{"id":5324,"date":"2018-02-27T13:38:28","date_gmt":"2018-02-27T18:38:28","guid":{"rendered":"https:\/\/www.med.unc.edu\/genetics\/?p=5324"},"modified":"2018-02-27T13:44:39","modified_gmt":"2018-02-27T18:44:39","slug":"new-human-subjects-and-clinical-trials-information-required-for-nih-grants","status":"publish","type":"post","link":"https:\/\/www.med.unc.edu\/genetics\/new-human-subjects-and-clinical-trials-information-required-for-nih-grants\/","title":{"rendered":"New Human Subjects and Clinical Trials Information Required for NIH Grants"},"content":{"rendered":"<p class=\"lead\">For grants submitted after January 25, 2018, NIH has instituted significant changes for applications proposing clinical trials and\/or work with human subjects.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignright wp-image-5325 size-full\" src=\"https:\/\/www.med.unc.edu\/genetics\/wp-content\/uploads\/sites\/481\/2018\/02\/NIH-logo_blue.png\" alt=\"NIH Logo\" width=\"225\" height=\"225\" srcset=\"https:\/\/www.med.unc.edu\/genetics\/wp-content\/uploads\/sites\/481\/2018\/02\/NIH-logo_blue.png 225w, https:\/\/www.med.unc.edu\/genetics\/wp-content\/uploads\/sites\/481\/2018\/02\/NIH-logo_blue-150x150.png 150w\" sizes=\"auto, (max-width: 225px) 100vw, 225px\" \/>The new requirements affect how and where information is presented regarding human subjects, enrollment and clinical trial information.\u00a0 This information will now be collected at the \u201cstudy\u201d level and an individual project may include multiple studies.\u00a0 Any lab performing human genetic studies (including DNA sequencing or utilization of human samples) will be impacted by this new requirement.\u00a0 In the \u201cFor Faculty\/Staff\u201d section of our department website, you can open the \u201cNIH Grant Templates and Guidance\u201d folder to find a decision tree to determine the applicability of these rules to your study (PrivateInfoORBioSpecimensDecisionChart) as well as an annotated version of the new FORM E (Annotated Forms HumanSubjects FORMS E).\u00a0 Additionally, here is a link to a\u00a0<a class=\"external-link\" title=\"\" href=\"https:\/\/www.youtube.com\/watch?v=nz9NWFhYOG8\" target=\"_blank\" rel=\"noopener noreferrer\">useful video<\/a>\u00a0that will walk you through the new process and\u00a0<a class=\"external-link\" title=\"\" href=\"https:\/\/grants.nih.gov\/policy\/clinical-trials\/new-human-subject-clinical-trial-info-form.htm\" target=\"_blank\" rel=\"noopener noreferrer\">a link<\/a>\u00a0to the NIH which explains the purpose, changes and provides resources. \u00a0If you have any questions, please contact Ann Nochlin.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>For grants submitted after January 25, 2018, NIH has instituted significant changes for applications proposing clinical trials and\/or work with human subjects. The new requirements affect how and where information is presented regarding human subjects, enrollment and clinical trial information.\u00a0 This information will now be collected at the \u201cstudy\u201d level and an individual project may &hellip; <a href=\"https:\/\/www.med.unc.edu\/genetics\/new-human-subjects-and-clinical-trials-information-required-for-nih-grants\/\" aria-label=\"Read more about New Human Subjects and Clinical Trials Information Required for NIH Grants\">Read more<\/a><\/p>\n","protected":false},"author":22429,"featured_media":5325,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":"","_links_to":"","_links_to_target":""},"categories":[2],"tags":[],"class_list":["post-5324","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","odd"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>New Human Subjects and Clinical Trials Information Required for NIH Grants | Department of Genetics<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.med.unc.edu\/genetics\/new-human-subjects-and-clinical-trials-information-required-for-nih-grants\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"New Human Subjects and Clinical Trials Information Required for NIH Grants | Department of Genetics\" \/>\n<meta property=\"og:description\" content=\"For grants submitted after January 25, 2018, NIH has instituted significant changes for applications proposing clinical trials and\/or work with human subjects. The new requirements affect how and where information is presented regarding human subjects, enrollment and clinical trial information.\u00a0 This information will now be collected at the \u201cstudy\u201d level and an individual project may &hellip; Read more\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.med.unc.edu\/genetics\/new-human-subjects-and-clinical-trials-information-required-for-nih-grants\/\" \/>\n<meta property=\"og:site_name\" content=\"Department of Genetics\" \/>\n<meta property=\"article:published_time\" content=\"2018-02-27T18:38:28+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2018-02-27T18:44:39+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.med.unc.edu\/genetics\/wp-content\/uploads\/sites\/481\/2018\/02\/NIH-logo_blue.png\" \/>\n\t<meta property=\"og:image:width\" content=\"225\" \/>\n\t<meta property=\"og:image:height\" content=\"225\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta 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