Conflicts of Interest (In Clinical Research) Multidisciplinary Clinical Research Career Development Program University of Maryland February 28, 2008 Some Things to Think About Which aspects of a given situation constitute CoI? Which are directly financial and which are not?
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Conflicts of Interest(In Clinical Research)
Multidisciplinary Clinical Research Career Development Program University of Maryland
February 28, 2008
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.
Conflicts of Interest
Baltimore Sun December 8, 2006
By Matthew Dolan
Government Scientist Pleads Guilty
Senior Alzheimer’s Researcher Admits
Taking $285,000 In Fees, Expenses
A senior government scientist working in Alzheimer’s disease research pleaded guilty today to accepting $285,000 in consulting fees and travel expenses from the world’s largest drug manufacturer without proper approval from his bosses.
As part of his agreement with federal prosecutors, Pearson “Trey” Sunderland III, chief of the geriatric psychiatry branch of the National Institute of Mental Health, which is part of the National Institutes of Health, will be sentenced to two years of supervised probation and must forfeit $300,000.
Conflicts of Interest
R P Taleyarkhan
Woo Suk Hwang
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
Reputation is a key asset
It’s all about gaining acceptance of a new idea
Passion for the enterprise is essential
Sources of Potential Conflict
Institutional vs Invididual CoI
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
Science Gone Wrong
What’s the worst that could happen?
R P Taleyarkhan
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 entity’s 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
Relationship betweenFunding Source and Conclusion amongNutrition-Related Scientific Articles
Data from Lesser, et al. PLoS Medicine, Jan 2007, pp 0001-0006
From Hopkins Magazine (Fall, 2006)
Spectrum of Conflicts
$$$ or Equity
Conflict of InterestvsConflict of Commitment
Applicable Policies and Procedures
USM Policy On Conflicts of Interest In Research or Development
UMB Procedures Implementing Board of Regents Policy on COI…
Maryland Public Ethics Law
Code of Maryland Regulations
15-501 and 15-523
Applicable Policies and Procedures(cont’d)
UMB IRB Policies and Procedures
6c: Investigator and Study Personnel Conflicts of Interest http://medschool.umaryland.edu/orags/hrpo/HRPP_Policies.pdf
NIH Objectivity In Science
Conflict of Commitment
A junior scientist at a university discovered a new prostate cancer drug. With the help of the University’s Office of Research and Development, he applied for a patent and established an agreement that splits the profits between him and the university.
Using venture capital, the university formed a start-up company based on the technology. The scientist and his department chair were on the board of directors. Other board members included several university administrators and a few employees of the venture capital company. The patent was awarded a few years later. The company still has not realized any profit, but is very close to marketing the drug.
The scientist, while at a conference, heard that a researcher at another university has come up with a drug very close in chemical structure to his, but one that is much more effective and has fewer side effects. Another group of venture capitalists has formed a company to manufacture the new drug as quickly as possible.
The junior scientist, with prodding from his original company, is now thinking about challenging the new company with a lawsuit on the basis of patent infringement.
National Lung Cancer Screening Trial