{"id":354,"date":"2022-02-14T12:37:37","date_gmt":"2022-02-14T17:37:37","guid":{"rendered":"https:\/\/research.ncsu.edu\/administration\/?page_id=354"},"modified":"2026-02-20T10:44:19","modified_gmt":"2026-02-20T15:44:19","slug":"irb-procedures-and-guidance","status":"publish","type":"page","link":"https:\/\/research.ncsu.edu\/administration\/compliance\/research-compliance\/irb\/irb-procedures-and-guidance\/","title":{"rendered":"IRB: Procedures and Guidance"},"content":{"rendered":"\n\n\n\n<div class=\"layout-one-column is-text wp-block-ncst-link-list\">\n        <ul class=\"link-list__container\">\n      \n\n\n    <\/ul>\n  <\/div>\n\n\n\n<p>This webpage organizes the NC State University IRB guidance into five thematic sections. Each section provides documents that summarize or link to relevant laws, regulations, policies, and contexts alongside suggestions for researchers in how to comply with those requirements within the research protocol submitted for NCSU IRB review and approval.  <\/p>\n\n\n\n<p>We begin with &#8220;IRB Operations and Expectations&#8221; which includes guidance on what is and is not regulated (and thus reviewed) by the NC State IRB office and general expectations of all University affiliated researchers engaged in human subjects in terms of training, conflicts of interest management, mandatory reporting processes, faculty point-of-contact oversight of student research, and specific guidance for individual units at the University. <\/p>\n\n\n\n<p>The second section, &#8220;IRB Application,&#8221; links to eIRB application screenshot tutorials, exemption-eligible research decision tree for educational research, and selected forms for exemption requests, protocol renewal, protocol closure, and IRB review by external IRBs.<\/p>\n\n\n\n<p>&#8220;Research Populations&#8221; follows the &#8220;IRB Application&#8221; section and here you will find NC State University specific guidance on vulnerable research participant populations commonly targeted by our researchers, such as students, minors, those who are incarcerated, pregnant, or affiliated with the Department of Defense, and those who will enroll in their own research. <\/p>\n\n\n\n<p>One of the largest portions on this page is our &#8220;Research Methods and Procedures&#8221; section that contains guidance on qualitative methods, primary and secondary data collection procedures, and use of specific data tools and types including artificial intelligence, software applications, medical devices, augmented and virtual reality,  biosampling, and more. <\/p>\n\n\n\n<p>The concluding section of this webpage, &#8220;Research Data Management, Use, and Sharing,&#8221; provides crucial information on data identifiability, sensitivity, and sharing that honor participant consent, participant privacy, data confidentiality, and applicable laws and regulations.<\/p>\n\n\n<div class=\"is-text wp-block-ncst-accordion\" >\n    <div class=\"accordion isLinked\" id=\"ncst-accordion-jaq47g\">\n          \n<details class=\"wp-block-ncst-accordion-item\" name=\"jaq47g\"  >\n      <summary class=\"accordion-item__header\">\n        <span class=\"accordion-item__expansion-indicator\">\n          <span class=\"ncst-plus-minus-toggle\"><\/span>\n        <\/span>\n        <h2 class=\"accordion-item__label h6\">IRB Operations and Expectations <\/h2>\n      <\/summary>\n      <p>\n        \n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1jgmeWpFSJhkFyawppbB3BGo44rm_FYSv_aha4cazW44\/edit?usp=sharing\" target=\"_blank\" rel=\"noreferrer noopener\">Is it Research? Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1WVDuyi5_t_oblhiffsucf7V0liwUBtNXSTIFMV_kYVs\/edit\" target=\"_blank\" rel=\"noreferrer noopener\">I<\/a><a href=\"https:\/\/docs.google.com\/document\/d\/1WVDuyi5_t_oblhiffsucf7V0liwUBtNXSTIFMV_kYVs\/edit?usp=sharing\" target=\"_blank\" rel=\"noreferrer noopener\">s it Human Subjects Research? Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1-tsGE5TPmVe-F_TO8Xpv1o1vubRQ8_St8N0zluZbBGM\/edit?usp=sharing\" target=\"_blank\" rel=\"noreferrer noopener\">Class Projects T<\/a><a href=\"https:\/\/docs.google.com\/document\/d\/1-tsGE5TPmVe-F_TO8Xpv1o1vubRQ8_St8N0zluZbBGM\/edit?usp=sharing\">hat Are Not Regulated Research Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/drive.google.com\/file\/d\/168OmPHTFvi1zT8-GqcCWOia25CMIV-bJ\/view\" target=\"_blank\" rel=\"noreferrer noopener\">Comparisons between Assessment\/Eval\/QA\/QI Projects and Research Regulated by the IRB<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1Emd5k4cHJuzXqeH0Bk5yPHKWcyOMJq6c\/edit?usp=share_link&amp;ouid=111628324854172758765&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">When Oral History Becomes Research with Human Subjects Regulated by the IRB<\/a><\/li>\n\n\n\n<li><a data-type=\"link\" data-id=\"https:\/\/docs.google.com\/document\/d\/1TCablyUuYCshVUSAMYcjVyB7G8m5aOL-\/edit?usp=sharing&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" href=\"https:\/\/docs.google.com\/document\/d\/1TCablyUuYCshVUSAMYcjVyB7G8m5aOL-\/edit?usp=sharing&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">When Pilot Studies and Feasibility Work is Regulated by the IRB<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1uOcIXWLkpWGXdb339dhvphxxQH4AUJw9\/edit\" target=\"_blank\" rel=\"noreferrer noopener\">Phased and Staged Research Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/drive.google.com\/file\/d\/15On0UevTEaZz9cXk9pVPdSstZPFgjnbO\/view?usp=sharing\" target=\"_blank\" rel=\"noreferrer noopener\">Human Subjects Research Training Requirements for All NCSU IRB Reviewed Studies<\/a> <\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/19WFYciiJKBeElvuFdJ1ziPQkmF1nAwqe\/edit?usp=sharing&amp;ouid=105295871509157233430&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">Faculty Points-of-Contact Unit Standard<\/a><\/li>\n\n\n\n<li><a rel=\"noreferrer noopener\" href=\"https:\/\/docs.google.com\/document\/d\/1-MvquGmC-pBi9S-aqfyQBtd0xnejWzo3\/edit?usp=sharing&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" data-type=\"link\" data-id=\"https:\/\/docs.google.com\/document\/d\/1-MvquGmC-pBi9S-aqfyQBtd0xnejWzo3\/edit?usp=sharing&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" target=\"_blank\">Managing Conflicts of Interest Unit Standard<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1F7dDVcC16qxhE-h0rPvhvJDV3X9IeaM22qlwD1lxOeo\/edit\" target=\"_blank\" rel=\"noreferrer noopener\">Mandated Reporting and Research with Human Subjects<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/drive.google.com\/file\/d\/14jeH4pWP71egotjg9UgeswatMPenBRDE\/view\" target=\"_blank\" rel=\"noreferrer noopener\">Researchers Enrolling in Their Own Research Guidance<\/a> <\/li>\n\n\n\n<li>Guidance for Specific NCSU Units\n<ul class=\"wp-block-list\">\n<li>Biomedical Engineering Joint Department with UNC-Chapel Hill\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<ul class=\"wp-block-list\">\n<li><a rel=\"noreferrer noopener\" href=\"https:\/\/docs.google.com\/document\/d\/1K7_39qsidaf7AkrGDRuGyceFTnwgBY7gUJmRt6qaYSk\/edit?usp=sharing\" data-type=\"link\" data-id=\"https:\/\/docs.google.com\/document\/d\/1K7_39qsidaf7AkrGDRuGyceFTnwgBY7gUJmRt6qaYSk\/edit?usp=sharing\" target=\"_blank\">NC State Univerisity IRB Review and Approval for Research Involving Human Subjects from the Joint Department of Biomedical Engineering (BME) Unit Standard <\/a><\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/research.ncsu.edu\/administration\/files\/2025\/07\/Participant-Procedures-Template-1.docx\" target=\"_blank\" rel=\"noreferrer noopener\">Research Procedures Template<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/drive.google.com\/file\/d\/1hlm_Rhf5O6t072JcuV6ZkmtIIbuesBYP\/view\" target=\"_blank\" rel=\"noreferrer noopener\">Study Submission or Update Checklist<\/a><\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>College of Education\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/research.ncsu.edu\/administration\/files\/2025\/06\/Educational-Research-Exempt-Review-Category-Decision-Tree-Checklist.docx\">Educational Research Exemption Eligibility Decision Tree  <\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/research.ncsu.edu\/administration\/files\/2025\/07\/FERPA-Secondary-Data-IRB-app-content-list.docx\">FERPA Secondary Data IRB Application and Supplemental Documentation