{"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":"2026-09-09T17:27:26","modified_gmt":"2026-09-09T21:27:26","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":{"_acf_changed":false,"footnotes":"","_members_access_role":[],"_members_access_error":""},"class_list":["post-14532","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":"accordion_new","anchor_id":"","classes":"","title":"<h2>Identifiable Data &amp; Specimens<\/h2>","description":"While the federal regulations that govern human subject research refer to \u2018identifiable private information\u2019, \u2018identifiable biospecimen\u2019, and \u2018identifiers\u2019, they do not specifically define data elements that could be used to identify subjects. As such, IRBs routinely defer to the 18 identifiers described in the Health Insurance Portability &amp; Accountability Act (HIPAA) regardless of whether the research contains health information or is conducted within a covered entity.","background":"decorative","background_color":"#ffffff","style":"row_blank","expand":"no","accordions":[{"acf_fc_layout":"accordion","accordion_title":"List of identifiers","icon":"","row_content":"<ol>\r\n \t<li>Names,<\/li>\r\n \t<li>Geographic subdivisions smaller than a State, including: street address, city, county, precinct, and zip code and their equivalent geocodes (except for the initial three digits of a zip code, if according to the current publicly-available data from the Bureau of Census: [1] the geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000; and [2] the initial three digits of the zip code for all such geographic unit containing 20,000 or fewer is changed to 000.),<\/li>\r\n \t<li>All elements of dates (except year) for dates directly related to an individual, including (but not limited to): birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of 90 or older,<\/li>\r\n \t<li>Telephone numbers,<\/li>\r\n \t<li>Fax numbers,<\/li>\r\n \t<li>E-mail addresses,<\/li>\r\n \t<li>Social security numbers,<\/li>\r\n \t<li>Medical record numbers,<\/li>\r\n \t<li>Health plan beneficiary,<\/li>\r\n \t<li>Account numbers,<\/li>\r\n \t<li>Certificate\/license numbers,<\/li>\r\n \t<li>Vehicle identifiers and serial numbers, including license plate numbers,<\/li>\r\n \t<li>Device identifiers and serial numbers,<\/li>\r\n \t<li>Web universal resource locators (URLs),<\/li>\r\n \t<li>Internet protocol (IP) address numbers,<\/li>\r\n \t<li>Biometric identifiers, including voice and fingerprints,<\/li>\r\n \t<li>Full-face photographic images and any comparable images, and<\/li>\r\n \t<li><span style=\"font-size: 1.25rem;\">Any other unique identifying number, characteristic, or code.\u00a0 \u00a0 \u00a0 \u00a0 \u00a0<\/span><\/li>\r\n<\/ol>","accordion_anchor":"identifiers"}]},{"acf_fc_layout":"accordion_new","anchor_id":"","classes":"","title":"<h2>Key Terms<\/h2>","description":"","background":"decorative","background_color":"#ffffff","style":"row_blank","expand":"no","accordions":[{"acf_fc_layout":"accordion","accordion_title":"Coded Data & Specimens","icon":"","row_content":"\u2018Coded\u2019, means that information that might readily identify a subject has been replaced with a number, letter, symbol or combination thereof (i.e., a code) <strong>and<\/strong> there is a separate key linking the code to the subject\u2019s identifiable information.\r\n\r\nFor example, if you assign John Doe the code \u201801\u2019 and use \u201901\u2019 to identify the subject within the data set and\/or label the subject\u2019s specimen, while simultaneously maintaining a separate key that identifies \u201801\u2019 as John Doe, the data\/specimen are considered coded.\r\n\r\nThe existence of the key means that the data\/specimens <strong>could<\/strong> be linked back to the individual and therefore makes the data\/specimens identifiable, albeit indirectly, to whoever has access to the key. Therefore, <strong>the term \u2018coded\u2019 is not synonymous with de-identified, anonymized, nor anonymous<\/strong>, because the information is identifiable to study team members with access to the code.\r\n\r\nCoding is often used when a study team needs to collect identifiable information in order to meet the aims of the research (e.g., they need to link subject data over time or they need to link subject data between multiple sources); coding is used as a means of maintaining confidentiality.","accordion_anchor":"coded"},{"acf_fc_layout":"accordion","accordion_title":"De-Identified\/Anonymized Data & Specimens","icon":"","row_content":"\u2018De-identified\u2019 means the data\/specimen cannot be related or attributed to a specific individual, either directly or indirectly, which means there is no reason to believe the data\/specimen could be used to identify an individual. In other words, the dataset does not include any of the identifiers listed above, nor are data\/specimens affiliated or linked with any of the identifiers listed above.\r\n\r\nDe-identified data\/specimens are often used in retrospective and secondary analysis research. For example, if a study team conducts a review of existing records (e.g., academic\/medical records) and only <strong>records<\/strong> the research data, without recording any information that directly or indirectly identifies the subjects (i.e., any of the identifiers listed above), the dataset would be considered de-identified. In this instance, the investigator may have access to or view identifiers during the data collection process but does not record, reference, collect, or link identifiers in the data set.