{"id":4453,"date":"2024-11-22T14:57:56","date_gmt":"2024-11-22T19:57:56","guid":{"rendered":"https:\/\/www.med.unc.edu\/spo\/?p=4453"},"modified":"2024-11-22T16:33:12","modified_gmt":"2024-11-22T21:33:12","slug":"update-to-the-just-in-time-118-letter-process","status":"publish","type":"post","link":"https:\/\/www.med.unc.edu\/spo\/2024\/11\/update-to-the-just-in-time-118-letter-process\/","title":{"rendered":"Update to the Just-In-Time\/118 Letter Process"},"content":{"rendered":"<h4>Update to the Just-In-Time\/118 Letter Process<\/h4>\n<p><a href=\"https:\/\/osp.unc.edu\/2024\/11\/update-to-the-just-in-time-118-letter-process\/\" target=\"_blank\" rel=\"noopener\">November 22, 2024<\/a><\/p>\n<p>As a reminder, the <a href=\"https:\/\/osp.unc.edu\/\" target=\"_blank\" rel=\"noopener\">Office of Sponsored Programs<\/a> (OSP) and the <a href=\"https:\/\/www.med.unc.edu\/spo\/\" target=\"_blank\" rel=\"noopener\">School of Medicine Sponsored Programs Office<\/a> (SOMSPO) are providing guidance on National Institutes of Health (NIH) Just-In-Time (JIT) requests related to human subjects research.<\/p>\n<p>If an <a href=\"https:\/\/research.unc.edu\/human-research-ethics\/about\/\" target=\"_blank\" rel=\"noopener\">Institutional Review Board<\/a> (IRB) approval of a protocol is needed for a sponsored program, <strong>either the approved IRB protocol number or a 118 Letter<\/strong> from the <a href=\"https:\/\/research.unc.edu\/human-research-ethics\/\" target=\"_blank\" rel=\"noopener\">Office of Human Research Ethics<\/a> (OHRE) must be provided.<\/p>\n<blockquote><p><strong>Just-in-Time \/ 118 Letter<\/strong><\/p>\n<p>OHRE issues a letter, known internally as the &#8220;<a href=\"https:\/\/research.unc.edu\/human-research-ethics\/standard-operating-procedures-sops\/just-in-time-118-process\/\" target=\"_blank\" rel=\"noopener\">118 Letter<\/a>,&#8221; for federally-funded applications and proposals that do not have definite plans for involving human subjects.<\/p>\n<p style=\"color: red\">This letter does NOT constitute IRB approval.<\/p>\n<p>Therefore, <strong>do not enter the date of the 118 Letter in the IRB approval date field in the JIT module of<\/strong> <a href=\"https:\/\/public.era.nih.gov\/commonsplus\/public\/login.era?TARGET=https%3A%2F%2Fpublic.era.nih.gov%3A443%2Fcommons\" target=\"_blank\" rel=\"noopener\">eRA Commons<\/a>.<\/p><\/blockquote>\n<p><strong>Project Delays<\/strong><\/p>\n<p>For projects facing significant delays in start date or IRB approval, it is advisable to <strong>request a delay in onset from the sponsor<\/strong> if the project will be submitted to the IRB for a 118 Letter.<\/p>\n<h4 style=\"text-align: center\"><strong>JIT\/118 Process Reminders<\/strong><\/h4>\n<p><strong>Department Responsibilities<\/strong>:<\/p>\n<ul>\n<li>Provide either the IRB study record number or 118 Letter via the<a href=\"https:\/\/ramses2.research.unc.edu\/ramses\/\" target=\"_blank\" rel=\"noopener\"> RAMSeS Internal Processing Form<\/a>.<\/li>\n<li>Date of the IRB study approval document should be entered as the IRB approval date in the JIT module of <a href=\"https:\/\/public.era.nih.gov\/commonsplus\/public\/login.era?TARGET=https%3A%2F%2Fpublic.era.nih.gov%3A443%2Fcommons\" target=\"_blank\" rel=\"noopener\">eRA Commons<\/a>.<\/li>\n<\/ul>\n<p><strong>Central Office (OSP\/SOMSPO) Responsibilities:<\/strong><\/p>\n<ul>\n<li>Approve and submit all JIT materials to the sponsor.<\/li>\n<li>Confirm approval date of the IRB study record number is accurately reported during the JIT process.<\/li>\n<li>During JIT submission, only the IRB approval date will be shared. Full IRB documentation is provided only upon request by the sponsor.