{"id":4866,"date":"2024-01-08T17:21:58","date_gmt":"2024-01-08T22:21:58","guid":{"rendered":"https:\/\/www.rochester.edu\/ohsp\/?page_id=4866"},"modified":"2025-12-18T15:13:13","modified_gmt":"2025-12-18T20:13:13","slug":"approval-criteria","status":"publish","type":"page","link":"https:\/\/www.rochester.edu\/ohsp\/irb-review\/approval-criteria\/","title":{"rendered":"Approval Criteria"},"content":{"rendered":"<p>Federal regulations define specific criteria that human subject research proposals must meet in order for an Institutional Review Board (IRB) to approve the research (<a class=\"u-link-external\" href=\"https:\/\/www.ecfr.gov\/cgi-bin\/retrieveECFR?gp=&amp;SID=83cd09e1c0f5c6937cd9d7513160fc3f&amp;pitd=20180719&amp;n=pt45.1.46&amp;r=PART&amp;ty=HTML#se45.1.46_1111\">45 CFR 46.111<\/a>; <a class=\"u-link-external\" href=\"https:\/\/www.ecfr.gov\/cgi-bin\/text-idx?SID=6dad394df90b6bac401b42df0cc98bc8&amp;mc=true&amp;node=pt21.1.56&amp;rgn=div5#se21.1.56_1111\">21 CFR 56.111<\/a>). At first glance, satisfying the criteria for IRB approval may seem relatively simple. However, given the complexities of ethical study design, meeting these criteria is not as easy as simply \u2018checking a box\u2019. Use the information on this page to identify:<\/p>\n<ul>\n<li>Key factors taken into consideration in evaluating whether each IRB approval criterion has been satisfied, in accordance with <a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_404_Criteria_for_Approval.pdf\">OHSP Policy 404: Criteria for RSRB Approval of Research<\/a>; and<\/li>\n<li>Ensuing sections of the study protocol that should address such factors.<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Federal regulations define specific criteria that human subject research proposals must meet in order for an Institutional Review Board (IRB) to approve the research (45 CFR 46.111; 21 CFR 56.111).&hellip;<\/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-4866","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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