{"id":14532,"date":"2025-03-11T17:25:06","date_gmt":"2025-03-11T21:25:06","guid":{"rendered":"https:\/\/www.rochester.edu\/ohsp\/?page_id=14532"},"modified":"2025-03-11T17:25:06","modified_gmt":"2025-03-11T21:25:06","slug":"identifiability","status":"publish","type":"page","link":"https:\/\/www.rochester.edu\/ohsp\/resources\/identifiability\/","title":{"rendered":"Identifiability of Research Data"},"content":{"rendered":"<p>Adequately and accurately describing the identifiability of research data and biospecimens throughout the life cycle of a study protocol is an important key to facilitating Institutional Review Board (IRB) review. The way data and\/or specimens are generated, collected (or recorded), and stored has ramifications for whether a research proposal meets the:<\/p>\n<ul>\n<li>Definition of human subject research (as defined by <a href=\"https:\/\/www.ecfr.gov\/on\/2018-07-19\/title-45\/subtitle-A\/subchapter-A\/part-46#46.102\">45 CFR 46.102<\/a>);<\/li>\n<li>Criteria for exemption determination (as defined by <a href=\"https:\/\/www.ecfr.gov\/on\/2018-07-19\/title-45\/subtitle-A\/subchapter-A\/part-46#46.104\">45 CFR 46.104<\/a>); and\/or<\/li>\n<li>Criteria for Institutional Review Board (IRB) approval (as defined by <a href=\"https:\/\/www.ecfr.gov\/on\/2018-07-19\/title-45\/subtitle-A\/subchapter-A\/part-46#46.111\">45 CFR 46.111<\/a> and <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-A\/part-56#56.111\">21CFR56.111<\/a>)<\/li>\n<\/ul>\n<p>Unfortunately, the terms typically used in study protocols to describe how data will be maintained \u2013 de-identified, coded, anonymized, and anonymous \u2013 are often used interchangeably, when they don\u2019t all have the same meaning. This leaves the IRB unsure of what the data looks like and how it will be protected, which can result in additional and potentially frustrating, back-and-forth with the study team.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Adequately and accurately describing the identifiability of research data and biospecimens throughout the life cycle of a study protocol is an important key to facilitating Institutional Review Board (IRB) review.&hellip;<\/p>\n","protected":false},"author":52,"featured_media":0,"parent":236,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-14532","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Identifiability of Research Data - Office for Human Subject Protection<\/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\/ohsp\/resources\/identifiability\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Identifiability of Research Data - 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