{"id":279,"date":"2019-10-09T22:07:27","date_gmt":"2019-10-09T16:37:27","guid":{"rendered":"https:\/\/medicineplexus.com\/?p=279"},"modified":"2019-10-09T22:07:27","modified_gmt":"2019-10-09T16:37:27","slug":"conflict-of-interest-coi-in-research","status":"publish","type":"post","link":"https:\/\/medicineplexus.com\/conflict-of-interest-coi-in-research\/","title":{"rendered":"Conflict of interest (COI) in Research"},"content":{"rendered":"\n<p><strong>Conflict of interest (COI)<\/strong><\/p>\n\n\n\n<p>when an <strong>individual has interests in the outcome of the research<\/strong> that may\nlead to a <strong>personal advantage<\/strong> and\nthat might, therefore, in actuality or appearance <strong>compromise the integrity of the research or investigator\u2019s judgment in\nconducting or reporting research<\/strong><\/p>\n\n\n\n<p>COIs can stem in a variety of ways in\nbiomedical research. <\/p>\n\n\n\n<ul><li>The <strong>potential sources of\nbias<\/strong> start from the <strong>study design and\nits conduct &nbsp;<\/strong><\/li><li>to <strong>conclusions made out of\nthe research<\/strong> and subsequently its <strong>publication.<\/strong>\n<\/li><li><strong>protocol violations may go unreported<\/strong>, contributing to a flawed outcome. <\/li><li>Researchers \u00e0 <strong>selective\nin reporting research outcomes or analyses<\/strong>, which is a well-documented\nsource of bias. <\/li><li>Evidence also shows that studies with an underlying financial COI,\ntend to publish research outcomes that favor the financial interest. <\/li><\/ul>\n\n\n\n<p><strong>TYPES OF COI<\/strong><\/p>\n\n\n\n<p>COI in clinical research may be\nclassified as financial or non-financial and can take place at the level of <\/p>\n\n\n\n<ul><li>Principal Investigator (PI), <\/li><li>Ethics Committee (EC) members, <\/li><li>Institutions or Sponsors <\/li><\/ul>\n\n\n\n<p><strong>At the level of a\nPI,<\/strong> <\/p>\n\n\n\n<ul><li>an underlying <strong>financial COI<\/strong>\ncould potentially <strong>influence<\/strong> his\/her <strong>professional decisions.<\/strong> <\/li><li>certain <strong>adverse events (AEs<\/strong>)\nduring a study may be chosen, to be <strong>under-reported<\/strong>\nby the PI. <\/li><li>This motive may, in turn, <strong>save\nthe sponsor from paying compensation<\/strong><\/li><li>However, such a move may prove detrimental to patient care and\nlater endanger public health. <\/li><li><strong>non-financial COIs<\/strong> involving PI can be <strong>academic where he\/she desires for prestige,\npower and professional advancement <\/strong>or has an interest in obtaining positive\nresults in order to obtain publications. <\/li><li>PI may also have a personal COI by way of <strong>preferring family and friends for a particular treatment<\/strong> such as in\nan unblinded study in a desire to alleviate pain and suffering.<\/li><\/ul>\n\n\n\n<p><strong>EC members<\/strong> <\/p>\n\n\n\n<ul><li>may similarly be involved in financial gain and may have an <strong>inclination towards approval of industry-sponsored\nstudies.<\/strong> <\/li><li><strong>personal preference may result in\nbiased decisions of EC members<\/strong> towards studies submitted by family and friends<\/li><\/ul>\n\n\n\n<p><strong>An institution<\/strong> <\/p>\n\n\n\n<ul><li>by way of favoring a <strong>pharmaceutical\ncompany<\/strong> to receive financial support for research may imply a financial\nCOI. <\/li><li>An institution may also be involved in <strong>non-financial COI for political reasons.<\/strong> <\/li><li>Further, when an institution <strong>conducts\na CME,<\/strong> acceptance of funding from the industry may <strong>bias the topic chosen for the CME event, in favor of the interests of\nthe industry<\/strong> rather than the institution&#8217;s own mission. <\/li><li>Such COIs may also lead to bias by the institution or organization\nwhile developing a guideline and advocating treatments to patients. <\/li><\/ul>\n\n\n\n<p>Sponsors often have underlying COIs as\nthey can profoundly influence study designs, analysis, and interpretation of\ndata. Further, they may also tend to suppress a negative result or AEs. <\/p>\n\n\n\n<p><strong>COIS IN INDIA <\/strong><\/p>\n\n\n\n<ul><li>One major instance of COI in India was the highly publicized\nclinical trial on the <strong>Human Papillomavirus\n(HPV) vaccine that was carried out in India in 2009. <\/strong><\/li><li>This trial was a collaboration between USA based organization <strong>PATH (Program for Appropriate Technology in\nHealth) and ICMR.