{"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":"2024-02-08T12:14:40","modified_gmt":"2024-02-08T20:14:40","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>Visit the <a href=\"https:\/\/www.washington.edu\/research\/hsd\/\">Human Subjects Division (HSD) website<\/a> for information about all aspects of human subjects research. <a href=\"http:\/\/www.washington.edu\/admin\/rules\/policies\/PO\/EO24.html\" target=\"_blank\" rel=\"noopener noreferrer\">Executive Order No. 24<\/a>\u00a0is the general UW policy about human subjects research.<\/p>\n<h2>Web-based Institutional Review Board (IRB) application system<\/h2>\n<p>The UW uses a web-based system called <strong>Zipline<\/strong> for IRB applications and for requesting HSD determinations (such as &#8220;not human subjects research&#8221; determinations). A UW NetID is required to use Zipline, and new users must <a href=\"https:\/\/www.washington.edu\/research\/hsd\/training\/zipline-online-help-library\/zipline-basics\/account-creation-and-management\/\">register<\/a>\u00a0with the system. The <a href=\"https:\/\/www.washington.edu\/research\/hsd\/training\/zipline-online-help-library\/\">Zipline Online Help Library<\/a> has online tutorials and detailed instruction documents.<\/p>\n<h2>How to obtain help<\/h2>\n<h3>Help email<\/h3>\n<p>The general help email address is <a href=\"mailto:hsdinfo@uw.edu\">hsdinfo@uw.edu<\/a>. It is monitored Monday through Friday during business hours.<\/p>\n<h3>Review team contacts<\/h3>\n<p>HSD has four review staff teams, each of which supports one of the UW\u2019s four IRB committees, and one staff team that specializes in IRB reliance and Single IRB arrangements. Each department and academic unit is associated with a specific team and IRB. Visit <a href=\"https:\/\/www.washington.edu\/research\/hsd\/hsd-contact\/\">Contacts<\/a> to find your team and email contact (each team has an email address such as hsdteama@uw.edu).<\/p>\n<h3>HSD main office phone<\/h3>\n<p>You may also call the main office at 206-543-0098 to leave a voicemail and someone from HSD will contact you.<\/p>\n<h2>Study setup issues and activities may include:<\/h2>\n<h3>Do you need IRB approval?<\/h3>\n<p>Some activities that you may consider to be human subjects research do not meet the regulatory definition of &#8220;human subjects research&#8221; \u2013 and vice versa. If you are not sure whether your planned research is &#8220;regulated human subjects research&#8221;, read this <a href=\"https:\/\/www.washington.edu\/research\/hsd\/do-i-need-irb-review\/\">guidance<\/a>. It is important to start at the beginning of the guidance and work your way through the issues in the order they are presented. Otherwise, you may come to an inaccurate conclusion.<\/p>\n<h3>Which IRB?<\/h3>\n<p>Most UW human subjects research is reviewed by the UW IRB. Exceptions:<\/p>\n<ul>\n<li>Most UW industry-initiated studies are reviewed by WCG IRB or Advarra instead of the UW IRB<\/li>\n<li>Most UW oncology studies that are greater than minimal risk are reviewed by the Fred Hutchinson Cancer Center instead of the UW IRB<\/li>\n<li>NIH funded, multi-site studies may be reviewed by another IRB<\/li>\n<\/ul>\n<p>Read this summary <a href=\"https:\/\/www.washington.edu\/research\/hsd\/is-the-uw-irb-the-right-irb\/general-information\/\" target=\"_blank\" rel=\"noopener noreferrer\">guidance<\/a>\u00a0for basic information.<\/p>\n<h3>Multi-site or collaborative research<\/h3>\n<p>Sponsors are increasingly likely to require the involved institutions to rely upon a <a href=\"https:\/\/www.washington.edu\/research\/hsd\/single-irb\/\">single IRB<\/a>. These arrangements may require HSD to establish IRB reliance agreements with the other institutions.<\/p>\n<h3><a href=\"https:\/\/www.washington.edu\/research\/hsd\/study-activities\/apply-for-review\/\">Obtain IRB approval or an exempt determination<\/a>&#8230;<\/h3>\n<p>before conducting any human subjects research or spending any research funding on such activities. Use the <a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/zipline-application-irb-protocol\/\">IRB Protocol form<\/a>. Explanatory information and guidance is provided with each question.<\/p>\n<h3>Certificate of Confidentiality<\/h3>\n<p>A federal certificate of confidentiality allows researchers to refuse to disclose name or any information, documents or biospecimens containing identifiable information about the research subjects. Review <a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/coc\/\">Certificate of Confidentiality guidance<\/a>.<\/p>\n<h3>Obtaining research consent<\/h3>\n<p>The UW 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 form.<\/p>\n<h3>Injury compensation<\/h3>\n<p>The UW has a <a href=\"https:\/\/www.washington.edu\/research\/policies\/human-subjects-assistance-program-2\/\">discretionary compensation program<\/a>\u00a0to provide treatment for subjects who experience a medical injury or adverse event that is research-related.<\/p>\n<h3>Data and Safety Monitoring Plan (DSMP)<\/h3>\n<p>A <a href=\"https:\/\/www.iths.org\/investigators\/services\/dsm\/data-and-safety-monitoring-plans\/\" target=\"_blank\" rel=\"noopener noreferrer\">DSMP<\/a> is required by many sponsors and\/or the IRB, especially if your study involves possible physical risks of harm to your subjects (for example, side effects from a study drug).<\/p>\n<h3>Register clinical trials<\/h3>\n<p>Studies that meet the definition of &#8220;clinical trial&#8221; must register at ClinicalTrials.gov. Read this <a href=\"https:\/\/www.washington.edu\/research\/hsd\/clinical-trials\/clinical-trials-registration-and-reporting\/\">guidance<\/a>\u00a0for more information. Registration must occur within 21 days after the first subject is enrolled, but can occur earlier if the study design and study protocol have been established.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>General Information Visit the Human Subjects Division (HSD) website for information about all aspects of human subjects research. Executive Order No. 24\u00a0is the general UW policy&#8230;<\/p>\n<div><a class=\"more\" href=\"https:\/\/www.washington.edu\/research\/myresearch-lifecycle\/setup\/compliance-requirements-non-financial\/human-subjects-research\/\">Read more<\/a><\/div>\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 v24.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Human Subjects Research - UW 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 - UW Research\" \/>\n<meta property=\"og:description\" content=\"General Information Visit the Human Subjects Division (HSD) website for information about all aspects of human subjects research. 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