{"id":32938,"date":"2024-09-09T07:15:33","date_gmt":"2024-09-09T11:15:33","guid":{"rendered":"https:\/\/marymount.edu\/academics\/?page_id=32938"},"modified":"2026-02-09T14:04:53","modified_gmt":"2026-02-09T19:04:53","slug":"submission-process-and-timeline","status":"publish","type":"page","link":"https:\/\/marymount.edu\/academics\/office-of-research\/institutional-review-board\/submission-process-and-timeline\/","title":{"rendered":"Submission Process and Timeline"},"content":{"rendered":"<h2><strong>Steps in Choosing the Correct IRB Application Form<\/strong><\/h2>\n<p><span data-contrast=\"auto\"><span class=\"TextRun SCXW178826571 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW178826571 BCX0\">Prior to completing and <\/span><span class=\"NormalTextRun SCXW178826571 BCX0\">submitting<\/span><span class=\"NormalTextRun SCXW178826571 BCX0\"> an IRB application, please:<\/span><\/span><span class=\"EOP SCXW178826571 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/span><\/p>\n<h3><span data-contrast=\"auto\">Step 1:<\/span><\/h3>\n<p><span data-contrast=\"none\">Read and understand the updated <\/span><a href=\"https:\/\/marymount.edu\/academics\/office-of-research\/institutional-review-board\/irb-policy-procedure-manual\/\"><b><span data-contrast=\"none\">Marymount IRB Policy &amp; Procedures Manual<\/span><\/b><\/a><\/p>\n<h3><span data-contrast=\"none\">Step 2:<\/span><\/h3>\n<p><span data-contrast=\"none\">Complete the required <\/span><a href=\"https:\/\/marymount.edu\/academics\/office-of-research\/institutional-review-board\/citi\/\"><b><span data-contrast=\"none\">CITI Training<\/span><\/b><\/a><span data-contrast=\"none\"> and obtain a completion certificate<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/p>\n<h3><span data-contrast=\"auto\">Step 3: <\/span><\/h3>\n<p><span data-contrast=\"auto\"><span class=\"TextRun SCXW9535040 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW9535040 BCX0\">Review the regulations and policies to <\/span><span class=\"NormalTextRun SCXW9535040 BCX0\">determine<\/span><span class=\"NormalTextRun SCXW9535040 BCX0\"> if your research <\/span><\/span><a class=\"Hyperlink SCXW9535040 BCX0\" href=\"https:\/\/marymount.edu\/academics\/office-of-research\/institutional-review-board\/is-it-research\/\" target=\"_blank\" rel=\"noreferrer noopener\"><span class=\"TextRun Underlined SCXW9535040 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW9535040 BCX0\" data-ccp-charstyle=\"Hyperlink\">qualifies as human subject research<\/span><\/span><\/a><span class=\"TextRun SCXW9535040 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW9535040 BCX0\">. If you plan to <\/span><span class=\"NormalTextRun SCXW9535040 BCX0\">disseminate<\/span><span class=\"NormalTextRun SCXW9535040 BCX0\"> the quality improvement (QI) project results externally (e.g., conference presentation, publication, thesis\/dissertation, poster, or other public venues), you must obtain an IRB determination letter before beginning research activity.<\/span><\/span> If you have questions, contact the IRB.<\/span><\/p>\n<ul>\n<li><span data-contrast=\"auto\">If research, determine the category of review required: <strong>Exempt, Expedited, <\/strong>or <strong>Full Board. <\/strong><\/span><strong>\u00a0<\/strong>Please see the <a href=\"https:\/\/marymount.edu\/academics\/wp-content\/uploads\/sites\/3\/2025\/08\/IRB-Manual_2025.08.15.pdf\">IRB Manual_2025.08.15<\/a><span data-contrast=\"auto\">, section 5.5, and <\/span><a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/index.html\"><span data-contrast=\"none\">OHRP<\/span><\/a><span data-contrast=\"auto\"> for more detailed descriptions of each risk level.