{"id":12,"date":"2016-05-05T14:34:16","date_gmt":"2016-05-05T18:34:16","guid":{"rendered":"http:\/\/blog.richmond.edu\/irbinsider\/?page_id=12"},"modified":"2016-06-09T16:49:40","modified_gmt":"2016-06-09T20:49:40","slug":"federal-requirements","status":"publish","type":"page","link":"https:\/\/blog.richmond.edu\/irbinsider\/policies\/federal-requirements\/","title":{"rendered":"Federal Requirements"},"content":{"rendered":"<p><strong>The University of Richmond IRB and its &#8220;FWA&#8221;<\/strong><\/p>\n<p>The University of Richmond has a federalwide assurance agreement (FWA) with the <a href=\"http:\/\/www.hhs.gov\/ohrp\/\">U.S. Office for Human Research Protections (OHRP)<\/a>.\u00a0 This assurance agreement is signed electronically by the University of Richmond President and is on file with IRB records in the IRB Chair&#8217;s Office in Richmond Hall, Rood 118 (in Suite 113).\u00a0 Changes to UR OHRP records must be made through the OHRP Electronic Submission System at<a href=\"http:\/\/ohrp.cit.nih.gov\/efile\"> http:\/\/ohrp.cit.nih.gov\/efile<\/a> .<\/p>\n<p>OHRP approval is necessary for the operation of an IRB where any of the research may involve federal funding.\u00a0 Directions on updating the FWA and related information follows.<\/p>\n<ul>\n<li>The University of Richmond&#8217;s FWA number is FWA00002622.\u00a0 The expiration of this FWA is currently 9\/22\/2020.\u00a0\u00a0\u00a0 The FWA must be updated at least every five years, prior to expiration, or when there is a change in the &#8220;Signatory Official&#8221; (the University of Richmond President).\u00a0 <em>The FWA organization name is &#8220;U Richmond&#8221;<\/em>.<\/li>\n<li>OHRP also assigns an IORG number, which for the University of Richmond is 0001935.\u00a0 IORG stands for the parent &#8220;Institution\/Organization&#8221; of the IRB.\u00a0 The University of Richmond only has one IRB, therefore the IORG period of approval and the IRB period of approval are the same.\u00a0 (Some institutions have multiple IRBs. For example, VCU has four IRBs.\u00a0 Three IRBs primarily review biomedical research and one IRB focuses on social\/behavioral\/educational research.) The UR IORG and IRB both expire on o5\/15\/2019.\u00a0 The IORG and IRB expiration dates &#8220;advance&#8221; to three years after a change or update is made to the IORG or IRB information.<\/li>\n<li>The name of the University of Richmond IORG is <em>U Richmond<\/em>.<\/li>\n<li>The registration name of the UR IRB is <em>U Richmond IRB #1.<\/em><\/li>\n<li>The University of Richmond&#8217;s IRB Number is 00002441.<\/li>\n<li>The Signatory Official for the UR IRB is the University President.\u00a0 The University of Richmond IRB Chair and administrator is Dr. R. Kirk Jonas.<\/li>\n<\/ul>\n<p><a href=\"https:\/\/richmond.box.com\/s\/1i90pdt7ifcj2km15mkm6bwt083j694s\">Changing Information in the OHRP Electronic Submission System<\/a>.\u00a0 For detailed information on changing information in the OHRP Electronic Submission System, click this link.<\/p>\n<p><a href=\"https:\/\/richmond.box.com\/s\/roorjaosa2jpben8cxgon32wph5oplke\">Key 2016 Information for UR IRB Assurance.<\/a>\u00a0 For key information on the content of information on the University of Richmond in the OHRP database, click this link.<\/p>\n<p><a href=\"https:\/\/richmond.box.com\/s\/oxn6ioq3pdct4r28d7911sx2b25xnzw9\">U.S. Department of Health and Human Services (HHS) Registration of an Institutional Review Board (IRB).<\/a>\u00a0 To view the current OHRP document that registers the University of Richmond IRB with OHRP, click this link.<\/p>\n<p>Please direct questions regarding the University&#8217;s FWA to Dr. R. Kirk Jonas, the IRB Chair.\u00a0 Questions may also be directed to irb@richmond.edu.<\/p>\n<p>The source of most UR-relevant federal policies relating to the protection of human subjects of research can be found at the website of the U.S. <a href=\"http:\/\/www.hhs.gov\/ohrp\/\">Office for the Protection of Human Subjects of Research (OHRP)<\/a>.\u00a0 Specifically, the sections on Policy and Guidance and the regulations at Title 45, Part 46 (Human Subjects of Research) are most relevant to the human subject research usually performed at the University of Richmond.\u00a0 These federal regulations are commonly known as 45 CFR 46, standing for Title 45 Code of Federal Regulations, Part 46.<\/p>\n<p>Subpart A of the 45 CFR 46 is often referred to as &#8220;The Common Rule&#8221; because many federal agencies have adopted the regulations in Subpart A in lieu of developing unique regulations of their own.\u00a0 The University of Richmond has &#8212; in its assurance agreement with OHRP &#8212; agreed to apply The Common Rule to all of its research, whether or not that research is funded by the federal government.\u00a0 It should be noted that the adoption of The Common Rule is standard practice among institutions of higher education in the United States.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The University of Richmond IRB and its &#8220;FWA&#8221; The University of Richmond has a federalwide assurance agreement (FWA) with the U.S. Office for Human Research Protections (OHRP).\u00a0 This assurance agreement is signed electronically by the University of Richmond President and &hellip; <a href=\"https:\/\/blog.richmond.edu\/irbinsider\/policies\/federal-requirements\/\">Continue reading <span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":2184,"featured_media":0,"parent":26,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-12","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/blog.richmond.edu\/irbinsider\/wp-json\/wp\/v2\/pages\/12","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blog.richmond.edu\/irbinsider\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/blog.richmond.edu\/irbinsider\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/blog.richmond.edu\/irbinsider\/wp-json\/wp\/v2\/users\/2184"}],"replies":[{"embeddable":true,"href":"https:\/\/blog.richmond.edu\/irbinsider\/wp-json\/wp\/v2\/comments?post=12"}],"version-history":[{"count":0,"href":"https:\/\/blog.richmond.edu\/irbinsider\/wp-json\/wp\/v2\/pages\/12\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/blog.richmond.edu\/irbinsider\/wp-json\/wp\/v2\/pages\/26"}],"wp:attachment":[{"href":"https:\/\/blog.richmond.edu\/irbinsider\/wp-json\/wp\/v2\/media?parent=12"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}