List<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/19N8JaMD4U1iI7sjl1qDQPaOZB_LQ3nYs\/edit?usp=share_link&amp;ouid=111628324854172758765&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">The Friday Institute and the IRB<\/a><\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1CZlub8rfWX8gTpfa7cj_hjB4U9BXUrbDSNjhysh9wTE\/edit\" target=\"_blank\" rel=\"noreferrer noopener\">College of Veterinary Medicine Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1zUWBDI09SFTXWnWEYJCVNeq1YTcGPwNP\/edit?usp=share_link&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">Community Counseling, Education, and Research Center (CCERC) Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1q-e61mWh5sJBsTi4I4Gjt_U0BFZvyeoI\/edit?usp=sharing&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\">DELTA Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/19YXDlDvGGMStMjQg8GJA1vyWdxfU-uPZ\/edit\" target=\"_blank\" rel=\"noreferrer noopener\">Food, Bioprocessing, and Nutrition Sciences Consumer Food Preference, Taste, and Quality in Human Subjects Research Guidance<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n      <\/p>\n  <\/details>\n\n\n<details class=\"wp-block-ncst-accordion-item\" name=\"jaq47g\"  >\n      <summary class=\"accordion-item__header\">\n        <span class=\"accordion-item__expansion-indicator\">\n          <span class=\"ncst-plus-minus-toggle\"><\/span>\n        <\/span>\n        <h2 class=\"accordion-item__label h6\">IRB Application<\/h2>\n      <\/summary>\n      <p>\n        \n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/research.ncsu.edu\/administration\/files\/2025\/03\/PROTECTED-Exemption-application-form-9.12.2025.docx\" target=\"_blank\" rel=\"noreferrer noopener\">Exemption Request Form<\/a>&nbsp;&#8211; updated 9\/12\/2025<\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1vVbB4aGlK_elrRioTIR9aNj3ps7cbYRb\/edit?usp=sharing&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" data-type=\"link\" data-id=\"https:\/\/docs.google.com\/document\/d\/1vVbB4aGlK_elrRioTIR9aNj3ps7cbYRb\/edit?usp=sharing&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">Exemption Unit Standard<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/research.ncsu.edu\/administration\/files\/2025\/06\/Educational-Research-Exempt-Review-Category-Decision-Tree-Checklist.docx\">Educational Research Exemption Eligibility Decision Tree<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/drive.google.com\/file\/d\/14VwdCkvdNef_A3DiajVzZ1dTi8VJ15mh\/view\" target=\"_blank\" rel=\"noreferrer noopener\">eIRB Screenshot Tutorial for Non-Exempt Protocol Applications and Protocol Amendments and Renewals (Exempt and Non-Exempt)<\/a> &#8211; updated 9\/22\/2025<\/li>\n\n\n\n<li><a href=\"https:\/\/drive.google.com\/file\/d\/1DCE7CKa0GQSxdrub5Ul9Csj0a9250v5L\/view?usp=share_link\" target=\"_blank\" rel=\"noreferrer noopener\">eIRB Application Screenshot Tutorial for Cooperative Research<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/research.ncsu.edu\/administration\/files\/2025\/09\/Renewal-Request-Supplement-\u2013-NIH-Funded-Protocols.docx\">Renewal Request Form for NIH Funded Studies<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/15SrjggCLLOhzYSAeDkiYKAVBkCA2c4cU\/edit?usp=drive_link&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">Risks and Benefits in Human Subjects Research Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/research.ncsu.edu\/administration\/files\/2025\/09\/Study-Closure-Request-Form.docx\" target=\"_blank\" rel=\"noreferrer noopener\">Study Closure Request Form<\/a><\/li>\n\n\n\n<li>Use of a Private IRB for Select More Than Minimal Risk Research Studies\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1L77uUVY4z9IZtEHpH1lif1kIGC0szh57\/edit?usp=share_link&amp;ouid=111628324854172758765&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">NC State University IRB Researchers&#8217; Use of a Private IRB Unit Standard<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1PAL7KRsxJ7lAy47J7MRcXaWxduXKCrtO\/edit?usp=share_link&amp;ouid=111628324854172758765&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">Private IRB Request Form<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n      <\/p>\n  <\/details>\n\n\n<details class=\"wp-block-ncst-accordion-item\" name=\"jaq47g\"  >\n      <summary class=\"accordion-item__header\">\n        <span class=\"accordion-item__expansion-indicator\">\n          <span class=\"ncst-plus-minus-toggle\"><\/span>\n        <\/span>\n        <h2 class=\"accordion-item__label h6\">Research Populations<\/h2>\n      <\/summary>\n      <p>\n        \n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1fwc8X1fVPamZ-wrKjZxyv7fQoK3fpPx8wc5-0u2NlbI\/edit\" target=\"_blank\" rel=\"noreferrer noopener\">Targeting NC State University Students as Research Participants Guidance<\/a><\/li>\n\n\n\n<li><a rel=\"noreferrer noopener\" href=\"https:\/\/docs.google.com\/document\/d\/1y8WSp_onJdgactahu59_9y3Gth3N4oAT\/edit?usp=sharing&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" data-type=\"link\" data-id=\"https:\/\/docs.google.com\/document\/d\/1y8WSp_onJdgactahu59_9y3Gth3N4oAT\/edit?usp=sharing&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" target=\"_blank\">Inclusion of Minors Attending Post-Secondary Institutions in Research Unit Standard<\/a><\/li>\n\n\n\n<li><a rel=\"noreferrer noopener\" href=\"https:\/\/docs.google.com\/document\/d\/1NMfxwHF5ESASQ2GW6PAZHArWoD8egPYg\/edit?usp=drive_link&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" data-type=\"link\" data-id=\"https:\/\/docs.google.com\/document\/d\/1NMfxwHF5ESASQ2GW6PAZHArWoD8egPYg\/edit?usp=drive_link&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" target=\"_blank\">Research Involving Minors Unit Standard<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/16IKH6EbO_rKxTyCcWH7bF0eBPwUMlL-u\/edit?usp=drive_link&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">Department of Defense (DoD) Affiliated Research Unit Standard<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1lASv8gXkxrV14wLfU6EnNRqmIEK_AnxS\/edit?usp=drive_link&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">Local Context and Participant Context Reviews Unit Standard<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1i1rXOfI3zWSDu1CzVSNvt6jY1B3NWoWY\/edit?usp=share_link&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">Research with Immigrants, Migrants, and Displaced Populations Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1QqF8xxkWrtaceaLx4tv4LynUgPr0uehN\/edit?usp=sharing&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" data-type=\"link\" data-id=\"https:\/\/docs.google.com\/document\/d\/1QqF8xxkWrtaceaLx4tv4LynUgPr0uehN\/edit?usp=sharing&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">Research with Pregnant People and Neonates Unit Standard<\/a><\/li>\n\n\n\n<li><a rel=\"noreferrer noopener\" href=\"https:\/\/drive.google.com\/file\/d\/1AkPLIO0hMwZRNqC-HriCpZJJ27C50cnk\/view?usp=sharing\" target=\"_blank\">Research with Those Who Are Incarcerated Unit Standard<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/drive.google.com\/file\/d\/14jeH4pWP71egotjg9UgeswatMPenBRDE\/view\" target=\"_blank\" rel=\"noreferrer noopener\">Researchers Enrolling in Their Own Research Guidance<\/a> <\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1Gm4iFKrYlhMSPGb6esmxiDtl3DKHg8NA\/edit?usp=share_link&amp;ouid=111628324854172758765&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">Research Match Procedures and Guidance<\/a><\/li>\n<\/ul>\n\n\n      <\/p>\n  <\/details>\n\n\n<details class=\"wp-block-ncst-accordion-item\" name=\"jaq47g\"  >\n      <summary class=\"accordion-item__header\">\n        <span class=\"accordion-item__expansion-indicator\">\n          <span class=\"ncst-plus-minus-toggle\"><\/span>\n        <\/span>\n        <h2 class=\"accordion-item__label h6\">Research Methods and Procedures<\/h2>\n      <\/summary>\n      <p>\n        \n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1Yva1_joErrkCwAJtXpECOltJ5KGBk1pH\/edit?usp=sharing&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">Artificial Intelligence Participant Information Sheet Elements<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/research.ncsu.edu\/administration\/files\/2025\/07\/AI-supplemental-information-form.docx\" target=\"_blank\" rel=\"noreferrer noopener\">Artificial Intelligence Supplemental