Conflict of interest

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 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

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.

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.

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 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.

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 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

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

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

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

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

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 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.

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.

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Conflict of interest

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