{"id":302,"date":"2017-03-16T14:46:46","date_gmt":"2017-03-16T14:46:46","guid":{"rendered":"http:\/\/research.unl.edu\/researchcompliance\/?page_id=302"},"modified":"2026-04-24T15:18:32","modified_gmt":"2026-04-24T15:18:32","slug":"policies-procedures","status":"publish","type":"page","link":"https:\/\/research.unl.edu\/researchcompliance\/policies-procedures\/","title":{"rendered":"HRPP Policies &amp; Procedures"},"content":{"rendered":"\n<p>The University of Nebraska-Lincoln\u2019s (UNL) Human Research Protection Program (HRPP) and the projects that are approved through the IRB must follow,&nbsp;<a href=\"https:\/\/research.unl.edu\/researchcompliance\/regulations\/\" target=\"_blank\" rel=\"noreferrer noopener\">Federal regulations, state regulations, institutional policies<\/a>. The individual HRPP policies and procedures listed below are the most up-to-date versions.<\/p>\n\n\n\n<p>Revisions to the Common Rule (45 CFR 46) went into effect as of January 21, 2019. We refer to these revised policies as those following the \u201c2018 requirements\u201d. &nbsp;If you have an active and ongoing project that was approved prior to January 21, 2019, &nbsp;your project will likely fall under the \u201cPre-2018\u201d requirements. The one exception to this is for projects funded by the Department of Justice (National Institute of Justice). Because the DOJ is not a signatory of the Revised Common Rule, these projects are reviewed using the Pre-2018 requirements. To find which set of requirements your project is subject to, simply navigate to your project in NuRamp and you will see the \u201cProject Regulation\u201d listed in the project details.&nbsp;<\/p>\n\n\n\n<figure class=\"wp-block-image aligncenter size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"252\" src=\"https:\/\/research.unl.edu\/researchcompliance\/wp-content\/uploads\/sites\/22\/2021\/09\/thumbnail_image002-1024x252.png\" alt=\"Image to describe where to find project regulation: To find which set of requirements your project is subject to, simply navigate to your project in NUgrant and you will see the \u201cProject Regulation\u201d listed in the project details.\u00a0\" class=\"wp-image-2410\" srcset=\"https:\/\/research.unl.edu\/researchcompliance\/wp-content\/uploads\/sites\/22\/2021\/09\/thumbnail_image002-1024x252.png 1024w, https:\/\/research.unl.edu\/researchcompliance\/wp-content\/uploads\/sites\/22\/2021\/09\/thumbnail_image002-300x74.png 300w, https:\/\/research.unl.edu\/researchcompliance\/wp-content\/uploads\/sites\/22\/2021\/09\/thumbnail_image002-768x189.png 768w, https:\/\/research.unl.edu\/researchcompliance\/wp-content\/uploads\/sites\/22\/2021\/09\/thumbnail_image002-950x234.png 950w, https:\/\/research.unl.edu\/researchcompliance\/wp-content\/uploads\/sites\/22\/2021\/09\/thumbnail_image002-600x148.png 600w, https:\/\/research.unl.edu\/researchcompliance\/wp-content\/uploads\/sites\/22\/2021\/09\/thumbnail_image002-700x172.png 700w, https:\/\/research.unl.edu\/researchcompliance\/wp-content\/uploads\/sites\/22\/2021\/09\/thumbnail_image002-624x154.png 624w, https:\/\/research.unl.edu\/researchcompliance\/wp-content\/uploads\/sites\/22\/2021\/09\/thumbnail_image002.png 1402w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p><strong>Additional Resources:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>List