{"id":48689,"date":"2023-08-31T09:40:12","date_gmt":"2023-08-31T16:40:12","guid":{"rendered":"https:\/\/www.washington.edu\/research\/?page_id=48689"},"modified":"2026-01-29T09:48:26","modified_gmt":"2026-01-29T17:48:26","slug":"getting-started","status":"publish","type":"page","link":"https:\/\/www.washington.edu\/research\/hsd\/getting-started\/","title":{"rendered":"Getting Started"},"content":{"rendered":"
An institutional review board is a group registered with the federal government that is formally designated to review and monitor research involving human subjects. The purpose of the reviews is to protect the safety, rights, and welfare of research participants and to ensure institutional compliance with federal and state regulations and University policies. The Human Subjects Division<\/a> manages the three Institutional Review Boards (IRBs) that review and oversee UW human subjects research.<\/p>\n Human subjects research requires IRB approval or a determination that the research is \u201cexempt\u201d from the federal regulations. Depending on the particulars of your project, you may not need to submit an IRB application at all! Whether or not IRB review is required is determined by going through a few key questions based on some regulatory definitions.<\/p>\n Researchers may self-determine that their project does not meet the definition of \u201chuman subjects research\u201d using the Human Subjects Research Determination worksheet<\/a>.<\/strong> Even if you determine that your project does not meet the definition, you may still wish to submit an application to request a formal determination letter, for example to obtain or access data from a source or if you have a complicated project. For more information:<\/p>\n Determinations that the human subjects research is \u201cexempt\u201d from the federal regulations must be made by HSD.<\/strong> If you believe your research may qualify for exempt status, submit an application and do not include consent materials.\u00a0 For more information:<\/p>\n Visit Do I Need IRB Review<\/a> to go through the steps in order to determine if you need to submit an application for your project.<\/p>\n Is your study eligible for UW IRB review? <\/strong>If your research is happening at UW, then it\u2019s UW research, right? It\u2019s not that simple, and whether a project is considered \u201cUW\u201d research has nothing to do with physical location. It depends on whether the UW is considered \u201cengaged\u201d in the research through direct federal funding or human subjects activities. For more information:\u00a0 Is the UW IRB the right IRB? <\/strong>While the UW IRB is usually the right choice for most UW research in which UW is conducting all or most of the research activities, there are many circumstances in which an external, or non-UW, IRB must review UW research instead of the UW IRB. HSD\u2019s Reliance Team must authorize the use of a non-UW IRB in advance.<\/strong> For more information:<\/p>\n Contact HSD\u2019s Reliance team at hsdrely@uw.edu<\/a><\/p>\n Human Subjects Protections Training<\/a>: The UW and HSD do not currently require that researchers complete training or submit documentation of training as part of the application review process except for student and medical resident researchers as explained below. However, HSD recommends<\/strong> that all researchers who are new to research involving human subjects complete training in the basic ethical principles for working with human research subjects. Additionally, many funding organizations and collaborating institutions require human subjects protections training<\/strong>.<\/p>\n IRB 101 Online Tutorial<\/a>: The IRB 101 tutorial is required for student and medical resident principal investigators<\/strong> and recommended for everyone new to working with the UW IRB. The tutorial walks you through the questions to ask to determine if you need IRB review and provides important practical information about navigating the IRB process at UW.<\/p>\n Good Clinical Practice Training<\/a>: Researchers working in behavioral or biomedical clinical research must sometimes complete training in Good Clinical Practice (GCP) to meet the requirements of the organizations they are affiliated with, funding agencies, or study sponsors. GCP training educates researchers on the fundamental principles of conducting high quality clinical trials.<\/p>\n Human subjects research must be reviewed and approved in advance. Review times can vary widely depending on the type of review that is needed. Applications that require review by the full convened IRB generally take the longest. Situations that typically require longer review times include:<\/p>\n Median Turnaround Times (TAT) for New Applications<\/strong><\/p>\n <\/p>\nDo I need to submit an IRB application?<\/h3>\n
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Should my IRB application go to the UW IRB or a non-UW IRB?<\/h3>\n
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What training should I take?<\/h3>\n
How long does IRB review take?<\/h3>\n
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