{"id":45390,"date":"2026-05-06T10:34:12","date_gmt":"2026-05-06T14:34:12","guid":{"rendered":"https:\/\/web.uri.edu\/research-admin\/?page_id=45390"},"modified":"2026-06-04T13:46:09","modified_gmt":"2026-06-04T17:46:09","slug":"irb-guidance-and-resources","status":"publish","type":"page","link":"https:\/\/web.uri.edu\/research-admin\/integrity-security\/human-subjects\/irb-guidance-and-resources\/","title":{"rendered":"IRB Guidance and Resources"},"content":{"rendered":"\n<h3 class=\"wp-block-heading\">Guidance Documents<\/h3>\n\n\n\n<p><a href=\"https:\/\/uri0.sharepoint.com\/:b:\/r\/sites\/DREDPolicyRevisions\/Shared%20Documents\/Website%20Documents\/ORI%20IRB%20Human%20Subjects\/Does%20My%20Project%20Need%20IRB%20Review.pdf?csf=1&amp;web=1&amp;e=Uv4cD9\" target=\"_blank\" rel=\"noreferrer noopener\">Does My Project Need IRB Review<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uri0.sharepoint.com\/:b:\/r\/sites\/DREDPolicyRevisions\/Shared%20Documents\/Website%20Documents\/ORI%20IRB%20Human%20Subjects\/Research%20with%20Human%20Subjects%20Conducted%20by%20Students.pdf?csf=1&amp;web=1&amp;e=u3TuJS\" target=\"_blank\" rel=\"noreferrer noopener\">Research with Human Subjects Conducted by Students<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uri0.sharepoint.com\/:b:\/r\/sites\/DREDPolicyRevisions\/Shared%20Documents\/Website%20Documents\/ORI%20IRB%20Human%20Subjects\/Collaborative%20Research.pdf?csf=1&amp;web=1&amp;e=7pSG9C\" target=\"_blank\" rel=\"noreferrer noopener\">Collaborative Research<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uri0.sharepoint.com\/:b:\/r\/sites\/DREDPolicyRevisions\/Shared%20Documents\/Website%20Documents\/ORI%20IRB%20Human%20Subjects\/IRB%20Data%20Security.pdf?csf=1&amp;web=1&amp;e=9BMU56\" target=\"_blank\" rel=\"noreferrer noopener\">IRB Data Security<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uri0.sharepoint.com\/:b:\/r\/sites\/DREDPolicyRevisions\/Shared%20Documents\/Website%20Documents\/ORI%20IRB%20Human%20Subjects\/Human%20Subject%20Regulations%20Decision%20Charts.pdf?csf=1&amp;web=1&amp;e=9hEfU9\" target=\"_blank\" rel=\"noreferrer noopener\">Human Subject Regulations Decision Charts<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uri0.sharepoint.com\/:b:\/r\/sites\/DREDPolicyRevisions\/Shared%20Documents\/Website%20Documents\/ORI%20IRB%20Human%20Subjects\/IRB%20Guidance%20-%20Exempt%20Category%201.pdf?csf=1&amp;web=1&amp;e=5rrRTM\" target=\"_blank\" rel=\"noreferrer noopener\">IRB Guidance \u2013 Exempt Category 1<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uri0.sharepoint.com\/:b:\/r\/sites\/DREDPolicyRevisions\/Shared%20Documents\/Website%20Documents\/ORI%20IRB%20Human%20Subjects\/IRB%20Guidance%20-%20Exempt%20Category%202.pdf?csf=1&amp;web=1&amp;e=7EDkxa\" target=\"_blank\" rel=\"noreferrer noopener\">IRB Guidance \u2013 Exempt Category 2<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uri0.sharepoint.com\/:b:\/r\/sites\/DREDPolicyRevisions\/Shared%20Documents\/Website%20Documents\/ORI%20IRB%20Human%20Subjects\/IRB%20Guidance%20-%20Exempt%20Category%203.pdf?csf=1&amp;web=1&amp;e=cs0GOu\" target=\"_blank\" rel=\"noreferrer noopener\">IRB Guidance &#8211; Exempt Category 3<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uri0.sharepoint.com\/:b:\/r\/sites\/DREDPolicyRevisions\/Shared%20Documents\/Website%20Documents\/ORI%20IRB%20Human%20Subjects\/IRB%20Exercise%20Policy.pdf?csf=1&amp;web=1&amp;e=OTXIeB\" target=\"_blank\" rel=\"noreferrer noopener\">IRB Exercise Policy<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Templates<\/h3>\n\n\n\n<p><a href=\"https:\/\/www.google.com\/url?q=https:\/\/uri0.sharepoint.com\/sites\/DREDPolicyRevisions\/_layouts\/download.aspx?SourceUrl%3Dhttps:\/\/uri0.sharepoint.com\/sites\/DREDPolicyRevisions\/Shared%2520Documents\/Website%2520Documents\/ORI%2520IRB%2520Human%2520Subjects\/Consent%2520Template%2520Expedited%2520and%2520Full%2520Board.doc&amp;sa=D&amp;source=editors&amp;ust=1780597753293859&amp;usg=AOvVaw1eeATeiwBkg9TCWeGue6xy\" target=\"_blank\" rel=\"noreferrer