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259,&quot;469777462&quot;:[720],&quot;469777927&quot;:[0],&quot;469777928&quot;:[8]}\">\u00a0<\/span><\/li>\n<\/ul>\n<h4><strong>Brief Overview of Categories of IRB Protocols<\/strong><\/h4>\n<h4><span style=\"text-decoration: underline\"><strong>Exempt Protocols<\/strong><\/span><\/h4>\n<p style=\"padding-left: 40px\"><span data-contrast=\"auto\">Overview:<\/span><span data-contrast=\"auto\"> Research that qualifies for an exempt review is considered to pose minimal risk to participants. This level is used for studies involving minimal risk and which fall into specific categories outlined by federal regulations.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559739&quot;:160,&quot;335559740&quot;:259,&quot;469777462&quot;:[720],&quot;469777927&quot;:[0],&quot;469777928&quot;:[8]}\">\u00a0<\/span><\/p>\n<p style=\"padding-left: 40px\"><span data-contrast=\"auto\">Examples<\/span><span data-contrast=\"auto\">: Research involving educational tests, surveys, interviews, or observations where data is collected ; studies involving public behavior where individuals cannot be identified.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559739&quot;:160,&quot;335559740&quot;:259,&quot;469777462&quot;:[720],&quot;469777927&quot;:[0],&quot;469777928&quot;:[8]}\">\u00a0<\/span><\/p>\n<p style=\"padding-left: 40px\"><span data-contrast=\"auto\">\u00a0Process<\/span><span data-contrast=\"auto\">: Although labeled &#8220;exempt,&#8221; these studies still require IRB review to confirm their exemption status. You cannot self-declare a protocol as \u2018exempt.\u2019 Exempt protocols are typically reviewed by one members of the IRB committee. They do not require annual reviews.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559739&quot;:160,&quot;335559740&quot;:259,&quot;469777462&quot;:[720],&quot;469777927&quot;:[0],&quot;469777928&quot;:[8]}\">\u00a0<\/span><\/p>\n<p style=\"padding-left: 40px\"><span data-contrast=\"auto\">Timeline<\/span><span data-contrast=\"auto\">: Exempt protocols can be submitted at any time. Investigators should anticipate up to 15 working days after submission to receive initial feedback.\u00a0 Recognize that your application may require modifications\/clarifications before it can be approved. It may take up to 5 business days to respond to each re-submission. <\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<h4><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559739&quot;:160,&quot;335559740&quot;:259,&quot;469777462&quot;:[720],&quot;469777927&quot;:[0],&quot;469777928&quot;:[8]}\"> <strong><span style=\"text-decoration: underline\">Expedited Protocols<\/span><\/strong><\/span><\/h4>\n<p style=\"padding-left: 40px\"><span data-contrast=\"auto\">\u00a0Overview:<\/span><span data-contrast=\"auto\"> Expedited review is for research that poses no more than minimal risk to participants but involves procedures that are not exempt,falling into one of the <\/span><a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/guidance\/categories-of-research-expedited-review-procedure-1998\/index.html\"><span data-contrast=\"none\">expedited categories authorized by 46 CFR 46 and 21 CFR 56<\/span><\/a><span data-contrast=\"auto\"> (DHHS regulations). See the link to the regulation for details.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559739&quot;:160,&quot;335559740&quot;:259,&quot;469777462&quot;:[720],&quot;469777927&quot;:[0],&quot;469777928&quot;:[8]}\">\u00a0<\/span><\/p>\n<p style=\"padding-left: 40px\"><span data-contrast=\"auto\">Examples:<\/span><span data-contrast=\"auto\"> Studies involving non-invasive procedures, collection of blood samples from adults in small amounts, or research on behavior that does not involve sensitive topics.