz, Ph.D.
Winship Cancer
Institute James Ramsay, M.D. Anesthesiology

Ex-Officio Members Claudia R. Adkison, J.D,
Ph.D., Exec. Assoc. Dean/Faculty Affairs
Administration Todd Sherer, Ph.D. Director,
OTT Brenda J. Seiton, J.D. Asst.
Dean for Administration Tanya Sudia-Robinson,
Ph.D. IRB/IACUC Office Shawn Akkerman, Pharm. D.
OSP Arri Eisen,
Ph.D. Center for
Ethics Biology
38
Questions/More Information

• Brenda J. Seiton, JD, Assistant Dean for
  Administration, bseiton_at_emory.edu 727-3413
• Claudia R. Adkison, JD, Ph.D., Executive
  Associate Dean/Administration Faculty Affairs,
  cadkison_at_emory.edu 727-5673
• Kris West, JD, Chief Compliance Officer, Emory
  University Research Office kwest02_at_emory.edu
  727-2237
• Emory Healthcare Anne Adams, MHA, JD, Chief
  Compliance Officer, EHC anne_adams_at_emoryhealthcare
  .org 778-2186