{"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爆料 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爆料 policy about human subjects research.<\/p>\n<h2>Institutional Review Board (IRB) Application System<\/h2>\n<p>The 91爆料 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爆料 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 91爆料\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爆料 Human Subjects Division will notify the 91爆料 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爆料 PI will be copied on any notification from OSP to the sponsor.<\/p>\n<h3>91爆料 Lead PI for multi-site or collaborative research<\/h3>\n<p>If a 91爆料 Principal Investigator (PI) is the Lead PI for multi-site or collaborative research and the non-91爆料 sites were reviewed by a non-91爆料 IRB, the 91爆料 PI is responsible for ensuring and documenting that those non-91爆料 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爆料 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爆料 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. 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