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559739&quot;:160,&quot;335559740&quot;:259,&quot;469777462&quot;:[720],&quot;469777927&quot;:[0],&quot;469777928&quot;:[8]}\">\u00a0<\/span><\/p>\n<p style=\"padding-left: 40px\"><span data-contrast=\"auto\">Process:<\/span><span data-contrast=\"auto\"> An IRB member or a small group of reviewers evaluates the research protocol. The process is quicker and less comprehensive than a full board review but still involves thorough evaluation. This level of review is used for studies the IRB can evaluate the risks and benefits without a full board review.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559739&quot;:160,&quot;335559740&quot;:259,&quot;469777462&quot;:[720],&quot;469777927&quot;:[0],&quot;469777928&quot;:[8]}\">\u00a0<\/span><\/p>\n<p style=\"padding-left: 40px\"><span data-contrast=\"auto\">Timeline: <\/span><span data-contrast=\"auto\">Expedited protocols can be submitted at any time. Investigators should anticipate up to 15 working days after submission to receive initial feedback.\u00a0 Recognize that your application may require modifications\/clarifications before it can be approved. It may take up to 15 business days to respond to each re-submission. <\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<h4><strong><span style=\"text-decoration: underline\">Full Board Review Protocols<\/span><\/strong><\/h4>\n<p style=\"padding-left: 40px\">Overview: Full board review is required for research that involves more than minimal risk to participants or does not fit into the other categories. This level is used for studies with potential for significant impact on participants&#8217; rights and welfare.<\/p>\n<p style=\"padding-left: 40px\">Examples: Clinical trials involving high-risk procedures, research on sensitive topics such as mental health or substance abuse, or studies involving vulnerable populations like prisoners.<\/p>\n<p style=\"padding-left: 40px\">Process: The entire IRB committee reviews the protocol during a scheduled meeting. This review is detailed and includes a comprehensive assessment of risks, benefits, and ethical considerations.<\/p>\n<p style=\"padding-left: 40px\">Timeline:<span data-contrast=\"auto\">\u00a0 Protocols requiring full board review must be submitted two weeks before a scheduled IRB committee meeting as all IRB members must review the protocol and participate in discussion about approval. Given the complexity of full board reviews, it is not unusual for the initial review to result in requests for additional information before approval can be provided. Based on the extent of the modifications\/clarifications required, the re-submission may be reviewed by a subset of the committee or may require full-board review which could require waiting until the next IRB committee meeting.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559739&quot;:160,&quot;335559740&quot;:259,&quot;469777462&quot;:[720],&quot;469777927&quot;:[0],&quot;469777928&quot;:[8]}\">\u00a0<\/span><\/p>\n<h4><span style=\"text-decoration: underline\"><strong>The IRB Committee Meetings for 2024-2025<\/strong><\/span><\/h4>\n<table style=\"width: 100%;height: 396px\" data-tablestyle=\"MsoTableGrid\" data-tablelook=\"1184\">\n<tbody>\n<tr style=\"height: 84px\">\n<td style=\"width: 33.7871%;height: 84px;text-align: center\" data-celllook=\"0\">\n<h5><span style=\"font-size: 12pt\"><strong>Submission deadline for a full board review protocol\u00a0<\/strong><\/span><\/h5>\n<\/td>\n<td style=\"width: 18.1931%;height: 84px;text-align: center\" data-celllook=\"0\">\n<h5><span style=\"font-size: 12pt\"><strong>IRB meeting date\u00a0<\/strong><\/span><\/h5>\n<\/td>\n<td style=\"width: 46.9059%;height: 84px;text-align: center\" data-celllook=\"0\">\n<h5><span style=\"font-size: 12pt\"><strong>Response provided<br \/>\n(approval or request for additional information)\u00a0<\/strong><\/span><\/h5>\n<\/td>\n<\/tr>\n<tr style=\"height: 48px\">\n<td style=\"width: 33.7871%;height: 48px\" data-celllook=\"0\"><span data-contrast=\"auto\">August 15, 2025\u00a0<\/span><\/td>\n<td style=\"width: 18.1931%;height: 48px\" data-celllook=\"0\"><span