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Conflict of Interest & Informed Consent for Pediatrics Fellows & Pediatric Neurology Residents. Presented by University of Pittsburgh’s COI Office David T. Wehrle, CPA, CIA, CFE/Director Khrys X. Myrddin/Associate Director September 23 , 2010. What is a Conflict of Interest?.
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Presented by University of Pittsburgh’s COI Office
David T. Wehrle, CPA, CIA, CFE/Director
Khrys X. Myrddin/Associate Director
September 23, 2010
If COI is not managed…
Researchers Fail to Reveal Full Drug Pay
By GARDINER HARRIS and BENEDICT CAREY
PUBLISHED: JUNE 8, 2008 in The New York Times
[Dr. Joseph Biederman], a Harvard child psychiatrist whose work has helped fuel an explosion in the use of antipsychotics in children earned at least $1.6 million in consulting fees from drugmakers from 2000 to 2007 but for years did not report much of the income to university officials, according to information given Congressional investigators, The New York Times reports.
a) possess an equity interest in the publicly-traded entity that either sponsors this research or owns the technology being evaluated that exceeds 5% ownership interest or a current value of $10,000?
b) possess any equity interest in the non-publicly-traded entity that either sponsors this research or owns the technology being evaluated?
* 'Investigator' means any member of the study team who participates in the design, conduct, or reporting of this research, as well as his/her spouse, registered domestic partner, dependents, or other members of his/her household.
c) receive salary, consulting fees, honoraria, royalties or other payments from the entity that either sponsors this research or owns the technology being evaluated that is expected to exceed $10,000 in any twelve-month period?
d) have rights to the intellectual property (IP) being evaluated, as either the inventor of the IP for which a patent has been issued, or as the inventor of the IP that has been optioned or licensed to a company?
e) have a financial relationship with a Licensed Start-up Company (which is being monitored by the COI Committee) that has an option or license to utilize the technology being evaluated?
f) receive compensation of any amount when the value of the compensation would be affected by the outcome of the research, such as compensation that is explicitly greater for a favorable outcome than for an unfavorable outcome or compensation in the form of an equity interest in the entity that either sponsors this research or owns the technology being evaluated.
*Cf. Bramstedt, KA: A guide to informed consent for clinician-investigators; Cleveland Clinic Journal of Medicine 2004;71:11. http://www.ccjm.org/PDFFILES/Bramstedt11_04.pdf
*Conflict of Interest Notification Survey
*Weinfurt, KP, Friedman JY, et.al: Disclosing Conflicts of Interest in Clinical Research: Views of Institutional Review Boards, Conflict of Interest Committees, and Investigators; Journal of Law, Medicine & Ethics 2006; 34 (3) 581-591. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1850937
*Weinfurt KP, Friedman JY, et.al: Views of Potential Research Participants on Conflicts of Interest; Journal of General Internal Medicine 2006; 901-906.
[Parent of sick child:] “It seems to me, with this kind of thing, there ought to be disclosure. I’ve never even thought of these kinds of scenarios until you brought them up here…and it’s opened my eyes to the possibilities of things that can be going on that we have no idea of. We’ve got little folks with lives on the line, and I think we deserve and ought to know.”
*Weinfurt K, Hall M, et al. Effects of disclosing financial interests on participation in medical research: A randomized vignette trial. American Heart Journal, Vol 156, Number 4 (October 2008)
* Weinfurt, KP, Hall, MA., et.al.: Disclosure of Financial Relationships to Participants in Clinical Research. New England Journal of Medicine 2009, 361:9