{"id":1374,"date":"2016-11-18T15:43:20","date_gmt":"2016-11-18T23:43:20","guid":{"rendered":"https:\/\/www.washington.edu\/research\/?page_id=1374"},"modified":"2026-01-30T09:35:07","modified_gmt":"2026-01-30T17:35:07","slug":"federal","status":"publish","type":"page","link":"https:\/\/www.washington.edu\/research\/myresearch-lifecycle\/setup\/sponsor-requirements\/federal\/","title":{"rendered":"Federal"},"content":{"rendered":"<h2>Contents<\/h2>\n<div class=\"table-of-contents\">\n<ul class=\"list-unstyled\">\n<li><a href=\"#agencies\">Agency Specific Requirements and Systems<\/a><\/li>\n<li><a href=\"#contracts\">Federal Contracts<\/a>\n<ul>\n<li><a href=\"#e-verify\">E-Verify<\/a><\/li>\n<li><a href=\"#small-business-subcontracting-plans\">Small Business Subcontracting Plans<\/a><\/li>\n<li><a href=\"#info-security\">Information Security Requirements<\/a><\/li>\n<\/ul>\n<\/li>\n<li><a href=\"#gms\">Federal Post Award Grants Management Systems<\/a><\/li>\n<li><a href=\"#hsr\">Human Subjects Research Considerations<\/a><\/li>\n<\/ul>\n<\/div>\n<p>The next steps necessary to set up your federal award will vary based on the type of award (contract vs. grant or cooperative agreement) and the awarding agency.<\/p>\n<p>Many requirements and restrictions can impact how you set up and manage federal awards. Some standard examples to be aware of include:<\/p>\n<ul>\n<li><a name=\"equipment\"><\/a><strong>Equipment<\/strong>\u00a0\u2013 Federal awards typically have prior approval and disposition requirements on equipment and equipment purchases. Review the award documentation, sponsor guidelines,\u00a0 and consult guidance from:\n<ul>\n<li><a href=\"https:\/\/finance.uw.edu\/pafc\/equipment\">Post Award Fiscal Compliance \u2013 Equipment<\/a>:\u00a0 includes information on prior approvals, cost allocations, and more\u2026<\/li>\n<li><a href=\"http:\/\/f2.washington.edu\/fm\/eio\/\">Equipment Inventory Office<\/a><\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/myresearch-lifecycle\/closeout\/equipment\/\">Equipment Closeout<\/a><\/li>\n<\/ul>\n<\/li>\n<li><strong>Foreign Interests<\/strong>\u00a0\u2013 review\u00a0<a href=\"https:\/\/washington.edu\/research\/compliance\/foreign-interests-in-sponsored-programs\/\">Foreign Interests in Sponsored Programs<\/a><\/li>\n<li><strong>Telecommunications Purchases<\/strong>\u00a0\u2013 review\u00a0<a href=\"https:\/\/finance.uw.edu\/pafc\/restrictions-telecommunications-equipment\">Telecommunications Purchase Restrictions<\/a><\/li>\n<\/ul>\n<p>Other examples may be agency or award specific.<\/p>\n<p><a name=\"agencies\"><\/a><\/p>\n<h2>Agency Specific Requirements and Systems<\/h2>\n<h3>Department of Defense (DoD)<\/h3>\n<h4 style=\"padding-left: 30px;\">US Army Medical Research and Materiel Command (USAMRMC)<\/h4>\n<p style=\"padding-left: 30px;\">Awards under the <a href=\"http:\/\/cdmrp.army.mil\/\" target=\"_blank\" rel=\"noopener noreferrer\">Congressionally Directed Medical Research Program (CDMRP)<\/a> may need approval from the USAMRMC\u2019s Office of Research Protections, in addition to UW Institutional Review Board and UW Institutional Animal Care and Use Committee protocol approvals.<\/p>\n<p style=\"padding-left: 30px;\">Resources including the Funded Investigators Guide from <a href=\"http:\/\/cdmrp.army.mil\/\" target=\"_blank\" rel=\"noopener noreferrer\">CDMRP<\/a>, will guide the PI through setting up awards from USAMRMC.<\/p>\n<h3>Department of Education (DoEd)<\/h3>\n<p>The <a href=\"http:\/\/www2.ed.gov\/fund\/landing.jhtml?src=ln\" target=\"_blank\" rel=\"noopener noreferrer\">DoEd<\/a> has a Grant Management System, <a href=\"https:\/\/www.g5.gov\/ext\/wps\/portal\" target=\"_blank\" rel=\"noopener noreferrer\">G5<\/a>, that OSP uses to retrieve awards and submit changes. We have a different DUNS number for DoED than for other sponsors. \u00a0Use this DUNS #: 042803536.