Conflicts of Interest

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Conflicts of Interest

• CIPP 909 Research Ethics
• March 11, 2009

Joe Giffels Research Integrity Office jgiff001_at_uma
ryland.edu
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Some Things to Think About

• Which aspects of a given situation constitute
  CoI? Which are directly financial and which are
  not?
• How can CoI affect the conduct of research? Of
  the scientific record?
• What are the ramifications of CoI for scientists
  as researchers? As consumers of scientific
  information?

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Some More Things to Think About

• What can scientists do to avoid the ramifications
  of CoI?
• What regulations apply to CoI in research?
• How is CoI in research routinely managed?
• How should CoI in research be managed?

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Conflict of Interest
Situation in which the integrity of academic
activity, especially research, may be, or may be
perceived to be, compromised by financial or
other interests.
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Conflicts of Interest

• Most are financially based
• Some are just accepted
• Owning an hypothesis
• Research results as proprietary information
  pending publication
• Continuing research support
• Developing intellectual property

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Similarities
Scientist
Entrepreneur

• Reputation is a key asset
• Its all about gaining acceptance of a new idea
• Passion for the enterprise is essential

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Differences
Entrepreneur
Scientist

• Produces data which may be built upon
• Uses the scientific method
• Rules out alternatives to an idea
• Avoids risky approaches to a problem

• Produces something marketable
• Uses business development models
• Develops support for an idea
• Is comfortable accepting and managing risk

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Sources of Potential Conflict

• Consultant
• Speaker
• Stock or Other Equity
• Management Position
• Income from Royalties or Licensing Fees

• Board or Scientific Advisory Board Member
• Gift
• Relationship with Competitor
• Loans (To or From)
• Family Member has Relationship

Institutional vs Invididual CoI
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Does conflict of interestpresent a legitimate
concern?

• Financial interests steer the academic activity
  to the point where it is compromised
• Financial interest gives the appearance that the
  academic activity may be compromised
• Maintaining full academic integrity would
  compromise the business plan and/or require
  excess resources

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Science Gone Wrong
Whats the worst that could happen?
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Woo Suk Hwang
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R P Taleyarkhan
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Jesse Gelsinger
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Examples of What We are Guarding Against

• Deciding not to publish research results which
  would be harmful to the entity
• Agreeing to develop a research protocol to the
  entitys specifications
• Falsifying or fabricating research results which
  would be beneficial to the entity
• Conducting research which poses significant risk
  in order to develop a technology licensed by the
  University

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Relationship betweenFunding Source and
Conclusion amongNutrition-Related Scientific
Articles

• 111 of 206 articles declared financial
  sponsorship
• 22 had all industry funding
• 47 had no industry funding
• 32 had mixed funding
• Funding source was significantly related to
  conclusions for all article types (p0.037)
• Odds ratio of favorable to unfavorable
  conclusions for all industry funding vs no
  industry funding was 7.61
• Interventional studies
• 0 unfavorable conclusions for all industry
  funding
• 37 unfavorable conclusions for no industry
  funding

Data from Lesser, et al. PLoS Medicine, Jan 2007,
pp 0001-0006
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Maryland Public Ethics Law

• Code of Maryland Regulations
• 15-501 and 15-523

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Applicable Policies and Procedures

• USM Policy On Conflicts of Interest In Research
  or Development
• www.umaryland.edu/hrpolicies/section3/t30111sa.htm
  l
• UMB Procedures Implementing Board of Regents
  Policy on COI
• www.ord.umaryland.edu/researchers/policies/umproce
  ed.php

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Applicable Policies and Procedures(contd)

• UMB IRB Policies and Procedures
• 6c Investigator and Study Personnel Conflicts
  of Interest http//medschool.umaryland.edu/orags/h
  rpo/HRPP_Policies.pdf

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NIH Objectivity In Science
http//grants1.nih.gov/grants/compliance/42_CFR_50
_subpart_F.htm
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Reporting Requirements

• Internal to UMB
• As required in provisions
• Annually
• Whenever a significant change occurs

• External to UMB
• Chancellor
• State Ethics Commission
• Public Record
• Research Sponsors, where applicable

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Exemption Provisions/Conditions(examples)
Conflict of Commitment
Insider Trading
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National Lung Cancer Screening Trial

• An example

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Conflicts of Interest

• CIPP 909 Research Ethics
• March 11, 2009

Joe Giffels Research Integrity Office jgiff001_at_uma
ryland.edu