of&nbsp;<a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQDg3FKuRSuTQZ2fyMIb2NJzAcoC6i3jjb-rEKBGaNm4HIA?e=EhODhi\" target=\"_blank\" rel=\"noreferrer noopener\">common abbreviations<\/a>&nbsp;found in UNL HRPP policy documents<\/li>\n\n\n\n<li><a href=\"https:\/\/research.unl.edu\/researchcompliance\/guidance-topics-a-z\/\" target=\"_blank\" rel=\"noreferrer noopener\">Guidance Topics (A-Z) page<\/a><\/li>\n<\/ul>\n\n\n\n<p><strong>Comprehensive Policy Documents (PDF of all policies and procedures):<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a rel=\"noreferrer noopener\" href=\"https:\/\/uofnebraska.sharepoint.com\/:b:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQB8HLC68bIFTak6oDmjUCTPAXulOmXnFg3sjwcWGzdtfBI?e=JnmjkP?e=eKpmpK\" target=\"_blank\">Pre-2018 Policies and Procedures<\/a><\/li>\n\n\n\n<li><a rel=\"noreferrer noopener\" href=\"https:\/\/uofnebraska.sharepoint.com\/:b:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQBiRa6pXRSdSZ6y0GbPe96QAStHA10uR_K3Ak6qOztlPRs?e=rjwXff\" target=\"_blank\">2018 Policies and Procedures<\/a><\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-css-opacity\" \/>\n\n\n\n<h3 class=\"wp-block-heading\">Organizational Commitment to the HRPP<\/h3>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQBoAmCfqDLgQLBwl0spx3qwAWRcGj1A5Agy47qtBnzeRkI?e=qkBMma\" target=\"_blank\" rel=\"noreferrer noopener\">1.001: The Institution and its Commitment to the HRPP<\/a><\/p>\n\n\n\n<p><a rel=\"noreferrer noopener\" href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQBn71ymuEnfS5I_nDWVP-XSAeuK5SAlesOcaHYnq1CRRV8?e=bJmjkc\" target=\"_blank\">1.002: Federal Wide Assurance<\/a><\/p>\n\n\n\n<p><a rel=\"noreferrer noopener\" href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQBpOCfeeT5GTKqkonMxv1tJAYh2AQHHomsmwJoa5Z32JqU?e=O5xARJ\" target=\"_blank\">1.003: Vision, Mission and Values Statement of UNL<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQCrDll2_z6SQrIx1Aj-E231AW1HI4IXbT9stYaUk2M6ZyE?e=spFeBY\" target=\"_blank\" rel=\"noreferrer noopener\">1.004: Vision, Mission and Values Statement for the HRPP<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQCCy9a-jissS5o4R16hp0EMASgy_SeSkuKEpeY7LvMGSMU?e=svENH4\" target=\"_blank\" rel=\"noreferrer noopener\">1.005: IRB Charter, Appointments and Administrative Structure<\/a><\/p>\n\n\n\n<p><a rel=\"noreferrer noopener\" href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQBpLmwjcHSRQLRl2sNyEuKmAeIfJHEzitO3AwIvFkAZt0Y?e=0URnAZ\" target=\"_blank\">1.006: Authority Granted by UNL to the IRB Operating in the HRPP<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQBoAAHXTAWyRrSEUsHvxYWaATjYucy-wWOvrAGZfwjC0g0?e=S6NLLa\" data-type=\"URL\" data-id=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQBoAAHXTAWyRrSEUsHvxYWaATjYucy-wWOvrAGZfwjC0g0?e=S6NLLa\" target=\"_blank\" rel=\"noreferrer noopener\">1.007: Human Research Protection Program Emergency Preparedness Plan<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">IRB Membership &amp; Standard Operating Procedures<\/h3>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQAuc8rdosaKQLwLMKxj8KrZAXzoMGHMOy7J-AYI1yRDmbw?e=7PgqBl\" target=\"_blank\" rel=\"noreferrer noopener\">2.001: IRB Membership Requirements and Responsibilities<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQCMfMlnWyCVTJRYtJI9AvAEAfweCDr5TEYqwMrhy51Togw?e=ufBBT4\" target=\"_blank\" rel=\"noreferrer