<\/p>\n<p>New to DoEd grants? \u00a0Check out <a href=\"https:\/\/www2.ed.gov\/fund\/grant\/about\/training-management.html?src=grants-page\" target=\"_blank\" rel=\"noopener noreferrer\">DoEd\u2019s e-learning opportunities<\/a>.<\/p>\n<h3>Department of Energy (DOE)<\/h3>\n<p>The <a href=\"https:\/\/pamspublic.science.energy.gov\/\" target=\"_blank\" rel=\"noopener noreferrer\">Portfolio Analysis and Management System (PAMS)<\/a> is used for:<\/p>\n<ul>\n<li>Viewing award documents<\/li>\n<li>PI submission of Progress Reports<\/li>\n<li>OSP submission of \u00a0Award Modification Requests<\/li>\n<\/ul>\n<h4><a name=\"foreign-natl-doe\"><\/a>Foreign National Participation on DOE Awards<\/h4>\n<p>When foreign national participation is anticipated on DOE awards that include FAR Clause 142.3A or 142.3B, the PI\/Dept. must notify <a href=\"mailto:osp@uw.edu\">osp@uw.edu<\/a>. This email should provide the following information:<\/p>\n<ul>\n<li>eGC1#<\/li>\n<li>Note there needs to be\u00a0 foreign national participation on the award<\/li>\n<li>Unit HR contact who will complete foreign national information (e.g. citizenship) details<\/li>\n<li>List of foreign nationals (first, last) who need to participate<\/li>\n<\/ul>\n<p>An OSP reviewer will contact the sponsor to initiate the secure DOE NETL Form or DOE FAST system process used to make a formal request to include foreign nationals. The appropriate departmental HR contact must provide personally identifiable information (PII) regarding each foreign national participant. Separately, the UW Export Control office may follow up with the PI to implement any needed security plan.<\/p>\n<h3>Department of Justice (DoJ)<\/h3>\n<p>DoJ grants run through the <a href=\"https:\/\/ojp.gov\/funding\/index.htm\" target=\"_blank\" rel=\"noopener noreferrer\">Office of Justice Programs (OJP)<\/a>. They use <a href=\"https:\/\/justicegrants.usdoj.gov\/\" target=\"_blank\" rel=\"noopener noreferrer\">JustGrants<\/a> for the award set up and post award activities such as progress reporting.<\/p>\n<p>Work closely with your OSP reviewer to setup your DoJ award.<\/p>\n<h3>Department of Health and Human Services (HHS)<\/h3>\n<p>Many agencies that fall under the HHS such as National Institutes of Health (NIH), Agency for Healthcare and Research Quality (AHRQ), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA) and Substance Abuse and Mental Health Services Administration (SAMHSA) use <a href=\"https:\/\/public.era.nih.gov\/commons\/public\/login.do?TYPE=33554433&amp;REALMOID=06-1edb031f-46c7-44b3-b803-60b537de74d2&amp;GUID=&amp;SMAUTHREASON=0&amp;METHOD=GET&amp;SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&amp;TARGET=-SM-http%3a%2f%2fpublic%2eera%2enih%2egov%2fcommons\" target=\"_blank\" rel=\"noopener noreferrer\">eRA Commons<\/a> for certain pre-award, post award, and closeout activities.<\/p>\n<p>Review the eRA Commons <a href=\"https:\/\/era.nih.gov\/reg_accounts\/account_roles.cfm\" target=\"_blank\" rel=\"noopener noreferrer\">roles<\/a> to determine which role you need, and <a href=\"mailto:ayee@uw.edu\">contact OSP<\/a> for access.<\/p>\n<p>More select agency guidance is available below.<\/p>\n<h3>Health Resources and Services Administration (HRSA)<\/h3>\n<p><a href=\"https:\/\/grants3.hrsa.gov\/2010\/WebEPSExternal\/Interface\/common\/accesscontrol\/login.aspx?\" target=\"_blank\" rel=\"noopener noreferrer\">HRSA Electronic Handbook<\/a> (EHB) is the single access point for all HRSA grant and non-grant programs for grant submission and administration. Create your EHB account following HRSA instructions.