<\/strong> <\/li><li>The trial drew much attention after several <strong>serious adverse events such as convulsions and death<\/strong> of numerous\nchildren were reported.<\/li><li>It was later reported by India\u2019s Parliamentary Standing <strong>Committee on Health and Family Welfare<\/strong>\nthat this trial had some major COIs. <\/li><li><strong>Firstly, the ICMR<\/strong>, which was to formulate ethical\nguidelines for researchers were found to be <strong>directly involved in the advisory committee of the project. <\/strong><\/li><li><strong>Secondly, manufacturers had earlier\nprovided financial support to conduct the vaccine trial<\/strong> in the Department of Obstetrics and\nGynecology, All India Institute of Medical Sciences <strong>(AIIMS), whose Head of Department was later appointed as a member of the\nenquiry committee. <\/strong><\/li><li>This was a clear instance of COI as her findings could not be\nrelied upon. There were several other lapses reported such as <strong>non-disclosure of an international trip of\nthe same individual, sponsored by the manufacturer,<\/strong> under the Foreign\nContribution Regulation Act (FCRA). <\/li><li>the trial was subsequently stopped <\/li><\/ul>\n\n\n\n<p><strong>DISCLOSURE OF COI<\/strong><\/p>\n\n\n\n<ul><li>Currently, the requirement for authors\nto disclose the list of companies that provide funding support for their\nstudies, while applying for publication, is greater than ever before. <\/li><li>The importance of disclosure of COI\nlies in the fact that readers, reviewers, and editors are allowed to assess for\nthemselves, <strong>potential biases and their\nimpact on the validity of the results and conclusions of any study.<\/strong><\/li><li>However, this does not imply the resolution\nor elimination of a COI.<\/li><\/ul>\n\n\n\n<p><strong>SHOULD PATIENTS BE INFORMED OF COI? <\/strong><\/p>\n\n\n\n<ul><li>In order to <strong>market a new\ndrug or device, a pharmaceutical company often provides gifts, royalties or\nconsultant payments to the clinician.<\/strong> <\/li><li>Such financial interests <strong>may\nprompt a clinician to subconsciously change his\/ her behavior<\/strong> towards the\npatient. <\/li><li>This would <strong>likely be\npertaining to the cost of health care rather than patient clinical outcomes.<\/strong><\/li><li>For the patient to understand and be fully aware of such\nconflicts, better methods need to be implemented. <\/li><li>These may include a <strong>one-on-one\ndialogue with the physician or reaching out to an institutional or public\ndomain,<\/strong> which provides information on financial disclosures and their\nimplications for example, on a <strong>medical\ncenter website. <\/strong><\/li><li>Such websites may help a patient to access and process the\ninformation at his\/her own pace and convenience.<\/li><\/ul>\n\n\n\n<p><strong>GUIDELINES\nFOR COI IN INDIA<\/strong><\/p>\n\n\n\n<ul><li>The <strong>Indian Good Clinical\nPractice (GCP) guidelines<\/strong>, emphasizes the need for identifying COI between\nscientific responsibilities and possible business interests of researchers<\/li><li>The <strong>latest ICMR guidelines, revised\nin 2017<\/strong>, suggest recommendations for research institutions, researchers and\nECs to help identify and manage COIs in research. However, <strong>a clear outline<\/strong> of what constitutes a COI is <strong>lacking.