{"id":6665,"date":"2017-02-02T12:11:54","date_gmt":"2017-02-02T20:11:54","guid":{"rendered":"https:\/\/www.washington.edu\/research\/?page_id=6665"},"modified":"2026-01-14T16:23:46","modified_gmt":"2026-01-15T00:23:46","slug":"human-subjects-research","status":"publish","type":"page","link":"https:\/\/www.washington.edu\/research\/myresearch-lifecycle\/manage\/compliance-requirements-non-financial\/human-subjects-research\/","title":{"rendered":"Human Subjects Research"},"content":{"rendered":"<h2>General Information<\/h2>\n<p>Activities that meet the regulatory definition of human subjects research require either IRB review or a determination of exempt status. The <a href=\"https:\/\/www.washington.edu\/research\/hsd\/\">Human Subjects Division (HSD)<\/a> is responsible for ensuring institutional compliance with federal and state regulations and  91探花policies that govern research with human subjects. <a href=\"http:\/\/www.washington.edu\/admin\/rules\/policies\/PO\/EO24.html\" target=\"_blank\" rel=\"noopener noreferrer\">Executive Order No. 24<\/a> is the general  91探花policy about human subjects research.<\/p>\n<h2>Institutional Review Board (IRB) Application System<\/h2>\n<p>The  91探花uses <a href=\"https:\/\/zipline.washington.edu\/\">Zipline<\/a>, a web-based system for:<\/p>\n<ul>\n<li>Submitting IRB applications<\/li>\n<li>Requesting HSD determinations (e.g., &#8216;Not Human Subjects Research&#8217;)<\/li>\n<\/ul>\n<p>Requirements:<\/p>\n<ul>\n<li>A valid  91探花NetID is required to access Zipline.<\/li>\n<li>New users must <a href=\"https:\/\/www.washington.edu\/research\/hsd\/training\/zipline-online-help-library\/zipline-basics\/account-creation-and-management\/\">register<\/a> before using the system.<\/li>\n<\/ul>\n<p>Resources:<\/p>\n<ul>\n<li>The <a href=\"https:\/\/www.washington.edu\/research\/hsd\/training\/zipline-online-help-library\/\">Zipline Online Help Library<\/a> provides tutorials and detailed instructions.<\/li>\n<\/ul>\n<h2>How to Get Help<\/h2>\n<p><strong>Email:<\/strong> Contact <a href=\"mailto:hsdinfo@uw.edu\">hsdinfo@uw.edu<\/a> (monitored during weekday business hours). <\/p>\n<p><strong>Review Team Contacts<\/strong><br \/>\nHSD has three review teams supporting UW\u2019s three IRB committees, plus a team specializing in IRB reliance and Single IRB arrangements. Each department is assigned to a specific team. Visit <a href=\"https:\/\/www.washington.edu\/research\/hsd\/hsd-contact\/\">Contacts<\/a> to find your team and email address (e.g., hsdteama@uw.edu). <\/p>\n<p><strong>Phone:<\/strong> Call 206-543-0098 to leave a voicemail; an HSD staff member will return your call.<\/p>\n<h2>Human subjects issues during a study may include:<\/h2>\n<h3>Obtaining IRB approval for study modifications<\/h3>\n<p>Almost all changes to the research must be approved in advance by the IRB via <a href=\"https:\/\/www.washington.edu\/research\/hsd\/study-activities\/modify\/\">study modification<\/a>.<\/p>\n<h3>Obtaining renewal of IRB approval<\/h3>\n<p>IRB approval for some studies is granted for a specific time period. IRB approval must be <a href=\"https:\/\/www.washington.edu\/research\/hsd\/study-activities\/renew\/\">renewed<\/a> before the IRB approval expiration date, if the study will continue past that date. Studies that do not have an expiration date are not required to renew IRB approval.<\/p>\n<h3>Reporting to the IRB<\/h3>\n<p>A <a href=\"https:\/\/www.washington.edu\/research\/hsd\/study-activities\/report-events-and-new-information\/guide-to-reporting-new-information\/\">wide variety of events and situations<\/a> must be promptly <a href=\"https:\/\/www.washington.edu\/research\/hsd\/study-activities\/report-events-and-new-information\/\">reported to the IRB<\/a>.<\/p>\n<h3>Reporting Safety\/Compliance Events to Sponsors<\/h3>\n<p>The Office of Sponsored Programs (OSP) is responsible for completing any institutional obligations <a href=\"https:\/\/www.washington.edu\/research\/hsd\/study-activities\/report-events-and-new-information\/\">reporting safety\/ compliance events<\/a> to funding agencies or other study sponsors under the terms of any research award, subaward or contract managed through its office. For funding that is not managed through OSP, the Principal Investigator (PI) is responsible for completing any reporting obligations to the study sponsor(s).