noopener\">2.002: IRB Meetings and IRB Member Responsibilities<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQC6Njt-FUKXRbap7f8g0l4oAagIwBBbkrQuiZ99IDEvO6c?e=gpTJLb\" target=\"_blank\" rel=\"noreferrer noopener\">2.003: IRB Consultants<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQC3nTj3gt1VT6Ell6Flnj1RAcP1o6Ma9Dn41Q8UzTecDug?e=IeMpDe\" target=\"_blank\" rel=\"noreferrer noopener\">2.004: Orientation and Initial Training for New IRB Members and HRPP Staff<\/a><\/p>\n\n\n\n<p>2.005: Reserved<\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQCCu5xUzXaaQ6U5umiBtrDIAdGOficn9YnxlsT7SZcVl-w?e=5Cfond\" target=\"_blank\" rel=\"noreferrer noopener\">2.006: Continuing Education Requirements for IRB Members and HRPP Staff<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQAziMw4GCruRKIxxMmxjSn8AZc8VXZ0tkdSrNHMJI-mNWY?e=TvpS8T\" target=\"_blank\" rel=\"noreferrer noopener\">2.007: Evaluation of IRB Members<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQAFy_s9RH2lT7eTY8Ksgt3WAai7aRTAzlSJZi9sg6ZTQp4?e=3VlrcY\" target=\"_blank\" rel=\"noreferrer noopener\">2.008: IRB Member Confidentiality<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQBAcDlWN8C6QolgPNqhoS-wAUng1dJr-ll6GbRU_wcYHJA?e=e9HqWA\" target=\"_blank\" rel=\"noreferrer noopener\">2.009: Full Board IRB Reviewer Assignment<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQA0EN1Z7wBEQYje3Kv8Y_jNAc3mlCWMvMe5si0mKdoAOBU?e=mkcTZM\" target=\"_blank\" rel=\"noreferrer noopener\">2.010: Written Reviews by IRB Members and Development of the IRB Review Letter<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQCe8NoIjKMJSZ03ZRG4hIxqAa5ePAJCs8jdYyvEVZLw-_8?e=olsLfW\" target=\"_blank\" rel=\"noreferrer noopener\">2.011: IRB Quorum and Voting Requirements<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQCtRhEaSBwnSa93F0uqKTYdARsl6pIwswuX2IRVA2at32o?e=qMoy9Z\" target=\"_blank\" rel=\"noreferrer noopener\">2.012: IRB Minutes<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQAdlWYpOy1NS6tf5VFOwcdoAdSCbYkzl3fA2D1c9YEqHLQ?e=GWUcXv\" target=\"_blank\" rel=\"noreferrer noopener\">2.013: HRPP Policy Review and Approval<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQCjj3FwRKU4RLbkEycFO3OgATodWxkSyp0KBWZWLh7cSdM?e=f0B4E9\" target=\"_blank\" rel=\"noreferrer noopener\">2.014: IRB Records<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQCaGJKuHDb-RKXLU7LIpOZyAR3oOEDVa-9Hb7gtz5Z9-84?e=cfwdCw\" target=\"_blank\" rel=\"noreferrer noopener\">2.015: Ongoing Research Transition to 2018 Requirements<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Initial IRB Review of Protocols<\/h3>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQDcBH-Z_LfkS53OkCCAdZf2AWDub7_Kw1iiTBoEl207CAI?e=ksWNhG\" target=\"_blank\" rel=\"noreferrer noopener\">3.001: Investigational Activities Requiring IRB Review and Approval<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQBy5D-Sl837Qrk2A3Wieg5gAen_XNpq1zsaJ7BDhWtHqU0?e=VXOrLL\" target=\"_blank\" rel=\"noreferrer noopener\">3.002: Ethical Principles Governing Research Under the Jurisdiction of the IRB<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQCFJpz80VkjSYIXDGY0p_QZARK1WLMgbqD5unuljGoDsZA?e=kxaegf\" target=\"_blank\" rel=\"noreferrer noopener\">3.003: Initial Application Submission<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQDl6TrdmV9LRLQKstx8rOAeAYWhNzKz1XadNL8OdcxA6Bc?e=LvMug4\" target=\"_blank\" rel=\"noreferrer