Form<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1wnk7-rXOmm6JOunWqdLBuVvtu6Icsb1r\/edit\" target=\"_blank\" rel=\"noreferrer noopener\">Applications and Software Information Sheet (Appendix D)<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1xGzMpDN79SUQaL0TQU3yBnRVj6advBiV\/edit\">Benign Behavioral Interventions Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1sv9GXl5Vbx_GUzltQCDVW3aZ_0e6wvga\/edit\" target=\"_blank\" rel=\"noreferrer noopener\">Blood Draws Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/drive.google.com\/open?id=14UYmLz-VDywHk5lVRYXaPaxbxO3DK5sR\" target=\"_blank\" rel=\"noreferrer noopener\">Clinical Trials&nbsp;Unit Standard<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1HnntehTsxohersPbEAz1PVjbgviUYHMC\/edit#heading=h.2et92p0\" target=\"_blank\" rel=\"noreferrer noopener\">Citizen Science Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/19YXDlDvGGMStMjQg8GJA1vyWdxfU-uPZ\/edit?usp=share_link&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">Consumer Food Preference, Taste, and Quality in Human Subjects Research Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/16IKH6EbO_rKxTyCcWH7bF0eBPwUMlL-u\/edit?usp=drive_link&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">Department of Defense (DoD) Affiliated Research Unit Standard<\/a><\/li>\n\n\n\n<li><a data-type=\"link\" data-id=\"https:\/\/docs.google.com\/document\/d\/1lyjsVyn19ugHCcowxVY_kSJUhjf98W-9\/edit?usp=share_link&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" href=\"https:\/\/docs.google.com\/document\/d\/1lyjsVyn19ugHCcowxVY_kSJUhjf98W-9\/edit?usp=share_link&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">FERPA Records Access for Research Purposes Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/research.ncsu.edu\/administration\/files\/2025\/07\/FERPA-Secondary-Data-IRB-app-content-list.docx\">FERPA Secondary Data IRB Applications and Supporting Documentation Guidance<\/a> <\/li>\n\n\n\n<li>Genetics and Genomics Research\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/drive.google.com\/open?id=14DFald0ctG98BgiodgwYoFkGaP22For_\">Ethical Considerations<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/drive.google.com\/open?id=14ID5YkCt0iTzmVSyCeMr78WqF4-lK9dA\">Genomics IRB Application Guidance for NCSU Researchers<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1bho1Fpadb075_YNyd7cfMz0cUYODP-bL\/edit\" target=\"_blank\" rel=\"noreferrer noopener\">NIH Grants and the IRB Guidance<\/a> <\/li>\n\n\n\n<li><a href=\"https:\/\/osp.od.nih.gov\/scientific-sharing\/policies\/\">NIH Policy on Genomic Data Sharing<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/osp.od.nih.gov\/scientific-sharing\/institutional-certifications\/\">NIH Guidance on Institutional Certification for Submission of Large-Scale Genomic Data to NIH<\/a><\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1LWpYDOyDUW0cZOkzAKTkx9dG8ugtMFW7\/edit?usp=drive_link&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\">Health Insurance Portability and Accountability Act (HIPAA) Unit Standard<\/a><\/li>\n\n\n\n<li>Modified or Purpose-Built Applications and Tools Used with Human Research Subjects\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1wnk7-rXOmm6JOunWqdLBuVvtu6Icsb1r\/edit\" target=\"_blank\" rel=\"noreferrer noopener\">Applications and Software Information Sheet<\/a><a href=\"https:\/\/docs.google.com\/document\/d\/1wnk7-rXOmm6JOunWqdLBuVvtu6Icsb1r\/edit\"> (Appendix D)<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1wnk7-rXOmm6JOunWqdLBuVvtu6Icsb1r\/edit\" target=\"_blank\" rel=\"noreferrer noopener\">Applications and Software Consent Addendum (Appendix C)<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/research.ncsu.edu\/administration\/files\/2025\/07\/AI-supplemental-information-form.docx\">Artificial Intelligence Supplemental Information Form<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1Yva1_joErrkCwAJtXpECOltJ5KGBk1pH\/edit?usp=sharing&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">Artificial Intelligence Participant Information Sheet Elements<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/research.ncsu.edu\/administration\/files\/2025\/06\/Code-Review-Form.docx\">Code