Conflict of Interest

Nidhi

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.

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

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)

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

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

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

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

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.

Financial interestFinancial 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

Ethical ConcernsI. The preservation of sound

science andII.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.

Preservation of Sound ScienceThreat 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.

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

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.

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.

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.

Institutional AssuranceThe 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.

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.

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.

Managing Conflict of Interestpeer 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

Managing Conflict of Interest

Acknowledge that some conflicts exist (or may exist) and must be “managed”

Prevent some relationshipsThose 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

DRAFT - For discussion purposes only

Managing Conflicts of InterestProhibiting Problematic financial

interest

Eliminate those actions that have inherent conflicts without obvious benefit

Free gifts, meals, junketsEquity holdingDrug samplesConflict free formulary committeesIndustry control of educational programsSpeakers bureausConsultation relationships and research funding

Managing Conflict of InterestAcademic implication

Ensure transparency to all stakeholdersSpecify deliverables in all relationships with industry Research funding Consulting agreements Publication and dissemination of

information (positive and negative) Intellectual property

Managing Conflict of InterestImplications for Patient Care

Clarify relationships to patientsInformed consentRole of industry in decisionmaking and clinical management

Consider participation by OmbudsmanTransfer decision making or care, as appropriate

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?

Scientific misconductIt 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.

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.

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.

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

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.

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.

Thank You