noopener\">3.004: Criteria for IRB Approval of Research<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQBydapGaO8xSqq5ms69GAQfAbtNTCceAf1DWcnFa-zKHiY?e=R4X0UA\" target=\"_blank\" rel=\"noreferrer noopener\">3.005: IRB Initial Review Categories<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQCxthofHHfwSZTjG6zFE1c1AbCxegn9FiVraoAl5ph7PoA?e=pPNBGj\" target=\"_blank\" rel=\"noreferrer noopener\">3.006: Scientific and Scholarly Merit Review of Proposals<\/a><\/p>\n\n\n\n<p>3.007: Reserved<\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQBWJTFaOfVbQIXK3_qLg8GGAdB5Vc0qdmKwR9G6DEahWpI?e=827JkH\" target=\"_blank\" rel=\"noreferrer noopener\">3.008: Qualification and Responsibilities of Research Personnel<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQB4wI5RQbCcQJX73Y5e8S7uAX2anBndGWhusJNdjWvsO1A?e=wH8x0g\" target=\"_blank\" rel=\"noreferrer noopener\">3.009: Required Training in the Protection of Human Participants<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQCnKzRPM4nwQ7KSWNeLGA8ZAXtEjoi8mbp9C-brFdEqFnM?e=cN2I56\" target=\"_blank\" rel=\"noreferrer noopener\">3.010: Assessing the Need for Interim Continuing Review, Monitoring and Verification for Sources Other than the Investigator<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQDrb3kASWvwR65VtOmeKPfuAX3BHLu2d2rJ5znV8uEDiqE?e=1X2D3A\" target=\"_blank\" rel=\"noreferrer noopener\">3.011: Certificate of Confidentiality<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQDH0H198CV8TaVNenzsw_zlAcEPUGe50Y21bHCVO4YqMgY?e=zpGfrx\" target=\"_blank\" rel=\"noreferrer noopener\">3.012: IRB Approval of Multi-Site or Cooperative Research<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQBy4CJ-IVO9Tr3X7oANszb9AWBfBAVplDgo-2LLZW-LhkI?e=ABtvkC\" target=\"_blank\" rel=\"noreferrer noopener\">3.013: Research Records Retention and Security<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQD9x70NQC9OQqLhpzDzN8pyAQleL-txV5QC_Ti4eK3iq_E?e=MmbywH\" target=\"_blank\" rel=\"noreferrer noopener\">3.014: PI Disagreements with IRB Decisions<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQBJZYufbstiSYNVCYEHGe03AVeVxnIEJ2jQIfg2qx5wEiU?e=h1HFgV\" target=\"_blank\" rel=\"noreferrer noopener\">3.015: Research Participant Payment and Incentives<\/a><\/p>\n\n\n\n<p><a rel=\"noreferrer noopener\" href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQAA6LP4CDnESaEJf5F6T8iTAeiqGsO-sLorzFmf98MMl7c?e=dsTIF2\" target=\"_blank\">3.016: Recruitment of Participants<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQA3NBiD5ChFSY38QwVldlXUAeRTI4IfNJ22a0zvaU9YBLI?e=Nbrsxh\" target=\"_blank\" rel=\"noreferrer noopener\">3.017: Individual Investigator Agreements<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQBvRHTAGlVcQZIhj2O3nO_4AQkDWy-m4l_MTZmiY6OyKBQ?e=7z4Uru\" target=\"_blank\" rel=\"noreferrer noopener\">3.018: Human Participant Research Involving Ionizing Radiation<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQDCMbde0RMrRK8o1nUWOZufAcWn9Etx9UMUVmb_GnXKnPk?e=8MeKGQ\" target=\"_blank\" rel=\"noreferrer noopener\">3.019: International Council for Harmonization &#8211; Good Clinical Practice (ICH-GCP) E6R2 Compliance <\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Exempt &amp; Expedited review<\/h3>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQBrSK57GqccRr173p_uCT_kAW5NuX8dGgYsONW9_7X2QTo?e=2QYDQt\" target=\"_blank\" rel=\"noreferrer