data-contrast=\"auto\">September 5, 2025\u00a0<\/span><\/td>\n<td style=\"width: 46.9059%;height: 48px\" data-celllook=\"0\"><span data-contrast=\"auto\">\u00a0September 12, 2025<\/span><\/td>\n<\/tr>\n<tr style=\"height: 48px\">\n<td style=\"width: 33.7871%;height: 48px\" data-celllook=\"0\"><span data-contrast=\"auto\">September 12, 2025\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:259,&quot;469777462&quot;:[720],&quot;469777927&quot;:[0],&quot;469777928&quot;:[8]}\">\u00a0<\/span><\/td>\n<td style=\"width: 18.1931%;height: 48px\" data-celllook=\"0\"><span data-contrast=\"auto\">October 3, 2025<\/span><\/td>\n<td style=\"width: 46.9059%;height: 48px\" data-celllook=\"0\"><span data-contrast=\"auto\">October 10, 2025<\/span><\/td>\n<\/tr>\n<tr style=\"height: 48px\">\n<td style=\"width: 33.7871%;height: 48px\" data-celllook=\"0\"><span data-contrast=\"auto\">October 10, 2025\u00a0<\/span><\/td>\n<td style=\"width: 18.1931%;height: 48px\" data-celllook=\"0\"><span data-contrast=\"auto\">\u00a0October 31, 2025<\/span><\/td>\n<td style=\"width: 46.9059%;height: 48px\" data-celllook=\"0\">November 7, 2025<\/td>\n<\/tr>\n<tr style=\"height: 48px\">\n<td style=\"width: 33.7871%;height: 48px\" data-celllook=\"0\"><span data-contrast=\"auto\">November 14, 2025<\/span><\/td>\n<td style=\"width: 18.1931%;height: 48px\" data-celllook=\"0\"><span data-contrast=\"auto\">December 5, 2025<\/span><\/td>\n<td style=\"width: 46.9059%;height: 48px\" data-celllook=\"0\"><span data-contrast=\"auto\">December 12, 2025<\/span><\/td>\n<\/tr>\n<tr style=\"height: 48px\">\n<td style=\"width: 33.7871%;height: 48px\" data-celllook=\"0\">January 9, 2026<\/td>\n<td style=\"width: 18.1931%;height: 48px\" data-celllook=\"0\"><span data-contrast=\"auto\">January 30, 2026<\/span><\/td>\n<td style=\"width: 46.9059%;height: 48px\" data-celllook=\"0\"><span data-contrast=\"auto\">February 6, 2026<\/span><\/td>\n<\/tr>\n<tr style=\"height: 24px\">\n<td style=\"width: 33.7871%;height: 24px\" data-celllook=\"0\"><span data-contrast=\"auto\">February 6, 2026\u00a0<\/span><\/td>\n<td style=\"width: 18.1931%;height: 24px\" data-celllook=\"0\">February 27, 2026<\/td>\n<td style=\"width: 46.9059%;height: 24px\" data-celllook=\"0\"><span data-contrast=\"auto\">\u00a0March 6, 2026<\/span><\/td>\n<\/tr>\n<tr style=\"height: 24px\">\n<td style=\"width: 33.7871%;height: 24px\" data-celllook=\"0\"><span data-contrast=\"auto\">March 27, 2026<\/span><\/td>\n<td style=\"width: 18.1931%;height: 24px\" data-celllook=\"0\"><span data-contrast=\"auto\">April 17, 2026<\/span><\/td>\n<td style=\"width: 46.9059%;height: 24px\" data-celllook=\"0\"><span data-contrast=\"auto\">\u00a0April 24, 2026<\/span><\/td>\n<\/tr>\n<tr style=\"height: 24px\">\n<td style=\"width: 98.8861%;height: 24px\" colspan=\"3\" data-celllook=\"0\"><span data-contrast=\"auto\">Please contact <\/span><a href=\"mailto:IRB@marymount.edu\"><span data-contrast=\"none\">IRB@marymount.edu<\/span><\/a><span data-contrast=\"auto\"> to discuss the potential for a full board review during the summer months<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:259,&quot;469777462&quot;:[720],&quot;469777927&quot;:[0],&quot;469777928&quot;:[8]}\">\u00a0<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3><span data-contrast=\"auto\">Step 4:<\/span><\/h3>\n<p><span class=\"TextRun SCXW155819491 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun CommentStart CommentHighlightPipeHovered CommentHighlightHovered SCXW155819491 BCX0\">For <strong>doctoral student-led research only<\/strong>, the student and faculty mentor must read, sign, and upload the <\/span><\/span><a class=\"Hyperlink SCXW155819491 BCX0\" href=\"https:\/\/marymount.edu\/academics\/office-of-research\/institutional-review-board\/student-research\/\" target=\"_blank\" rel=\"noreferrer noopener\"><span class=\"TextRun Underlined