{"id":1738,"date":"2016-12-09T12:34:18","date_gmt":"2016-12-09T20:34:18","guid":{"rendered":"https:\/\/www.washington.edu\/research\/?page_id=1738"},"modified":"2024-01-16T13:57:21","modified_gmt":"2024-01-16T21:57:21","slug":"is-your-project-considered-research","status":"publish","type":"page","link":"https:\/\/www.washington.edu\/research\/hsd\/do-i-need-irb-review\/is-your-project-considered-research\/","title":{"rendered":"Step 1. Is Your Project Considered Research?"},"content":{"rendered":"<p>If your research involves institutions or researchers other than, or in addition to UW, please consider steps 1-4 before making a decision about whether to submit an application.<\/p>\n<h2>Why this matters<\/h2>\n<ul>\n<li>If your activity doesn\u2019t fit one of the definitions of research (below), you do not need to obtain Institutional Review Board (IRB) approval or a determination of exempt status.<\/li>\n<li>The specific definition (if any) that applies to your activity determines which regulations and requirements govern your research. Use the worksheet, <a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/worksheet-human-subjects-research\/\">Human Subjects Research Determination<\/a> to make your own determination about whether your activity meets either of the two definitions described here.<\/li>\n<\/ul>\n<h2>Two definitions of \u201cresearch\u201d<\/h2>\n<h3>Definition 1: FDA-regulated research<\/h3>\n<p><strong>Applies to: <\/strong>Activities that are regulated by the Food and Drug Administration (FDA) and that involve the use of a drug, device, or other item regulated by the FDA.<\/p>\n<p>The activity is research if <strong>both<\/strong> of the following conditions are met:<\/p>\n<ul>\n<li>The intent of the activity is to develop information about a drug, medical device (including diagnostic tests), or biologic substance for submission to the federal Food and Drug Administration (FDA), <strong>and<\/strong><\/li>\n<li>The activity involves the prospective physical use of drug, medical device (including diagnostic tests), or biologic substance, in a way that is not completely up to the discretion of a clinical practitioner.<\/li>\n<\/ul>\n<h3>Definition 2: Research that is not regulated by the FDA<\/h3>\n<p><strong>Applies to:<\/strong> All activities that are not described in Definition 1.<\/p>\n<p>Research is a <strong>systematic investigation<\/strong>, including research development, testing, and\/or evaluation, designed to develop or contribute to <strong>generalizable knowledge<\/strong>.<\/p>\n<p><em><strong>Systematic investigation<\/strong>: A detailed or careful examination that has or involves a prospectively identified approach to the activity based on a system, method, or plan. <\/em><\/p>\n<p><em><strong>Generalizable knowledge<\/strong>: The information is expected to expand the knowledge base of a scientific discipline or other scholarly field of study and yield one or both of the following: <\/em><\/p>\n<ul>\n<li>Results that are applicable to a larger population beyond the site of data collection or the specific subjects studied<\/li>\n<li>Results that are intended to be used to develop, test, or support theories, principles, and statements of relationships, or to inform policy beyond the study.<\/li>\n<\/ul>\n<h2>Special cases<\/h2>\n<p>Activities can be considered research even if they are also considered to be program evaluation, quality improvement, public health surveillance, preliminary work, or pilot studies. For more information about these and other special situations, consult the HSD guidance, <a href=\"https:\/\/www.washington.edu\/research\/guidance\/research\/\">Is It Research<\/a>?<\/p>\n<h2>Request a determination (optional)<\/h2>\n<p>Follow these directions if you\u2019d like to have a formal determination about whether your activity is research. Example situations for which a determination might be appropriate:\u00a0(1) you need a determination in order to obtain or access data from a source; (2) you think you might need a determination later when you publish results; (3) you have a complicated project.<\/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<p><em>\u00a0<\/em><\/p>\n<h2>Next step, if you think your activity is research<\/h2>\n<p><a href=\"https:\/\/www.washington.edu\/research?page_id=1751\">Determine whether your activity involves human subjects.<\/a><\/p>\n<p><strong>More information<\/strong><\/p>\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\/forms-and-templates\/worksheet-human-subjects-research\/\">WORKSHEET Human Subjects Research Determination<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/guidance\/research\/\">GUIDANCE Is It Research?<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/policies\/guidance-case-reports-irb-review-hipaa\/\">GUIDANCE Case Reports, IRB Review and HIPAA<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>If your research involves institutions or researchers other than, or in addition to UW, please consider steps 1-4 before making a decision about whether to submit&#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-1738","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 1. 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