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Conflicts of Interest and Disclosure A Critical Assessment of the Current COI Policy and the Value of Integrity Su

IntegrityHistoryDisclosure. Overview. . Defining Integrity. Current Perspective. Integrity in Research IndividualIntellectual honestyObjectivity Personal responsibilityTransparency in conflicts of interest or potential conflicts of interestInstitutionalPromote responsible conduct and foster

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Conflicts of Interest and Disclosure A Critical Assessment of the Current COI Policy and the Value of Integrity Su

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    1. Conflicts of Interest and Disclosure A Critical Assessment of the Current COI Policy and the Value of Integrity Susan S. Night, JD, LLM health Policy and Ethics Fellow Baylor College of Medicine Houston, Texas Office of Research Integrity 2009 Research Conference on Research Integrity

    2. Integrity History Disclosure Overview

    3. Defining Integrity

    4. Current Perspective Integrity in Research Individual Intellectual honesty Objectivity Personal responsibility Transparency in conflicts of interest or potential conflicts of interest Institutional Promote responsible conduct and foster integrity Anticipate, reveal and manage individual and institutional conflicts of interest

    5. Revised Perspective

    6. Conflicts of Interest

    7. Is it possible to promote and even accelerate the progress of research while maintaining public trust in research by having a balance in, but not eliminating industry-academia relationships?

    8. What is a COI? A conflict of interest may occur when a clinician, researcher, public official, IRB member, university official, author, reviewer, editor allows a secondary interest financial gain, publication opportunity, career advancement, outside employment, personal considerations, relationships, investments, gifts to interfere with a primary interest patient welfare, research validity, publication of research, obligation to act in the best interest of another

    9. History of Conflicts of Interest

    10. History Foundations are primary funding source for research Federal funding = threat to scientific freedom Employment by industry “domination by government” vs. “domination by industry” Research on behalf of the country-partnership with industry Beginning of federal funding for research Merton’s objectivity COI - meetings Prior to 1940 1940s

    11. History Industry sponsors retain publication rights and restrictions COI related to federal employees Academia and industry address drug safety COI related to defense of public interest Federal funding now 60% AAUP report on COI 1950s 1960s

    12. History Mandates on disclosing COIs – McCarthyism? Disclosure more than required by federal statute COIs – environmental and occupational exposure Bayh-Dole Pajaro Dunes – COIs managed according to “special circumstances and traditions” 1970s 1980s

    13. History NIH policy on COI withdrawn AAMC, AAU, AAHC reports on COI 8 reports on guidelines and/or recommendations for COI 1990s 2000s

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    15. Disclosure

    16. Goal of Disclosure Objectivity in research – reduce bias Prevent harm Increase public trust

    17. Impact of Disclosure Advantages Consistent with policy approaches in other areas Stock analysts Sarbanes-Oxley McCain-Finegold Can help management govern better Consistent with principle of autonomy Reduces the need for other remedies e.g. regulation

    18. Impact of Disclosure Disadvantages Shift responsibility away from one who discloses – caveat emptor Does not achieve goal of Objectivity/Elimination of Bias Implicit and unconscious bias Banaji and Loewenstein www.tolerance.org/hidden_bias Does not meet the criteria for Integrity Discernment = NO Act = yes Speak = yes

    19. Disclosure in the Real World Individual researcher disclosure “In order to manage this conflict of interest, the Committee requires that you keep your consulting fees from XXX to an amount equal to or less than $10,000 on an annual basis….In doing so, you will eliminate your conflict of interest as defined by….policies and PHS regulations. Institutional Conflict of Interest Virginia Commonwealth University Master Service agreement with Philip Morris

    20. Final Thoughts History tells the story of collaboration Honesty and objectivity = disclosure Integrity = encourages exploration of unconscious bias What would Cicero say? There are 3 questions when considering a course of action What is honorable? What is useful? What is apparently useful conflicts with what is right “for when the useful seems to pull them forward towards itself and rectitude seems to draw them back in its direction, the mind as it reflects is tugged in opposite directions, and this makes for troubled indecision”

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