{"id":3786,"date":"2024-01-04T16:36:36","date_gmt":"2024-01-04T21:36:36","guid":{"rendered":"https:\/\/www.rochester.edu\/ohsp\/?page_id=3786"},"modified":"2025-03-11T17:49:47","modified_gmt":"2025-03-11T21:49:47","slug":"secondary-use","status":"publish","type":"page","link":"https:\/\/www.rochester.edu\/ohsp\/irb-review\/secondary-use\/","title":{"rendered":"Secondary Use"},"content":{"rendered":"

Under the revised Common Rule (45 CFR 46<\/a>), secondary research of data\/records\/biospecimens can now be deemed exempt<\/a> when:<\/p>\n

    \n
  1. The review involves \u2018secondary research\u2019 only (meaning the information\/biospecimens were originally collected for some other purpose); and<\/li>\n
  2. One of the following criteria are met:\n
      \n
    1. The information\/biospecimens are publicly available;<\/li>\n
    2. The information (including information about a biospecimen) is recorded in a manner that the identity of the subjects cannot be readily ascertained (either directly or indirectly through links\/codes), the investigator does not contact the subject, and the investigator will not re-identify subjects;<\/li>\n
    3. The research involves only the collection and analysis of identifiable health information regulated by the Health Insurance Portability and Accountability Act (HIPAA); or<\/strong><\/li>\n
    4. The research is conducted by or on behalf of a Federal department or agency using government-generated or government-collected information obtained for non-research activities.<\/li>\n<\/ol>\n<\/li>\n<\/ol>\n

      While these criteria seem relatively straightforward, it\u2019s important to keep them in mind as secondary use or retrospective review protocols are developed. If Institutional Review Board (IRB) personnel cannot validate that these criteria are met, the research may require revision or may require a different level of IRB review.<\/p>\n

      \n","protected":false},"excerpt":{"rendered":"

      Under the revised Common Rule (45 CFR 46), secondary research of data\/records\/biospecimens can now be deemed exempt when: The review involves \u2018secondary research\u2019 only (meaning the information\/biospecimens were originally collected…<\/p>\n","protected":false},"author":36,"featured_media":0,"parent":356,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-3786","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\nSecondary Use - Office for Human Subject Protection - University of Rochester<\/title>\n<meta name=\"description\" content=\"Learn about secondary use of data, records, and specimens in the IRB review process. 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