{"id":2921,"date":"2026-06-10T17:11:58","date_gmt":"2026-06-10T17:11:58","guid":{"rendered":"https:\/\/in.nau.edu\/research\/?page_id=2921"},"modified":"2026-08-15T03:04:49","modified_gmt":"2026-08-15T03:04:49","slug":"human-research","status":"publish","type":"page","link":"https:\/\/in.nau.edu\/research\/research-compliance\/human-research-protection-program\/guidance\/human-research\/","title":{"rendered":"What is human research"},"content":{"rendered":"<div class=\"nau-block nau-block-left-nav-top-bound\">\n    \t<button id=\"left-nav-toggle-btn\" onclick=\"toggleNav();\">\n\t\tON THIS PAGE \n\t\t<i id=\"chevron-icon\" class=\"fas fa-solid fa-chevron-down\"><\/i>\n\t<\/button>\n\t<div id=\"left-nav-menu-track\">\n\t\t<div id=\"left-nav-wrapper\">\n\t\t\t<div class=\"rfi-above-anchor-tags\">\n\t\t\t\t<div class=\"ri-container\">\n\t\t\t\t\t<a href=\"https:\/\/nau.edu\/admissions\/request-information\/\" id=\"request-info\" class=\"btn bg-true-blue left-nav-menu-bottom-button display-mobile\">Request info&nbsp;&nbsp;<\/a>\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t\t<div id=\"left-nav-menu\">\n\t\t\t\t<div class=\"menu-section menu-section-links\"><h6 class=\"hidden-mobile left-nav-list-header\">ON THIS PAGE<\/h6><ul class=\"left-nav-menu-list left-nav-automatic on-this-page\"><\/ul><div class=\"ri-container\"><a href=\"https:\/\/nau.edu\/admissions\/request-information\/\" id=\"request-info\" class=\"btn bg-true-blue left-nav-menu-bottom-button display-mobile\">Request info&nbsp;&nbsp;<\/a><\/div><\/div>\t\t\t\t\t\t\t\t<div class=\"menu-section backcolor\">\n\t\t\t\t\t<div class=\"header\">\n\t\t\t\t\t\tHOW CAN WE HELP?\t\t\t\t\t<\/div>\n\t\t\t\t\t<ul class=\"responsive-icons\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><a href=\"tel:928-523-9551\"><img decoding=\"async\" src=\"https:\/\/in.nau.edu\/wp-content\/themes\/nau-marketing-2021\/img\/icon-phone.svg\" alt=\"Telephone:\"> 928-523-9551<\/a>\n\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t\t\t\t\t<li><a href=\"mailto:IRB@nau.edu\"><img decoding=\"async\" src=\"https:\/\/in.nau.edu\/wp-content\/themes\/nau-marketing-2021\/img\/icon-email.svg\" alt=\"Email:\"><span class=\"left-nav-email\"> IRB&#8203;@nau.edu <\/span><\/a><\/li>\n\t\t\t\t\t<\/ul>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n<section class=\"nau-block left-nav-section\"><header class=\"entry-header\"><div class=\"breadcrumb\"><ol class=\"breadcrumbs\"><li><a href=\"https:\/\/stage.in.nau.edu\">IN<\/a><span class=\"breadcrumb-chevron\" aria-hidden=\"true\">&gt;<\/span><\/li><li><a href=\"https:\/\/in.nau.edu\/research\">NAU Research<\/a><span class=\"breadcrumb-chevron\" aria-hidden=\"true\">&gt;<\/span><\/li><li class=\"current\">Pages<\/li><\/ol><\/div><h1 class=\"entry-title text-left \">What is human research<\/h1><hr class=\"h1-hr  text-left \" role=\"none\"><\/header><!-- .entry-header --><\/section><!-- <section class=\"nau-block left-nav-section grid-md-12\">\n    <header class=\"entry-header\">\n        <h1 class=\"entry-title text-left \" tabindex=\"0\" id=\"h1-first\">Dummy H1<\/h1>\n        <hr class=\"h1-hr  text-left \" role=\"none\">\n    <\/header>\n<\/section> -->\n\n<section class=\"nau-block left-nav-section grid-md-12\">\n    <div class=\"page-content\">\n        \n\n<h2 class=\"wp-block-heading\">Overview<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Any &#8220;agent&#8221; of NAU (e.g., faculty, staff or students) requires IRB oversight when the activity is both &#8220;research&#8221; that involves \u2018human subjects.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>First, is the activity research?<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Research\u00a0means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Research does&nbsp;<strong>NOT<\/strong>&nbsp;include:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.<\/li>\n\n\n\n<li>Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters)<\/li>\n\n\n\n<li>Collection and analysis of information, biospecimens, or records for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.