<\/p>\n<h3>National Institutes of Health (NIH)<\/h3>\n<p>Notice of Grant Awards (NOAs) from NIH are sent directly to the Office of Sponsored Programs. PIs do not need to provide a copy to OSP. NOAs are also available in the <a href=\"https:\/\/public.era.nih.gov\/commons\/public\/login.do?TYPE=33554433&amp;REALMOID=06-1edb031f-46c7-44b3-b803-60b537de74d2&amp;GUID=&amp;SMAUTHREASON=0&amp;METHOD=GET&amp;SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&amp;TARGET=-SM-http%3a%2f%2fpublic%2eera%2enih%2egov%2fcommons\" target=\"_blank\" rel=\"noopener noreferrer\">eRA Commons.<\/a><\/p>\n<p>Be sure to review the <a href=\"https:\/\/grants.nih.gov\/policy\/nihgps\/index.htm\" target=\"_blank\" rel=\"noopener noreferrer\">NIH Grants Policy Statement<\/a> in addition to the terms of your award.<\/p>\n<div class=\"featured-content-wrapper\">\n<div class=\"featured-content-body\" style=\"padding-left: 30px;\"><a href=\"https:\/\/grants.nih.gov\/grants\/acknow.htm\">Communicating and Acknowledging Federal Funding<\/a><\/div>\n<div class=\"featured-content-body\" style=\"padding-left: 30px;\"><a href=\"https:\/\/www.washington.edu\/research\/announcements\/nih-formatting-attachments-pdfs-esignatures\/\">NIH Formatting Attachments, PDFs, and Electronic Signatures<\/a><\/div>\n<\/div>\n<h3>National Oceanic and Atmospheric Administration (NOAA)<\/h3>\n<p>NOAA uses the Department of Commerce\u2019s <a href=\"https:\/\/public.era.nih.gov\/commons\/public\/login.do?TYPE=33554433&amp;REALMOID=06-1edb031f-46c7-44b3-b803-60b537de74d2&amp;GUID=&amp;SMAUTHREASON=0&amp;METHOD=GET&amp;SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&amp;TARGET=-SM-http%3a%2f%2fpublic%2eera%2enih%2egov%2fcommons\" target=\"_blank\" rel=\"noopener noreferrer\">eRA Commons.<\/a><\/p>\n<h4>Resources<\/h4>\n<p><a href=\"https:\/\/www.noaa.gov\/organization\/acquisition-grants\" target=\"_blank\" rel=\"noopener noreferrer\">NOAA Grants Policy<\/a><\/p>\n<h3>National Science Foundation (NSF)<\/h3>\n<p>Awards from NSF are sent directly to OSP. PIs do not need to provide a copy to OSP. Awards are also available in the sponsor system (Research.gov).<\/p>\n<p>PIs get access during <a href=\"https:\/\/www.washington.edu\/research\/myresearch-lifecycle\/plan-and-propose\/sponsor-requirements\/federal\/#nsf-proposal-instructions\">proposal preparation<\/a>. The same user information is used to log into <a href=\"http:\/\/www.research.gov\/research-portal\/appmanager\/base\/desktop?_nfpb=true&amp;_pageLabel=research_home_page\" target=\"_blank\" rel=\"noopener noreferrer\">Research.gov<\/a> for project reporting and financial management.<\/p>\n<h2><a name=\"contracts\"><\/a>Federal Contracts<\/h2>\n<p>Federal Contracts require compliance with numerous federal rules and regulations including the\u00a0<a href=\"http:\/\/www.acquisition.gov\/far\/\" target=\"_blank\" rel=\"noopener noreferrer\">Federal Acquisition Regulation (FAR)<\/a>.<\/p>\n<p>Project set up, reporting, and management must be handled according to specific requirements in the contract. There can be a significant amount of planning, work, and cost involved to implement and follow these requirements.<\/p>\n<p>In some cases, this planning and work must be done before the contract is even awarded.<\/p>\n<p>Failure to comply, perform or follow deadlines in federal contracts can result in criminal\/civil and financial consequences for the PI and the University.<\/p>\n<h3><a name=\"e-verify\"><\/a>E-Verify<\/h3>\n<p>Many federal contracts and flow-through federal contracts require the use of <a href=\"https:\/\/isc.uw.edu\/admin-corner\/hcm-resources\/e-verify\/\" target=\"_blank\" rel=\"noopener noreferrer\">E-Verify<\/a> to establish employment eligibility of designated employees. This requirement does not apply to grants.