noopener\">Consent Template Expedited and Full Board<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/www.google.com\/url?q=https:\/\/uri0.sharepoint.com\/sites\/DREDPolicyRevisions\/_layouts\/download.aspx?SourceUrl%3Dhttps:\/\/uri0.sharepoint.com\/sites\/DREDPolicyRevisions\/Shared%2520Documents\/Website%2520Documents\/ORI%2520IRB%2520Human%2520Subjects\/Agreement%2520to%2520Participate%2520Template.docx&amp;sa=D&amp;source=editors&amp;ust=1780597753291681&amp;usg=AOvVaw1naK-6FH9984S9ZYyaU_2l\" target=\"_blank\" rel=\"noreferrer noopener\">Agreement to Participate Template<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/www.google.com\/url?q=https:\/\/uri0.sharepoint.com\/sites\/DREDPolicyRevisions\/_layouts\/download.aspx?SourceUrl%3Dhttps:\/\/uri0.sharepoint.com\/sites\/DREDPolicyRevisions\/Shared%2520Documents\/Website%2520Documents\/ORI%2520IRB%2520Human%2520Subjects\/Child%2520Assent%2520Template.doc&amp;sa=D&amp;source=editors&amp;ust=1780597753293585&amp;usg=AOvVaw0849YByVO-DnYM6vJVSizy\" target=\"_blank\" rel=\"noreferrer noopener\">Child Assent Template<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/www.google.com\/url?q=https:\/\/uri0.sharepoint.com\/sites\/DREDPolicyRevisions\/_layouts\/download.aspx?SourceUrl%3Dhttps:\/\/uri0.sharepoint.com\/sites\/DREDPolicyRevisions\/Shared%2520Documents\/Website%2520Documents\/ORI%2520IRB%2520Human%2520Subjects\/Legally%2520Authorized%2520Rep%2520Consent%2520Template.doc&amp;sa=D&amp;source=editors&amp;ust=1780597753311831&amp;usg=AOvVaw0BABRtsuJUZh9Sd1sG4wtx\" target=\"_blank\" rel=\"noreferrer noopener\">Legally Authorized Representative Consent Template<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/www.google.com\/url?q=https:\/\/uri0.sharepoint.com\/sites\/DREDPolicyRevisions\/_layouts\/download.aspx?SourceUrl%3Dhttps:\/\/uri0.sharepoint.com\/sites\/DREDPolicyRevisions\/Shared%2520Documents\/Website%2520Documents\/ORI%2520IRB%2520Human%2520Subjects\/Parental%2520Consent%2520Template.doc&amp;sa=D&amp;source=editors&amp;ust=1780597753314276&amp;usg=AOvVaw2YE9mc41X7kT7odW-WeK_c\" target=\"_blank\" rel=\"noreferrer noopener\">Parental Consent Template<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/www.google.com\/url?q=https:\/\/uri0.sharepoint.com\/sites\/DREDPolicyRevisions\/_layouts\/download.aspx?SourceUrl%3Dhttps:\/\/uri0.sharepoint.com\/sites\/DREDPolicyRevisions\/Shared%2520Documents\/Website%2520Documents\/ORI%2520IRB%2520Human%2520Subjects\/GDPR%2520Consent%2520Addendum.doc&amp;sa=D&amp;source=editors&amp;ust=1780597753297767&amp;usg=AOvVaw0iflt-sQlwjeW_Sm7vBJno\" target=\"_blank\" rel=\"noreferrer noopener\">GDPR Consent Addendum<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/www.google.com\/url?q=https:\/\/uri0.sharepoint.com\/sites\/DREDPolicyRevisions\/_layouts\/download.aspx?SourceUrl%3Dhttps:\/\/uri0.sharepoint.com\/sites\/DREDPolicyRevisions\/Shared%2520Documents\/Website%2520Documents\/ORI%2520IRB%2520Human%2520Subjects\/HIPAA%2520Consent%2520Addendum.doc&amp;sa=D&amp;source=editors&amp;ust=1780597753298561&amp;usg=AOvVaw0Be4Hp1-wImPGhtYswOt33\" target=\"_blank\" rel=\"noreferrer noopener\">HIPAA Consent Addendum<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/www.google.com\/url?q=https:\/\/uri0.sharepoint.com\/sites\/DREDPolicyRevisions\/_layouts\/download.aspx?SourceUrl%3Dhttps:\/\/uri0.sharepoint.com\/sites\/DREDPolicyRevisions\/Shared%2520Documents\/Website%2520Documents\/ORI%2520IRB%2520Human%2520Subjects\/IAA%2520Template.pdf&amp;sa=D&amp;source=editors&amp;ust=1780597753299347&amp;usg=AOvVaw1O4NTcfkvKfTqvKzSNta3Z\" target=\"_blank\" rel=\"noreferrer noopener\">IAA Template<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/www.google.com\/url?q=https:\/\/uri0.sharepoint.com\/sites\/DREDPolicyRevisions\/_layouts\/download.aspx?SourceUrl%3Dhttps:\/\/uri0.sharepoint.com\/sites\/DREDPolicyRevisions\/Shared%2520Documents\/Website%2520Documents\/ORI%2520IRB%2520Human%2520Subjects\/IIA%2520Template.pdf&amp;sa=D&amp;source=editors&amp;ust=1780597753306792&amp;usg=AOvVaw0S7ZZBGTQbK_CQ2sdheHiO\" target=\"_blank\" rel=\"noreferrer