{"id":1751,"date":"2016-12-09T12:44:41","date_gmt":"2016-12-09T20:44:41","guid":{"rendered":"https:\/\/www.washington.edu\/research\/?page_id=1751"},"modified":"2026-04-02T08:55:48","modified_gmt":"2026-04-02T15:55:48","slug":"does-your-research-involve-human-subjects","status":"publish","type":"page","link":"https:\/\/www.washington.edu\/research\/hsd\/do-i-need-irb-review\/does-your-research-involve-human-subjects\/","title":{"rendered":"Step 2. Does Your Research Involve Human Subjects?"},"content":{"rendered":"<h2>Why this matters<\/h2>\n<ul>\n<li>If your research does not involve human subjects, 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 \u201chuman subject\u201d<\/h2>\n<p><strong>Definition 1: FDA-regulated research<\/strong><\/p>\n<p><strong>Applies to<\/strong>: Research that is regulated by the Food and Drug Administration (FDA) <strong>and<\/strong> that involves the use of a drug, device, or other item regulated by the FDA.<\/p>\n<p><strong>Human subject<\/strong>: A living individual who participates in a research investigation, as (a) a recipient of an item regulated by the FDA; (b) as a control; or (c) on whose specimen an investigational device is used.<\/p>\n<p><strong>Definition 2: Research that is not regulated by the FDA<\/strong><\/p>\n<p><strong>Applies to<\/strong>: All research that is not described in Definition 1.<\/p>\n<p><strong>Human subject<\/strong>: A living individual <strong>about whom<\/strong> a researcher obtains (1) data through <strong>intervention<\/strong> or <strong>interaction<\/strong> with the individual or (2) <strong>identifiable<\/strong> <strong>private<\/strong> information. Review the worksheet, <a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/worksheet-human-subjects-research\/\">Human Subjects Research Determination<\/a> for definitions of the bolded words.<\/p>\n<h2>Relationship to obtaining consent<\/h2>\n<p>Individuals may be human subjects before they have provided consent, if the criteria defining a \u201chuman subject\u201d have been met. This is most likely to occur when with screening or pre-screening activities, such as examining identifiable medical records in order to select possible participants.<\/p>\n<h2>Special cases<\/h2>\n<ul>\n<li><strong>Deceased individuals<\/strong>. This refers to individuals who are not alive, as defined by applicable local and national laws. Deceased individuals are not considered to be human subjects.<\/li>\n<li><strong>Specimens, records, data (no interaction or contact with living individuals)<\/strong>. Private identifiable specimens, records and data about individuals are considered to be human subjects, even if the researcher has no contact or interaction with the individuals.<\/li>\n<li><strong>Third party or secondary subjects<\/strong>. This refers to situations in which the researcher obtains information about one individual (\u201cA\u201d) through interaction with another individual (\u201cB\u201d). If the information about A is private and identifiable, then A is a human subject. Example: Subjects in a cancer study are asked about the cancer history of their relatives.\u00a0 If the information is provided in a way that is not individually identifiable to the researchers, then the relatives are not subjects.\u00a0 If the information <strong>is<\/strong> individually and readily identifiable to the researchers, then the relatives are subjects.<\/li>\n<li><strong>Self-experimentation in human subjects research.<\/strong> Federal regulations do not distinguish between self-experimentation and research involving other human subjects. Investigators who participate in their own research are considered human subjects and therefore must submit an application to the ÂÒÂ×ÉçÇø Institutional Review Board (IRB) to obtain IRB approval prior to enrolling themselves or initiating the experiment. Applications involving self-experimentation must describe how informed consent will be obtained from all participants, including the investigator acting as a participant. IRB review of self-experimentation is required for the following reasons:\n<ol>\n<li><strong>Protection of the investigator-participant.<\/strong> Researchers may underestimate or overlook potential risks due to enthusiasm for generating new knowledge. Independent IRB review helps ensure that investigators are protected from unwarranted risks.<\/li>\n<li><strong>Protection of the integrity and credibility of the research process.<\/strong> Independent review by a neutral third party helps address concerns related to the validity, credibility, and ethical conduct of research involving human subjects.<\/li>\n<\/ol>\n<\/li>\n<\/ul>\n<h2>Request a determination (optional)<\/h2>\n<p>You may perform and document a self-determination, following the instructions in the worksheet, <a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/worksheet-human-subjects-research\/\">Human Subjects Research Determination<\/a>. Note that HSD has the authority to over-rule a researcher\u2019s self-determination or the determination of another institution.<\/p>\n<p>Otherwise, follow these directions if you\u2019d like to have a formal determination about whether your activity involves human subjects. Example situations for which a determination might be appropriate:\u00a0<strong>(1)<\/strong> you need a determination in order to obtain or access data from a source; <strong>(2)<\/strong> you think you might need a determination later when you publish results; <strong>(3)<\/strong> you have a complicated project. When a formal HSD determination is requested, the project activities should not begin until HSD sends the determination letter.<\/p>\n<ol>\n<li>Complete the &#8220;determination&#8221; questions 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>\u00a0version 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>Researcher responsibilities for projects that do not involve human subjects research activities.<\/h2>\n<p>The determination applies only to the activity as initially described. A new determination should be made before making changes to the project that might affect the determination.<\/p>\n<p>Researchers continue to be responsible for:<\/p>\n<ul>\n<li>Complying with applicable federal and state laws and UW policies (e.g., Material Transfer Agreements or Data Use Agreements).<\/li>\n<li>Ensuring that information\/biospecimens are collected in an ethical manner.<\/li>\n<li>Acting in accordance with relevant professional standards and codes of conduct as generally accepted in the relevant academic and\/or professional discipline(s).<\/li>\n<li>Promptly notifying HSD of any new information about risks or relevant problems associated with the activity that might affect the human subjects research determination.<\/li>\n<\/ul>\n<h2>Next step, if you think your activity involves research with human subjects<\/h2>\n<p><a href=\"https:\/\/www.washington.edu\/research\/hsd\/is-your-human-subjects-research-exempt-from-regulations\/\">Determine whether your activity may qualify for exempt status.<\/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\/forms-and-templates\/worksheet-human-subjects-research\/\">WORKSHEET Human Subjects Research Determination<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Why this matters If your research does not involve human subjects, you do not need to obtain Institutional Review Board (IRB) approval or a determination of&#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-1751","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 2. 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