{"id":3036,"date":"2024-01-03T11:02:11","date_gmt":"2024-01-03T16:02:11","guid":{"rendered":"https:\/\/www.rochester.edu\/ohsp\/?page_id=3036"},"modified":"2026-09-09T17:04:59","modified_gmt":"2026-09-09T21:04:59","slug":"watermarked-documents","status":"publish","type":"page","link":"https:\/\/www.rochester.edu\/ohsp\/click-irb\/watermarked-documents\/","title":{"rendered":"Watermarked Documents"},"content":{"rendered":"<p>Institutional Review Boards (IRBs) routinely apply a watermark to consent forms and recruitment materials at the time of IRB approval (including initial approvals, as well as modifications and continuing reviews).<\/p>\n<p>IRBs typically further require study staff to utilize the current, watermarked version of these documents during the recruitment and informed consent process. In other words, the current, watermarked versions are the only versions of the documents the IRB recognizes as valid (the watermark validates IRB-approval of the document\u2019s contents).<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Institutional Review Boards (IRBs) routinely apply a watermark to consent forms and recruitment materials at the time of IRB approval (including initial approvals, as well as modifications and continuing reviews).&hellip;<\/p>\n","protected":false},"author":36,"featured_media":0,"parent":316,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":"","_members_access_role":[],"_members_access_error":""},"class_list":["post-3036","page","type-page","status-publish","hentry"],"acf":{"lead_in":"","display_title":"Accessing and Utilizing Watermarked Documents","subtitle":"","call_to_action":"","hero_image_placement":"no_image","hero_media":"images","hero_pattern_option":"","hero_video":"","hero_image_landing":"","hero_image_landing_two":"","hero_image_landing_three":"","content_modules":[{"acf_fc_layout":"text","anchor":"","css_class":"","title":"<h2>What is required?<\/h2>","content":"Requirements related to what documents are watermarked and when study teams are required to use them, will depend on the Reviewing IRB. Generally, it\u2019s safe to assume that if a document is watermarked by the IRB, then the study team is required to utilize the current, watermarked version of that document during study conduct.\r\n\r\nLocally, the IRB watermarks all consent forms and recruitment materials. <a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_901_Investigator_Responsibilities.pdf\">OHSP Policy 901: Investigator Responsibilities<\/a> requires all investigators to obtain informed consent utilizing the current, watermarked version of the document.\r\n\r\nSimilarly, watermarked versions of recruitment materials should be utilized when appropriate, based on the nature of the materials (reference <a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/703a_GDL_Recruitment_Methods_Materials.pdf\">OHSP Guideline for Recruitment Methods and Materials<\/a>). For example, printed flyers posted in public locations should include the watermark, whereas language approved for a social media post would not need to include the watermark as doing so would not be feasible.\r\n\r\n<a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_901_Investigator_Responsibilities.pdf\">OHSP Policy 901 Investigator Responsibilities<\/a> further requires study teams to 'maintain documentation to support IRB determinations...' This means that study teams should maintain documentation of all IRB-approved materials, including <em>all<\/em> versions of <em>any<\/em> watermarked documents.\r\n\r\nReference our <a href=\"https:\/\/www.rochester.edu\/ohsp\/resources\/study-documentation\/requirements\/\">Study Documentation Requirements page<\/a> for more information.","background_color":"#f4f4f4","width":"width-medium"},{"acf_fc_layout":"text","anchor":"","css_class":"","title":"<h2>What does the watermark look like?<\/h2>","content":"The format of an IRB watermark will vary by IRB. The URochester IRB watermark appears in the lower right-hand corner of an approved document and minimally includes the IRB approval date. Based on the type of document, the watermark may also include an expiration date.\r\n<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/click-irb\/#blank\">Click IRB FAQ: Why is the expiration\/approval end date field blank in Click IRB?