{"id":179429,"date":"2024-12-31T06:29:17","date_gmt":"2024-12-31T06:29:17","guid":{"rendered":"https:\/\/learnexams.com\/blog\/?p=179429"},"modified":"2024-12-31T06:29:19","modified_gmt":"2024-12-31T06:29:19","slug":"issued-in-1974","status":"publish","type":"post","link":"https:\/\/www.learnexams.com\/blog\/2024\/12\/31\/issued-in-1974\/","title":{"rendered":"Issued in 1974"},"content":{"rendered":"\n<p>Issued in 1974, 45 ?CFR 46 ?raised to regulatory status:<\/p>\n\n\n\n<p>The 1974 ?National Research Act<\/p>\n\n\n\n<p>Kefauver-Harris Drug Amendments to the Federal Food, Drug &amp; Cosmetics Act<\/p>\n\n\n\n<p>The Nuremberg Code<\/p>\n\n\n\n<p>US Public Health Service Policy<\/p>\n\n\n\n<p><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-ast-global-color-6-color\"><strong>The Correct Answer and Explanation is :<\/strong><\/mark><\/p>\n\n\n\n<p>The correct answer is: <strong>The 1974 National Research Act<\/strong>.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Explanation:<\/h3>\n\n\n\n<p>In 1974, the <strong>National Research Act<\/strong> was signed into law in the United States, marking a pivotal moment in the ethical oversight of research involving human subjects. This Act led to the establishment of the regulatory framework codified in <strong>45 CFR 46<\/strong>, which raised ethical principles to regulatory status. Here is a breakdown of its significance:<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Historical Context:<\/strong><\/li>\n<\/ol>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The Act was a direct response to egregious ethical violations in research, such as the <strong>Tuskegee Syphilis Study<\/strong>, where participants were misled and harmed. Public outrage and ethical concerns spurred the need for regulatory measures to protect research participants.<\/li>\n<\/ul>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Creation of the National Commission for the Protection of Human Subjects:<\/strong><\/li>\n<\/ol>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The National Research Act established this commission, tasked with identifying basic ethical principles to guide human research. These principles were later articulated in the <strong>Belmont Report (1979)<\/strong>.<\/li>\n<\/ul>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Introduction of 45 CFR 46:<\/strong><\/li>\n<\/ol>\n\n\n\n<ul class=\"wp-block-list\">\n<li>This section of the Code of Federal Regulations outlines the federal policy for the protection of human subjects. It introduced key concepts such as:\n<ul class=\"wp-block-list\">\n<li><strong>Institutional Review Boards (IRBs):<\/strong> Committees to review research protocols for ethical compliance.<\/li>\n\n\n\n<li><strong>Informed Consent:<\/strong> Ensuring participants are fully informed about the research and voluntarily agree to participate.<\/li>\n\n\n\n<li><strong>Special Protections:<\/strong> Additional safeguards for vulnerable populations like pregnant women, prisoners, and children.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Broader Implications:<\/strong><\/li>\n<\/ol>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The regulatory framework established under the Act applies to federally funded research but has influenced ethical standards in all human research domains, including private and international studies.<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p><strong>Other Options:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The <strong>Kefauver-Harris Drug Amendments (1962)<\/strong> focused on drug safety and efficacy but did not establish broad ethical research guidelines.<\/li>\n\n\n\n<li>The <strong>Nuremberg Code (1947)<\/strong> was an ethical guideline, not a regulation.<\/li>\n\n\n\n<li>The <strong>US Public Health Service Policy<\/strong> pertains to research animals, not human subjects.<\/li>\n<\/ul>\n\n\n\n<p>Thus, the National Research Act is the cornerstone of modern research ethics in the U.S.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Issued in 1974, 45 ?CFR 46 ?raised to regulatory status: The 1974 ?National Research Act Kefauver-Harris Drug Amendments to the Federal Food, Drug &amp; Cosmetics Act The Nuremberg Code US Public Health Service Policy The Correct Answer and Explanation is : The correct answer is: The 1974 National Research Act. Explanation: In 1974, the National [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[25],"tags":[],"class_list":["post-179429","post","type-post","status-publish","format-standard","hentry","category-exams-certification"],"_links":{"self":[{"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/posts\/179429","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/comments?post=179429"}],"version-history":[{"count":0,"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/posts\/179429\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/media?parent=179429"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/categories?post=179429"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/tags?post=179429"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}