<\/p>\n<p>During the award set up process, OSP notifies departments and PIs if their federal contracts contain the E-Verify clause. Visit the Integrated Service Center&#8217;s <a href=\"https:\/\/isc.uw.edu\/admin-corner\/hcm-resources\/e-verify\/\" target=\"_blank\" rel=\"noopener noreferrer\">E-Verify guidance<\/a> for details on the process.<\/p>\n<h3><a name=\"small-business-subcontracting-plans\"><\/a>Small Business Subcontracting Plans<\/h3>\n<p>If the contract proposal requires the submission of a Small Business Subcontracting Plan, review the Procurement Services <a href=\"http:\/\/finance.uw.edu\/fm\/ps\/resources\/forms\" target=\"_blank\" rel=\"noopener noreferrer\">small business subcontracting plan instructions and worksheet<\/a>.<\/p>\n<h3><a name=\"info-security\"><\/a>Information and Security Requirements<\/h3>\n<p>Check your contract to determine whether it includes requirements related to Homeland Security Presidential Directive 12 (<a href=\"https:\/\/hspd12.usda.gov\/\" target=\"_&quot;blank&quot;\" rel=\"noopener noreferrer\">HSPD-12<\/a>), Federal Information Processing Standards (FIPS), and\/or Federal Information Security Management Act (<a href=\"https:\/\/www.dhs.gov\/fisma\" target=\"_blank\" rel=\"noopener noreferrer\">FISMA<\/a>).<\/p>\n<p>If the contract includes them, these requirements may impact your budget, consider costs when preparing your proposal.<\/p>\n<h4 style=\"padding-left: 30px;\">Typical HSPD-12\/FIPS\/FISMA Requirements:<\/h4>\n<p style=\"padding-left: 30px;\">Information Technology (IT) Security Plans, Risk Assessment and FIPS 199 Assessment are all due within 30 days of the contract being awarded. Security Certification &amp; Accreditation is due within 3 months after a contract has been awarded.<\/p>\n<p style=\"padding-left: 30px;\"><b>Due within 30 Days After Contract Award<\/b><\/p>\n<p style=\"padding-left: 30px;\"><b>IT Security Plans (IT-SP)<\/b><\/p>\n<p style=\"padding-left: 30px;\">These plans must describe the process and procedures that will be followed to ensure the security of IT resources. It must also comply with numerous federal regulations such as: FISMA, <a href=\"http:\/\/csrc.nist.gov\/publications\/PubsSPs.html\" target=\"_blank\" rel=\"noopener noreferrer\">National Institute of Standards and Technology (NIST) 800-18 and 800-26<\/a>, HHS Office of the Chief Information Officer (OCIO) Information Systems as well as others.<\/p>\n<p style=\"padding-left: 30px;\"><b>IT Risk Assessment (IT-RA)<\/b><\/p>\n<p style=\"padding-left: 30px;\">Must be consistent with NIST 800-30-Risk Management Guide for Information Technology Systems and any additions for augmentations described in the HHS-OCIO Information Systems Security &amp; Privacy Policy<\/p>\n<p style=\"padding-left: 30px;\"><b>FIPS 199 Assessment<\/b><\/p>\n<p style=\"padding-left: 30px;\">Must follow the <a href=\"http:\/\/csrc.nist.gov\/publications\/PubsSPs.html \">NIST standard<\/a>.<\/p>\n<p style=\"padding-left: 30px;\"><b>Due within 3 Months After Contract Award<\/b><\/p>\n<p style=\"padding-left: 30px;\"><b>IT Security Certification &amp; Accreditation (IT-SCA)<\/b><br \/>\nMust follow the HHS Chief Information Security Officer&#8217;s Certification &amp; Accreditation Checklist, NIST 800-37, and 800-53.<\/p>\n<p style=\"padding-left: 30px;\">Contractors must submit written proof that an IT-SCA was performed for applicable information systems. The draft IT-SCA must be signed by a senior management official.<\/p>\n<h2><a name=\"gms\"><\/a>Federal Post Award Grants Management Systems<\/h2>\n<p>Many sponsors have their own post award grants management systems. Set up access for required individuals including the PI.