noopener\">4.001: Exempt Research<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQCaVnjdKuG2Q4LMtRhWRXcXATCGUWHiMh-bMkJqdVZJvvo?e=Wdit6H\" target=\"_blank\" rel=\"noreferrer noopener\">4.002: Expedited Research<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQBBJQ88EHD1QagnLPXOvYOaAe194hIVfTh7UP4gwQ6tFn8?e=d0RL7t\" target=\"_blank\" rel=\"noreferrer noopener\">4.003: Exempt Research &#8211; Limited Review<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Vulnerable Populations and Special Classes of Participants<\/h3>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQDnOp3zWOdxS4fEgN-PrCNCAXYdZWPQlCgYcwHecNwJJ58?e=lgfKl0\" target=\"_blank\" rel=\"noreferrer noopener\">5.001: Additional Protections for Vulnerable Populations<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQBrsEACwf0FR7__MIADdmFlAYU6pkA7t7ORoalObYYf5ls?e=FU0JGw\" target=\"_blank\" rel=\"noreferrer noopener\">5.002: Research Involving Pregnant Women, Human Fetuses and Neonates<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQDoElPZLjWRQJX042oJRHpoAWf7gSFYQnNnskd1KUo9XzI?e=ckdPMa\" target=\"_blank\" rel=\"noreferrer noopener\">5.003: Research Involving Prisoners<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQCaz527rCi5S5fMJZdMae6fAfDnWqLExHSggUb9TlzaHCo?e=ZgN9eH\" target=\"_blank\" rel=\"noreferrer noopener\">5.004: Research Involving Children<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQCLTwIzxu6FSKuaVJhcudy8AT6PiEmANbZjSniIxHCg2TA?e=BnUJrK\" target=\"_blank\" rel=\"noreferrer noopener\">5.005: <span class=\"hotkey-layer \"><span class=\"hotkey-layer preview-overlay is-preview-sidebar-visible\">Research Involving Persons with Impaired Decision-making Capacity<\/span><\/span><\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQBv0rQDos9VRbDowVCbLxt1AXZSKiom8q-XZx8yNR2vHEE?e=5W8dDp\" target=\"_blank\" rel=\"noreferrer noopener\">5.006: Research Involving Extra Credit Compensation<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Section 6<\/h3>\n\n\n\n<p><span style=\"color: #808080\"><b>Reserved<\/b><\/span><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Random Compliance Review<\/h3>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQC8tiF9nzj_Tbes92nWVkS_AQJl4QWeMoAOtl-adz7fivY?e=6cKthm\" target=\"_blank\" rel=\"noreferrer noopener\">7.001: <span class=\"hotkey-layer \"><span class=\"hotkey-layer preview-overlay is-preview-sidebar-visible\">Human Research Protection Program Quality Assurance &amp; Quality Improvement Program<\/span><\/span><\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQAHMfVnqEaORpdFmHqerISlAfuh-i818Dtoe0XcQlLl7kw?e=jIK2O5\" target=\"_blank\" rel=\"noreferrer noopener\">7.002: <span class=\"hotkey-layer \"><span class=\"hotkey-layer preview-overlay is-preview-sidebar-visible\">Directed and Routine Compliance Reviews<\/span><\/span><\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQDCUJ7_v68dS6vctrM0RUSXAf65uASFY_jRS4avMhoy7bo?e=Eg5a4Q\" target=\"_blank\" rel=\"noreferrer noopener\">7.003: <span class=\"hotkey-layer \"><span class=\"hotkey-layer preview-overlay is-preview-sidebar-visible\">Compliance Review Monitoring and Reporting Process<\/span><\/span><\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">General Requirements and Guidelines<\/h3>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQB60nUQlu_LTpRwaH04a5WfAUcJNDWnyVh7wtkafg35dL0?e=W7Uk8i\" target=\"_blank\" rel=\"noreferrer