{"id":1753,"date":"2016-12-09T12:59:41","date_gmt":"2016-12-09T20:59:41","guid":{"rendered":"https:\/\/www.washington.edu\/research\/?page_id=1753"},"modified":"2024-01-16T13:58:21","modified_gmt":"2024-01-16T21:58:21","slug":"is-your-human-subjects-research-exempt-from-regulations","status":"publish","type":"page","link":"https:\/\/www.washington.edu\/research\/hsd\/do-i-need-irb-review\/is-your-human-subjects-research-exempt-from-regulations\/","title":{"rendered":"Step 3. Is Your Human Subjects Research Exempt from Regulations?"},"content":{"rendered":"<h2>Why this matters<\/h2>\n<ul>\n<li>If HSD determines that your human subjects research qualifies for exempt status, you do not need to obtain Institutional Review Board (IRB) approval.<\/li>\n<li>The answer to this question determines which regulations and requirements govern your research.<\/li>\n<\/ul>\n<h2>Criteria for exempt status (summary)<\/h2>\n<ul>\n<li>Your research involves no more than minimal risk to your subjects.<\/li>\n<li>Your research methods must fit into one of several categories.<\/li>\n<li>Your research is not governed by the regulations of the Food and Drug Administration.<\/li>\n<li>There are some limits on the use of deception, prisoner subjects, and children subjects.<\/li>\n<li>Full details can be found in HSD&#8217;s guidance <a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/exempt\/\">Exempt Research<\/a><\/li>\n<\/ul>\n<h2>If you believe your research may qualify for exempt status<\/h2>\n<p>Follow these directions for a determination about whether your research qualifies for exempt status. HSD staff are the only individuals authorized at the UW to make exempt determinations.<\/p>\n<ol>\n<li>Complete the questions marked &#8220;determination&#8221; on the standard <a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/zipline-application-irb-protocol\/\">IRB Protocol form<\/a> or on the <a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/zipline-application-irb-protocol-no-contact-with-subjects\/\">No Contact <\/a>version of the form.<\/li>\n<li>In <a href=\"https:\/\/www.washington.edu\/research\/hsd\/zipline\/\">Zipline<\/a>, create a new application by clicking on the <strong>Create a New Study<\/strong> button and following the instructions. Attach your completed IRB Protocol form at the indicated place. Do not attach any consent materials.<\/li>\n<li>HSD will assess your application and issue a formal determination.<\/li>\n<\/ol>\n<h2>Next step if you believe your research is likely not exempt<\/h2>\n<p><a href=\"https:\/\/www.washington.edu\/research\/hsd\/is-your-research-considered-to-be-uw-research\/\">Determine whether the UW is \u201cengaged\u201d in the research<\/a>.<\/p>\n<h2>More information<\/h2>\n<ul>\n<li>Contact your <a href=\"https:\/\/www.washington.edu\/research\/contact-us\/?keyword=508\">HSD Team<\/a> or send an email to <a href=\"mailto:hsdinfo@uw.edu\">hsdinfo@uw.edu<\/a> if you have questions or want guidance. Identify your department in your email.<\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/hsd\/guidance\/exempt\/\">GUIDANCE Exempt Research<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Why this matters If HSD determines that your human subjects research qualifies for exempt status, you do not need to obtain Institutional Review Board (IRB) approval&#8230;.<\/p>\n","protected":false},"author":15,"featured_media":0,"parent":6327,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"templates\/page-builder-units-small-hero.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-1753","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>Step 3. 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