Conflicts of Interest and Disclosure A Critical Assessment of the

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

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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

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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

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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

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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

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Disclosure

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

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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

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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

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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

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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”