<\/p>\n<p>The  91探花Human Subjects Division will notify the  91探花PI (and applicable relying site PI) of a reportable event in advance. This allows the researcher the opportunity to alert any sponsor prior to notification from OSP. The  91探花PI will be copied on any notification from OSP to the sponsor.<\/p>\n<h3> 91探花Lead PI for multi-site or collaborative research<\/h3>\n<p>If a  91探花Principal Investigator (PI) is the Lead PI for multi-site or collaborative research and the non- 91探花sites were reviewed by a non- 91探花IRB, the  91探花PI is responsible for ensuring and documenting that those non- 91探花sites obtain IRB approval for modifications, obtain renewals of IRB approval, and report relevant events to their IRBs. Failure to do so is considered noncompliance.<\/p>\n<h3>Update clinical trials registration record<\/h3>\n<p>Studies that meet the definition of &#8220;clinical trial&#8221; must register and then <a href=\"https:\/\/www.washington.edu\/research\/hsd\/clinical-trials\/how-to-update-a-clinical-trial-record\/\">provide updates<\/a>\u00a0at least annually at ClinicalTrials.gov. Studies approved on or after January 21, 2019 must also upload a blank copy of a study consent form to a public federal website.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>General Information Activities that meet the regulatory definition of human subjects research require either IRB review or a determination of exempt status. The Human Subjects Division&#8230;<\/p>\n","protected":false},"author":117,"featured_media":0,"parent":469,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"templates\/page-builder-lifecycle.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-6665","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>Human Subjects Research -  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\/myresearch-lifecycle\/manage\/compliance-requirements-non-financial\/human-subjects-research\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Human Subjects Research -  91探花Research\" \/>\n<meta property=\"og:description\" content=\"General Information Activities that meet the regulatory definition of human subjects research require either IRB review or a determination of exempt status. The Human Subjects Division...\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.washington.edu\/research\/myresearch-lifecycle\/manage\/compliance-requirements-non-financial\/human-subjects-research\/\" \/>\n<meta property=\"og:site_name\" content=\" 91探花Research\" \/>\n<meta property=\"article:modified_time\" content=\"2026-01-15T00:23:46+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.washington.edu\/research\/myresearch-lifecycle\/manage\/compliance-requirements-non-financial\/human-subjects-research\/\",\"url\":\"https:\/\/www.washington.edu\/research\/myresearch-lifecycle\/manage\/compliance-requirements-non-financial\/human-subjects-research\/\",\"name\":\"Human Subjects Research -  91探花Research\",\"isPartOf\":{\"@id\":\"https:\/\/www.washington.edu\/research\/#website\"},\"datePublished\":\"2017-02-02T20:11:54+00:00\",\"dateModified\":\"2026-01-15T00:23:46+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/www.washington.edu\/research\/myresearch-lifecycle\/manage\/compliance-requirements-non-financial\/human-subjects-research\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.washington.edu\/research\/myresearch-lifecycle\/manage\/compliance-requirements-non-financial\/human-subjects-research\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.washington.edu\/research\/myresearch-lifecycle\/manage\/compliance-requirements-non-financial\/human-subjects-research\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.washington.edu\/research\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"MyResearch Project Lifecycle\",\"item\":\"https:\/\/www.washington.edu\/research\/myresearch-lifecycle\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Manage\",\"item\":\"https:\/\/www.washington.edu\/research\/myresearch-lifecycle\/manage\/\"},{\"@type\":\"ListItem\",\"position\":4,\"name\":\"Compliance Requirements (Non-Financial)\",\"item\":\"https:\/\/www.washington.edu\/research\/myresearch-lifecycle\/manage\/compliance-requirements-non-financial\/\"},{\"@type\":\"ListItem\",\"position\":5,\"name\":\"Human Subjects Research\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.washington.edu\/research\/#website\",\"url\":\"https:\/\/www.washington.edu\/research\/\",\"name\":\" 91探花Research\",\"description\":\"\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.washington.edu\/research\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Human Subjects Research -  91探花Research","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.washington.edu\/research\/myresearch-lifecycle\/manage\/compliance-requirements-non-financial\/human-subjects-research\/","og_locale":"en_US","og_type":"article","og_title":"Human Subjects Research -  91探花Research","og_description":"General Information Activities that meet the regulatory definition of human subjects research require either IRB review or a determination of exempt status. The Human Subjects Division...","og_url":"https:\/\/www.washington.edu\/research\/myresearch-lifecycle\/manage\/compliance-requirements-non-financial\/human-subjects-research\/","og_site_name":" 91探花Research","article_modified_time":"2026-01-15T00:23:46+00:00","twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.washington.edu\/research\/myresearch-lifecycle\/manage\/compliance-requirements-non-financial\/human-subjects-research\/","url":"https:\/\/www.washington.edu\/research\/myresearch-lifecycle\/manage\/compliance-requirements-non-financial\/human-subjects-research\/","name":"Human Subjects Research -  91探花Research","isPartOf":{"@id":"https:\/\/www.washington.edu\/research\/#website"},"datePublished":"2017-02-02T20:11:54+00:00","dateModified":"2026-01-15T00:23:46+00:00","breadcrumb":{"@id":"https:\/\/www.washington.edu\/research\/myresearch-lifecycle\/manage\/compliance-requirements-non-financial\/human-subjects-research\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.washington.edu\/research\/myresearch-lifecycle\/manage\/compliance-requirements-non-financial\/human-subjects-research\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.washington.edu\/research\/myresearch-lifecycle\/manage\/compliance-requirements-non-financial\/human-subjects-research\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.washington.edu\/research\/"},{"@type":"ListItem","position":2,"name":"MyResearch Project Lifecycle","item":"https:\/\/www.washington.edu\/research\/myresearch-lifecycle\/"},{"@type":"ListItem","position":3,"name":"Manage","item":"https:\/\/www.washington.edu\/research\/myresearch-lifecycle\/manage\/"},{"@type":"ListItem","position":4,"name":"Compliance Requirements (Non-Financial)","item":"https:\/\/www.washington.edu\/research\/myresearch-lifecycle\/manage\/compliance-requirements-non-financial\/"},{"@type":"ListItem","position":5,"name":"Human Subjects Research"}]},{"@type":"WebSite","@id":"https:\/\/www.washington.edu\/research\/#website","url":"https:\/\/www.washington.edu\/research\/","name":" 91探花Research","description":"","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.washington.edu\/research\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"}]}},"_links":{"self":[{"href":"https:\/\/www.washington.edu\/research\/wp-json\/wp\/v2\/pages\/6665","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.washington.edu\/research\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.washington.edu\/research\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.washington.edu\/research\/wp-json\/wp\/v2\/users\/117"}],"replies":[{"embeddable":true,"href":"https:\/\/www.washington.edu\/research\/wp-json\/wp\/v2\/comments?post=6665"}],"version-history":[{"count":32,"href":"https:\/\/www.washington.edu\/research\/wp-json\/wp\/v2\/pages\/6665\/revisions"}],"predecessor-version":[{"id":61525,"href":"https:\/\/www.washington.edu\/research\/wp-json\/wp\/v2\/pages\/6665\/revisions\/61525"}],"up":[{"embeddable":true,"href":"https:\/\/www.washington.edu\/research\/wp-json\/wp\/v2\/pages\/469"}],"wp:attachment":[{"href":"https:\/\/www.washington.edu\/research\/wp-json\/wp\/v2\/media?parent=6665"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}