1. Conflict of Interest
Nidhi

2. Introduction

Increased involvement of academician in
research has raised potential of conflict of
Interest.

Arises from oppourtunities a faculty or other
members might have to benefit financially from
the outcome of research.

Granting agencies wants assurance from the
institution that member involved in research will
not utilise the funds to promote financial gain for
themselves or for families.

Institution should have written policies

conflict of interest

to provide a mechanism for faculty and staff
to disclose such conflicts.

3. Important aspects

The institutional Conflict of Interest policy must
include”

financial interests, gifts, gratuities and favors,
nepotism,

and other areas such as political participation
and bribery.

These rules must also indicate how outside
activities, relationships, and financial interests are
reviewed by the responsible and objective
institution official(s).

In addition, the institution has the responsibility
for maintaining objectivity in research by ensuring
that the design, conduct, or reporting of research
will not be biased by any conflicting financial
interest of investigator

4. Views
“Conflicts of interest are ubiquitous in academic life,
indeed all professional life; conflicts of interest can
never be eliminated. Moreover, the existence of
conflicts of interest has to be accepted and not
equated with scientific misconduct” (Korn 2000).
“Financial conflicts of interest are not inherent to the
research enterprise. They’re entirely optional –
unlike intellectual or personal conflicts of interest to
which they’re often compared” (Angell 2000)

5. What is a Conflict of Interest?

Situation in which the integrity of academic
activity, especially research, may be, or may be
perceived to be, compromised by financial or
other interests.

A conflict of interest occurs when a secondary
interest distorts or has the potential to distort a
judgment related to a primary interest

A professional’s judgment does not necessarily
have to be biased in order for that researcher
to have a conflict of interest — even the
appearance of a conflict of interest is ethically
worrisome

6. Primary Interests

Professionals have a primary interest—
the goal of their profession

For researchers:
− Producing generalizable knowledge
− Ensuring the safety of research
subjects
− Disseminating research results

7. Secondary Interests

Professional goals

Publishing

Obtaining future research funding

Gaining recognition and fame

Personal goals

Spending time with his/her family

Earning a good income

Other personal interests such as religion,
traveling, social activities, etc.

Political activism

8. Types
Conflicts of interest are of two major types.

Conflicts between the professional’s personal or
financial interests and the interests of a subject/
participant, patient or client, and

Conflicts that involve competing loyalties, to two
or more subjects, patients or clients.
Alternatively,

the conflict may be between a
subject/participant, client or patient and a third
party to whom the professional owes
contractual duties, for example, sponsors of
research, insurance companies, employers, etc.
The term competing interest rather than conflict of interest is preferred
by some as a way of lessening any implicit sense of misconduct

9. Financial Conflicts of Interest

The paradigm conflict of interest is financial interest.

non-financial (or only indirectly financial) forms of bias
can pose serious risks to research and to human safety
and dignity

Significant financial interests must be disclosed to
institutional officials and be appropriately managed
[Title 42 CFR, Section 50, Parts 604 and 605].

A “significant financial interest,” according to the PHS,
is one that that could directly and significantly affect the
design, conduct, or publication of research and thus
bear on issues of human subject’s protection.

The PHS sets a monetary threshold of a $10,000
interest or 5% ownership in an entity that would
reasonably be affected by research, neither PHS nor
FDA regulations specify types of financial interests that
may be held, or those that may not be held.

10. Financial interest
Financial interests include, but are not limited to:

Compensation from employment (by other than
grantee institution)

Paid consultancy, advisory board service, etc.

Stock ownership or options

Intellectual property rights (patents, copyrights,
trademarks, licensing agreements, and royalty
arrangements)

Paid expert testimony

Honoraria, speakers’ fees

Gifts

Trips

11. Ethical Concerns
I. The preservation of sound
science and
II.The protection of human subjects.

Both are integrally related.

Robust protection of human subjects –
and those who use the products of
science – depends on ensuring the
soundness of research.