Review Form<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1wnk7-rXOmm6JOunWqdLBuVvtu6Icsb1r\/edit?usp=share_link&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">Use of Applications and Software for Research with Human Subjects Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1x9SjOR9IqPRXpjqwKThZHCZYi1fd_6A7\/edit?usp=share_link&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">Use of Artificial Intelligence in Human Subjects Research Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1DuWI1DmitW1dISBfR48OyNaOiRas6PSR\/edit?usp=sharing&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">When Mobile Software Applications and Wearables Become Medical Devices Guidance<\/a><\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1SNbPGc2sXzmvxyARkAXtCLVYiRd3V148\/edit?usp=share_link&amp;ouid=111628324854172758765&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">Images and Recordings in Research with Human Subjects Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1cC-u1Cy_zvqbNTHXqcCgtP37Ms-tgZs91mk3LwP585s\/edit?tab=t.0\" target=\"_blank\" rel=\"noreferrer noopener\">Incentives and Compensation for Research Participants Guidance<\/a><\/li>\n\n\n\n<li>Medical Devices\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.fda.gov\/medical-devices\" target=\"_blank\" rel=\"noreferrer noopener\">Food and Drug Administration (FDA) Webpage with Medical Devices Database links<\/a> <\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1g70sT2W8egJ2ZYYDZp3W7z6y2bM4eRhD\/edit?usp=sharing&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\">Medical Devices IRB Unit Standard<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/research.ncsu.edu\/administration\/files\/2025\/07\/Medical-Devices-Used-in-Research-Form.docx\" target=\"_blank\" rel=\"noreferrer noopener\">Medical Devices Used in Research Form<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1DuWI1DmitW1dISBfR48OyNaOiRas6PSR\/edit?usp=sharing&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">When Mobile Software Applications and Wearables Become Medical Devices Guidance<\/a><\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1uOcIXWLkpWGXdb339dhvphxxQH4AUJw9\/edit\" target=\"_blank\" rel=\"noreferrer noopener\">Phased and Staged Research Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1rfmYT1UvIPWDLLtbcUtw7VSPkKSp_hg3\/edit?usp=share_link&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">Photovoice Ethics Agreement Form<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/drive.google.com\/file\/d\/1PHbZjykErR2OpFmP0c9sFpB0GObW3oRC\/view\" target=\"_blank\" rel=\"noreferrer noopener\">Qualitative Research Methods and the IRB Guidance<\/a><\/li>\n\n\n\n<li>Qualtrics (an NCSU licensed online survey tool) Informational Weblinks\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/isa.ncsu.edu\/surveys\/qualtrics\/\" target=\"_blank\" rel=\"noreferrer noopener\">What is Qualtrics?<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/isa.ncsu.edu\/surveys\/qualtrics\/accessing-qualtrics-at-nc-state\/\" target=\"_blank\" rel=\"noreferrer noopener\">How Do I Access Qualtrics at NC State?<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.qualtrics.com\/security-statement\/\" target=\"_blank\" rel=\"noreferrer noopener\">Qualtrics and Data Security<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/basecamp.qualtrics.com\/page\/learn-to-use-qualtrics-research-core\" target=\"_blank\" rel=\"noreferrer noopener\">Qualtrics Video Tutorials<\/a><\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/14olPHJTWxRQUZY6RERk1Qu5gjrCiaAse\/edit\">Research Involving Deception Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1Gm4iFKrYlhMSPGb6esmxiDtl3DKHg8NA\/edit?usp=share_link&amp;ouid=111628324854172758765&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">Research Match Procedures and Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/drive.google.com\/file\/d\/14jeH4pWP71egotjg9UgeswatMPenBRDE\/view\" target=\"_blank\" rel=\"noreferrer noopener\">Researchers Enrolling in Their Own Research Guidance<\/a> <\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1ytvLEFsIgAcZhLtvnFcNNAUyJ72IlJwP\/edit?usp=share_link&amp;ouid=111628324854172758765&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">Secondary