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Conflicts of Interest

Conflicts of Interest

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Conflicts of Interest

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  1. Conflicts of Interest CIPP 909 Research Ethics March 10, 2010 Joe Giffels Research Integrity Office jgiff001@umaryland.edu

  2. 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?

  3. 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 shouldCoI in research be managed?

  4. 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.

  5. 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

  6. Similarities Scientist Entrepreneur Reputation is a key asset It’s all about gaining acceptance of a new idea Passion for the enterprise is essential

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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 (p=0.037) • 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

  12. October 25, 2009 University Doctors Got Paid in Drug's Sales Campaign Money for speeches highlights murky area for conflicts of interest Getty Images By Paul Basken Fourteen university-affiliated physicians collected more than $400,000 from the makers of the anti-cholesterol drug Vytorin as part of a campaign to encourage the use of the medication. The 2008 campaign went on after an internal company study showed that the drug, with several billion dollars in sales, had little or no overall value for most patients.

  13. Maryland Public Ethics Law Code of Maryland Regulations 15-501 and 15-523

  14. Applicable Policies and Procedures USM Policy On Conflicts of Interest In Research or Development www.umaryland.edu/hrpolicies/section3/t30111sa.html UMB Procedures Implementing Board of Regents Policy on COI… www.ord.umaryland.edu/researchers/policies/umproceed.php

  15. 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

  16. NIH Objectivity In Science http://grants1.nih.gov/grants/compliance/42_CFR_50_subpart_F.htm

  17. 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

  18. Exemption Provisions/Conditions(examples) Conflict of Commitment Insider Trading