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University/Industry Relationships and Conflict of Interest. John Jay Gargus, M.D., PH.D. Professor, Physiology & Biophysics/Pediatrics Chair, Conflict of Interest Oversight Committee April 24, 2013. Agenda. University/Industry Relationships Conflict of Interest Disclosure Requirements
John Jay Gargus, M.D., PH.D.
Professor, Physiology & Biophysics/Pediatrics
Chair, Conflict of Interest Oversight Committee
April 24, 2013
The Bayh-Dole Actor University and Small Business Patent Procedures Act is United States legislation dealing with intellectual property arising from federal government-funded research. Adopted in 1980, it gave US universities, small businesses and non-profits intellectual property control of their inventions and other intellectual property that resulted from such funding.
Birch Evans Bayh II
Robert Joseph Dole
Editorial by The New York Times
White, Gayle and Schneider, Craig. “Depression Expert at Emory Pulls out of Research Projects.” The Atlanta Journal Constitution, October 14, 2008.
UC Technology Transfer Annual Report 2011 http://www.ucop.edu/ott/genresources/documents/IASRptFY11.pdf
Revised PHS Regulations
(Final rule published August 25, 2011)
Implementation began August 24, 2012
Physician Payment Sunshine Act
(Final Rule Issued February 8, 2013)
First report due on March 31, 2014 for payments made from August 1, 2013 to December 31, 2013.
Anything of economic value from an outside entity including:
…. then you would be required to submit a COI addendum for review
If you are responsible for design, conduct or reporting of the NSF funded research and received one or more of the following from an outside entity with interests related to the research:
…then you would indicate “Yes” on the Federal Financial Disclosure Form and submit a COI addendum for review
If you are responsible for design, conduct or reporting of the PHS funded research and received one or more of the following from an outside entity with interests related to your institutional responsibilities:
…then you would indicate “Yes” for each type of financial interest on the Form 800
If you are listed as research personnel on the protocol application and received one or more of the following from an outside entity with interests related to the research:
…then you would indicate “Yes” on the IRB application and submit a COI addendum for review
of UCI’s COIOC
Faculty (3 year terms; appointed by VC-Research)
School of Biological Sciences – 0
School of Medicine – 4
College of Health Sciences – 0
School of Engineering – 1
School of Physical Sciences – 2
School of Information and Computer Sciences – 0
School of Social Sciences – 1
Merage School of Business – 0
Bruce Morgan – Assistant Vice Chancellor of Research
Kevin Kennan, J.D. – Office of Res-Tech Alliances
Grace Park, J.D. – COI Administrator
Nadia Wong – COI Analyst
PNAS 2009 vol. 106 4906-4911
When is the best time to raise a concern about a COI? > When thesis advisor and project are chosen or anytime student has a concern. School has a form that must be signed at the end of the first year when student transfers from the Gateway Program to a lab.