{"id":24012,"date":"2026-07-28T13:15:10","date_gmt":"2026-07-28T17:15:10","guid":{"rendered":"https:\/\/www.rochester.edu\/university-research\/?page_id=24012"},"modified":"2026-07-28T13:25:33","modified_gmt":"2026-07-28T17:25:33","slug":"research-data-sharing-informed-consent-and-secondary-use","status":"publish","type":"page","link":"https:\/\/www.rochester.edu\/university-research\/compliance\/research-data-sharing-informed-consent-and-secondary-use\/","title":{"rendered":"Research Data Sharing, Informed Consent, and Secondary Use"},"content":{"rendered":"<p>The University <strong>generally will not approve waivers or alterations of informed consent or authorization for secondary use of patient or research data<\/strong> when the primary purpose is to commercialize the data, or to train, develop, validate, or commercialize artificial intelligence or machine learning models for third-party commercial purposes, unless the proposed use demonstrates clear scientific, clinical, institutional, or patient\/community value; includes appropriate privacy, security, governance, and contractual safeguards; and satisfies all applicable regulatory criteria for waiver or alteration of consent.<\/p>\n<p>Projects that primarily serve external commercial objectives, lack meaningful value to University of Rochester stakeholders or University of Rochester Medicine patients, or are inconsistent with reasonable patient expectations should not proceed under a waiver of consent or authorization.<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The University generally will not approve waivers or alterations of informed consent or authorization for secondary use of patient or research data when the primary purpose is to commercialize the&hellip;<\/p>\n","protected":false},"author":82,"featured_media":0,"parent":9506,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":"","_members_access_role":[],"_members_access_error":""},"class_list":["post-24012","page","type-page","status-publish","hentry"],"acf":{"lead_in":"","display_title":"","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":"<h5>Required Process to Share Research or Patient Data for Secondary Use<\/h5>","content":"<strong>Before submitting your IRB, ask:<\/strong>\r\n\r\n<strong>Does your study involve data sharing that is prohibited under the University\u2019s Position Statement, and will informed consent\u00a0<em>not<\/em>\u00a0be obtained for the data sharing?<\/strong>\r\n<ul>\r\n \t<li><strong>No --&gt; <\/strong>Submit your IRB application through the standard review process.<\/li>\r\n \t<li><strong>Yes --&gt; <\/strong>Follow the steps below.<\/li>\r\n<\/ul>\r\n<ol>\r\n \t<li><strong>The IRB will not review your application until the prohibited data sharing is addressed<\/strong>.\r\n<ol>\r\n \t<li>If your study can proceed without the proposed data sharing, revise your IRB application to remove it.<\/li>\r\n \t<li>If your study cannot proceed without the proposed data sharing, withdraw your IRB application and request an exception.<\/li>\r\n<\/ol>\r\n<\/li>\r\n \t<li>To\u00a0<strong>request an exception, the Principal Investigator must obtain approval from all of the following<\/strong> (email approval is acceptable):\r\n<ol>\r\n \t<li>Vice President for Research (VPR)<\/li>\r\n \t<li>Senior Associate Dean for Clinical Research (SADCR)<\/li>\r\n \t<li>General Counsel<\/li>\r\n \t<li>Any additional institutional leadership required by the VPR and SADCR<\/li>\r\n<\/ol>\r\n<\/li>\r\n \t<li><strong>After obtaining all required approvals<\/strong>, submit a new IRB application and include documentation of each approval. The IRB will review only after all required approvals have been received.<\/li>\r\n<\/ol>","background_color":"#f4f4f4","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>Research Data Sharing, Informed Consent, and Secondary Use - Office of the Vice President for Research<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.rochester.edu\/university-research\/compliance\/research-data-sharing-informed-consent-and-secondary-use\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Research Data Sharing, Informed Consent, and Secondary Use - Office of the Vice President for Research\" \/>\n<meta property=\"og:description\" content=\"The University generally will not approve waivers or alterations of informed consent or authorization for secondary use of patient or research data when the primary purpose is to commercialize the&hellip;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.rochester.edu\/university-research\/compliance\/research-data-sharing-informed-consent-and-secondary-use\/\" \/>\n<meta property=\"og:site_name\" content=\"Office of the Vice President for Research\" \/>\n<meta property=\"article:modified_time\" content=\"2026-07-28T17:25:33+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.rochester.edu\/university-research\/wp-content\/uploads\/2022\/10\/Link-Preview-Office-of-the-VP-for-Research-1200x630.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\n\t<meta property=\"og:image:height\" content=\"630\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.rochester.edu\\\/university-research\\\/compliance\\\/research-data-sharing-informed-consent-and-secondary-use\\\/\",\"url\":\"https:\\\/\\\/www.rochester.edu\\\/university-research\\\/compliance\\\/research-data-sharing-informed-consent-and-secondary-use\\\/\",\"name\":\"Research Data Sharing, Informed Consent, and Secondary Use - 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