Why Disclose Conflicts of Interest

1
Why Disclose Conflicts of Interest?

• Gina Lee-Glauser, Ph.D.
• Associate VP for Research

2
Conflict of Interest

• A Conflict of Interest exists when an
  Investigators financial interests may reasonably
  be affected by research, scholarship, educational
  or other externally funded activity.

3
Purpose

• Ensure objectivity of research decisions
  investigators make for the University about
• Research design conduct
• Research results reporting
• Research training oversight
• Protect research integrity and public trust
• Segregate the finanical and the research
  decisions, so that they are separately and
  independently managed.
• Scientifically driven decisions, not business!

4
Why Disclosure?

• Avoid, reduce, or eliminate real and appearance
  of conflict of interest
• Remind oneself of it and allows others to take
  his/her conflict of interest into account
• Manage conflict by one who does not have a
  conflict of interest to make decisions about or
  monitor the matter
• Having conflict is not wrong, but failure to
  disclose is wrong

5
Impetus for Policies on COI Affecting Objectivity
in Research

• Bayh-Dole Act and regulations early 1980s
• Increasing collaboration between academic and
  industry
• Highly publicized cases of research misconduct,
  in some cases apparently influenced by commercial
  ties of the PI
• Heated Congressional investigations

6
Federal Requirements

• NIH and NSF Regulations Policies on Objectivity
  in Research 1995
• Universities are required to adopt policies and
  procedures dealing with PIs COI affecting
  NIH/NSF research
• SU COI policy applies to all external funding

7
Syracuse University Policy

• Policy on Conflict of Interest for Research
  Investigators affecting objectivity in
  scholarship and research
• http//www.syr.edu/publications/facultymanual/pol
  icies.html8

8
Who must Disclose?

• All Investigators who are responsible for
  designing, conducting or reporting research in
  the course of funded or proposed sponsored
  activity must make disclosure under this Policy

9
What is Significant Financial Interest?

• Anything of monetary value aggregated for the
  Investigator and the Investigators spouse,
  domestic partner and dependent children
• Exceed 10,000 over 12 months
• Equity interest gt5 ownership interest or
  gt10,000 in value
• Serves as an officer, director, or in any other
  executive position

10
Investigators responsibilities

• Complete the annual disclosure form
• Certify annual disclosure is filed, current and
  complete or updated prior to proposal submission
• Disclose new reportable interests within 60 days
• Comply with any management plan, if applicable

11
Flow of COI Disclosure, Review and Managment
12
Summary

• Conflicts of interest in research is NOT wrong
• Conflicts of interest in research can have
  serious adverse consequences to
• Confidence in credibility and objectivity
• Openness of science research integrity and
  public trust
• The University has a policy and procedure for
  disclosur, and for elimination, reduction or
  management of COI to avoid such consequences

13
Consulting Scenario

• Dr. Oak signed consulting agreement that
  includes
• Not disclose any info that he learns during his
  discussions with Co X
• Any inventions made in his field of expertise
  will be owned by Co X
• Very lucrative and attractive compensation
• Dr. Oak volunteers graduate student to conduct
  experiments that complement the studies at Co X

14
Consulting Scenario

• Dr. Oaks consulting is highly productive
  resulting Co X to spin out the research project
  into a separate company (Co Y)
• Co Y wants Co X assign both its consulting
  agreement with Dr. Oak and Co Xs intellectual
  property
• For scientific credibility and the prestige
  affiliation of U, Dr. Oak is named co-founder and
  the head of scientific advisory board
• Dr. Oak is delighted with opp and signs the
  agreements

15
IRB Scenario

• When Dr. C submitted a protocol study sponsored
  by Big Pharma, one of the IRB member is openly
  negative about the promise of the study. He
  informs the board that he recalls an abstract
  that counters the study. He expresses amazement
  that the study is progressing.

16
Procurement Scenario

• Dr. L serves on the dept promotion and tenure
  committee and is a mentor and colleague of Dr.
  Jr. Dr. Jr has worked with Aqua (where Dr. L is a
  president) and wants to continue to use their
  services for continuity with the methods used in
  her previous work. She completed a PO and a sole
  source justification to buy services from Aqua
  using her start-up funds

17
Procurement Scenario

• Dr. L assembles a team to write a proposal to
  NIH. With Dr. L as PI, they win a 4M award.
  Dr. L wants the university to permit her, under a
  sole source justification, to procure the work
  for her project from Aqua.