<\/strong> <\/li><li>ICMR\nproposes that <ul><li><strong>research institutions should develop<\/strong> and\nimplement policies and Standard operating procedures <strong>(SOPs) to address COI<\/strong>\nissues\u00e0 <\/li><\/ul><ul><li><strong>educate their staff<\/strong> about such\npolicies\u00e0 <\/li><\/ul><ul><li><strong>monitor the research for accuracy<\/strong> and\nobjectivity and advise \u00e0 <\/li><\/ul><ul><li><strong>not to interfere in the functioning\nand decision making of the EC. <\/strong><\/li><\/ul><ul><li>Researchers\nare advised to ensure that <strong>documents submitted to the EC include disclosure\nof COI <\/strong>(financial or nonfinancial) that may affect their research<\/li><\/ul><ul><li>IECs on the other hand, are suggested to <strong>evaluate\neach study based on any disclosed COI and ensure that appropriate action is\ntaken to mitigate thi<\/strong>s and <strong><\/strong><\/li><\/ul><ul><li>recommends that their members should also disclose\ntheir own COI and take appropriate measures to recuse themselves from reviewing\nor decision making on protocols related to their COI and make appropriate\nsuggestions for management, if COI is detected at the institutional or\nresearchers level. <\/li><\/ul><\/li><\/ul>\n\n\n\n<p><strong>MANAGING COIS<\/strong><\/p>\n\n\n\n<ul><li>Financial and non-financial COIs are\noften treated the same way. However, their implications remain different. <\/li><li>Some <strong>non-financial COIs may be associated with ethical and privacy issues\nand may affect disclosure<\/strong>. For example, in certain studies like <strong>abortion-related health outcomes or\nsame-sex transmission of disease<\/strong>, it may be difficult to disclose the\nresearchers&#8217; own experience with abortion or their sexual affiliation\nrespectively.<\/li><li>When a COI\ndisclosure reveals a potential, perceived or actual COI, <strong>a management\nstrategy should be developed to document and proactively address the issue<\/strong>.\n<\/li><li>In some\ncircumstances, <strong>simply the act of declaring the conflict may be sufficient to<\/strong>\nadequately mitigate or manage it. <\/li><li>Other\nstrategies \u00e0 &nbsp;<strong>consideration of removal from situation or\nconflict or restricting the access of the person to relevant information<\/strong>\nthat is sensitive or confidential and <\/li><li><strong>recruitment of an independent third\nparty to oversee part or all of the process<\/strong> which can\nbe applied to the level of PI, EC, and Institution. <\/li><li>when a member of the <strong>IEC is himself\/herself in a clear COI<\/strong>,\nduring the review of his\/her own research project(s). In such instances, <strong>the member must be refrained from being\npresent during the particular project\u2019s review<\/strong>.<\/li><li>Occasionally, the parent organization\nmight have a strong interest in bringing a project to fruition. In such cases,\nit is important for the IEC to act independently from the parent organization\nand institutions must respect the autonomy of the IEC<\/li><li>institutions to have policies for declaring and\nmanaging COIs that should be percolated to all stakeholders (investigators, IEC\nmembers, sponsors, authors, and editors) <strong>through workshops organized by\ncentral agencies drawing examples from real-life scenarios.<\/strong><\/li><\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Conflict of interest (COI) when an individual has interests in the outcome of the research that may lead to a personal advantage and that might, therefore, in actuality or appearance compromise the integrity of the research or investigator\u2019s judgment in conducting or reporting research COIs can stem in a variety of ways in biomedical research.[&#8230;]\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_seopress_robots_primary_cat":"","_seopress_titles_title":"","_seopress_titles_desc":"","_seopress_robots_index":"","footnotes":""},"categories":[3],"tags":[],"_links":{"self":[{"href":"https:\/\/medicineplexus.com\/wp-json\/wp\/v2\/posts\/279"}],"collection":[{"href":"https:\/\/medicineplexus.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medicineplexus.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medicineplexus.com\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/medicineplexus.com\/wp-json\/wp\/v2\/comments?post=279"}],"version-history":[{"count":0,"href":"https:\/\/medicineplexus.com\/wp-json\/wp\/v2\/posts\/279\/revisions"}],"wp:attachment":[{"href":"https:\/\/medicineplexus.com\/wp-json\/wp\/v2\/media?parent=279"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medicineplexus.com\/wp-json\/wp\/v2\/categories?post=279"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medicineplexus.com\/wp-json\/wp\/v2\/tags?post=279"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}