<\/li>\n\n\n\n<li>Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.<\/li>\n<\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Second, does the activity involve human subjects?<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">If the investigator is conducting &#8220;research&#8221; as described above, and the project involves a human subject as defined below, then activity is \u2018human research\u2019 and requires IRB oversight.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Human subject\u00a0means a living individual about whom an investigator (whether professional or student) conducting research:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or<\/li>\n\n\n\n<li>Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">The definitions below will help frame and understand the terms listed in the definition of human subject above:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Intervention\u00a0<\/strong>includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject\u2019s environment that are performed for research purposes.<\/li>\n\n\n\n<li><strong>Interaction<\/strong>&nbsp;includes communication or interpersonal contact between investigator and subject.<\/li>\n\n\n\n<li><strong>Private information<\/strong>&nbsp;includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).<\/li>\n\n\n\n<li><strong>Identifiable private information<\/strong>* is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information. *Note that if the private information is health information from a healthcare covered entity (CE) it may be subject to the HIPAA rules.<\/li>\n\n\n\n<li><strong>Identifiable biospecimen<\/strong>* is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen. *Note the biospecimen may be subject to the HIPAA rules if it is obtained from a healthcare covered entity (CE).<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>What to do next?<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">If it is not clear whether the project is human research, then the investigator should complete the &#8220;determination of human research&#8221; form found in the IRBNet forms and templates library.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Submit the completed form to the HRPP for review. The investigator will receive a formal letter of determination for their files. If the project clearly IS human research, then the investigator should follow the instructions for submitting a &#8220;New Project&#8221; using the application forms and project narrative template found in IRBNet. The HRPP will review the activity and submit it to the IRB for approval.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>Version 2019.8<\/em><\/p>\n\n\n    <\/div>\n<\/section>\n\n<div class=\"nau-block nau-block-left-nav-bottom-bound\">\n\n<\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":105,"featured_media":3036,"parent":2599,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"ring_central_script_selection":"","footnotes":""},"class_list":["post-2921","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/in.nau.edu\/research\/wp-json\/wp\/v2\/pages\/2921","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/in.nau.edu\/research\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/in.nau.edu\/research\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/in.nau.edu\/research\/wp-json\/wp\/v2\/users\/105"}],"replies":[{"embeddable":true,"href":"https:\/\/in.nau.edu\/research\/wp-json\/wp\/v2\/comments?post=2921"}],"version-history":[{"count":3,"href":"https:\/\/in.nau.edu\/research\/wp-json\/wp\/v2\/pages\/2921\/revisions"}],"predecessor-version":[{"id":5557,"href":"https:\/\/in.nau.edu\/research\/wp-json\/wp\/v2\/pages\/2921\/revisions\/5557"}],"up":[{"embeddable":true,"href":"https:\/\/in.nau.edu\/research\/wp-json\/wp\/v2\/pages\/2599"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/in.nau.edu\/research\/wp-json\/wp\/v2\/media\/3036"}],"wp:attachment":[{"href":"https:\/\/in.nau.edu\/research\/wp-json\/wp\/v2\/media?parent=2921"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}