12. Preservation of Sound Science
Threat to scientific integrity by introducing forms of bias
that affect the enterprise of science itself

Financial relationships among investigators,
academic research centers and private industry
create incentives to serve commercial interests
rather than the advancement of scientific knowledge

Sponsors may seek to restrict publication in order to avoid
advancing the work of competitors.

They may conceal negative study findings by maintaining control
of publication

Restricted or partial publication increases the cost of clinical
progress and can jeopardize the health of future study subjects
and future patients.

It also impedes or disrupts the work of other scientists whose
work would otherwise improve, build on or impeach prior
investigations.

13. Preservation of Sound Science

The soundness of study results can be profoundly
influenced by study design decisions: treatments to
be tested

placebo control or active control,

favorable and adverse endpoints,

the characteristics of eligible and ineligible
participants,

stopping or modifying a trial, and so on.

Without an investigator’s being aware of it,
conflicts of interest may influence the design and
conduct of research in ways that render study
results unsound, with the potential to misinform the
practice of many physicians and to affect the
health of patients

14. Preservation of Sound Science

The availability of capitation payments

fees paid by study sponsors to physicians for
each patient enrolled in a study – may decreases
interest in basic science research

may serve as an inducement for researchers and
research institutions to choose projects that are of
interest to generous sponsors rather than
alternatives that might be of more benefit to
patients or society.

15. Protection of Human Subjects

Multiple roles of clinician in clinical research leading
to compromised loyalties.

Investigators, sponsors, grantee institutions, and
physicians in private practice all stand to benefit by a
patient’s participation in research.

Enrolling sufficient number of subjects to obtain
funding, (conflict between potential subject interests and those of
investigators. )

The concern is that investigators – under pressure to
recruit – may undermine the consent process by

misrepresenting the research

inappropriately influencing patients to participate.

16. Current requirements applicable to
investigators

Before beginning a study,

Investigators
− are required to disclose financial interests
that may be affected by the outcome of
research to designated institutional
officials.

Institutions
− are required to report the existence of
conflicts of interest – but not substantive
details – to funding agencies
− to take steps to reduce, eliminate or
manage conflicts of interest.

17. Institutional Assurance
The regulations state that:
Obtain information regarding financial conflicts of
interest from all investigators according to
institutional policies and procedures.
Research institutions are formally responsible for
developing and communicating a process for
reviewing, authorizing and monitoring arrangements
that present conflicts of interest.
Investigators are advised to ensure compliance with
all of their institution’s policies relating to conflicts of
interest .
Improperly managed conflicts of interest can result
in suspending funding to the offending grantee.

18. Impact of the 2003 Guidance on
current requirements
On March 31, 2003, the Department of Health
and Human Services (DHHS) published revised
“draft guidance”Financial Relationships and
Interests in Research Involving Human
Subjects: Guidance for Human Subject
Protection”
The 2003 guidance defines a “conflicting financial
interest” as “a financial interest related to a
research study that will, or may reasonably be
expected to create a bias.” It continues to rely on
institutional assurance rather than prescription.

19. Managing Conflict of Interest
The 2003 Guidance states: “financial interests may
be managed by eliminating them or mitigating their
potentially negative impact.”
The primary strategies for managing conflicts of
interest are disclosure and prohibition.
A number of influential professional societies,
researchers and institutions have advocated a total
ban on paid consultancies and equity holdings in
entities related to their research; some have
recommended barring investigators from
investments in fields in which they are conducting
research.

20. Managing Conflict of Interest
peer review of the study design
independent oversight of the research
insulating investigator from knowledge about
the impact of financial interests through blind-
trust type devices
insulating the subject/participant from the
influence of financial considerations on
professional judgment by having an
investigator with a conflict abstain from
problematic aspects of the study
disclosure of the financial interest to subjects
on the consent form

21. Managing Conflict of Interest
Acknowledge that some conflicts exist (or may
exist) and must be “managed”
Prevent some relationships
Those of no scientific, academic value
Those for which the conflict is deemed “too great”
Those for which the faculty member has been “irresponsible”,
unethical, unprofessional
Manage those relationships that are determined to be
appropriate/worthwhile to minimize the conflict
Clarify what constitutes a Conflict of Interest

