{"id":3790,"date":"2021-09-28T11:10:38","date_gmt":"2021-09-28T15:10:38","guid":{"rendered":"https:\/\/umaine.edu\/research-compliance\/?page_id=3790"},"modified":"2026-02-20T15:35:22","modified_gmt":"2026-02-20T20:35:22","slug":"regulations","status":"publish","type":"page","link":"https:\/\/umaine.edu\/research-compliance\/human-subjects\/regulations\/","title":{"rendered":"Federal and State Regulations &amp; Guidance Materials for Human Subjects Research and Institutional Review Board (IRB)"},"content":{"rendered":"\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/belmont-report\/index.html\">The Belmont Report (external link)<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/ori.hhs.gov\/content\/chapter-3-The-Protection-of-Human-Subjects-nuremberg-code-directives-human-experimentation\" data-type=\"link\" data-id=\"https:\/\/ori.hhs.gov\/content\/chapter-3-The-Protection-of-Human-Subjects-nuremberg-code-directives-human-experimentation\">The Nuremberg Code (external link)<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.wma.net\/policies-post\/wma-declaration-of-helsinki\/\" data-type=\"link\" data-id=\"https:\/\/www.wma.net\/policies-post\/wma-declaration-of-helsinki\/\">Declaration of Helsinki (external link)<\/a> (\u201cThe World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects.\u201d)<\/li>\n\n\n\n<li><a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/regulations\/common-rule\/index.html\">The Common Rule (external link)<\/a> \u2013 Federal Policy for the Protection of Human Subjects<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Office for Human Research Protections (OHRP)<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.hhs.gov\/ohrp\/index.html\">Office for Human Research Protections (OHRP) (external link)<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.ecfr.gov\/current\/title-45\/subtitle-A\/subchapter-A\/part-46\" data-type=\"link\" data-id=\"https:\/\/www.ecfr.gov\/current\/title-45\/subtitle-A\/subchapter-A\/part-46\">45 CFR 46 (external link)<\/a> \u2013 Federal Regulations for the Protection of Human Subject \u2013 applies to ALL human subjects studies<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">National Institutes of Health (NIH)<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/grants.nih.gov\/faqs#\/hs-human-subjects-education.htm\">NIH Human Subjects Education: Frequently Asked Questions (external link)<\/a>: Frequently asked questions (FAQs) regarding the NIH Education Requirement<\/li>\n\n\n\n<li><a href=\"https:\/\/grants.nih.gov\/grants\/guide\/notice-files\/NOT-OD-26-043.html\" data-type=\"link\" data-id=\"https:\/\/grants.nih.gov\/grants\/guide\/notice-files\/NOT-OD-26-043.html\">NIH NOT-OD-26-043: Reminder of Requirement for Certification of IRB Approval (external link)<\/a><\/li>\n\n\n\n<li>Special Topics:\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/grants.nih.gov\/policy-and-compliance\/policy-topics\/human-subjects\/coc\" data-type=\"link\" data-id=\"https:\/\/grants.nih.gov\/policy-and-compliance\/policy-topics\/human-subjects\/coc\">Certificates of Confidentiality (external link)<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/grants.nih.gov\/policy-and-compliance\/policy-topics\/sharing-policies\/dms\/policy-overview\" data-type=\"link\" data-id=\"https:\/\/grants.nih.gov\/policy-and-compliance\/policy-topics\/sharing-policies\/dms\/policy-overview\">Data Management &amp; Sharing Policy Overview (external link)<\/a>\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/grants.nih.gov\/grants\/guide\/notice-files\/NOT-OD-22-214.html\" data-type=\"link\" data-id=\"https:\/\/grants.nih.gov\/grants\/guide\/notice-files\/NOT-OD-22-214.html\">NOT-OD-22-214: Responsible Management and Sharing of American Indian\/Alaska Native Participant Data (external link)<\/a><\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><a href=\"https:\/\/grants.nih.gov\/policy-and-compliance\/policy-topics\/inclusion\" data-type=\"link\" data-id=\"https:\/\/grants.nih.gov\/policy-and-compliance\/policy-topics\/inclusion\">Inclusion Policies for Research Involving Human Subjects (external link)<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/grants.nih.gov\/grants\/guide\/notice-files\/NOT-OD-24-098.html\" data-type=\"link\" data-id=\"https:\/\/grants.nih.gov\/grants\/guide\/notice-files\/NOT-OD-24-098.html\">NOT-OD-24-098: Update to HeLa Cell Whole Genome Sequence Data Submission and Access Under the NIH Lacks-Family Agreement (external link)<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/grants.nih.gov\/policy-and-compliance\/policy-topics\/human-subjects\/single-irb-policy-multi-site-research\" data-type=\"link\" data-id=\"https:\/\/grants.nih.gov\/policy-and-compliance\/policy-topics\/human-subjects\/single-irb-policy-multi-site-research\">Single