{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,4,25]],"date-time":"2024-04-25T00:21:23Z","timestamp":1714004483313},"reference-count":23,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2024,3,6]],"date-time":"2024-03-06T00:00:00Z","timestamp":1709683200000},"content-version":"vor","delay-in-days":5,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100005821","name":"DHHS Office of the Secretary","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005821","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Ethics &amp; Human Research"],"published-print":{"date-parts":[[2024,3]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:p>How research during a public health emergency is conducted is recognized as essential to the public health response to that emergency. Such research needs to undergo substantive and meaningful ethical review in a timely manner. Rapid ethical review may be accomplished through a number of mechanisms, including use of local rapid\u2010response institutional review boards (IRBs). We describe use of such a model in the setting of the 2014 Ebola virus disease epidemic and the Rapid\u2010Response IRB's subsequent transition to a multisite single IRB model during the current Covid\u201019 pandemic. The rapid\u2010response review model is characterized by a small IRB with extensive use of alternate members with specific expertise and by close collaboration with the investigator in an iterative process.<\/jats:p>","DOI":"10.1002\/eahr.500203","type":"journal-article","created":{"date-parts":[[2024,3,6]],"date-time":"2024-03-06T15:18:02Z","timestamp":1709738282000},"page":"16-21","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Rapid Review of Therapy Protocols for Public Health Emergencies"],"prefix":"10.1002","volume":"46","author":[{"given":"Bruce G.","family":"Gordon","sequence":"first","affiliation":[{"name":"Assistant vice\u2010chancellor for regulatory affairs, and executive chairman of the IRBs at the University of Nebraska Medical Center"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Abigail E.","family":"Lowe","sequence":"additional","affiliation":[{"name":"Assistant professor at the College of Allied Health Professions and a scholar at the Global Center for Health Security at the University of Nebraska Medical Center"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christopher J.","family":"Kratochvil","sequence":"additional","affiliation":[{"name":"Senior advisor and Distinguished Chair at the Global Center for Health Security, and vice chancellor of external relations at the University of Nebraska Medical Center"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,3,6]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(17)31602-1"},{"key":"e_1_2_8_2_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmjgh-2017-000534"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMsb1209510"},{"key":"e_1_2_8_3_2","doi-asserted-by":"publisher","DOI":"10.4269\/ajtmh.20-0205"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1177\/1740774520988669"},{"key":"e_1_2_8_5_1","volume-title":"An R&D Blueprint for Action to Prevent Epidemics: Plan of Action","author":"World Health Organization","year":"2016"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12910-019-0366-x"},{"key":"e_1_2_8_7_1","volume-title":"Integrating Clinical Research into Epidemic Response: The Ebola Experience","author":"National Academies of Sciences, Engineering, and Medicine","year":"2017"},{"key":"e_1_2_8_8_1","volume-title":"Ethics and Ebola: Public Health Planning and Response","author":"World Health Organization","year":"2015"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12910-015-0002-3"},{"key":"e_1_2_8_10_1","unstructured":"National Academies of Sciences Engineering and Medicineet al. Integrating Clinical Research into Epidemic Response."},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1289\/EHP2378"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMsb1209510"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.7326\/M20-4631"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2020.4362"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1097\/QCO.0000000000000176"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1089\/hs.2017.0005"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1089\/hs.2018.0106"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1089\/hs.2021.0181"},{"key":"e_1_2_8_19_1","volume-title":"FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency","author":"U. S. 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