22. Managing Conflicts of Interest
Prohibiting Problematic financial
interest
Eliminate those actions that have inherent
conflicts without obvious benefit
Free gifts, meals, junkets
Equity holding
Drug samples
Conflict free formulary committees
Industry control of educational programs
Speakers bureaus
Consultation relationships and research funding
DRAFT - For discussion purposes only

23. Managing Conflict of Interest
Academic implication
Ensure transparency to all stakeholders
Specify deliverables in all relationships
with industry

Research funding

Consulting agreements

Publication and dissemination of
information (positive and negative)

Intellectual property

24. Managing Conflict of Interest
Implications for Patient Care
Clarify relationships to patients
Informed consent
Role of industry in decisionmaking and
clinical management
Consider participation by Ombudsman
Transfer decision making or care, as
appropriate

25. Conclusion:
How should conflicts of interest be
dealt with?
Several options exist; all require
identifying COIs!
Eliminating conflict
Disclosing conflict (e.g., to participants, to
colleagues or superior)
Introducing intermediaries (e.g., consent
monitor)
What other approaches might be
sensible?

26. Scientific misconduct
It is the violation of the standard codes of scholarly
conduct and ethical behavior in professional
scientific research. The main forms of scientific
misconduct are:
fabrication – the publication of deliberately
false or misleading research, often subdivided
in:
fabrication – v-the actual making up of
research data and (the intent of) publishing
them
falsification – manipulation of research data
and processes or omitting critical data or
results
plagiarism – the act of taking credit (or
attempting to take credit) for the work of
another.

27. Motivation to commit scientific
misconduct

Career pressure

"publish or perish"

Believing that one "knows the right answer"

intend to introduce a fact that they believe is
true, without actually performing the
experiments required.

The ability to get away with it

Consequences:

vary based on the severity of the fraud, the level of
notice it receives, and how long it goes undetected.

Even a case of plagiarism can cause damage through
resources being misdirected to others who may be less
capable of using them effectively and certainly are less
deserving of them.

28. Suppression/non-publication of data

Studies may be suppressed or remain unpublished
because

the findings are perceived to undermine the
commercial, political or other interests of the
sponsoring agent

they fail to support the ideological goals of the
researcher.

It may be possible in some cases to use statistical
methods to show that the datasets offered in relation to a
given field are incomplete

Some cases go beyond the failure to publish complete
reports of all findings with researchers knowingly making
false claims based on falsified data.

29. Responsibility of authors and of
coauthors

All authors, including coauthors, are expected to have
made reasonable attempts to check findings submitted
to academic journals for publication

Simultaneous submission of scientific findings to more
than one journal or duplicate publication of findings is
usually regarded as misconduct, under what is known
as the Ingelfinger rule.

Guest authorship and ghost authorship ( are
commonly regarded as forms of research misconduct

Authors are expected to keep all study data for later
examination even after publication

to provide information about ethical aspects of research

Provision of incorrect information to journals may be
regarded as misconduct

30. Summary

Increased involvement of academic researchers has
raised the potential for Conflict of Interest (CoI).

Professionals have a conflict of interest when their
interests or commitments

compromise their judgments,

compromise their research reports.

compromise their communications to research
subjects, participants, patients, or clients.

Multiple role of clinician has led to compromised
loyalties

Human subject recruitment in industry-sponsored trials
conflicts with the fiduciary role.

Investigators, sponsors, grantee institutions, and
physicians in private practice all stand to benefit by a
patient’s participation in research.

31. Summary

Before beginning a study, investigators are required
to disclose financial interests that may be affected by
the outcome of research

Institutions are required to report the existence of
conflicts of interest – but not substantive details – to
funding agencies and to take steps to reduce,
eliminate or manage conflicts of interest.

The goal of managing conflicts of interest is to
minimize the extent to which the design and conduct
of research is influenced – consciously or
unconsciously – by financial considerations

Scientific misconduct is the violation of the standard
codes of scholarly conduct and ethical behavior in
professional scientific research.

32. Thank You