IRB (external link)<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">National Science Foundation (NSF)<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/new.nsf.gov\/funding\/research-involving-human-subjects\" data-type=\"link\" data-id=\"https:\/\/new.nsf.gov\/funding\/research-involving-human-subjects\">Research Involving Human Subjects (external link)<\/a> \u2013 NSF Policy for human subjects research (HSR)<\/li>\n\n\n\n<li><a href=\"https:\/\/new.nsf.gov\/funding\/faq\/research-involving-human-subjects\" data-type=\"link\" data-id=\"https:\/\/new.nsf.gov\/funding\/faq\/research-involving-human-subjects\">Behavioral and Social Science Research (external link)<\/a> \u2013 NSF interpretation of Common Rule and Behavioral and Social Science Research<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Food and Drug Administration (FDA)<\/h3>\n\n\n\n<p>Studies using investigational drugs, devices or biologics<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-A\/part-50\">21 CFR 50 (external link)<\/a> \u2013 FDA Regulations for Protection of Human Subjects<\/li>\n\n\n\n<li><a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-A\/part-56\">21 CFR 56 (external link)<\/a> \u2013 FDA Regulations for Institutional Review Boards<\/li>\n\n\n\n<li><a href=\"https:\/\/www.fda.gov\/science-research\/clinical-trials-and-human-subject-protection\/clinical-trials-guidance-documents\">Guidance for interpreting 21 CFR 50 and 56 (external link)<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.fda.gov\/science-research\/good-clinical-practice-educational-materials\/comparison-fda-and-hhs-human-subject-protection-regulations\">Comparison of Food and Drug Administration (FDA) and U.S. Department of Health &amp; Human Services (HHS) Human Subject Regulations (external link)<\/a><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Veterans Health Administration (VHA)<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.va.gov\/oro\/\">Office of Research Oversight (ORO)<\/a><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">HIPPA Regulations (Health Insurance Portability and Accountability Act)<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.hhs.gov\/sites\/default\/files\/hipaa-simplification-201303.pdf\">45 CFR 160, 162 and 164 (PDF) (external link)<\/a><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Department of Defense (DoD)<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.esd.whs.mil\/DD\/\">DoD Directives (external link)<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.esd.whs.mil\/Portals\/54\/Documents\/DD\/issuances\/dodi\/321602p.pdf\">DoD Instruction 3216.02 (PDF) (external link)<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Office for Human Research Protections (OHRP) National Institutes of Health (NIH) National Science Foundation (NSF) Food and Drug Administration (FDA) Studies using investigational drugs, devices or biologics Veterans Health Administration (VHA) HIPPA Regulations (Health Insurance Portability and Accountability Act) Department of Defense (DoD)<\/p>\n","protected":false},"author":1621,"featured_media":0,"parent":6675,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"templates\/page-withsidebar.php","meta":{"_seopress_robots_primary_cat":"","_seopress_titles_title":"","_seopress_titles_desc":"","_seopress_robots_index":"","_kad_blocks_custom_css":"","_kad_blocks_head_custom_js":"","_kad_blocks_body_custom_js":"","_kad_blocks_footer_custom_js":"","_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-3790","page","type-page","status-publish","hentry"],"taxonomy_info":[],"featured_image_src_large":false,"author_info":{"display_name":"cdoiron","author_link":"https:\/\/umaine.edu\/research-compliance\/author\/cdoiron\/"},"comment_info":"","_links":{"self":[{"href":"https:\/\/umaine.edu\/research-compliance\/wp-json\/wp\/v2\/pages\/3790","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/umaine.edu\/research-compliance\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/umaine.edu\/research-compliance\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/umaine.edu\/research-compliance\/wp-json\/wp\/v2\/users\/1621"}],"replies":[{"embeddable":true,"href":"https:\/\/umaine.edu\/research-compliance\/wp-json\/wp\/v2\/comments?post=3790"}],"version-history":[{"count":49,"href":"https:\/\/umaine.edu\/research-compliance\/wp-json\/wp\/v2\/pages\/3790\/revisions"}],"predecessor-version":[{"id":8675,"href":"https:\/\/umaine.edu\/research-compliance\/wp-json\/wp\/v2\/pages\/3790\/revisions\/8675"}],"up":[{"embeddable":true,"href":"https:\/\/umaine.edu\/research-compliance\/wp-json\/wp\/v2\/pages\/6675"}],"wp:attachment":[{"href":"https:\/\/umaine.edu\/research-compliance\/wp-json\/wp\/v2\/media?parent=3790"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}