{"id":35,"date":"2023-01-23T22:00:05","date_gmt":"2023-01-23T22:00:05","guid":{"rendered":"https:\/\/in.nau.edu\/human-research-protection-program\/?page_id=35"},"modified":"2023-04-04T19:02:58","modified_gmt":"2023-04-04T19:02:58","slug":"human-research-determination","status":"publish","type":"page","link":"https:\/\/in.nau.edu\/human-research-protection-program\/irbnet\/human-research-determination\/","title":{"rendered":"Human research determination"},"content":{"rendered":"<h1>Human research determination<\/h1>\n<!-- shortcode-right-column -->\n<div class=\"shortcode-right-column\" >\n    <div class=\"shortcode-right-column__container\">\n<h4>Resources<\/h4>\n<ul>\n<li><a href=\"https:\/\/in.nau.edu\/wp-content\/uploads\/sites\/255\/2023\/01\/IRB-Process-Flowchart.pdf\">IRB process flowchart<\/a><\/li>\n<li><a href=\"https:\/\/in.nau.edu\/wp-content\/uploads\/sites\/255\/2023\/01\/IRBNet-Account-Registration.pdf\">Instructions on creating a IRBNet account<\/a><\/li>\n<li><a href=\"https:\/\/in.nau.edu\/human-research-protection-program\/instructional-videos\/\">Instructional videos<\/a><\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n<p>All research applications must be submitted to the IRB through\u00a0<a href=\"https:\/\/irbnet.org\/release\/index.html\" target=\"_blank\" rel=\"noopener noreferrer\">IRBNet<\/a>, an externally-hosted software product. All IRB forms must be obtained from the IRBNet Forms and Templates library.<\/p>\n<p>If you are unsure if the activities you are conducting are considered Human Subjects Research, please complete a <a href=\"https:\/\/in.nau.edu\/wp-content\/uploads\/sites\/255\/2023\/01\/Determination-Tip.pdf\">Determination of human research form<\/a>.<\/p>\n<p>The Human Research Protection Program will provide a written determination which can be used to provide sponsors, collaborators, journal editors, and others with verification from an impartial source as to whether or not the proposed activities require IRB approval.<\/p>\n<h2>Determination submission<\/h2>\n<p><strong>All determinations require the following:<\/strong><\/p>\n<ol>\n<li>Complete and upload the <a href=\"https:\/\/in.nau.edu\/wp-content\/uploads\/sites\/255\/2023\/01\/Determination-Tip.pdf\">Determination of human research form<\/a>.<\/li>\n<li><a href=\"https:\/\/in.nau.edu\/wp-content\/uploads\/sites\/255\/2023\/01\/Sharing-Tip.pdf\">Share your project<\/a> with the NAU IRB Office, granting \u201cFull\u201d access.<\/li>\n<li><a href=\"https:\/\/in.nau.edu\/wp-content\/uploads\/sites\/255\/2023\/01\/Signing-Tip.pdf\">The PI must sign the package.<\/a>\u00a0Student projects must be signed by the faculty advisor as well as by the student PI.<\/li>\n<li>Submit the package by clicking the &#8220;Submit&#8221; button in IRBNet.\u00a0Select \u201cOther\u201d from the \u201cSubmission Type\u201d dropdown options.<\/li>\n<\/ol>\n<p><strong>Additional information about determinations:<\/strong><\/p>\n<p>This form is required if the proposed study involves any of the following activities and it is unclear whether these activities require IRB review:<\/p>\n<p>Because research must be systematic and designed to be generalizable, it does not include:<\/p>\n<ul>\n<li>Scholarly and journalistic activities (e.g., oral history, journalism, biography, and historical scholarship) that focus directly on the specific individuals about whom the information is collected;<\/li>\n<li>Public health surveillance;<\/li>\n<li>Activities for criminal justices agencies as authorized by law;<\/li>\n<li>Homeland security and intelligence activities<\/li>\n<\/ul>\n<!