\r\n\r\nAnother common scenario is for a study team to obtain data\/specimens from a publicly available dataset, a tissue\/data bank, or from previously conducted research. Whether these data\/specimens are considered de-identified hinges on the study team\u2019s access to the original source data\/specimens (i.e., the original dataset\/bank\/research) and how the data\/specimens for the <strong>current<\/strong> research are provided to the study team.\r\n<ul>\r\n \t<li>If the study team does <strong>not <\/strong>have access to the original source data\/documents<strong> and<\/strong> the data\/specimens are provided by a \u2018gatekeeper\u2019 in a manner that is neither directly nor indirectly identifiable (i.e., does not include any of the identifiers listed above), the data\/specimen would be considered de-identified.<\/li>\r\n \t<li>If the study team was involved in the original data collection, the gatekeeper engages in the current research study, or the source data\/specimens are identifiable, the data\/specimens would continue to be considered identifiable. Anytime <strong>any<\/strong> member of the study team has access to identifiable source data\/specimens (even if stored separately), the secondary use of the data\/specimens would be considered identifiable. A common example of this is conducting secondary research on a dataset pulled from prior research. Even if only one member of the study team has access to the original, identifiable (or coded) data set, the dataset used for the secondary analysis would still be considered identifiable.<\/li>\r\n<\/ul>\r\nStudy teams will also often de-identify a previously coded or directly identifiable dataset once the research is complete, as a means of further protecting the data. Meaning, all identifiers listed above are removed from the data\/specimens and any code, key, or link that previously identified the data\/specimens is destroyed. This is also often referred to as \u2018anonymized\u2019 data\/specimens.\r\n\r\nTo reiterate, to be considered de-identified or anonymized:\r\n<ul>\r\n \t<li>the data\/specimens collected cannot include any of the identifiers listed above,<\/li>\r\n \t<li>links or keys that indirectly identify the data\/specimens cannot exist, nor the ability to access links\/keys by any study team members, and<\/li>\r\n \t<li>the data\/specimens cannot be re-identified.<\/li>\r\n<\/ul>","accordion_anchor":"deidentified"},{"acf_fc_layout":"accordion","accordion_title":"Anonymous Data & Specimens","icon":"","row_content":"\u2018Anonymous\u2019 means the data\/specimens were collected without identifiers and a code\/key linking the data\/specimens to identifiable information never existed (so there is no way for the data\/specimen to be linked back to a specific individual). For example, data pulled from a publicly available database and one-time surveys and specimen collections, where no identifiers are ever collected or recorded would be considered anonymous. One-time interviews and focus groups might also be considered anonymous provided no identifiers are recorded, only pseudonyms are used (in place of names), and they are not audio-recorded.","accordion_anchor":"anonymous"}]},{"acf_fc_layout":"text","anchor":"","css_class":"","title":"<h2 style=\"text-align: center;\">Tips for facilitating IRB review<\/h2>","content":"<ul>\r\n \t<li>Carefully consider whether you need to collect identifiers to achieve the aims of your research.<\/li>\r\n \t<li>Provide consistent information throughout your protocol and all supporting IRB submission materials, including the <a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Guideline_on_HSR_Research_Electronic_Data_Security_Assessment_Form.doc\">Human Subject Research Electronic Data Security Assessment Form<\/a>.<\/li>\r\n \t<li>Do not cut and paste from previously approved protocols and supporting IRB submission materials, doing so increases the likelihood of providing inconsistent information.<\/li>\r\n \t<li>Do not inaccurately indicate that the data will be de-identified or limit yourself to only collecting de-identified data under the (false!) assumption that doing so will make IRB review easier. Collect the data you need to in order to meet the aims of your research, but do so with a plan to adequately protect the data\/specimens.<\/li>\r\n \t<li>Be aware that the identifiability of the data\/specimens collected may change over the course of the study (e.g., once data collection is complete) and accurately providing this clarification within the study protocol will aid the IRB review process.<\/li>\r\n \t<li>Carefully consider context and access while communicating about the identifiability of your data\/specimens. Identifiability may vary based on a team member or site\u2019s role in the research.\u00a0 For example, an investigator or study coordinator may have access to identifiable information whereas a statistician may only have access to de-identified information.\u00a0 Similarly, a local study team may have access to identifiable information but may only share de-identified data with an external collaborating site.\u00a0 Clearly distinguishing access can play a critical role in both the IRB review process and any required research-related agreements.\u00a0 For the purposes of IRB review, the IRB needs to make determinations from a global viewpoint, inclusive of all engaged roles\/sites they are reviewing for.\u00a0 Whereas research-related agreements (e.g., data use or material transfer agreements), may be executed for more granular components of research.\u00a0 Using appropriate terminology in consideration of roles\/sites and context will further facilitate the process.