November 22, 2024<\/a><\/p>\n As a reminder, the Office of Sponsored Programs<\/a> (OSP) and the 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 If an Institutional Review Board<\/a> (IRB) approval of a protocol is needed for a sponsored program, either the approved IRB protocol number or a 118 Letter<\/strong> from the Office of Human Research Ethics<\/a> (OHRE) must be provided.<\/p>\n Just-in-Time \/ 118 Letter<\/strong><\/p>\n OHRE issues a letter, known internally as the “118 Letter<\/a>,” for federally-funded applications and proposals that do not have definite plans for involving human subjects.<\/p>\n This letter does NOT constitute IRB approval.<\/p>\n Therefore, do not enter the date of the 118 Letter in the IRB approval date field in the JIT module of<\/strong> eRA Commons<\/a>.<\/p><\/blockquote>\n Project Delays<\/strong><\/p>\n For projects facing significant delays in start date or IRB approval, it is advisable to request a delay in onset from the sponsor<\/strong> if the project will be submitted to the IRB for a 118 Letter.<\/p>\n Department Responsibilities<\/strong>:<\/p>\n Central Office (OSP\/SOMSPO) Responsibilities:<\/strong><\/p>\n Additional Resources<\/strong><\/p>\n Contacts<\/strong><\/p>\n 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 … 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":[],"featured_image":false,"featured_image_medium":false,"featured_image_medium_large":false,"featured_image_large":false,"featured_image_thumbnail":false,"featured_image_alt":false,"category_details":[{"name":"News","link":"https:\/\/www.med.unc.edu\/spo\/category\/news\/"}],"tag_details":[],"_links_to":[],"_links_to_target":[],"_links":{"self":[{"href":"https:\/\/www.med.unc.edu\/spo\/wp-json\/wp\/v2\/posts\/4453","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.med.unc.edu\/spo\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.med.unc.edu\/spo\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.med.unc.edu\/spo\/wp-json\/wp\/v2\/users\/3716"}],"replies":[{"embeddable":true,"href":"https:\/\/www.med.unc.edu\/spo\/wp-json\/wp\/v2\/comments?post=4453"}],"version-history":[{"count":0,"href":"https:\/\/www.med.unc.edu\/spo\/wp-json\/wp\/v2\/posts\/4453\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.med.unc.edu\/spo\/wp-json\/wp\/v2\/media?parent=4453"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.med.unc.edu\/spo\/wp-json\/wp\/v2\/categories?post=4453"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.med.unc.edu\/spo\/wp-json\/wp\/v2\/tags?post=4453"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}JIT\/118 Process Reminders<\/strong><\/h4>\n
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