-- shortcode-accordion -->\n<div class=\"shortcode-accordion shortcode-accordion--closed\" style=\"position: relative;\" >\n        <a class=\"shortcode-accordion__trigger\" data-header=\"Case report_0\" href=\"#\">\n      <div class=\"shortcode-accordion__header\">\n          <h4>Case report <span class=\"screen-reader-text\">Accordion Closed<\/span><\/h4>\n          <span class=\"shortcode-accordion__header__arrow\"><\/span>\n      <\/div>\n    <\/a>\n    <div class=\"shortcode-accordion__body\">\n        <!DOCTYPE html PUBLIC \"-\/\/W3C\/\/DTD HTML 4.0 Transitional\/\/EN\" \"http:\/\/www.w3.org\/TR\/REC-html40\/loose.dtd\">\n<html><body>\n<p>The proposed activity is a case report or case series of no more than three (3) cases describing an interesting treatment, presentation, or outcomes.<\/p>\n<\/body><\/html>\n\n    <\/div>\n<\/div>\n\n<!-- shortcode-accordion -->\n<div class=\"shortcode-accordion shortcode-accordion--closed\" style=\"position: relative;\" >\n        <a class=\"shortcode-accordion__trigger\" data-header=\"Program evaluation\/quality improvement\/quality assurance_0\" href=\"#\">\n      <div class=\"shortcode-accordion__header\">\n          <h4>Program evaluation\/quality improvement\/quality assurance <span class=\"screen-reader-text\">Accordion Closed<\/span><\/h4>\n          <span class=\"shortcode-accordion__header__arrow\"><\/span>\n      <\/div>\n    <\/a>\n    <div class=\"shortcode-accordion__body\">\n        <!DOCTYPE html PUBLIC \"-\/\/W3C\/\/DTD HTML 4.0 Transitional\/\/EN\" \"http:\/\/www.w3.org\/TR\/REC-html40\/loose.dtd\">\n<html><body>\n<p>The proposed activity will assess, analyze, critique, and improve current processes of a program OR health care delivery in an institutional setting. These projects involve data-guided, systematic activities designed to bring about prompt improvements in a program or health care delivery.<\/p>\n<\/body><\/html>\n\n    <\/div>\n<\/div>\n\n<!-- shortcode-accordion -->\n<div class=\"shortcode-accordion shortcode-accordion--closed\" style=\"position: relative;\" >\n        <a class=\"shortcode-accordion__trigger\" data-header=\"Course-related activities_0\" href=\"#\">\n      <div class=\"shortcode-accordion__header\">\n          <h4>Course-related activities <span class=\"screen-reader-text\">Accordion Closed<\/span><\/h4>\n          <span class=\"shortcode-accordion__header__arrow\"><\/span>\n      <\/div>\n    <\/a>\n    <div class=\"shortcode-accordion__body\">\n        <!DOCTYPE html PUBLIC \"-\/\/W3C\/\/DTD HTML 4.0 Transitional\/\/EN\" \"http:\/\/www.w3.org\/TR\/REC-html40\/loose.dtd\">\n<html><body>\n<p>The proposed activity is limited to course-related activities designed specifically for educational or teaching purposes.<\/p>\n<\/body><\/html>\n\n    <\/div>\n<\/div>\n\n<!-- shortcode-accordion -->\n<div class=\"shortcode-accordion shortcode-accordion--closed\" style=\"position: relative;\" >\n        <a class=\"shortcode-accordion__trigger\" data-header=\"Oral history_0\" href=\"#\">\n      <div class=\"shortcode-accordion__header\">\n          <h4>Oral history <span class=\"screen-reader-text\">Accordion Closed<\/span><\/h4>\n          <span class=\"shortcode-accordion__header__arrow\"><\/span>\n      <\/div>\n    <\/a>\n    <div class=\"shortcode-accordion__body\">\n        <!DOCTYPE html PUBLIC \"-\/\/W3C\/\/DTD HTML 4.0 Transitional\/\/EN\" \"http:\/\/www.w3.org\/TR\/REC-html40\/loose.dtd\">\n<html><body>\n<p>The activity is limited to oral history activities, such as open ended interviews that only document a specific historical event or the experiences of individuals without the intent to draw conclusions or generalize findings.<\/p>\n<\/body><\/html>\n\n    <\/div>\n<\/div>\n\n<!