{"id":40122,"date":"2021-10-08T12:04:51","date_gmt":"2021-10-08T19:04:51","guid":{"rendered":"https:\/\/www.washington.edu\/research\/?page_id=40122"},"modified":"2026-01-29T09:54:41","modified_gmt":"2026-01-29T17:54:41","slug":"guidance","status":"publish","type":"page","link":"https:\/\/www.washington.edu\/research\/hsd\/guidance\/","title":{"rendered":"Topic-Based Guidance"},"content":{"rendered":"<h3>Below you will find a topic-based table of contents for HSD&#8217;s policies, procedures, and guidance.<\/h3>\n<p>Can&#8217;t find what you&#8217;re looking for? Contact <a href=\"mailto:hsdinfo@uw.edu\">hsdinfo@uw.edu<\/a>.<\/p>\n<p>&nbsp;<\/p>\n<div class=\"box-outer\">\n<div class=\"box three\">\n<div class=\"tile\" style=\"padding: 10px; margin-right: 0; background-color: #fff; border: 1px solid #e3e3e3; border-top: 5px solid #4b2e83; border-radius: 4px; box-shadow: 3px 3px 5px #bdc3c7;\">\n<h2 style=\"font-size: 18px;\">Types of IRB Review<\/h2>\n<ul>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/do-i-need-irb-review\/\">Step-by-step instructions<\/a> for deciding whether you need review<\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/review-resources\/\">Resources<\/a> for deciding whether your project is research with human subjects, exempt, or if you need expedited or full board review<\/li>\n<\/ul>\n<\/div>\n<div class=\"tile\" style=\"padding: 10px; border: 1px solid #e3e3e3; border-top: 5px solid #4b2e83; border-radius: 4px; box-shadow: 3px 3px 5px #bdc3c7;\">\n<h2 style=\"font-size: 18px;\"> 91探花IRB as the Single IRB<\/h2>\n<p><a href=\"https:\/\/www.washington.edu\/research\/hsd\/single-irb\/uw-irb-as-a-single-irb\/\">Guidance<\/a> about when  91探花can review on behalf of non- 91探花institutions, organizations and individuals<\/p>\n<\/div>\n<div class=\"tile\" style=\"padding: 10px; border: 1px solid #e3e3e3; border-top: 5px solid #4b2e83; border-radius: 4px; box-shadow: 3px 3px 5px #bdc3c7;\">\n<h2 style=\"font-size: 18px;\">Studies Reviewed by a Non- 91探花IRB<\/h2>\n<ul>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/is-the-uw-irb-the-right-irb\/identify-the-correct-irb\/\">Guidance<\/a> on identifying the correct IRB<\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/is-the-uw-irb-the-right-irb\/how-to-ask-for-a-non-uw-irb\/\">Obtain authorization from HSD<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/policies\/guidance-consent-elements-externally-reviewed-studies\/\">Consent Requirements<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/checklist-external-irb-uw-researchers\/\">Researcher Responsibilities<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/is-the-uw-irb-the-right-irb\/identify-the-correct-irb\/industry-sponsored-research\/\">Industry Research<\/a><\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"box-outer\">\n<div class=\"box three\">\n<div class=\"tile\" style=\"padding: 10px; border: 1px solid #e3e3e3; border-top: 5px solid #4b2e83; border-radius: 4px; box-shadow: 3px 3px 5px #bdc3c7;\">\n<h2 style=\"font-size: 18px;\">Consent and Recruitment<\/h2>\n<ul>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/consent\/\">General guidance<\/a> and <a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/consent\/consent-tip-sheets\/\">tipsheets<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/consent\/design\/\">Guidance <\/a>, <a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/consent\/templates\/\">templates<\/a>, <a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/consent\/examples\/\">example consent forms<\/a> for designing the consent process and form<\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/recruitment\/cold-contact-recruitment\/\">Cold contact recruitment<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/policies\/guidance-research-at-valley-medical-center\/\">Recruiting at Valley Medical Center<\/a><\/li>\n<\/ul>\n<\/div>\n<div class=\"tile\" style=\"padding: 10px; margin-right: 0; background-color: #fff; border: 1px solid #e3e3e3; border-top: 5px solid #4b2e83; border-radius: 4px; box-shadow: 3px 3px 5px #bdc3c7;\">\n<h2 style=\"font-size: 18px;\">Other Review Considerations<\/h2>\n<ul>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/subject-payment\/\">Paying subjects<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/results\/\">Return of individual results<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/ancillary\/gds\/\">Genomic Data Sharing<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/policies\/sop-financial-conflict-of-interest-2\/\">Financial conflict of interest<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/policies\/human-subjects-assistance-program-2\/\"> 91探花injury compensation<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/international-research\/\">International research<\/a><\/li>\n<li><a href=\".