Conflict of interest

in research
Sanda-Maria Copotoiu

Disclosure

?! Importance
Consequences

Definition
of
COI

Potentially damage the entire

research enterprise
trust & confidence
COI = abuse

Scientific tradition

Present
time

Openness
Free inquiry
Free exchange of opinion

Proprietary interests
Restricted access to research
directed to products of commercial
value

Scientific tradition

Present
time

Openness
Free inquiry
Free exchange of opinion

Proprietary interests
Restricted access to research
directed to products of commercial
value

Present time
Scientists
encouraged to
contribute to the
financial stability of
the employer and
to the economic
development of a
nation.
S. Gaylen Bradley
Managing competing interests, in
Francis Macrina, Scientific
ientergrity, 3rd Ed, ASMPress,
2005:159-173

Scientific tradition
Openness
Free inquiry
Free exchange of opinion

Proprietary interests
Restricted access to research
directed to products of commercial
value

Present time
Scientists
encouraged to
contribute to the
financial stability of
the employer and
to the economic
development of a
nation.
S. Gaylen Bradley
Managing competing interests, in
Francis Macrina, Scientific
ientergrity, 3rd Ed, ASMPress,
2005:159-173

Scientific tradition
Openness
Free inquiry
Free exchange of opinion

Proprietary interests
Restricted access to research
directed to products of commercial
value

 Tangible financial relationships

COI
Definition

Intangible academic,
scholarships

Causes of
COI

Bias in judgement
A desire to validate a pet theory over
confidence about a particular concept
Overreliance on a team
Overreliance about a particular concept
A belief held by a special group
Ruling out uncomfortable data
Pressure to get a specific result

Causes of
COI

Bias in judgement
A desire to validate a pet theory over
confidence about a particular concept
Overreliance on a team
Overreliance about a particular concept
A belief held by a special group
Ruling out uncomfortable data
Pressure to get a specific result

Causes of
COI

Bias in judgement
A desire to validate a pet theory over
confidence about a particular concept
Overreliance on a team
Overreliance about a particular concept
A belief held by a special group
Ruling out uncomfortable data
Pressure to get a specific result

Causes of
COI

Bias in judgement
A desire to validate a pet theory over
confidence about a particular concept
Overreliance on a team
Overreliance about a particular concept
A belief held by a special group
Ruling out uncomfortable data
Pressure to get a specific result

Causes of
COI

Bias in judgement
A desire to validate a pet theory over
confidence about a particular concept
Overreliance on a team
Overreliance about a particular concept
A belief held by a special group
Ruling out uncomfortable data
Pressure to get a specific result

Causes of
COI

Bias in judgement
A desire to validate a pet theory over
confidence about a particular concept
Overreliance on a team
Overreliance about a particular concept
A belief held by a special group
Ruling out uncomfortable data
Pressure to get a specific result

Causes of
COI

Bias in judgement
A desire to validate a pet theory over
confidence about a particular concept
Overreliance on a team
Overreliance about a particular concept
A belief held by a special group
Ruling out uncomfortable data
Pressure to get a specific result

Causes of
COI

Bias in judgement
A desire to validate a pet theory over
confidence about a particular concept
Overreliance on a team
Overreliance about a particular concept
A belief held by a special group
Ruling out uncomfortable data
Pressure to get a specific result
Selective innattendance

BIAS
Too subtle to
recognize
Too difficult
to control

Research questions selected &

framed
Design
Participants
Data collection & analysis
Interpretation
Publication
Sharing of results

 Challenge to promote

Academic
COI

Competition
Disengagement

 Commitment = of effort
Of obligation = too much to do for
several stakeholders

Other COI
Of conscience conscience clause
As to intellectual property Columbia
University if not specifically waived

 Scientific integrity

Clinical
research

Patients safety
Investigation objectivity

A relevant
detail for
clinical
trials

Orlowski JP, Christensen JA, Chest

2002;121;2023-2028
2383 acronyms for CRTs
7% possible, probably or almost
certainly coercive

Paris, June 2012

21

Orlowski JP, Christensen JA, Chest 2002;121;20232028

The
subtlety of
the
pressure
exerted by
clinical
trials
acronyms

2383 acronyms for CRTs

7% possible, probably or almost certainly

coercive

Almost certainly coercive

ALIVE, CURE, HELP, HOPE, LIFE
Probably coercive
ACCEPT, ACCORD, AMIABLE, PEACE, GUARANTEE
Possible coercive
ATLAST, BOSS, PATCH, CHEAPER, CHOICE