noopener\">IIA Template<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/www.google.com\/url?q=https:\/\/uri0.sharepoint.com\/sites\/DREDPolicyRevisions\/_layouts\/download.aspx?SourceUrl%3Dhttps:\/\/uri0.sharepoint.com\/sites\/DREDPolicyRevisions\/Shared%2520Documents\/Website%2520Documents\/ORI%2520IRB%2520Human%2520Subjects\/Letter%2520of%2520Introduction%2520for%2520Student%2520Project%2520Involving%2520Human%2520Subjects.docx&amp;sa=D&amp;source=editors&amp;ust=1780597753311930&amp;usg=AOvVaw0u1Njc53gbLpgTSHy8SE1h\" target=\"_blank\" rel=\"noreferrer noopener\">Letter of Introduction for Student Project Involving Human Subjects<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Useful Links<\/h3>\n\n\n\n<p><a href=\"https:\/\/web.uri.edu\/ehs\/\" target=\"_blank\" rel=\"noreferrer noopener\">URI Environmental Health and Safety<\/a><\/p>\n\n\n\n<p><a href=\"http:\/\/www.hhs.gov\/ohrp\/\" target=\"_blank\" rel=\"noreferrer noopener\">DHHS Office of Human Research Protections (OHRP)<\/a><\/p>\n\n\n\n<p><a href=\"http:\/\/www.hhs.gov\/ohrp\/humansubjects\/guidance\/45cfr46.html\" target=\"_blank\" rel=\"noreferrer noopener\">DHHS Regulations for the Protection of Human Subjects (Common Rule, 45 CFR 46)<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/www.fda.gov\/science-research\/clinical-trials-and-human-subject-protection\/fda-policy-protection-human-subjects\" target=\"_blank\" rel=\"noreferrer noopener\">FDA Policy for the Protection of Human Subjects (21 CFR 50 and 56)<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/www.hhs.gov\/hipaa\/for-professionals\/privacy\/index.html\" target=\"_blank\" rel=\"noreferrer noopener\">HIPAA Privacy Rule<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/grants.nih.gov\/policy-and-compliance\/policy-topics\/human-subjects\/coc\" target=\"_blank\" rel=\"noreferrer noopener\">NIH Certificates of Confidentiality<\/a><\/p>\n\n\n\n<p><a href=\"http:\/\/grants.nih.gov\/grants\/guide\/notice-files\/not98-024.html\" target=\"_blank\" rel=\"noreferrer noopener\">NIH Policy and Guidelines on the Inclusion of Children in Research<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/grants.nih.gov\/grants\/guide\/notice-files\/not94-100.html\" target=\"_blank\" rel=\"noreferrer noopener\">NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Guidance Documents Does My Project Need IRB Review Research with Human Subjects Conducted by Students Collaborative Research IRB Data Security Human Subject Regulations Decision Charts IRB Guidance \u2013 Exempt Category 1 IRB Guidance \u2013 Exempt Category 2 IRB Guidance &#8211; Exempt Category 3 IRB Exercise Policy Templates Consent Template Expedited and Full Board Agreement to [&hellip;]<\/p>\n","protected":false},"author":701,"featured_media":0,"parent":43444,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":"","_links_to":"","_links_to_target":""},"class_list":["post-45390","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/web.uri.edu\/research-admin\/wp-json\/wp\/v2\/pages\/45390","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/web.uri.edu\/research-admin\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/web.uri.edu\/research-admin\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/web.uri.edu\/research-admin\/wp-json\/wp\/v2\/users\/701"}],"replies":[{"embeddable":true,"href":"https:\/\/web.uri.edu\/research-admin\/wp-json\/wp\/v2\/comments?post=45390"}],"version-history":[{"count":2,"href":"https:\/\/web.uri.edu\/research-admin\/wp-json\/wp\/v2\/pages\/45390\/revisions"}],"predecessor-version":[{"id":45473,"href":"https:\/\/web.uri.edu\/research-admin\/wp-json\/wp\/v2\/pages\/45390\/revisions\/45473"}],"up":[{"embeddable":true,"href":"https:\/\/web.uri.edu\/research-admin\/wp-json\/wp\/v2\/pages\/43444"}],"wp:attachment":[{"href":"https:\/\/web.uri.edu\/research-admin\/wp-json\/wp\/v2\/media?parent=45390"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}