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
- 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
Communicate
Basis 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
- This page intentionally
left blank
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”