Scientific method unprejudiced

& repeatable results

COI &
Clinical
trials

Steps
1. Identifying a problem observation
2. Hypothesis
3. Test the hypothesis data collection +
analysis
4. Deriving a conclusion

 Stick to the scientific method

Safeguard
s

For RCTs, clinical trials

DSMB Data and Safety Monitoring
Board

Research on the market

Off label income

Selling
research

Figures

Research on the market

Selling
research

Off label income

Gabapentin

20%

Research on the market

Selling
research

Off label income

Gabapentin

20%

GlaxoSmithKline fined $3bn after bribing doctors to

increase drugs sales The Guardian, 3 July 2012

International level
1980 USA Bay Dole Act

Laws &
regulation
s

Recipients of federal funds can obtain

the title to the inventions they develop
under their federally funded projects,
and to transfer the technology to the
private sector.
Requires federally founded researchers
patent seek for commercial
opportunities & report to the NIH on the
use of their discoveries.

Actual
figure of
real or
potential
COI?

Growing
Disturbing
Unintended consequences of the
legislation

Carta UMF
Regulamente
Comisia de
etica a
cercetarii
stiintifice
UMF TG.Mures

USA
NSF National Science Foundation
Responsibility of Applicants for
Promoting Objectivity in Research =
regulations requiring institutions to
establish standards & procedures that
ensure that the design, conduct, or
reporting of research is not biased by
any conflicting financial interests of the
investigator.

USA

Significant financial interest

Declaration threshold
< 25 000$ disclosure by sponsors
= a more reasonable total

1. Disclosure
2. Financial conflict can never be
managed

COI
Manageme
nt

3. Alternative opinion = zero tolerance

...the only sure safeguard is for the
investigator to have absolutely no
financial relationships with entities that
support his/her research.
Angell M. Is Academic Medicine for Sale? N Engl J Med
2003; 342(20):1516-1518

 Conflict of Interest Policy

The first author is also responsible for adhering to the ASCOs Policy For Relationships With Companies (Conflict
of Interest), obtaining disclosure information from all coauthors, and ensuring that all coauthors meet the
definition of authorship as stated by the International Committee of Medical Journal Editors.
ASCO's Policy For Relationships With Companies
*For questions regarding the 2013 ASCO Policy For Relationships With Companies, please see the
Frequently Asked Questions page.

American
Society of
Clinical
Oncology

In compliance with standards established by theASCO's Policy For Relationships With Companies (Conflict
of Interest; J Clin Oncol. 2013;31[16]:20432043) and the Accreditation Council for Continuing Medical
Information (ACCME), ASCO's intent is to promote balance, independence, objectivity, and scientific rigor
through the disclosure of financial and other interests, and in the identification and management of potential
conflicts. According to theASCO's Policy For Relationships With Companies , all authors are expected to
provide general disclosure information for 11 disclosure categories of relationships with for-profit health care
companies.
The requirements in ASCO Conflict of Interest Policy apply to all abstract authors. Authors may enter their own
disclosures using the ASCO Disclosure Management System online atcoi.asco.org . By establishing a disclosure
oncoi.asco.org , authors will have a unified disclosure across all ASCO activities, including volunteer service,
journals, and abstracts submissions. If an author has provided disclosure through ASCO Disclosure Management
System, the information will automatically populate in the submission site.
Alternatively, a submitting author can enter disclosure information from coauthors who opt not to use the ASCO
Disclosure Management System through the Abstract Submitter program. Copies of the Disclosure Form can be
sent to coauthors for completion and returned to the submitting author before submission of the abstract.
Per theImplementation Plan to Manage Relationships with Companies for CME Activities , all oral
abstract presenters will be subject to the same disclosure review and management strategies as faculty who
participate in ASCO CME activities.Please visitasco.org/rwcfor more information on the ASCO Conflict of
Interest Policy and the Conflict of Interest Policy Implementation Plan for CME Activities.
Additional Disclosure Questions for First, Last, and Corresponding Authors of Original Research
The first, last, and corresponding authors are required to answer additional questions specific to their abstract.
ASCO will not enforce restrictions listed in ASCO's Policy For Relationships With Companies on first, last, and
corresponding authors and will reconsider whether to do so after a period of data gathering and analysis that will
continue at least through April 22, 2016. Financial relationships of first, last, and corresponding authors are still
required to be disclosed and will be managed in accordance with ASCO procedures.