<\/li>\r\n<\/ul>","background_color":"#f4f4f4","width":"width-large"},{"acf_fc_layout":"card_grid","anchor":"","css_class":"","title":"<h2 style=\"text-align: center;\">Additional Resources<\/h2>","description":"","background_color":"#f4f4f4","width":"width-large","columns":"2","cards":[{"card_title":"<h5>Human subject research data security requirements<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"","url":"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Guideline_on_HSR_Research_Data_Security_Requirements.pdf","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""},{"card_title":"<h5>Data de-identification services<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"","url":"https:\/\/www.rochester.edu\/university-research\/resources\/data-de-identification-services\/","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""},{"card_title":"<h5>OHSP Guideline for De-Identification of Data for Publishing\/Presentation<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"","url":"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/901b_GDL_Deidentification_Data_Publishing.pdf","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""},{"card_title":"<h5>HIPAA Policy OP30 - De-Identification of Protected Health Information<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"","url":"https:\/\/sharepoint19.mc.rochester.edu\/sites\/HIPAA\/Privacy\/P30.pdf","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""}]}]},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.4 - 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 - Office for Human Subject Protection\" \/>\n<meta property=\"og:description\" content=\"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;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.rochester.edu\/ohsp\/resources\/identifiability\/\" \/>\n<meta property=\"og:site_name\" content=\"Office for Human Subject Protection\" \/>\n<meta property=\"article:modified_time\" content=\"2026-09-09T21:27:26+00:00\" \/>\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\\\/ohsp\\\/resources\\\/identifiability\\\/\",\"url\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/resources\\\/identifiability\\\/\",\"name\":\"Identifiability of Research Data - Office for Human Subject Protection\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/#website\"},\"datePublished\":\"2025-03-11T21:25:06+00:00\",\"dateModified\":\"2026-09-09T21:27:26+00:00\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/resources\\\/identifiability\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/resources\\\/identifiability\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/resources\\\/identifiability\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Resources\",\"item\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/resources\\\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Identifiability of Research Data\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/#website\",\"url\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/\",\"name\":\"Office for Human Subject Protection\",\"description\":\"ÌÇÐÄ´«Ã½\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Identifiability of Research Data - Office for Human Subject Protection","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.rochester.edu\/ohsp\/resources\/identifiability\/","og_locale":"en_US","og_type":"article","og_title":"Identifiability of Research Data - Office for Human Subject Protection","og_description":"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;","og_url":"https:\/\/www.rochester.edu\/ohsp\/resources\/identifiability\/","og_site_name":"Office for Human Subject Protection","article_modified_time":"2026-09-09T21:27:26+00:00","twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.rochester.edu\/ohsp\/resources\/identifiability\/","url":"https:\/\/www.rochester.edu\/ohsp\/resources\/identifiability\/","name":"Identifiability of Research Data - Office for Human Subject Protection","isPartOf":{"@id":"https:\/\/www.rochester.edu\/ohsp\/#website"},"datePublished":"2025-03-11T21:25:06+00:00","dateModified":"2026-09-09T21:27:26+00:00","breadcrumb":{"@id":"https:\/\/www.rochester.edu\/ohsp\/resources\/identifiability\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.rochester.edu\/ohsp\/resources\/identifiability\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.rochester.edu\/ohsp\/resources\/identifiability\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.rochester.edu\/ohsp\/"},{"@type":"ListItem","position":2,"name":"Resources","item":"https:\/\/www.rochester.edu\/ohsp\/resources\/"},{"@type":"ListItem","position":3,"name":"Identifiability of Research Data"}]},{"@type":"WebSite","@id":"https:\/\/www.rochester.edu\/ohsp\/#website","url":"https:\/\/www.rochester.edu\/ohsp\/","name":"Office for Human Subject Protection","description":"ÌÇÐÄ´«Ã½","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.rochester.edu\/ohsp\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"}]}},"_links":{"self":[{"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/pages\/14532","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/users\/52"}],"replies":[{"embeddable":true,"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/comments?post=14532"}],"version-history":[{"count":6,"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/pages\/14532\/revisions"}],"predecessor-version":[{"id":14592,"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/pages\/14532\/revisions\/14592"}],"up":[{"embeddable":true,"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/pages\/236"}],"wp:attachment":[{"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/media?parent=14532"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}