{"id":63885,"date":"2019-01-15T00:00:00","date_gmt":"2019-01-15T06:00:00","guid":{"rendered":"https:\/\/www.unmc.edu\/newsroom\/2019\/01\/15\/irb-application-offline-as-new-rules-go-into-effect\/"},"modified":"2022-08-29T15:59:28","modified_gmt":"2022-08-29T20:59:28","slug":"irb-application-offline-as-new-rules-go-into-effect","status":"publish","type":"post","link":"https:\/\/www.unmc.edu\/newsroom\/2019\/01\/15\/irb-application-offline-as-new-rules-go-into-effect\/","title":{"rendered":"IRB application offline as new rules go into effect"},"content":{"rendered":"<div class=\"panel body-content\"><div class=\"panel__container\"><p>As revisions to the regulations governing human subjects research (the &#8220;Common Rule&#8221;) are scheduled to go into effect on Jan. 21, the UNMC Institutional Review Board&#8217;s <a href=\"https:\/\/net.unmc.edu\/rss\/\">online application<\/a> (research support system, or RSS) will be unavailable for new applications from Wednesday, Jan. 16, through Jan. 23, to facilitate transition to the new rule.<\/p>\n<p>The changes to the Common Rule will have significant and far ranging effects on the regulation of human subject research at UNMC, Nebraska Medicine, UNO, Bellevue Medical Center and Children&#8217;s Hospital &#038; Medical Center, said Bruce Gordon, M.D., assistant vice chancellor for regulatory affairs and executive chair of the IRB, in an email to investigators Monday.<\/p>\n<p>Some of the revisions will be more visible to investigators than others, including:<\/p>\n<ul>\n<li>Changes to consent form format and boilerplate language, and including the requirement for a &#8220;concise and focused presentation of the key information&#8221; (as a two-page &#8220;Executive Summary&#8221;).\n<li>Elimination of the requirement for Continuing Review for certain classes of research.<\/ul>\n<p><b>See more information on changes <a href=\"https:\/\/app1.unmc.edu\/PublicAffairs\/TodaySite\/images\/siteimages\/Rule0115.pdf\" target=\"_blanK\" rel=\"noopener\">here<\/a>.<\/b><\/p>\n<p>All new research submitted on or after Jan. 21, and any research submitted before Jan. 21 but not yet approved, is subject to the new rule.<\/p>\n<p>An extensively revised new IRB application compliant with the new rule, and with new consent form templates, will be available shortly in RSS.  <\/p>\n<p>To facilitate transition to the new rule, applications already started may be continued and completed or may be transferred to the new online application.<\/p>\n<\/div><\/div>","protected":false},"excerpt":{"rendered":"<p>System will be unavailable for new applications between Jan. 16-23.<\/p>\n","protected":false},"author":27,"featured_media":59384,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[1],"tags":[],"class_list":["post-63885","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized","department-unmc-today-todays-headlines","department-vice-chancellor-research"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>IRB application offline as new rules 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