\/ai\">Artificial Intelligence<\/a><\/li>\n<\/ul>\n<\/div>\n<div class=\"tile\" style=\"padding: 10px; border: 1px solid #e3e3e3; border-top: 5px solid #4b2e83; border-radius: 4px; box-shadow: 3px 3px 5px #bdc3c7;\">\n<h2 style=\"font-size: 18px;\">Report Safety or Compliance Events<\/h2>\n<ul>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/study-activities\/report-events-and-new-information\/\">Guidance on reporting<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/policies\/sop-rni-reporting-by-researchers\/\">SOP RNI Reporting by Researchers<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/inquiries\/\">Research inquiries<\/a><\/li>\n<li>Contact <a href=\"mailto:hsdreprt@uw.edu\">hsdreprt@uw.edu<\/a> with questions, complaints, or concerns about  91探花research<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"box-outer\">\n<div class=\"box three\">\n<div class=\"tile\" style=\"padding: 10px; margin-right: 0; background-color: #fff; border: 1px solid #e3e3e3; border-top: 5px solid #4b2e83; border-radius: 4px; box-shadow: 3px 3px 5px #bdc3c7;\">\n<h2 style=\"font-size: 18px;\">Specific Federal Agency Requirements<\/h2>\n<ul>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/fda\/\">Food and Drug Administration<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/specific-agencies\/dod\/\">Department of Defense<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/doe\/\">Department of Energy<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/specific-agencies\/doj\/\">Department of Justice<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/epa\/\">Environmental Protection Agency<\/a><\/li>\n<\/ul>\n<\/div>\n<div class=\"tile\" style=\"padding: 10px; margin-right: 0; background-color: #fff; border: 1px solid #e3e3e3; border-top: 5px solid #4b2e83; border-radius: 4px; box-shadow: 3px 3px 5px #bdc3c7;\">\n<h2 style=\"font-size: 18px;\">Clinical Trials<\/h2>\n<ul>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/clinical-trials\/\">ClinicalTrials.gov<\/a> registration and reporting requirements<\/li>\n<li>Guidance about the  91探花policy requirement to develop a <a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/dct\/\">Diversity Plan for Clinical Trials<\/a><\/li>\n<\/ul>\n<\/div>\n<div class=\"tile\" style=\"padding: 10px; border: 1px solid #e3e3e3; border-top: 5px solid #4b2e83; border-radius: 4px; box-shadow: 3px 3px 5px #bdc3c7;\">\n<h2 style=\"font-size: 18px;\">Privacy and Confidentiality<\/h2>\n<ul>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/data-security\/\">Data security protections<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/coc\/\">Certificate of Confidentiality<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/mandatory-reporting\/\">Mandatory state reporting<\/a><\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"box-outer\">\n<div class=\"box three\">\n<div class=\"tile\" style=\"padding: 10px; border: 1px solid #e3e3e3; border-top: 5px solid #4b2e83; border-radius: 4px; box-shadow: 3px 3px 5px #bdc3c7;\">\n<h2 style=\"font-size: 18px;\">HIPAA<\/h2>\n<ul>\n<li><a href=\"https:\/\/www.washington.edu\/research\/policies\/guidance-hipaa-2\/\">HIPAA guidance<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/policies\/sop-hipaa-2\/\">HIPAA SOP<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/policies\/guidance-case-reports-irb-review-hipaa\/\">Case report guidance<\/a><\/li>\n<\/ul>\n<\/div>\n<div class=\"tile\" style=\"padding: 10px; border: 1px solid #e3e3e3; border-top: 5px solid #4b2e83; border-radius: 4px; box-shadow: 3px 3px 5px #bdc3c7;\">\n<h2 style=\"font-size: 18px;\">Protected and Vulnerable Populations<\/h2>\n<ul>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/protected-vulnerable-populations\/pregnant-women\/\">Pregnant women and neonates<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/protected-vulnerable-populations\/children\/\">Children<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/protected-vulnerable-populations\/prisoners\/\">Prisoners<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/suicide-risk\/\">Participants At Risk Of Suicide<\/a><\/li>\n<\/ul>\n<\/div>\n<div class=\"tile\" style=\"padding: 10px; border: 1px solid #e3e3e3; border-top: 5px solid #4b2e83; border-radius: 4px; box-shadow: 3px 3px 5px #bdc3c7;\">\n<h2 style=\"font-size: 18px;\">Funding and Support<\/h2>\n<ul>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/delayed-onset-human-research-dohr\/\">Delayed Onset Human Research (DOHR)<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/just-in-time-and-irb-review\/\">Just In Time<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/policies\/sop-grant-approval-and-certification\/\">Grant approval and certification<\/a><\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"box-outer\">\n<div class=\"box three\">\n<div class=\"tile\" style=\"padding: 10px; margin-right: 0; background-color: #fff; border: 1px solid #e3e3e3; border-top: 5px solid #4b2e83; border-radius: 4px; box-shadow: 3px 3px 5px #bdc3c7;\">\n<h2 style=\"font-size: 18px;\">Post Approval