<\/li>\n<\/ul>\n<p style=\"text-align: center\"><strong>Additional Resources<\/strong><\/p>\n<ul>\n<li><a href=\"https:\/\/research.unc.edu\/human-research-ethics\/standard-operating-procedures-sops\/just-in-time-118-process\/\" target=\"_blank\" rel=\"noopener\">OHRE Just-In-Time\/118 Letter Process<\/a><\/li>\n<li><a href=\"https:\/\/nam12.safelinks.protection.outlook.com\/?url=https%3A%2F%2Fclick.mailchimp.com%2Ftrack%2Fclick%2F30010842%2Fpolicies.unc.edu%3Fp%3DeyJzIjoicEE1MFhSZmJDNllFbHY5MXN6RjJCbGtGVWlRIiwidiI6MSwicCI6IntcInVcIjozMDAxMDg0MixcInZcIjoxLFwidXJsXCI6XCJodHRwczpcXFwvXFxcL3BvbGljaWVzLnVuYy5lZHVcXFwvVERDbGllbnRcXFwvMjgzM1xcXC9Qb3J0YWxcXFwvS0JcXFwvQXJ0aWNsZURldD9JRD0xMzIyOTZcIixcImlkXCI6XCI1MzZkODA5MzdiNjU0MzVhYjIzNTJkZjM0MjM5OTU4YVwiLFwidXJsX2lkc1wiOltcIjE2MGFmYWQ0MjlhMzhiOWMxN2MzMjdjMzBlZjAxNmRlODlmYTgwNmZcIl19In0&amp;data=05%7C02%7C%7C2210143d51634d56801c08dd0b1b887a%7C58b3d54f16c942d3af081fcabd095666%7C1%7C0%7C638678935082707220%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=%2FOMdyzvPSlFp5SmmWIbmyP1vXiYy90uQGgPuaVhvr1A%3D&amp;reserved=0\" target=\"_blank\" rel=\"noopener\">OSP &#8211; 300.10, Procedure 1 &#8211; Completing JIT Requirements for NIH Proposals<\/a><\/li>\n<li><a href=\"https:\/\/nam12.safelinks.protection.outlook.com\/?url=https%3A%2F%2Fclick.mailchimp.com%2Ftrack%2Fclick%2F30010842%2Fpolicies.unc.edu%3Fp%3DeyJzIjoibWk2WVI0QXI3SzBPQ282dkc1OHFpNFFCZWFzIiwidiI6MSwicCI6IntcInVcIjozMDAxMDg0MixcInZcIjoxLFwidXJsXCI6XCJodHRwczpcXFwvXFxcL3BvbGljaWVzLnVuYy5lZHVcXFwvVERDbGllbnRcXFwvMjgzM1xcXC9Qb3J0YWxcXFwvS0JcXFwvQXJ0aWNsZURldD9JRD0xMzIyOTVcIixcImlkXCI6XCI1MzZkODA5MzdiNjU0MzVhYjIzNTJkZjM0MjM5OTU4YVwiLFwidXJsX2lkc1wiOltcIjE2MGFmYWQ0MjlhMzhiOWMxN2MzMjdjMzBlZjAxNmRlODlmYTgwNmZcIl19In0&amp;data=05%7C02%7C%7C2210143d51634d56801c08dd0b1b887a%7C58b3d54f16c942d3af081fcabd095666%7C1%7C0%7C638678935082721388%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=p7mBBRCj2MHHn1ORz56UbG8gUF87gt4oJorogJGNzMI%3D&amp;reserved=0\" target=\"_blank\" rel=\"noopener\">OSP &#8211; 300.10 &#8211; Just-in-Time Submission Requirements<\/a><\/li>\n<li><a href=\"https:\/\/grants.nih.gov\/grants\/policy\/nihgps\/html5\/section_2\/2.5.1_just-in-time_procedures.htm\" target=\"_blank\" rel=\"noopener\">NIH JIT Procedures<\/a><\/li>\n<li><a href=\"https:\/\/grants.nih.gov\/policy-and-compliance\/policy-topics\/human-subjects\/pre-and-post-award-processes\/jit\" target=\"_blank\" rel=\"noopener\">NIH JIT Procedures for Grants Involving Human Subjects<\/a><\/li>\n<li><a href=\"https:\/\/www.era.nih.gov\/applicants\/submit-jit.htm\" target=\"_blank\" rel=\"noopener\">Submit a JIT in eRA Commons<\/a><\/li>\n<\/ul>\n<p style=\"text-align: center\"><strong>Contacts<\/strong><\/p>\n<ul>\n<li>Contact your department&#8217;s OSP SPS or SOMSPO Grants Analyst for questions on specific proposals.<\/li>\n<li>Contact OHRE for questions regarding IRB review and process.<\/li>\n<li>Contact SponsoredPrograms@unc.edu for all other questions.<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Update to the Just-In-Time\/118 Letter Process November 22, 2024 As a reminder, the Office of Sponsored Programs (OSP) and the School of Medicine Sponsored Programs Office (SOMSPO) are providing guidance on National Institutes of Health (NIH) Just-In-Time (JIT) requests related to human subjects research. If an Institutional Review Board (IRB) approval of a protocol is &hellip; <a href=\"https:\/\/www.med.unc.edu\/spo\/2024\/11\/update-to-the-just-in-time-118-letter-process\/\" aria-label=\"Read more about Update to the Just-In-Time\/118 Letter Process\">Read more<\/a><\/p>\n","protected":false},"author":3716,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":"","_links_to":"","_links_to_target":""},"categories":[1],"tags":[],"class_list":["post-4453","post","type-post","status-publish","format-standard","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>Update to the Just-In-Time\/118 Letter Process - Sponsored Programs Office<\/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\/spo\/2024\/11\/update-to-the-just-in-time-118-letter-process\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Update to the Just-In-Time\/118 Letter Process - Sponsored Programs Office\" \/>\n<meta property=\"og:description\" content=\"Update to the Just-In-Time\/118 Letter Process November 22, 2024 As a reminder, the Office of Sponsored Programs (OSP) and the School of Medicine Sponsored Programs Office (SOMSPO) are providing guidance on National Institutes of Health (NIH) Just-In-Time (JIT) requests related to human subjects research. 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