{"id":6581,"date":"2017-02-01T18:12:26","date_gmt":"2017-02-02T02:12:26","guid":{"rendered":"https:\/\/www.washington.edu\/research\/?page_id=6581"},"modified":"2026-01-14T15:16:11","modified_gmt":"2026-01-14T23:16:11","slug":"human-subjects-research","status":"publish","type":"page","link":"https:\/\/www.washington.edu\/research\/myresearch-lifecycle\/setup\/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>Study Setup: Key Questions<\/h2>\n<h3>Do you need IRB approval?<\/h3>\n<p>If you are not sure if your project requires IRB approval, review the guidance <a href=\"https:\/\/www.washington.edu\/research\/hsd\/do-i-need-irb-review\/\">Do I Need IRB Review?<\/a> from start to finish to avoid incorrect conclusions.<\/p>\n<p>Our <a href=\"https:\/\/www.washington.edu\/research\/hsd\/getting-started\/\">Getting Started<\/a> webpage also provides answers to common questions.<\/p>\n<h3>Which IRB?<\/h3>\n<p>Most  91探花human subjects research is reviewed by the  91探花IRB. Exceptions:<\/p>\n<ul>\n<li> 91探花industry-initiated studies are reviewed by WCG IRB or Advarra<\/li>\n<li> 91探花oncology studies that are greater than minimal risk are reviewed by the Fred Hutchinson Cancer Center<\/li>\n<li>NIH funded, multi-site studies may be reviewed by another IRB<\/li>\n<\/ul>\n<p>Review the summary guidance titled <a href=\"https:\/\/www.washington.edu\/research\/hsd\/is-the-uw-irb-the-right-irb\/\">Reliance on a Non- 91探花IRB<\/a> for basic information, as well as consulting <a href=\"https:\/\/www.washington.edu\/research\/hsd\/is-the-uw-irb-the-right-irb\/identify-the-correct-irb\/\">Identify the Correct IRB<\/a>.<\/p>\n<h3>Multi-site or collaborative research<\/h3>\n<p>Sponsors often require the involved institutions to rely upon a <a href=\"https:\/\/www.washington.edu\/research\/hsd\/single-irb\/\">single IRB<\/a>. HSD may need to establish IRB reliance agreements with the other institutions.<\/p>\n<h3>What training do I need to complete?<\/h3>\n<p>HSD only requires training for student and resident Principal Investigators (PIs). However, researchers who work with human subjects or with data or samples from humans may need to complete human subjects protections training to meet the requirements of their department, affiliated organizations, or funders.<\/p>\n<p>For details about training expectations and available options, please see the <a href=\"https:\/\/www.washington.edu\/research\/hsd\/training\/required-training\/\">Human Subjects Training<\/a> webpage.<\/p>\n<h2>Additional Requirements<\/h2>\n<ul>\n<li><strong>Certificate of Confidentiality<\/strong>: Protects identifiable research data from disclosure, review the <a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/coc\/\">Certificate of Confidentiality guidance<\/a> for more information.<\/li>\n<li><strong>Research Consent<\/strong>:  91探花IRB provides <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>, and <a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/consent\/examples\/\">examples<\/a> to assist researchers with designing the consent process and forms.<\/li>\n<li><strong>Injury Compensation<\/strong>: The  91探花has a <a href=\"https:\/\/www.washington.edu\/research\/policies\/human-subjects-assistance-program-2\/\">discretionary compensation program<\/a> to provide treatment for subjects who experience a medical injury or adverse event that is research-related.<\/li>\n<li><strong>Data and Safety Monitoring Plan (DSMP)<\/strong>: A <a href=\"https:\/\/www.iths.org\/investigators\/services\/dsm\/data-and-safety-monitoring-plans\/\">DSMP<\/a> is required by many sponsors and\/or the IRB, especially if your study involves possible physical risks of harm to your subjects (e.g., side effects from a study drug).<\/li>\n<li><strong><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/dct\/\"> 91探花Diversity in Clinical Trials policy<\/a><\/strong> applies to <a href=\"https:\/\/www.washington.edu\/research\/hsd\/clinical-trials\/\">clinical trials<\/a> submitted to HSD for either  91探花IRB or external IRB review with <a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/dct\/#3\">some exceptions<\/a>. The requirements of this policy will necessitate additional staff time and financial resources. It is important that you plan and budget for these.<\/li>\n<li><strong>Clinical Trial Registration<\/strong>: Read our <a href=\"https:\/\/www.washington.edu\/research\/hsd\/clinical-trials\/\">ClinicalTrials.gov<\/a> page for more information.<\/li>\n<\/ul>\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":457,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"templates\/page-builder-lifecycle.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-6581","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\/setup\/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. 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