noopener\">8.001: Students as Researchers<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQBE15qQ_e2eSorJ_3uOcHvgAaY-hyVMSzQ2QTPodSCFLnY?e=ztvbM1\" target=\"_blank\" rel=\"noreferrer noopener\">8.002: Epidemiological Research Guidelines<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQC_TS59p3dwSI5Wom143FtOAckaVUSnaa8RASMUNlIYYGc?e=yvXuHw\" target=\"_blank\" rel=\"noreferrer noopener\">8.003: Exercise Protocol Guidelines<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQDQ9c4dSzz8TruZ_bn6b5m1AUFdX-WkikJ9R_zqy7l_kZU?e=qHTvsV\" target=\"_blank\" rel=\"noreferrer noopener\">8.004: Research Conducted in Foreign Countries<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQAZ-Cj7hUNTRJonakV1PS9WAcdhstJI2dAyPy6Zgqxl5hI?e=HzMKCo\" target=\"_blank\" rel=\"noreferrer noopener\">8.005: Community-Based Participatory Research<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQC_ZD-qWl_JSID0nk4WzW3HAb9iIwllMeqOR2c5pCHeUW4?e=qXASrj\" target=\"_blank\" rel=\"noreferrer noopener\">8.006: Enhancing Understanding of Participants, Prospective Participants, and the Community<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQCy32t_P9A3T54HFSs5WpzvAaR8JwPlm_2wPKI7x5ZzGwI?e=3IeY0W\" target=\"_blank\" rel=\"noreferrer noopener\">8.007: Incidental Findings<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQAoPtuZZyZXToKlqk8AcprgAQGuPqc1liBGiVDvqjZuGFA?e=SfE4Tx\" target=\"_blank\" rel=\"noreferrer noopener\">8.008: Pregnancy Testing of Females of Childbearing Potential<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQAqFMVIklN_Qq0VAomFrf1xAa6vdhRW24E6QfKMAkfsbyo?e=idhHsz\" target=\"_blank\" rel=\"noreferrer noopener\">8.009: Use of Deception in Research<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQDqhTymkd1AT6jGrZWY7lDsATD3LZjYrNgZwEOGvNvpmgg?e=TupZum\" target=\"_blank\" rel=\"noreferrer noopener\">8.010: Banking Human Biological Material for Future Research<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQAXUEwTyJJLRLnDXfrSPh5SAZ7IXVwODcB3NrBF_rTIr5o?e=UwJPbP\" target=\"_blank\" rel=\"noreferrer noopener\">8.011: Use of Human Biological Material in Research<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQD5k_e74PtKR5yYr9Vsns5EARBYEM7JtEZLzbob8q_NwcI?e=R5Tgjl\" target=\"_blank\" rel=\"noreferrer noopener\">8.012: Participant Registries, Subject Pools, and Data Repositories<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQBuMNldDP52S6loK8vNkkjfAY2OLCoWKIxDE5m0jpdzsWg?e=eYjfac\" target=\"_blank\" rel=\"noreferrer noopener\">8.013: Registering Clinical Trials (ClinicalTrials.gov)<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Informed Consent<\/h3>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQCPBsJnhQjwT4Yz3bTUquUCAcq3eh8Ov1RW-y9iDQ9SM1s?e=eHd7Rd\" target=\"_blank\" rel=\"noreferrer noopener\">9.001: Required Elements for Informed Consent Documents<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQBz3IaGAMI7S6YFiV-liC6iAZ-72K8FIbR06bx0pg03l24?e=UbRLte\" target=\"_blank\" rel=\"noreferrer noopener\">9.002: Development of the Informed Consent Document<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQANwkPAEO2JSprtSxQP4Mj1ARInFrqF5kGg0PnM_prG42c?e=2TM1Np\" target=\"_blank\" rel=\"noreferrer noopener\">9.003: Remote Consent<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQADRiAG7WmIQ6W1u2QV1tbzAdFTLlkYRbi1T_Cqj7_mMNI?e=8Nj5tX\" target=\"_blank\" rel=\"noreferrer