Verification and Education (PAVE) Monitoring Program<\/h2>\n<ul>\n<li><a href=\"https:\/\/www.washington.edu\/research\/policies\/sop-pave-evaluation\/\">SOP PAVE Evaluation<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/pave\/\">Post-Approval Verification and Education Guidance<\/a><\/li>\n<\/ul>\n<\/div>\n<div class=\"tile\" style=\"padding: 10px; border: 1px solid #e3e3e3; border-top: 5px solid #4b2e83; border-radius: 4px; box-shadow: 3px 3px 5px #bdc3c7;\">\n<h2 style=\"font-size: 18px;\">Access to Unapproved Drugs, Biologics, and Devices<\/h2>\n<ul>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/expanded-access\/\">All Expanded Access mechanisms<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/expanded-access\/specu\/\">Single Patient Emergency or Compassionate Use<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/hud\/\">Humanitarian Use Device (HUD)<\/a><\/li>\n<\/ul>\n<\/div>\n<div class=\"tile\" style=\"padding: 10px; border: 1px solid #e3e3e3; border-top: 5px solid #4b2e83; border-radius: 4px; box-shadow: 3px 3px 5px #bdc3c7;\">\n<h2 style=\"font-size: 18px;\">Emergency Medicine Research<\/h2>\n<p><a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/supplement-exception-from-informed-consent-for-emergency-research-efic\/\">Exception from Informed Consent for Emergency Research<\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"box-outer\">\n<div class=\"box three\">\n<div class=\"tile\" style=\"padding: 10px; border: 1px solid #e3e3e3; border-top: 5px solid #4b2e83; border-radius: 4px; box-shadow: 3px 3px 5px #bdc3c7;\">\n<h2 style=\"font-size: 18px;\">Human Subjects Regulations<\/h2>\n<ul>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/ethical-principles\/\">Ethical principles<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/policies\/guidance-authority-and-responsibilities-of-hsd-and-uw-irb\/\">Authority and responsibilities of HSD and the  91探花IRB<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/policies\/guidance-human-subjects-regulations-2\/\">Human subjects regulations<\/a><\/li>\n<\/ul>\n<\/div>\n<div class=\"tile\" style=\"padding: 10px; border: 1px solid #e3e3e3; border-top: 5px solid #4b2e83; border-radius: 4px; box-shadow: 3px 3px 5px #bdc3c7;\">\n<h2 style=\"font-size: 18px;\">The Convened IRB<\/h2>\n<ul>\n<li><a href=\"https:\/\/www.washington.edu\/research\/policies\/sop-convened-irb-meetings\/\">Convened IRB meetings<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/worksheet-irb-review-outcomes\/\">IRB review outcomes<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/worksheet-options-for-irb-actions\/\">Options for IRB Actions<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/policies\/sop-guests-at-irb-meetings-2\/\">SOP Guests at IRB Meetings<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/policies\/information-for-irb-guests-2\/\">Information for IRB Guests<\/a><\/li>\n<\/ul>\n<\/div>\n<div class=\"tile\" style=\"padding: 10px; border: 1px solid #e3e3e3; border-top: 5px solid #4b2e83; border-radius: 4px; box-shadow: 3px 3px 5px #bdc3c7;\">\n<h2 style=\"font-size: 18px;\">IRB Members<\/h2>\n<ul>\n<li><a href=\"https:\/\/www.washington.edu\/research\/policies\/sop-irb-members\/\">SOP IRB Members<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/policies\/sop-irb-member-standards-and-responsibilities\/\">IRB member standards and responsibilities<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/policies\/sop-reviewer-conflict-of-interest\/\">IRB reviewer conflict of interest<\/a><\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<h3>Topics described elsewhere on the HSD website<\/h3>\n<ul>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/zipline\/\">Access Zipline<\/a>, the e-IRB submission system<\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/study-activities\/\">Steps for obtaining approval and managing your approved application<\/a><\/li>\n<li>New users and students should first visit our <a href=\"https:\/\/www.washington.edu\/research\/hsd\/getting-started\/\">Getting Started<\/a> page<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Below you will find a topic-based table of contents for HSD&#8217;s policies, procedures, and guidance. Can&#8217;t find what you&#8217;re looking for? Contact hsdinfo@uw.edu. &nbsp; Types of&#8230;<\/p>\n","protected":false},"author":15,"featured_media":0,"parent":274,"menu_order":3,"comment_status":"closed","ping_status":"closed","template":"templates\/page-builder-units-small-hero.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-40122","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Topic-Based Guidance -  91探花Research<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Topic-Based Guidance -  91探花Research\" \/>\n<meta property=\"og:description\" content=\"Below you will find a topic-based table of contents for HSD&#8217;s policies, procedures, and guidance. 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