Data and the IRB Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/14cZlNJYujcdM1O8GUhDdU4iKCxU20Wiu\/edit\" target=\"_blank\" rel=\"noreferrer noopener\">Survey Research and the IRB Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1AFNFMVXfneIzrcMcHP3UEaXP4bEc_4-9\/edit?usp=share_link&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">Translation Verification Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1wnk7-rXOmm6JOunWqdLBuVvtu6Icsb1r\/edit?usp=share_link&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">Use of Applications and Software for Research with Human Subjects Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1x9SjOR9IqPRXpjqwKThZHCZYi1fd_6A7\/edit?usp=share_link&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">Use of Artificial Intelligence in Human Subjects Research Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1bsS_1Jeq2xNf0IgDynlynQOxUBKA2IBP\/edit?usp=share_link&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\">Use of Augmented Reality (AR) and Virtual Reality (VR) Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1cayeZ_vtFXBos-qPEvrzPReKgCLbIpDU\/edit?usp=share_link&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\">Use of Social Media for Research with Human Subjects Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1PKXRnwmEWgle8bAVlNgkjllid3U42rLZ\/edit\" target=\"_blank\" rel=\"noreferrer noopener\">Water, Soil, and Farmed Food Sampling Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1DuWI1DmitW1dISBfR48OyNaOiRas6PSR\/edit?usp=sharing&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\">When Mobile Software Applications and Wearables Become Medical Devices Guidance<\/a><\/li>\n<\/ul>\n\n\n      <\/p>\n  <\/details>\n\n\n<details class=\"wp-block-ncst-accordion-item\" name=\"jaq47g\"  >\n      <summary class=\"accordion-item__header\">\n        <span class=\"accordion-item__expansion-indicator\">\n          <span class=\"ncst-plus-minus-toggle\"><\/span>\n        <\/span>\n        <h2 class=\"accordion-item__label h6\">Research Data Management, Sharing, and Use<\/h2>\n      <\/summary>\n      <p>\n        \n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1BLaR3ApInihnwUWfcr8waNRpNVwNlvJo\/edit?usp=share_link&amp;ouid=111628324854172758765&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">Collection and Reporting of Demographic Information Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1ttm68MoFa3hJPtB0LXfbnhqGAe_DKMfy\/edit?usp=share_link&amp;ouid=111628324854172758765&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">Data Security and the IRB Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/research.ncsu.edu\/administration\/data-use-agreements\/\" target=\"_blank\" rel=\"noreferrer noopener\">&#8220;Data Use Agreements&#8221; Research Administration and Compliance Webpage<\/a><\/li>\n\n\n\n<li><a data-type=\"link\" data-id=\"https:\/\/docs.google.com\/document\/d\/1lyjsVyn19ugHCcowxVY_kSJUhjf98W-9\/edit?usp=share_link&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" href=\"https:\/\/docs.google.com\/document\/d\/1lyjsVyn19ugHCcowxVY_kSJUhjf98W-9\/edit?usp=share_link&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">FERPA Records Access for Research Purposes Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/drive.google.com\/file\/d\/1AUGmOl7nXsPrliti2LVpPF-JkpW9BCm0\/view\" target=\"_blank\" rel=\"noreferrer noopener\">General Data Protection Regulation (GDPR) Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1DhQ2xDQs8daep9SKmKqiTFM6bLZFu3Tu\/edit?usp=share_link&amp;ouid=111628324854172758765&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">Identifiable Data Sets Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1cC-u1Cy_zvqbNTHXqcCgtP37Ms-tgZs91mk3LwP585s\/edit?tab=t.0\" target=\"_blank\" rel=\"noreferrer noopener\">Incentives and Compensation for Research Participants Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1F7dDVcC16qxhE-h0rPvhvJDV3X9IeaM22qlwD1lxOeo\/edit\" target=\"_blank\" rel=\"noreferrer noopener\">Mandated Reporting in Human Subjects