noopener\">9.004: Re-consent\/Assent Research Participants<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQDpzsnN_OUITJyeq5MEX4_3AZyQHXAvbt7efeRPBVogn6M?e=L7Dx34\" target=\"_blank\" rel=\"noreferrer noopener\">9.005: Absence of Valid Consent: Re-Consent and Use of Data<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQB1n2nlSHKhRp_vlmASCtA9AUYDtnlT39j_j_YruPqKZKA?e=ll4N2h\" target=\"_blank\" rel=\"noreferrer noopener\">9.006: Waiver or Alteration of Consent and Consent Documentation<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQAxs8MaWcmvT4UjPCeK1WO4AY5WsipRudBNR5d6ewTrO8s?e=cj1Dkc\" target=\"_blank\" rel=\"noreferrer noopener\">9.007: Use of the Short Form Consent Document<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Protected Health Information &amp; Research<\/h3>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQBpaA5Y2qvUQZks26HlZPtuAakn6NDP6xKKjMCNgYyqMGA?e=qtgmod\" target=\"_blank\" rel=\"noreferrer noopener\">10.001: Use of Protected Health Information in Research and Registries<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Continuing Review<\/h3>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQDtgJ0Qev3FRrGvv_Bh32axAUYwS2hrLKg4WnQf9jr2XFc?e=dspz1R\" target=\"_blank\" rel=\"noreferrer noopener\">11.001: Continuing Review and Annual Update<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQAIi5ic4KYhT7LjPVe0vJICAc7DzbuWTzqxu4fcEy9gZxc?e=vcPWeH\" target=\"_blank\" rel=\"noreferrer noopener\">11.002: IRB Disapproval, Study Hold, Suspension, and Termination<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQA1gdbWhCXtSaGI6XcvLcoUAZsHamyN1X-9nvTqRJC3sJY?e=vbubqH\" target=\"_blank\" rel=\"noreferrer noopener\">11.003: Minimization of Risk and Data Safety Monitoring<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Amendments to Approved Protocols<\/h3>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQAO2ZyUxDIwS7hRATWXUk9AAauq2ffe4WMXTQF4jywxzOo?e=1ZiRk2\" target=\"_blank\" rel=\"noreferrer noopener\">12.001: Request for Change<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Reportable New Information<\/h3>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQBo8bx_GGJpTq_pBBzYTlWvAeEk4uTtyE01eZXZcGtClGI?e=6y2Ibe\" target=\"_blank\" rel=\"noreferrer noopener\">13.001: Reportable New Information (Protocol Deviations, Violations, Unanticipated Problems Involving Risk and Adverse Events)<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQDtRfhidD0PSqrvdNYKzhR3Afr8Yj009luknEgnchhnxko?e=BcirCq\" target=\"_blank\" rel=\"noreferrer noopener\">13.002: Study Related Complaints<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Compliance<\/h3>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQAmwmbKYTN3R4gCU6z8jZMVAUY6J-lGLHI77fT5YhoElGg?e=aqseBl\" target=\"_blank\" rel=\"noreferrer noopener\">14.001: Noncompliance<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQBX5IxHw3ZERpsS2nz3CORmAa13b-DeTA_9gYp5IHH1Z4A?e=DVeG7p\" target=\"_blank\" rel=\"noreferrer noopener\">14.002: Reporting Incidents to Institutional Officials, OHRP, Department and Agency Heads, Sponsors, and AAHRPP<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQBuk4bI8wz6QqEXqlafXB8DAcByujiOa5Hi8zP5JBD4wos?e=eyl2t2\" target=\"_blank\" rel=\"noreferrer noopener\">14.003: Audits by Outside Agencies<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Funding