{"id":2612,"date":"2024-03-11T10:38:12","date_gmt":"2024-03-11T14:38:12","guid":{"rendered":"https:\/\/wwwcp.umes.edu\/research2\/?page_id=2612"},"modified":"2025-05-22T11:33:47","modified_gmt":"2025-05-22T15:33:47","slug":"application-process-irb-webpage","status":"publish","type":"page","link":"https:\/\/wwwcp.umes.edu\/research\/irb\/application-process-irb-webpage\/","title":{"rendered":"Application Process IRB Webpage"},"content":{"rendered":"\n<h2 class=\"wp-block-heading has-text-align-center\"><strong>IRB Initial Application<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">At the University of Maryland Eastern Shore, all research that involves the use of human subjects requires review by the Institutional Review Board (IRB) prior to the initiation of the research.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Submission Process<\/h3>\n\n\n\n<ol style=\"color:#000\" class=\"wp-block-list maroonlink\">\n<li class=\"has-black-color has-text-color has-link-color wp-elements-8a3af799c756abe98a90bdcb16077152\">The principal investigator(s) (faculty, staff, director) and student investigator(s) must complete CITI training. Click <a href=\"https:\/\/wwwcp.umes.edu\/research\/irb\/how-to-access-citi\/\" data-type=\"URL\" data-id=\"https:\/\/wwwcp.umes.edu\/research\/irb\/how-to-access-citi\/\" target=\"_blank\" rel=\"noreferrer noopener\">HERE <\/a>for directions to access CITI and which courses to select. Download each course certificate and name it as follows: InvestigatorLastName_Course (Bobenko_RCR_HSR or Bobenko_SBR or Bobenko_Biomed).<\/li>\n\n\n\n<li class=\"has-black-color has-text-color has-link-color wp-elements-a7a5de36c1f1e9bef91b5cd258f0888f\">Complete the application cover page. Click <a href=\"https:\/\/wwwcp.umes.edu\/grad\/wp-content\/uploads\/sites\/120\/2023\/09\/IRB_Cover_July_2023-Fillable.pdf\" data-type=\"URL\" target=\"_blank\" rel=\"noreferrer noopener\">HERE<\/a><a rel=\"noreferrer noopener\" href=\"https:\/\/wwwcp.umes.edu\/irb\/wp-content\/uploads\/sites\/77\/2023\/02\/IRB_Application_Jan_2023.pdf\" data-type=\"URL\" data-id=\"https:\/\/wwwcp.umes.edu\/irb\/wp-content\/uploads\/sites\/77\/2023\/02\/IRB_Application_Jan_2023.pdf\" target=\"_blank\"> <\/a>to access the cover page.\n<ul class=\"wp-block-list\">\n<li class=\"has-black-color has-text-color has-link-color wp-elements-c607583d8a5c2eac522fd09cb734349e\">After reviewing the exemption categories, if you think your application meets one or more of the exempt categories, indicate the category number(s) on your cover sheet. An exempt category notation does NOT mean that the application is exempt from being reviewed and approved by the IRB. Thus, your notation of this category is simply a helpful recommendation. The IRB will decide whether a protocol is exempt from federal regulations and by which category.<\/li>\n\n\n\n<li>Please name the file as follows: <mark>PrincipalInvestigator\u2019sLastName_Cover<\/mark><\/li>\n<\/ul>\n<\/li>\n\n\n\n<li class=\"has-black-color has-text-color has-link-color wp-elements-9fffef596b2eab53c4bf5eae1e05feca\">Complete the IRB application. The application can be accessed <a href=\"https:\/\/docs.google.com\/document\/d\/14Lm8K9U-Ix1AAPio_3Zx3LWM2M_aEKAz\/edit?usp=drive_link&amp;ouid=111188033916107308397&amp;rtpof=true&amp;sd=true\">HERE<\/a>. The application must be formatted as presented. All questions within the application must be answered.<br><br>Briefly, the IRB application must contain the following (please see the IRB application for more details):\n<ol class=\"wp-block-list\">\n<li class=\"has-black-color has-text-color has-link-color wp-elements-6084c3920158e5d2b8676662a52d0f7e\">A&nbsp;<em>brief description&nbsp;<\/em>of the research project.<\/li>\n\n\n\n<li class=\"has-black-color has-text-color has-link-color wp-elements-1f7ab5458c072a94498988cfb0105172\"><em>Subject Selection<\/em>&nbsp;\u2013 A description of the subjects and how they will be recruited.<\/li>\n\n\n\n<li class=\"has-black-color has-text-color has-link-color wp-elements-d01f02c247daa08d301f1c73d40e9caa\"><em>Procedures<\/em>&nbsp;\u2013 This is a detailed explanation of what will be done to the subjects, methods, and procedures in terms of what will be done to the subjects, and copies of the questionnaires or handouts used in the research.&nbsp;<\/li>\n\n\n\n<li class=\"has-black-color has-text-color has-link-color wp-elements-1c06e5e653e543d68b45148876aaff90\"><em>Risks and Benefits<\/em>&nbsp;\u2013 A list of the risks and\/or benefits possible to the subjects.<\/li>\n\n\n\n<li class=\"has-black-color has-text-color has-link-color wp-elements-0ce4d08c0c982a56f6c321307dc6f287\"><em>Confidentiality<\/em>&nbsp;\u2013 Explain how the procedures will adequately provide, to protect the privacy of subjects and maintain the confidentiality of identifiable information. An explanation of data storage, data location, and duration, description of persons with access to the data, and method of destroying the data when completed.<\/li>\n\n\n\n<li class=\"has-black-color has-text-color has-link-color wp-elements-7a06d605d6b95e153758b8f94404b120\"><em>Consent Forms<\/em>&nbsp;\u2013 Statement of what information will be provided to the subjects about the investigation.