 Conflict of Interest Policy

The first author is also responsible for adhering to the ASCOs Policy For Relationships With Companies (Conflict
of Interest), obtaining disclosure information from all coauthors, and ensuring that all coauthors meet the
definition of authorship as stated by the International Committee of Medical Journal Editors.
ASCO's Policy For Relationships With Companies
*For questions regarding the 2013 ASCO Policy For Relationships With Companies, please see the
Frequently Asked Questionspage.

American
Society of
Clinical
Oncology

In compliance with standards established by theASCO's Policy For Relationships With Companies(Conflict of
Interest; J Clin Oncol. 2013;31[16]:20432043) and the Accreditation Council for Continuing Medical Information
(ACCME), ASCO's intent is to promote balance, independence, objectivity, and scientific rigor through the
disclosure of financial and other interests, and in the identification and management of potential conflicts.
According to theASCO's Policy For Relationships With Companies, all authors are expected to provide general
disclosure information for 11 disclosure categories of relationships with for-profit health care companies.
The requirements in ASCO Conflict of Interest Policy apply to all abstract authors. Authors may enter their own
disclosures using the ASCO Disclosure Management System online at coi.asco.org. By establishing a disclosure
oncoi.asco.org, authors will have a unified disclosure across all ASCO activities, including volunteer service,
journals, and abstracts submissions. If an author has provided disclosure through ASCO Disclosure Management
System, the information will automatically populate in the submission site.
Alternatively, a submitting author can enter disclosure information from coauthors who opt not to use the ASCO
Disclosure Management System through the Abstract Submitter program. Copies of the Disclosure Form can be
sent to coauthors for completion and returned to the submitting author before submission of the abstract.
Per theImplementation Plan to Manage Relationships with Companies for CME Activities, all oral abstract
presenters will be subject to the same disclosure review and management strategies as faculty who participate
in ASCO CME activities.Please visitasco.org/rwcfor more information on the ASCO Conflict of Interest Policy and
the Conflict of Interest Policy Implementation Plan for CME Activities.
Additional Disclosure Questions for First, Last, and Corresponding Authors of Original Research
The first, last, and corresponding authors are required to answer additional questions specific to their abstract.
ASCO will not enforce restrictions listed in ASCO's Policy For Relationships With Companies on first, last, and
corresponding authors and will reconsider whether to do so after a period of data gathering and analysis that
will continue at least through April 22, 2016. Financial relationships of first, last, and corresponding authors are
still required to be disclosed and will be managed in accordance with ASCO procedures.

Jesse Gelsinger

Last
sentence

Slowing
the
approval
process
out of
excessive
cautiousne
ss

A couple of
years before
the lethal
outcome of
gene
therapy

Reaction
to cutting
financial
resources

Conseque
nce of
funding
shortage

Concerns
with
disclosure

Integrity in Science
Website

Many ties to industries

Breach of privacy &
confidentiality = deterrent to
disclosure
Tarnish reputation
Websites activity as COI police

1.Identification
2. Management

COI
Manageme
nt
strategy

Reduced = disclosure +
Eliminated =
zero tolerance
+ oversight of the research by an
independent board

 Modifying the research plan

Changing the sites of investigation

Other COI
Manageme
nt
strategy

Monitoring of research by independent

reviewers: oversight on participant
recruitment- enrolment, the informed consent
process, analysis of the study data, subsequent
reporting the sponsors
Divestiture of significant financial interests
Disqualification of the researcher from part or
all of the research project
At the level of potential COI: many IRBs include
a statement in the informed consent form
which notifies the prospective research
participant of this relationship.
Eg: The investigator of your study is
supported by the sponsor

RESPONSIBILI
TY

Responsibility for
recognizing and avoiding COI
rests primarily with the
individual.
Columbia University Handbook 2008 Obligations and
responsibilities of officers of instruction and research

Accountab
ility

Cross sharing=
denying

The individual

Accountab
ility

Mea culpa

Scientific
misconduc
t on the
road
to
scientific
writing

Take home messages

The
elegant
soft
approach
for us

1. avoid
2. disclose
3. de-escalate
4. ask for help
5. establish institutional strategies
6. and establish organism to minimize
the consequences
7. take advantage, turn it into a win
situation on the long run.