Conflicts of Interest and Commitment

1
Conflicts of Interest and Commitment

• GWs Policy
• Office of Research Graduate Studies
• 2005

2
Guiding Thought

• Always do rightThis will gratify some and
  astonish the rest
• --Mark Twain

3
Possible COIs

• In 1999, Jesse Gelsinger died in a gene therapy
  experiment. The director of the University
  institute conducting the research had a financial
  interest in the company that funded the research.
  
• Is it a perceived or actual conflict?
• Can it be managed?

4
Conflict of Interest

• a divergence between a Faculty Members private
  interests and professional service to the
  University.
• EX In Gelsinger case, making money through drug
  company vs. conducting objective research and
  protecting human subjects from harm

5
Conflict of Commitment

• When pursuit of outside activities interferes
  with fulfilling University responsibilities
• EX Too much time consulting.

6
The Real Issues

• Maintaining INTEGRITY in research, education, and
  service
• Fulfilling RESPONSIBILITIES to the federal
  government, to GW, to oneself
• Preventing disaster Ex-GWU Professor Charged in
  600,000 Theft

7
Possible COIs

• A department chair purchases computer equipment
  from a company run by his son
• Or influences a junior colleague to purchase
  supplies from his own company.

8
Possible COIs

• A Research Scientist gives a friend who runs a
  company access to GW laboratory resources
  (without telling anyone or reimbursing GW).
• A GW researcher invents a new device and seeks a
  patent on it without disclosing the invention to
  the University.

9
Possible COIs

• A PI hires his spouse as a consultant on his
  grant.
• A professor who authored a textbook requires it
  in a large course for which it is a dubious
  choice.

10
Possible COIs

• A regular active-status faculty member, allowed
  to consult one day a week, consults more than one
  day a week and makes more than incidental use of
  U resources to do so.
• A research professor consults one day a week when
  he/she is paid full-time by GW from grant funds.

11
Possible COIs

• A faculty member involves her graduate students
  in doing the work on her consulting project.
• A graduate student reveals confidential
  information about a GW invention to a company,
  without authorization.

12
Federal Mandates Regarding Research Conflict of
Interest

• NSF An institutional conflict of interest
  policy should require that each investigator
  discloseall significant financial interests
• NIH
• Others

13
Stricter Every Day

• Case in Point 2005 NIH conflict of interest
  policy forbidding receipt by NIH employees of
  even honoraria, much less consulting fees, from
  drug and biotech companies, and requiring them to
  divest of drug/biotech stock over 15,000.

14

• GW Policy on Conflicts of Interest and Commitment
  for Faculty and Investigators
• my.gwu.edu/files/policies/ConflictofInterestandC
  ommitment.pdf

15
1998 Policy Revised in 2004

• Approved by Faculty Senate and Board of Trustees
  May, 2004
• Brought into compliance with federal regulations
• Covers not only faculty but those responsible for
  the design, conduct or reporting of externally
  sponsored research

16
Further Revisions in 2005

• New, more explicit disclosure forms that ask
  about specific types of conflicts referenced in
  the policy
• Items from the officers/managers COI form on
  gifts from GW suppliers, connections to GW
  suppliers, and involvement in higher ed or
  patient care organizations.
• Attention not only to immediate family but to
  parents, siblings, in laws
• Policy focuses primarily on financial conflicts,
  but thought should be given to nonfinancial ones
  as well

17
Sample Item from New Faculty Annual Report Form

• You have or an immediate family member has a
  significant financial interest in the proposed or
  current sponsor of, or a proposed or current
  subcontractor, vendor, or collaborator for, a
  sponsored project involving The George Washington
  University.

18
Faculty Annual Report vs. Annual Conflict of
Interest Disclosure

• Faculty Annual Report Remunerative Activities
  Item Asks for nature of and days/yr spent on all
  professionally-related outside activities.
• Annual Conflict of Interest Disclosure Asks
  about only those remunerative activities or other
  financial interests that intersect in some way
  with GW activities such as spending of grant
  funds.

