CONFLICT OF INTEREST

1
CONFLICT OF INTEREST

• Presentation to
• IRB Research Review Coordinators
• Jerome L. Rosenberg, PhD (Chair/COI Committee)
• David T. Wehrle, CPA, CIA, CFE (Director/COI
  Office)
• May 26, 2005

2
What is a Conflict of Interest (COI)?

• The investigator has a significant financial
  interest that could be affected, or perceived to
  be affected, by the outcome of the research study.

3
What is a Significant Financial Interest (SFI)?

• The investigator and/or immediate family members
  own equity interests gt 5 or valued at gt 10,000
  in the research sponsor, or in the technology
  being evaluated for example
• Stocks
• Stock options

4
What is a Significant Financial Interest (SFI)?
contd

• Receive remuneration gt 10,000 per year from the
  research sponsor, or the technology being
  evaluated, for example
• Consulting
• Honoraria
• Royalties not received through the University of
  Pittsburgh
• Speakers Bureau activities
• Scientific Advisory Board membership

5
Special Provisions for Investigators Involved in
Start-Up Companies Monitored by the EOC

• Thresholds for equity and remuneration are 0
  (zero) in determining whether an SFI exists.

6
FDA Halts Gene Experiments at University of
Pennsylvania By Rick Weiss and Deborah
NelsonWashington Post Staff WritersSaturday,
January 22, 2000 Page A1 The federal
government yesterday halted all human gene
therapy experiments involving a prominent
researcher at the University of Pennsylvania,
saying an investigation into the September death
of a teenager there found the school's
prestigious program in serious disarray.
7
May 18, 2000 -- Vol. 342, No. 20 Is Academic
Medicine for Sale? Marcia Angell, M.D. In 1984
the Journal became the first of the major medical
journals to require authors of original research
articles to disclose any financial ties with
companies that make products discussed in papers
submitted to us. (1) We were aware that such ties
were becoming fairly common, and we thought it
reasonable to disclose them to readers. Although
we came to this issue early, no one could have
foreseen at the time just how ubiquitous and
manifold such financial associations would
become. The article by Keller et al. (2) in this
issue of the Journal provides a striking example.
The authors ties with companies that make
antidepressant drugs were so extensive that it
would have used too much space to disclose them
fully in the Journal. We decided merely to
summarize them and to provide the details on our
Web site.
8
IRB COI Policy

• Full text of the IRBs COI policy can be found on
  the COI Offices new Web site
• www.rcco.pitt.edu/coi
• Go to Policies
• Scroll down to IRB COI Policy

9
IRB COI Policy contd

• Highlights of COI policy related to human subject
  research
• Researcher with a potential conflict cannot be
  principal investigator (PI)
• Researcher can be a co-investigator with the
  implementation of the standard plan designed to
  manage the potential COI

10
IRB COI Policy contd

• SFIs must be disclosed
• at time of initial protocol submission or at any
  time during the conduct of the research study if
  new outside interest are accrued.
• PI must disclose the name of the research sponsor
  at the time of initial submission and in the
  submission for renewal approval.

11
IRB COI Policy contd

• PART E of COVER SHEET
• Part E CONFLICT OF INTEREST Does the principal
  investigator or any co-investigator or research
  coordinator involved in this study (or in
  aggregate with his/her spouse, dependents or
  members of his/her household)
• a. possess an equity interest in the entity that
  sponsors this research or the technology being
  evaluated that exceeds 5 ownership interest or a
  current value of 10,000? Yes No
• b. receive salary, royalty or other payments from
  the entity that sponsors this research or the
  technology being evaluated that is expected to
  exceed 10,000 per year? Yes No
• c. possess a license agreement with the
  University or an external entity that would
  entitle sharing the current or future commercial
  proceeds of the technology being evaluated?
  Yes No

12
IRB COI Policy contd

• For commercially sponsored human subject research
  studies, the IRB verifies, through the
  Universitys COI database, whether any SFIs of
  the investigators include the commercial sponsor.
• Verification is undertaken upon initial
  submission of research study for IRB review and
  approval, and during submission for renewal
  approval.

13
Research Review Coordinators Role

• Invoke the Standard COI Management Plan when the
  answer is Yes to questions a or b, and
  under certain conditions, to question c in Part
  E of the IRBs cover sheet.
• The IRB should alert the COI Office when the
  Standard COI Management Plan has been invoked,
  indicating
• the name of the PI, the investigator with the
  SFI, and the name of the research sponsor.

14
Requests for Exceptions

• If the IRB and/or the investigator with the SFI
  wishes to request an exception to the standard
  plan (e.g., to add/remove elements to/from the
  plan), the request should be communicated to the
  director of the COI Office.
• The request will then be forwarded to a
  subcommittee of the Conflict of Interest
  Committee for deliberation. The results of these
  deliberations will be reported to the IRB within
  two weeks of receiving the request.
• Exceptions to the PI exclusion rule must be
  approved by the Authorized Institutional Official
  for human subject research (Dr. Randy Juhl).

15
Discussion of Mechanics in Implementing the
Standard Plan

• Introductory Paragraph
• Specify the name of the research sponsor and/or
  the technology being evaluated in which the
  investigator has an SFI
• Provide the IRB protocol number.

16
Discussion of Mechanics in Implementing the
Standard Plan contd

• Item 1
• Indicate the responsibilities of the
  co-investigator.
• Note if the PI listed on the protocol
  application has an SFI in the research sponsor or
  in the technology being evaluated, a replacement
  PI must be selected and subsequently approved by
  the IRB. The investigator with the SFI may,
  however, serve as a co-investigator.

17
Discussion of Mechanics in Implementing the
Standard Plan contd

• Item 7
• The Informed Consent Form must include the
  language appearing in the Standard COI Management
  Plan and be customized as follows
• Add study-specific information
• Provide name and telephone number of the
  IRB-approved PI of the research study.

18
Discussion of Mechanics in Implementing the
Standard Plan contd

• Item 8
• The name of the investigator with the SFI should
  be recorded on the Notification of Significant
  Financial Interest form
• The investigator should then distribute this form
  to other individuals (e.g., students, staff, or
  other faculty members) involved in the research
  

19
Discussion of Mechanics in Implementing the
Standard Plan contd

• Item 8 contd
• The investigator should be instructed to return
  the signed form(s) to the IRB for its files.

20
Discussion of Mechanics in Implementing the
Standard Plan contd

• Signatures
• The investigator with the SFI and the
  IRB-approved PI must sign the Standard Management
  Plan (or the approved amended Management Plan).
• The IRB will retain a copy of the signed plan in
  its files.

21
Discussion of Mechanics in Implementing the
Standard Plan contd

• Signatures contd
• Copies of the signed plan should be distributed
  to the dean and department chair of the
  investigator with the SFI, and to the director of
  the COI Office.

22
Questions?

• Contacts
• Jerome L. Rosenberg 412-624-3007
• jrosenb_at_pitt.edu
• David T. Wehrle 412-383-1774
• wehrledt_at_upmc.edu
• Hannelore N. Rogers 412-383-1968
• rogershn_at_upmc.edu
• Visit our Web site www.rcco.pitt.edu/coi