{"id":293,"date":"2020-03-30T21:05:48","date_gmt":"2020-03-30T21:05:48","guid":{"rendered":"https:\/\/sites.une.edu\/research\/?p=293"},"modified":"2020-08-13T14:40:16","modified_gmt":"2020-08-13T14:40:16","slug":"letter-to-irb-pi-covid-19","status":"publish","type":"post","link":"https:\/\/sites.une.edu\/research\/letter-to-irb-pi-covid-19\/","title":{"rendered":"Letter to IRB PI    COVID-19"},"content":{"rendered":"\n<p>March 20, 2020<\/p>\n\n\n\n<p>Dear Researchers,<\/p>\n\n\n\n<p>As we all work to\nnavigate the challenges posed by the COVID-19 pandemic, we would like to offer\nsome direct guidance for PIs with open protocols involving human subjects.<\/p>\n\n\n\n<p>As\nnoted in the research guidance letter issued by the Associate Provost for\nResearch and Scholarship\/Research Integrity Officer (attached), <strong>human\nsubjects research must be paused at this time <\/strong>for any project involving\nface-to-face interaction. This is due to the risk of viral transmission and\nethical principles of research and federal regulations for the protection of\nhuman research participants.<\/p>\n\n\n\n<p>Some\nstudies may lend themselves to modification\u2014for example, changing in-person\nencounters to an online modality.&nbsp; PIs\nwho wish to change their study in any way will need to follow the usual process\nfor submitting an amendment to their protocol. See this link for information: <a href=\"https:\/\/www.une.edu\/research\/compliance\/irb\">https:\/\/www.une.edu\/research\/compliance\/irb<\/a> .&nbsp; IRB personnel\nwill work through amendments in the order they are received.<\/p>\n\n\n\n<p>Some\nof you have asked about the possibility of \u201cautomatic approvals\u201d. The IRB\ncannot issue automatic approvals for changes to virtual modality for approved\nprotocols, because each study involves different risks, consent forms will need\nto change, and the IRB will need to assess the software\/platforms proposed for\nvirtual encounters to ensure that confidentiality and privacy of research\nparticipants are protected.&nbsp;<\/p>\n\n\n\n<p>We\nrecognize that this may involve significant delays to research, particularly\ngiven that the Office of Research Compliance is substantially understaffed at\npresent. We are pleased to share with you that the new Director of Research\nIntegrity is scheduled to start on March 30, 2020. <\/p>\n\n\n\n<p>Our\nhighest responsibility is to the safety of our research participants.&nbsp; We appreciate your patience and understanding\nduring this trying time as we collectively work to ensure it. Please take care\nand be safe.<\/p>\n\n\n\n<p>Sincerely,<\/p>\n\n\n\n<p>Karen L. Houseknecht, PhD&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;      Mary DeSilva, ScD, MS, MSFS <\/p>\n\n\n\n<p>Associate Provost for Research               &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Chair, Institutional Review Board<\/p>\n\n\n\n<p>and Scholarship<\/p>\n\n\n\n<p>Research Integrity Officer<\/p>\n","protected":false},"excerpt":{"rendered":"<p>March 20, 2020 Dear Researchers, As we all work to navigate the challenges posed by the &hellip;<\/p>\n","protected":false},"author":49,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[31],"tags":[],"post_folder":[],"class_list":["post-293","post","type-post","status-publish","format-standard","hentry","category-covid-19-operating-plans"],"acf":[],"_links":{"self":[{"href":"https:\/\/sites.une.edu\/research\/wp-json\/wp\/v2\/posts\/293","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sites.une.edu\/research\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/sites.une.edu\/research\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/sites.une.edu\/research\/wp-json\/wp\/v2\/users\/49"}],"replies":[{"embeddable":true,"href":"https:\/\/sites.une.edu\/research\/wp-json\/wp\/v2\/comments?post=293"}],"version-history":[{"count":18,"href":"https:\/\/sites.une.edu\/research\/wp-json\/wp\/v2\/posts\/293\/revisions"}],"predecessor-version":[{"id":324,"href":"https:\/\/sites.une.edu\/research\/wp-json\/wp\/v2\/posts\/293\/revisions\/324"}],"wp:attachment":[{"href":"https:\/\/sites.une.edu\/research\/wp-json\/wp\/v2\/media?parent=293"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/sites.une.edu\/research\/wp-json\/wp\/v2\/categories?post=293"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/sites.une.edu\/research\/wp-json\/wp\/v2\/tags?post=293"},{"taxonomy":"post_folder","embeddable":true,"href":"https:\/\/sites.une.edu\/research\/wp-json\/wp\/v2\/post_folder?post=293"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}