{"id":1792,"date":"2013-10-16T12:15:32","date_gmt":"2013-10-16T12:15:32","guid":{"rendered":"https:\/\/www.editage.com\/insights\/ethical-requirements-for-clinical-trials\/"},"modified":"2025-04-04T11:50:37","modified_gmt":"2025-04-04T11:50:37","slug":"ethical-requirements-for-clinical-trials","status":"publish","type":"post","link":"https:\/\/www.editage.com\/insights\/ethical-requirements-for-clinical-trials","title":{"rendered":"Ethical requirements for clinical trials"},"content":{"rendered":"<p style=\"text-align: justify;\"><span style=\"font-family: verdana,geneva,sans-serif;\"><span style=\"font-size: 14px;\">The <a href=\"http:\/\/www.icmje.org\/\">International Committee of Medical Journal Editors (ICMJE)<\/a> defines a clinical trial as any research project wherein human subjects are prospectively assigned to an intervention group or a control group to study the cause-and-effect relationship between a medical intervention and a health outcome. \u00a0A <a href=\"http:\/\/jama.jamanetwork.com\/article.aspx?articleid=192740\">report<\/a> published in the Journal of the American Medical Association lists seven major ethical requirements that should be fulfilled while conducting a clinical trial.<\/span><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-family: verdana,geneva,sans-serif;\"><span style=\"font-size: 14px;\">(1) <strong>Value<\/strong>\u2014Ensure that the study enhances health or generates knowledge that can form a basis for further research.<\/span><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-family: verdana,geneva,sans-serif;\"><span style=\"font-size: 14px;\">(2) <strong>Scientific validity<\/strong>\u2014The research must be methodologically sound for the results to be scientifically reliable, valid, and reproducible. \u00a0<\/span><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-family: verdana,geneva,sans-serif;\"><span style=\"font-size: 14px;\">(3) <strong>Favorable risk-benefit ratio<\/strong>\u2014 It is very important that the potential benefits to individuals and knowledge gained for society outweigh the risks associated with the study.\u00a0 In case the risks exceed the potential medical benefit, the clinical study would not be justifiable.<\/span><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-family: verdana,geneva,sans-serif;\"><span style=\"font-size: 14px;\">(4) <strong>Independent review<\/strong>\u2014Unaffiliated individuals must review the study and approve, amend, or terminate it.<\/span><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-family: verdana,geneva,sans-serif;\"><span style=\"font-size: 14px;\">(5) <strong>Fair subject selection<\/strong>\u2014Selection of subjects should be governed by the objectives of the study and not by any bias. For example, exclusion of women from the study population without a logical reason would be considered unethical.<\/span><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-family: verdana,geneva,sans-serif;\"><span style=\"font-size: 14px;\">(6) <strong>Informed consent<\/strong>\u2014Individuals should be informed about the research in its entirety\u2014 its purpose, methods, risks, and benefits\u2014before providing their voluntary consent in writing. \u00a0<\/span><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-family: verdana,geneva,sans-serif;\"><span style=\"font-size: 14px;\">(7) <strong>Respect for enrolled subjects<\/strong>\u2014The confidentiality of the subjects should be well protected. For example, all personal and identifiable information, like the subject\u2019s name and date or place of treatment should be removed.\u00a0 If photographs are to be used in the study report, they should be modified to ensure that the subjects cannot be identified. In addition, the subjects should be allowed to change their mind and withdraw their participation at any point in the study, without being penalized.\u00a0<\/span><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-family: verdana,geneva,sans-serif;\"><span style=\"font-size: 14px;\">Researchers tend to miss out on items 7\u201310 in the above list because these issues are not directly related to the overall impact and value of the study. Very often, peer reviewers or ethical review committee members raise an alarm when a clinical trial fails to mention the inclusion and exclusion criteria for subject selection, or in case signed informed consent forms are not submitted. The above-mentioned guidelines would prove very helpful in such situations.<\/span><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-family: verdana,geneva,sans-serif;\"><span style=\"font-size: 14px;\">As an aside, apart from adhering to all the above-mentioned ethical guidelines, the ICMJE mandates that all <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-trials\">clinical trials<\/a> be registered. <\/span><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-family: verdana,geneva,sans-serif;\"><span style=\"font-size: 14px;\">Some of the suggested registries are available at the following links: <\/span><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-family: verdana,geneva,sans-serif;\"><span style=\"font-size: 14px;\"><a href=\"http:\/\/www.anzctr.org.au\/\"><strong>www.anzctr.org.au<\/strong><\/a><\/span><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-family: verdana,geneva,sans-serif;\"><span style=\"font-size: 14px;\"><a href=\"http:\/\/www.clinicaltrials.gov\/\"><strong>www.clinicaltrials.gov<\/strong><\/a><\/span><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-family: verdana,geneva,sans-serif;\"><span style=\"font-size: 14px;\"><a href=\"http:\/\/www.isrctn.org\/\"><strong>www.ISRCTN.org<\/strong><\/a><\/span><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-family: verdana,geneva,sans-serif;\"><span style=\"font-size: 14px;\"><strong><a href=\"http:\/\/www.umin.ac.jp\/ctr\/index\/htm\">www.umin.ac.jp\/ctr\/index\/htm<\/a><\/strong><\/span><\/span><\/p>\n<p style=\"text-align: justify;\"><a style=\"font-size: 14px; font-family: verdana, geneva, sans-serif;\" href=\"http:\/\/www.trialregister.nl\/\"><strong>www.trialregister.nl<\/strong><\/a><\/p>\n<p style=\"text-align: justify;\"><a style=\"font-size: 14px; font-family: verdana, geneva, sans-serif;\" href=\"https:\/\/eudract.ema.europa.eu\/\"><strong>https:\/\/eudract.ema.europa.eu\/<\/strong><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The International Committee of Medical Journal Editors (ICMJE) defines a clinical trial as any research project wherein human subjects are prospectively assigned to an intervention group or a control group to study the cause-and-effect relationship between a medical intervention and a health outcome. \u00a0A report published in the Journal of the American Medical Association lists [&hellip;]<\/p>\n","protected":false},"author":12,"featured_media":33313,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[2418],"tags":[589,2519],"new_categories":[],"new_tags":[],"series":[],"class_list":["post-1792","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-research-ethics","tag-clinical-trial","tag-ethicalconsent"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Ethical requirements for clinical trials | Editage Insights<\/title>\n<meta name=\"description\" content=\"The International Committee of Medical Journal Editors (ICMJE) defines a clinical trial as any research project wherein human subjects are prospectively assigned to an intervention group or a control group to study the cause-and-effect 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