MacChromeBold SCXW155819491 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun CommentHighlightHovered SCXW155819491 BCX0\" data-ccp-charstyle=\"Hyperlink\">Student PI and Faculty Mentor Agreement Form<\/span><\/span><\/a> <span class=\"TextRun SCXW155819491 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun CommentHighlightHovered SCXW155819491 BCX0\">to the IRB application (more information below about the student-led research). <\/span><\/span><span class=\"EOP CommentHighlightPipeHovered SCXW155819491 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/p>\n<h3><span data-contrast=\"auto\">Step 5:<\/span><\/h3>\n<p><span class=\"TextRun SCXW106388024 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun CommentStart CommentHighlightPipeClicked CommentHighlightClicked SCXW106388024 BCX0\">Complete the <\/span><\/span><a class=\"Hyperlink SCXW106388024 BCX0\" href=\"https:\/\/marymount.edu\/academics\/office-of-research\/institutional-review-board\/sitero-mentor\/\" target=\"_blank\" rel=\"noreferrer noopener\"><span class=\"TextRun Underlined SCXW106388024 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun CommentHighlightClicked SCXW106388024 BCX0\" data-ccp-charstyle=\"Hyperlink\">IRB application in Sitero Mentor<\/span><\/span><\/a><span class=\"TextRun SCXW106388024 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun CommentHighlightClicked SCXW106388024 BCX0\"> by writing a clear and detailed description of the purpose of the research and research procedures. Providing the IRB reviewers with a clear understanding of your plan, data management, and data security plan will ensure participants\u2019 safety, confidentiality, and privacy are protected, and those involved in the research understand the experience and expectations of the study. Be sure to include all related material, including instruments and consent forms, in the IRB application.<\/span><\/span><span class=\"EOP CommentHighlightPipeClicked SCXW106388024 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<hr \/>\n<p><span data-contrast=\"none\">Applications with significant writing deficiencies (unclear purpose, poor alignment, significant grammatical errors, incomplete sections) will be returned to the Principal Investigator (PI) until these issues are addressed. Please ensure your submissions meet professional standards.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Steps in Choosing the Correct IRB Application Form Prior to completing and submitting an IRB application, please:\u00a0 Step 1: Read and understand the updated Marymount IRB Policy &amp; Procedures Manual Step 2: Complete the required CITI Training and obtain a completion certificate\u00a0 Step 3: Review the regulations and policies to determine if your research qualifies [&#8230;]<\/p>\n<p><a class=\"btn btn-secondary understrap-read-more-link\" href=\"https:\/\/marymount.edu\/academics\/office-of-research\/institutional-review-board\/submission-process-and-timeline\/\">Read More&#8230;<\/a><\/p>\n","protected":false},"author":211,"featured_media":0,"parent":2691,"menu_order":3,"comment_status":"closed","ping_status":"closed","template":"page-templates\/left-sidebarpage.php","meta":{"_acf_changed":false,"_lmt_disableupdate":"no","_lmt_disable":"","ngg_post_thumbnail":0,"footnotes":"","advanced-sidebar-menu\/link-title":"Submission Process and Timeline","advanced-sidebar-menu\/exclude-page":false},"class_list":["post-32938","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.0 (Yoast SEO v27.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Submission Process and Timeline - Marymount University<\/title>\n<meta name=\"description\" content=\"Steps in Choosing the Correct IRB Application Form Prior to completing and submitting an IRB application, please:\u00a0 Step 1: Read and understand the updated . 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