-- shortcode-accordion -->\n<div class=\"shortcode-accordion shortcode-accordion--closed\" style=\"position: relative;\" >\n        <a class=\"shortcode-accordion__trigger\" data-header=\"Public use datasets_0\" href=\"#\">\n      <div class=\"shortcode-accordion__header\">\n          <h4>Public use datasets <span class=\"screen-reader-text\">Accordion Closed<\/span><\/h4>\n          <span class=\"shortcode-accordion__header__arrow\"><\/span>\n      <\/div>\n    <\/a>\n    <div class=\"shortcode-accordion__body\">\n        <!DOCTYPE html PUBLIC \"-\/\/W3C\/\/DTD HTML 4.0 Transitional\/\/EN\" \"http:\/\/www.w3.org\/TR\/REC-html40\/loose.dtd\">\n<html><body>\n<p>The activity is limited to analyzing de-identified data contained within a publicly available dataset.&nbsp;<strong>NOTE: <\/strong>This does not include reviewing or analyzing information from social media.<\/p>\n<\/body><\/html>\n\n    <\/div>\n<\/div>\n\n<!-- shortcode-accordion -->\n<div class=\"shortcode-accordion shortcode-accordion--closed\" style=\"position: relative;\" >\n        <a class=\"shortcode-accordion__trigger\" data-header=\"Journalism\/documentary activities_0\" href=\"#\">\n      <div class=\"shortcode-accordion__header\">\n          <h4>Journalism\/documentary activities <span class=\"screen-reader-text\">Accordion Closed<\/span><\/h4>\n          <span class=\"shortcode-accordion__header__arrow\"><\/span>\n      <\/div>\n    <\/a>\n    <div class=\"shortcode-accordion__body\">\n        <!DOCTYPE html PUBLIC \"-\/\/W3C\/\/DTD HTML 4.0 Transitional\/\/EN\" \"http:\/\/www.w3.org\/TR\/REC-html40\/loose.dtd\">\n<html><body>\n<p>The activities are limited to investigations and interviews that focus on specific events, views, etc., and that lead to publication in any medium (including electronic), documentary production, or are part of training that is explicitly linked to journalism. There is no intent to test a hypothesis.<\/p>\n<\/body><\/html>\n\n    <\/div>\n<\/div>\n\n<!-- shortcode-accordion -->\n<div class=\"shortcode-accordion shortcode-accordion--closed\" style=\"position: relative;\" >\n        <a class=\"shortcode-accordion__trigger\" data-header=\"Purchased cell lines_0\" href=\"#\">\n      <div class=\"shortcode-accordion__header\">\n          <h4>Purchased cell lines <span class=\"screen-reader-text\">Accordion Closed<\/span><\/h4>\n          <span class=\"shortcode-accordion__header__arrow\"><\/span>\n      <\/div>\n    <\/a>\n    <div class=\"shortcode-accordion__body\">\n        <!DOCTYPE html PUBLIC \"-\/\/W3C\/\/DTD HTML 4.0 Transitional\/\/EN\" \"http:\/\/www.w3.org\/TR\/REC-html40\/loose.dtd\">\n<html><body>\n<p>The activity involves commercially available, de-identified non-human embryonic cell lines.<\/p>\n<\/body><\/html>\n\n    <\/div>\n<\/div>\n\n<!-- shortcode-accordion -->\n<div class=\"shortcode-accordion shortcode-accordion--closed\" style=\"position: relative;\" >\n        <a class=\"shortcode-accordion__trigger\" data-header=\"Database creation_0\" href=\"#\">\n      <div class=\"shortcode-accordion__header\">\n          <h4>Database creation <span class=\"screen-reader-text\">Accordion Closed<\/span><\/h4>\n          <span class=\"shortcode-accordion__header__arrow\"><\/span>\n      <\/div>\n    <\/a>\n    <div class=\"shortcode-accordion__body\">\n        <!DOCTYPE html PUBLIC \"-\/\/W3C\/\/DTD HTML 4.0 Transitional\/\/EN\" \"http:\/\/www.w3.org\/TR\/REC-html40\/loose.dtd\">\n<html><body>\n<p>The primary reason for establishing this database is for clinical purposes or an improvement project (IRB approval of a new protocol must be obtained before any data from this database may be used for research purposes).<\/p>\n<\/body><\/html>\n\n    <\/div>\n<\/div>\n\n<!