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CONFLICTS OF INTEREST AND DISCLOSURE
A CRITICAL ASSESSMENT OF THE CURRENT COI POLICY
AND THE VALUE OF INTEGRITY
SUSAN S. NIGHT, JD, LLMHEALTH POLICY AND ETHICS FELLOW
BAYLOR COLLEGE OF MEDICINEHOUSTON, TEXAS
Office of Research Integrity2009 Research Conference on Research Integrity
•Integrity•History•Disclosure
Overview
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
Actions Based Upon
Discernment
CommunicateBasis of Actions
Moral Discernment
What are my values and beliefs?What do I think is right and wrong?What are the standards of my profession?Do my personal beliefs conflict with my profession?
Reflection of commitment to beliefs.Standing for something even at personal cost.Typically requires courage.
Say that one’s actions are consistent with what one believes is right.Forthright in explaining what one is doing.
Reevaluate beliefs of right and wrong.Correction or reevaluation of commitments given changing circumstances.Integrity as a continuous process.
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?
Prohibition Capitalism
COIs are a prima facie wrong
• Any interaction with drug industry presents fundamental COI
• All interactions of physicians with Pharma unethical and serious cause of COI
• Zero tolerance policy for IRB members to have financial interest in studies
• No legitimate justification for institutional decision makers to have financial interest
• Disclosure is only a warning flag to alert possibility of future problems, not a fix
• Delicate balance has swung too far toward private profit at the expense of public trust
• Unacceptable, faculty members makes decision not in institution’s interest
• Financial COI of institution subject to oversight and management
• COIs are ubiquitous and inevitable, learn to recognize and manage them
• Don’t promulgate rules that prohibit conduct of reasonable corp. research
Academic capitalism is the present and future of research in AMCs
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
History of Conflicts of Interest
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
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
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
History
NIH policy on COI withdrawn
AAMC, AAU, AAHC reports on COI
8 reports on guidelines and/or recommendations for COI
1990s 2000s
14
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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”