19
In a COI, the faculty member or investigator

• Deprives GW of appropriate (compensated) time and
  effort
• Makes substantial use of GW human or material
  resources for non-University purposes
• Has financial involvements that appear to affect
  his/her academic responsibilities, scholarly
  activity, or freedom of action
• Deprives GW of potential financial gain (e.g.,
  grant revenue, invention royalties)

20
Must Report Significant Financial Interests
Involving Self or Family Member, GW, and an
Outside Entity

• Stock or ownership interest of the lesser of
  10,000 or 5 ownership in the outside entity
  (but not mutual funds)
• Receipt, right, or expectation of income in any
  form of gt 10,000 per 12 month period
• Serving as PI for or having a management position
  in the outside entity

21
Transactions Covered Include

• Gifts to GW that will be controlled by or will
  support Ps activity (P Faculty Member,
  Investigator, or immediate family member)
• Proposals in which P has financial interest in
  the proposed sponsor, subcontractor, vendor, or
  collaborator
• University technology-licensing arrangements with
  a company in which P has an interest

22
Transactions Covered Include

• Procurement of materials or services from the
  entity if P is personally involved or can
  influence the procurement
• Submission of a proposal that would affect the
  Ps interest in the outside entity or its
  financial interests

23
To Be Clear

• You are NOT being asked to divulge all your
  financial holdings.
• You ARE being asked to reveal on COI disclosure
  forms any financial interests that intersect in
  some way with GW or your GW activities.
• And, in the separate faculty annual report, you
  must report all professional remunerative
  activities, who they are with, and how many days
  they involved. Many of these entail no conflict
  of interest.

24
Responsibility to Disclose Current or Pending
Conflicts

• Whenever the issue arises/ad hoc
• With the routing sheet for grant proposals (PI
  must ensure that anyone to be involved discloses
  any COI)
• On annual disclosure form (required of faculty,
  Research Professors, Research Scientists)
• With applications for IRB approval in research
  involving human subjects

25
Ask Yourself

• Could a financial interest I have or that someone
  in my family has affect the design, conduct, or
  reporting of a research project?
• Could it compromise my responsibilities to GW in
  education, administration, service?
• Am I giving GW the full effort I owe it?
• If what I am doing showed up on the front page of
  the Washington Post, would it look bad?

26
Who Must Disclose?

• Faculty (including Research Professors)
• Investigators (any person responsible for the
  design, conduct or reporting of externally
  sponsored University research, including without
  limitation Research Scientists, Senior Research
  Scientists, and Lead Research Scientists

27
Process after Disclosure
28
Possible Outcomes

• Activity is judged not to involve COI or is a
  permissible COI
• Activity involves a COI but is allowed with a
  management plan in place
• Activity is disallowed COI must be reduced or
  eliminated

29
Examples of Management Plans

• A person other than the PI must supervise a
  particular staff member
• Service agreements or purchases must be reviewed
  by the chair and Dean
• The individual must give up control of a
  financial interest
• A relationship with a company must be disclosed
  in all publications and presentations and on
  informed consent forms used in human subjects
  research

30
More Management Plans

• A special committee must be formed to oversee the
  activity (e.g., a startup company)
• The COI must be disclosed to students working
  with the investigator
• The research plan must be changed to distance the
  individual from the company

31
Still More Management Plans

• The purchaser must provide comparative data
  showing that the company in which she has an
  interest is the only or best source of the
  materials or services to be purchased
• Evaluation of the consulting companys work
  products must be done by someone other than the
  researcher

32
Appeal

• The individual can seek review by the Schools
  Conflicts Consultation Committee of action by the
  Dean and EVPAA
• The Dean and EVPAA render a decision after
  receiving the Committees report
• Final appeal to the University Conflicts
  Resolution Panel can be made.

33
Closing Thoughts

• Its not necessarily wrong to have a COI it IS
  wrong not to disclose it and/or not to properly
  manage it.
• Doing the right things means resting assured that
  you are on safe ground.
• Keep The Washington Post in mind
• When in doubt, ask.

34
Closing Quote

• It is necessary for us to learn from others
  mistakes. You will not live long enough to make
  them all yourself.
• --Admiral Hyman G. Rickover