<br \/>\n<span style=\"font-weight: 400;\"><\/p>\n<div class=\"accordion non-bold\" id=\"accessible-accordion\">\n<div class=\"screen-reader-text\">Accessible Accordion<\/div>\n<p><\/span><\/p>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Department of Energy<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p><a href=\"https:\/\/pamspublic.science.energy.gov\/\" target=\"_blank\" rel=\"noopener noreferrer\">Portfolio Analysis and Management System (PAMS)<\/a><\/p>\n<ul>\n<li>Pre-award and post award functions<\/li>\n<li><a href=\"https:\/\/www.washington.edu\/research\/contact-us\/?keyword=598\">Contact your Office of Sponsored Programs (OSP) Reviewer<\/a> for access<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Department of the Interior<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p><a href=\"https:\/\/www.doi.gov\/grants\/grantsolutions\" target=\"_blank\" rel=\"noopener noreferrer\">GrantSolutions<\/a><\/p>\n<ul>\n<li>DOI award recipients who don\u2019t already have a GrantSolutions account, must <a href=\"https:\/\/www.grantsolutions.gov\/home\/getting-started-request-a-user-account\/\" target=\"_blank\" rel=\"noopener noreferrer\">request an account<\/a>.<\/li>\n<li>Complete and sign the <a href=\"https:\/\/www.grantsolutions.gov\/home\/getting-started-request-a-user-account\/\" target=\"_blank\" rel=\"noopener noreferrer\">Recipient User Account Request Form<\/a>, Part 1 (Rules of Behavior) on the <a href=\"https:\/\/www.grantsolutions.gov\/home\/getting-started-request-a-user-account\/\" target=\"_blank\" rel=\"noopener noreferrer\">GrantSolutions Getting Started<\/a> page.<\/li>\n<li>Complete Part 2 and email the entire form to <a href=\"mailto:osp@uw.edu\" target=\"_blank\" rel=\"noopener noreferrer\">osp@uw.edu<\/a> for signature. OSP will sign Part 2 and submit the both parts to GrantSolutions.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Department of Justice<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<ul>\n<li><a href=\"https:\/\/justicegrants.usdoj.gov\/\" target=\"_blank\" rel=\"noopener noreferrer\">JustGrants<\/a><\/li>\n<li>Review <a href=\"https:\/\/justicegrants.usdoj.gov\/training-resources\/justgrants-training\/grants-management-lifecycle\" target=\"_blank\" rel=\"noopener noreferrer\">JustGrants Training Resources<\/a><\/li>\n<\/ul>\n<\/div>\n<\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">National Institutes of Health<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p><a href=\"https:\/\/public.era.nih.gov\/commons\/public\/login.do?TYPE=33554433&amp;REALMOID=06-1edb031f-46c7-44b3-b803-60b537de74d2&amp;GUID=&amp;SMAUTHREASON=0&amp;METHOD=GET&amp;SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&amp;TARGET=-SM-http%3a%2f%2fpublic%2eera%2enih%2egov%2fcommons\" target=\"_blank\" rel=\"noopener noreferrer\">eRA Commons<\/a><\/p>\n<ul>\n<li>PI needs access starting at the proposal phase<\/li>\n<li><a href=\"mailto:ayee@uw.edu@uw.edu\">Contact OSP<\/a> for access<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">National Science Foundation<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p><a href=\"https:\/\/www.research.gov\/research-portal\/appmanager\/base\/desktop?_nfpb=true&amp;_pageLabel=research_home_page\" target=\"_blank\" rel=\"noopener noreferrer\">Research.gov<\/a><\/p>\n<ul>\n<li>PI needs access starting at the proposal phase<\/li>\n<li>Used to prepare proposals, request post-award changes, reporting, and other post award management functions<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<h2><a name=\"hsr\"><\/a>Human Subjects Research Considerations<\/h2>\n<p><em>See the <a href=\"https:\/\/www.washington.edu\/research\/hsd\/\">Human Subjects Division (HSD) website<\/a> for information about all aspects of human subjects research.