<\/li>\n\n\n\n<li class=\"has-black-color has-text-color has-link-color wp-elements-da35d87a4be5f6d1143b1ab414fd576a\">Plan for data collection, storage, and data analysis.<\/li>\n\n\n\n<li class=\"has-black-color has-text-color has-link-color wp-elements-ec5c225e9f878d6f0ca7f1bc91f93154\"><em>Conflict of Interest<\/em>&nbsp;\u2013 Description of potential conflict of interest.<\/li>\n\n\n\n<li class=\"has-black-color has-text-color has-link-color wp-elements-87ddecd36719d54a7b246f693109d743\"><em>HIPAA Compliance<\/em>&nbsp;\u2013 Information pertaining to protected health information.\n<ul style=\"color:#000\" class=\"wp-block-list\">\n<li>Please name the file as follows: <mark>PrincipalInvestigator\u2019sLastName_Application<\/mark><\/li>\n<\/ul>\n<\/li>\n<\/ol>\n<\/li>\n\n\n\n<li class=\"has-black-color has-text-color has-link-color wp-elements-b76ff92838c5b13fd058ddb9cadd2b53\">Please submit the CITI training certificates, cover page, and application to the Chair of the IRB via email: <a href=\"mailto:JCBobenko@umes.edu\" target=\"_blank\" rel=\"noreferrer noopener\">JCBobenko@umes.edu<\/a>.<\/li>\n\n\n\n<li class=\"has-black-color has-text-color has-link-color wp-elements-6975ed7063a1df3f4ed899510f1de5c4\">The IRB Chair will confirm receipt of the application and accompanying documents via email to the principal investigator only.<\/li>\n\n\n\n<li class=\"has-black-color has-text-color has-link-color wp-elements-9e54d5d588c1ff5dc2977cc5c47fd8e4\">Please allow for up to three weeks for an initial review of your application. The IRB Chair will contact you via email to request revisions and clarifications, and provide you with a determination\/approval notice.<br><\/li>\n<\/ol>\n\n\n\n<h3 class=\"wp-block-heading has-black-color has-text-color has-link-color wp-elements-58395101562548476fc145aab56680d5\"><em><strong>Renewals and Amendments<\/strong><\/em><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Applications that are not deemed exempt are approved for a maximum of 364 days. At the end of the approval period, all research must cease if a renewal has been granted by the IRB. If a renewal is required, please contact the IRB office for assistance. Renewal applications must be made at least one month prior to the end of the protocol approval date.&nbsp;<strong>It is the responsibility of the Principal Investigator to monitor the IRB approval and expiration dates for their study.<\/strong><\/p>\n\n\n\n<p class=\"maroonlink wp-block-paragraph\">Amendments to protocols can be made to an active protocol at any time. A memorandum should be submitted to the IRB detailing the rationale of the amendment. <\/p>\n\n\n\n<p class=\"maroonlink wp-block-paragraph\">Click <a href=\"https:\/\/wwwcp.umes.edu\/research\/wp-content\/uploads\/sites\/172\/2024\/03\/Amendment_template.docx\" data-type=\"URL\" data-id=\"https:\/\/wwwcp.umes.edu\/irb\/wp-content\/uploads\/sites\/77\/2023\/02\/Amendment_template.docx\" target=\"_blank\" rel=\"noreferrer noopener\">HERE <\/a>for an example of an amendment.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-9ac00cf961d1ea846fe5a532228b76c6 wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>IRB Initial Application At the University of Maryland Eastern Shore, all research that involves the use of human subjects requires review by the Institutional Review Board (IRB) prior to the initiation of the research. Submission Process Renewals and Amendments Applications that are not deemed exempt are approved for a maximum of 364 days. At the&#8230;<span class=\"cpschool-read-more-link-holder\"><a class=\"btn btn-basic cpschool-read-more-link\" href=\"https:\/\/wwwcp.umes.edu\/research\/irb\/application-process-irb-webpage\/\">Read more <span class=\"sr-only\">Application Process IRB Webpage<\/span><\/a><\/span><\/p>\n","protected":false},"author":2,"featured_media":0,"parent":2599,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_coblocks_attr":"","_coblocks_dimensions":"","_coblocks_responsive_height":"","_coblocks_accordion_ie_support":"","footnotes":""},"folder":[15],"class_list":["post-2612","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/wwwcp.umes.edu\/research\/wp-json\/wp\/v2\/pages\/2612","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/wwwcp.umes.edu\/research\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/wwwcp.umes.edu\/research\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/wwwcp.umes.edu\/research\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/wwwcp.umes.edu\/research\/wp-json\/wp\/v2\/comments?post=2612"}],"version-history":[{"count":0,"href":"https:\/\/wwwcp.umes.edu\/research\/wp-json\/wp\/v2\/pages\/2612\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/wwwcp.umes.edu\/research\/wp-json\/wp\/v2\/pages\/2599"}],"wp:attachment":[{"href":"https:\/\/wwwcp.umes.edu\/research\/wp-json\/wp\/v2\/media?parent=2612"}],"wp:term":[{"taxonomy":"folder","embeddable":true,"href":"https:\/\/wwwcp.umes.edu\/research\/wp-json\/wp\/v2\/folder?post=2612"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}