Requirements<\/h3>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQD7W6lJ8cIkT51aKHh2P65LAed4tr8L8e6tqv-uN_QTa7A?e=ZLIeo0\" target=\"_blank\" rel=\"noreferrer noopener\">15.001: Human Research Compliance with Department of Education Regulations<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQD9pQ0SU5cHTqIjjLbmHaklAZG9eAd9pxul4m5XbvMiTHU?e=BU1Dz4\" target=\"_blank\" rel=\"noreferrer noopener\">15.002: Human Research Compliance with Environmental Protection Agency Regulations<\/a><\/p>\n\n\n\n<p>15.003 Reserved: The Department of Justice (DOJ) is not a signatory of the Revised Common Rule. Please see the Pre-2018 policy #15.003 for HRPP Requirements.<\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQB88QSa6NkASoOUkCf8Bv_jAQKlXXcH_Sk6sUKhBSCeF0Q?e=jQ6rSK\" target=\"_blank\" rel=\"noreferrer noopener\">15.004: Human Research Compliance with Department of Defense Regulations<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQCEgj6V3wj6QqNNjhGf1FReAVkMIsne3im5BDOVEpAii6k?e=g6M2BT\" target=\"_blank\" rel=\"noreferrer noopener\">15.005: Human Research Compliance with Department of Energy Regulations<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQCCOpM8gluCSLL_k9vqdYYEAfN9h_0dg9o87KTD00Q8plM?e=ywz1nK\" target=\"_blank\" rel=\"noreferrer noopener\">15.006: Sponsored Research<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQCtg1deBV17R5Qg5YQ1Y1PDAT4egdrm4DFiGX8wt7lT3zY?e=OIAH0k\" target=\"_blank\" rel=\"noreferrer noopener\">15.007: External Funding<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Conflict of Interest<\/h3>\n\n\n\n<p><a href=\"https:\/\/uofnebraska.sharepoint.com\/:w:\/s\/UNL-ResearchComplianceServicesSharepoint\/IQAlnU9PwwdbSquVEyjcASi5AaaQqMabMaEugKpIHsu6Llk?e=Tx4r2R\" target=\"_blank\" rel=\"noreferrer noopener\">16.001: Conflict of Interest (COI) Identification and Management<\/a><\/p>\n\n\n\n<p>16.002: Reserved<\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The University of Nebraska-Lincoln\u2019s (UNL) Human Research Protection Program (HRPP) and the projects that are approved through the IRB must follow,&nbsp;Federal regulations, state regulations, institutional policies. The individual HRPP policies and procedures listed below are the most up-to-date versions. Revisions to the Common Rule (45 CFR 46) went into effect as of January 21, 2019. [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-302","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/research.unl.edu\/researchcompliance\/wp-json\/wp\/v2\/pages\/302","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/research.unl.edu\/researchcompliance\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/research.unl.edu\/researchcompliance\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/research.unl.edu\/researchcompliance\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/research.unl.edu\/researchcompliance\/wp-json\/wp\/v2\/comments?post=302"}],"version-history":[{"count":419,"href":"https:\/\/research.unl.edu\/researchcompliance\/wp-json\/wp\/v2\/pages\/302\/revisions"}],"predecessor-version":[{"id":4751,"href":"https:\/\/research.unl.edu\/researchcompliance\/wp-json\/wp\/v2\/pages\/302\/revisions\/4751"}],"wp:attachment":[{"href":"https:\/\/research.unl.edu\/researchcompliance\/wp-json\/wp\/v2\/media?parent=302"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}