<\/em><\/p>\n<p>Almost all federally funded human subjects research must comply with several specific requirements that are part of setting up the project.<\/p>\n<p><strong>Obtain Institutional Review Board (IRB) approval or an exempt determination<\/strong> before conducting any human subjects activities or spending any research funding on such activities.<\/p>\n<h3>Complete Required Training<\/h3>\n<p>Federal sponsors require <a href=\"https:\/\/www.washington.edu\/research\/glossary\/seniorkey-personnel-per-nih\/\">senior\/key personnel<\/a> to complete <a href=\"https:\/\/www.washington.edu\/research\/hsd\/training\/required-training\/human-subjects-protections-training\/\">training in human subjects protections<\/a>. In addition, principal investigators and clinical trial staff conducting NIH supported clinical trials must complete a <a href=\"https:\/\/www.washington.edu\/research\/hsd\/training\/required-training\/good-clinical-practice-training\/\">Good Clinical Practice (GCP)<\/a> course every three years.<\/p>\n<h3>Establish a single IRB for multi-site clinical trials<\/h3>\n<p>A single IRB must be used to review all domestic sites participating in federally-funded multi-site or collaborative research, beginning January 20, 2020. <a href=\"mailto:hsdinfo@uw.edu\">Contact HSD<\/a> for consultation about who should be the single IRB and how to start the single IRB process.<\/p>\n<h3><strong>Register Clinical Trials<\/strong><\/h3>\n<p>Studies that meet the definition of &#8220;clinical trial&#8221; must <a href=\"https:\/\/clinicaltrials.gov\/ct2\/manage-recs\/register\" target=\"_blank\" rel=\"noopener noreferrer\">register at ClincalTrials.gov<\/a>.<\/p>\n<h3>Genomic Data Certification<\/h3>\n<p>NIH funded studies that will create human genomic data are required to send the data to an NIH database, for broad sharing with other researchers. This data must be &#8220;certified&#8221; by the PI&#8217;s institution prior to sending the data. The <a href=\"https:\/\/www.washington.edu\/research\/policies\/sop-request-for-genomic-data-sharing-certification-investigators-2\/\">certification process<\/a>\u00a0is usually part of the Just-in-Time process and part of the initial IRB process.<\/p>\n<h3>Specific Federal Agency Requirements<\/h3>\n<p>See HSD&#8217;s Worksheets for information about specific human subjects requirements for the following federal agencies: <a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/worksheet-department-of-defense-dod\/\">Department of Defense<\/a>, <a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/worksheet-department-of-justice\/\">Department of Justice<\/a> (includes the National Institute of Justice), <a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/worksheet-environmental-protection-agency\/\">Environmental Protection Agency<\/a>, and <a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/worksheet-department-of-energy\/\">Department of Energy<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Contents Agency Specific Requirements and Systems Federal Contracts E-Verify Small Business Subcontracting Plans Information Security Requirements Federal Post Award Grants Management Systems Human Subjects Research Considerations&#8230;<\/p>\n","protected":false},"author":13,"featured_media":0,"parent":449,"menu_order":1,"comment_status":"closed","ping_status":"closed","template":"templates\/page-builder-lifecycle.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-1374","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - 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