Research Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/cybersecurity.ncsu.edu\/data-management\/data-management-framework\/\" target=\"_blank\" rel=\"noreferrer noopener\">NCSU OIT Data Management Framework Webpage<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/spreadsheets\/d\/1cHJnpD7ObV3a48AIKcCe2AMRZ0MmN4GHkuZMAm1kljg\/edit?gid=1639595516#gid=1639595516\" target=\"_blank\" rel=\"noreferrer noopener\">NCSU OIT Data Sensitivity Framework Google Sheet<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1wnk7-rXOmm6JOunWqdLBuVvtu6Icsb1r\/edit?usp=share_link&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">Use of Applications and Software for Research with Human Subjects Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1x9SjOR9IqPRXpjqwKThZHCZYi1fd_6A7\/edit?usp=share_link&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">Use of Artificial Intelligence in Human Subjects Research Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1cayeZ_vtFXBos-qPEvrzPReKgCLbIpDU\/edit?usp=share_link&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">Use of Social Media for Human Subjects Research Guidance<\/a><\/li>\n<\/ul>\n\n\n      <\/p>\n  <\/details>\n\n\n    <\/div>\n  <\/div>\n\n\n<div class=\"is-text wp-block-ncst-buttons\">\n    \n<div class=\"is-style-secondary wp-block-ncst-button\">\n      <a\n        class=\"ncst-block__button-link btn\"\n        href=\"https:\/\/research.ncsu.edu\/administration\/compliance\/research-compliance\/irb\/#lifecycle\"\n        data-ncst-lightbox=\"false\"\n         target=\"_blank\"          rel=\"noreferrer noopener\"       >\n                  <span class=\"text\">Go to the IRB Lifecycle<\/span><span class=\"arrow-indicator\"><svg class=\"wolficon wolficon-arrow-right-bold\" role=\"img\"  aria-hidden=\"true\">\n\t\t\t\n\t\t\t<use xlink:href=\"#wolficon-arrow-right-bold\">\n\t\t<\/svg><\/span>\n              <\/a>\n    <\/div>\n  \n\n  <\/div>\n\n\n<div class=\"wp-block-ncst-button is-style-secondary\"><a href=\"https:\/\/research.ncsu.edu\/administration\/compliance\/research-compliance\/irb\/\" class=\"btn ncst-component__button-link is-style-secondary\" data-ncst-lightbox=\"false\" data-ua-cat=\"Button Block\" data-ua-action=\"Button Click\" data-ua-label=\"https:\/\/research.ncsu.edu\/administration\/compliance\/research-compliance\/irb\/\"><span class=\"ncst-component__button-container\"><span>Return to IRB <\/span><span class=\"nowrap\"><span>Homepage&nbsp;<\/span><span class=\"arrow-indicator\"> <svg class=\"wolficon\" role=\"img\" aria-hidden=\"true\"><use xlink:href=\"#wolficon-arrow-right-bold\"\/><\/svg> <\/span><\/span><\/span><\/a><\/div>\n\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>This webpage organizes the NC State University IRB guidance into five thematic sections. Each section provides documents that summarize or link to relevant laws, regulations, policies, and contexts alongside suggestions&hellip;<\/p>\n","protected":false},"author":284,"featured_media":0,"parent":338,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"source":"","ncst_custom_author":"","ncst_show_custom_author":false,"ncst_dynamicHeaderBlockName":"ncst\/default-header","ncst_dynamicHeaderData":"{\"pageIntro\":\"The NC State University IRB maintains a wealth of documentation and other resources to assist researchers throughout the IRB lifecycle. Here, you'll find all of our guidance documents on study design, data collection methods and modes, and other considerations.  \"}","ncst_content_audit_freq":"","ncst_content_audit_date":"","ncst_content_audit_display":false,"ncst_backToTopFlag":"","footnotes":""},"tags":[],"class_list":["post-354","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>IRB: Procedures and Guidance - Research Administration and Compliance<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/research.ncsu.edu\/administration\/compliance\/research-compliance\/irb\/irb-procedures-and-guidance\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"IRB: Procedures and Guidance - Research Administration and Compliance\" \/>\n<meta property=\"og:description\" content=\"This webpage organizes the NC State University IRB guidance into five thematic sections. 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