-- shortcode-accordion -->\n<div class=\"shortcode-accordion shortcode-accordion--closed\" style=\"position: relative;\" >\n        <a class=\"shortcode-accordion__trigger\" data-header=\"Native American\/Alaskan Native_0\" href=\"#\">\n      <div class=\"shortcode-accordion__header\">\n          <h4>Native American\/Alaskan Native <span class=\"screen-reader-text\">Accordion Closed<\/span><\/h4>\n          <span class=\"shortcode-accordion__header__arrow\"><\/span>\n      <\/div>\n    <\/a>\n    <div class=\"shortcode-accordion__body\">\n        <!DOCTYPE html PUBLIC \"-\/\/W3C\/\/DTD HTML 4.0 Transitional\/\/EN\" \"http:\/\/www.w3.org\/TR\/REC-html40\/loose.dtd\">\n<html><body>\n<p>The activity involves access to tribal resources (e.g. cultural artifacts, environmental samples, or people), but the activity is not intended to produce generalizable knowledge.<\/p>\n<\/body><\/html>\n\n    <\/div>\n<\/div>\n\n<!-- shortcode-accordion -->\n<div class=\"shortcode-accordion shortcode-accordion--closed\" style=\"position: relative;\" >\n        <a class=\"shortcode-accordion__trigger\" data-header=\"dbGap_0\" href=\"#\">\n      <div class=\"shortcode-accordion__header\">\n          <h4>dbGap <span class=\"screen-reader-text\">Accordion Closed<\/span><\/h4>\n          <span class=\"shortcode-accordion__header__arrow\"><\/span>\n      <\/div>\n    <\/a>\n    <div class=\"shortcode-accordion__body\">\n        <!DOCTYPE html PUBLIC \"-\/\/W3C\/\/DTD HTML 4.0 Transitional\/\/EN\" \"http:\/\/www.w3.org\/TR\/REC-html40\/loose.dtd\">\n<html><body>\n<p>Receipt of data from the dbGap that requires IRB approval, but the data you will receive<\/p>\n<ul>\n<li>Is de-identified, but the Data Use Committee requires IRB approval<\/li>\n<li>The researcher did not submit any of the original data to dbGap<\/li>\n<li>The researcher will not collaborate with others on the project who submitted the original data to dbGap<\/li>\n<\/ul>\n<\/body><\/html>\n\n    <\/div>\n<\/div>\n\n<p>If in the future, the intent of the project changes to meet the definition of research or human subject research, please note that an amendment to the original project needs to be submitted through IRBNet.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Human research determination All research applications must be submitted to the IRB through\u00a0IRBNet, an externally-hosted software product. All IRB forms must be obtained from the IRBNet Forms and Templates library. If you are unsure if the activities you are conducting are considered Human Subjects Research, please complete a Determination of human research form. The Human [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":251,"parent":16,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","ring_central_script_selection":"","footnotes":""},"class_list":["post-35","page","type-page","status-publish","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/in.nau.edu\/human-research-protection-program\/wp-json\/wp\/v2\/pages\/35","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/in.nau.edu\/human-research-protection-program\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/in.nau.edu\/human-research-protection-program\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/in.nau.edu\/human-research-protection-program\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/in.nau.edu\/human-research-protection-program\/wp-json\/wp\/v2\/comments?post=35"}],"version-history":[{"count":5,"href":"https:\/\/in.nau.edu\/human-research-protection-program\/wp-json\/wp\/v2\/pages\/35\/revisions"}],"predecessor-version":[{"id":417,"href":"https:\/\/in.nau.edu\/human-research-protection-program\/wp-json\/wp\/v2\/pages\/35\/revisions\/417"}],"up":[{"embeddable":true,"href":"https:\/\/in.nau.edu\/human-research-protection-program\/wp-json\/wp\/v2\/pages\/16"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/in.nau.edu\/human-research-protection-program\/wp-json\/wp\/v2\/media\/251"}],"wp:attachment":[{"href":"https:\/\/in.nau.edu\/human-research-protection-program\/wp-json\/wp\/v2\/media?parent=35"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}