<\/a><\/li>\r\n<\/ul>","background_color":"#ffffff","width":"width-medium"},{"acf_fc_layout":"text","anchor":"","css_class":"","title":"<h2>How is the watermark applied?<\/h2>","content":"Watermarks are routinely built into the Reviewing IRB\u2019s electronic approval process.\u00a0 IRB watermarking occurs via programming within the Click IRB platform, based on the document category selected by the study team when a document is uploaded. For example, when a document is uploaded and identified as a consent form, the document will be watermarked with both an approval and expiration date (if applicable) when the submission is processed for approval. Whereas, if the document is identified as an information sheet, it will only be watermarked with an approval date at the time of approval.\r\n\r\nAs the process is automated, IRB staff do not have the ability to move or adjust where the watermark appears. The watermark will always appear in the lower right-hand corner of the document. As such, <strong>study teams should format consent and recruitment materials with at least a 1-inch footer and leave the lower right-hand footer of all consent and recruitment documents blank<\/strong> (<a href=\"https:\/\/www.rochester.edu\/ohsp\/templates\/#consent\">IRB consent form templates<\/a> are already formatted to accommodate the watermark). Any content (e.g., page numbers or version dates) included in this area will be covered by the watermark, once it is applied.\r\n\r\nIn the event that a consent\/recruitment document watermark is missing or does not appear to be accurate, contact the <a href=\"https:\/\/www.rochester.edu\/ohsp\/irb-review\/coordinator\/\">IRB Coordinator<\/a>.","background_color":"#f4f4f4","width":"width-medium"},{"acf_fc_layout":"text","anchor":"","css_class":"","title":"<h2>Where can watermarked documents be accessed?<\/h2>","content":"For research reviewed by the IRB, all approved study team members and individuals listed on the study\u2019s guest list can access watermarked documents as follows:\r\n<h3>Current watermarked documents<\/h3>\r\nAll current watermarked IRB-approved documents are available on the \u2018Documents\u2019 tab in the <strong>STUDY<\/strong> workspace (labeled \u2018<strong>STUDY<\/strong>0000\u2026\u2019; reference the image below). Watermarked versions are available under the \u2018Final\u2019 heading.\r\n\r\n<img class=\"alignnone wp-image-3046 size-large\" src=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Watermarked-documents-screenshot-in-platform-1024x398.png\" alt=\"A screenshot of the Click IRB platform that has the &quot;STUDY&quot; workspace label highlighted, the &quot;Documents Tab&quot; highlighted, and the &quot;Watermarked Documents&quot; field highlighted\" width=\"1024\" height=\"398\" \/>\r\n<h3>Historic watermarked documents<\/h3>\r\nHistoric (outdated) watermarked RSRB-approved documents are available on the \u2018Documents\u2019 tab of the applicable follow-on submission workspace (labeled based on the submission type, e.g., \u2018<strong>MOD<\/strong>0000\u2026\u2019, \u2018<strong>CR<\/strong>0000\u2026\u2019, \u2018<strong>MODCR<\/strong>0000\u2026\u2019). For example, the documents approved with Modification #1 are available on the \u2018Documents\u2019 tab in the workspace of Modification #1.\r\n\r\n<strong>Exception<\/strong>: Once the first follow-on submission is approved (e.g., a modification or continuing review), the watermarked documents approved with the <em>original<\/em> RSRB approval are no longer accessible. This occurs because the documents approved with a follow-on submission copy to the main <strong>STUDY<\/strong> workspace to replace the previously approved documents. <strong>Study staff must be cognizant of downloading and maintaining the documents approved with the original IRB approval in a timely manner (i.e., prior to submission of the first follow-on submission).\u00a0<\/strong>\r\n\r\nFor research reviewed by an External IRB, access will depend on the Reviewing IRB.","background_color":"#ffffff","width":"width-medium"}]},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Watermarked Documents - Office for Human Subject Protection - University of Rochester<\/title>\n<meta name=\"description\" content=\"Guidance on accessing and utilizing watermarked documents in the Click IRB platform. 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