{"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":"2026-09-03T14:34:44","modified_gmt":"2026-09-03T18:34:44","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 class=\"wp-block-paragraph\"><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 class=\"wp-block-paragraph\"><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 class=\"wp-block-paragraph\"><a href=\"https:\/\/uri0.sharepoint.com\/:b:\/r\/sites\/DREDPolicyRevisions\/Shared%20Documents\/Website%20Documents\/ORI%20IRB%20Human%20Subjects\/Conducting%20Research%20with%20URI%20Students%20as%20Subjects.pdf?d=wbae2431890a7414a89ca633c2f2f65f8&amp;csf=1&amp;web=1&amp;e=TF2hPQ\" target=\"_blank\" rel=\"noreferrer noopener\">Conducting Research with URI Students as Subjects<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><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 class=\"wp-block-paragraph\"><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 class=\"wp-block-paragraph\"><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 class=\"wp-block-paragraph\"><a href=\"https:\/\/uri0.sharepoint.com\/:b:\/r\/sites\/DREDPolicyRevisions\/Shared%20Documents\/Website%20Documents\/ORI%20IRB%20Human%20Subjects\/Exempt%20Category%201%20Guidance.pdf?d=wd75391d8f50244b19abfeaeb3652123f&amp;csf=1&amp;web=1&amp;e=FQy12S\" target=\"_blank\" rel=\"noreferrer noopener\">IRB Guidance \u2013 Exempt Category 1<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/uri0.sharepoint.com\/:b:\/r\/sites\/DREDPolicyRevisions\/Shared%20Documents\/Website%20Documents\/ORI%20IRB%20Human%20Subjects\/Exempt%20Category%202%20Guidance.pdf?d=w2ff24128b79b450c8c83d302977e6224&amp;csf=1&amp;web=1&amp;e=tXdyeR\" target=\"_blank\" rel=\"noreferrer noopener\">IRB Guidance \u2013 Exempt Category 2<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/uri0.sharepoint.com\/:b:\/r\/sites\/DREDPolicyRevisions\/Shared%20Documents\/Website%20Documents\/ORI%20IRB%20Human%20Subjects\/Exempt%20Category%203%20Guidance.pdf?d=w31a6d54c27d3414b9080e67d4b1c7983&amp;csf=1&amp;web=1&amp;e=OwAveN\" target=\"_blank\" rel=\"noreferrer noopener\">IRB Guidance &#8211; Exempt Category 3<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/uri0.sharepoint.com\/:b:\/r\/sites\/DREDPolicyRevisions\/Shared%20Documents\/Website%20Documents\/ORI%20IRB%20Human%20Subjects\/Guidance%20for%20Exercise%20Testing%20and%20Interventions%20with%20Human%20Subjects.pdf?d=w609dd027e562478b876dc0e616585cfb&amp;csf=1&amp;web=1&amp;e=chSsDO\" target=\"_blank\" rel=\"noreferrer noopener\">Exercise Testing and Interventions with Human Subjects<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Templates<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><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 class=\"wp-block-paragraph\"><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 class=\"wp-block-paragraph\"><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 class=\"wp-block-paragraph\"><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 class=\"wp-block-paragraph\"><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 class=\"wp-block-paragraph\"><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 class=\"wp-block-paragraph\"><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 class=\"wp-block-paragraph\"><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 class=\"wp-block-paragraph\"><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 class=\"wp-block-paragraph\"><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 class=\"wp-block-paragraph\"><a href=\"https:\/\/web.uri.edu\/ehs\/\" target=\"_blank\" rel=\"noreferrer noopener\">URI Environmental Health and Safety<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><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 class=\"wp-block-paragraph\"><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 class=\"wp-block-paragraph\"><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 class=\"wp-block-paragraph\"><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 class=\"wp-block-paragraph\"><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 class=\"wp-block-paragraph\"><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 class=\"wp-block-paragraph\"><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 Conducting Research with URI Students as Subjects 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 Exercise Testing and Interventions with [&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":4,"href":"https:\/\/web.uri.edu\/research-admin\/wp-json\/wp\/v2\/pages\/45390\/revisions"}],"predecessor-version":[{"id":45737,"href":"https:\/\/web.uri.edu\/research-admin\/wp-json\/wp\/v2\/pages\/45390\/revisions\/45737"}],"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}]}}