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Key concepts such as IRB of record, relying/reviewing IRBs, lead institution, collaborating sites, and common reliance agreements are defined to support consistent compliance.",{"@graph":14,"@context":73},[15,34,56],{"@type":16,"itemListElement":17},"BreadcrumbList",[18,23,27,31],{"item":19,"name":20,"@type":21,"position":22},"https://docshare.wps.com","Home","ListItem",1,{"item":24,"name":25,"@type":21,"position":26},"https://docshare.wps.com/template/","Template",2,{"item":28,"name":29,"@type":21,"position":30},"https://docshare.wps.com/template/forms/","Forms",3,{"item":32,"name":10,"@type":21,"position":33},"https://docshare.wps.com/template/ugahrp-010a-3-purpose-definitions-and-single-irb-of-record-guidance/307145/",4,{"url":32,"name":10,"@type":35,"image":36,"author":41,"headline":10,"publisher":44,"fileFormat":47,"inLanguage":8,"description":12,"dateModified":48,"datePublished":49,"encodingFormat":47,"isAccessibleForFree":50,"interactionStatistic":51},"DigitalDocument",{"url":37,"@type":38,"width":39,"height":40},"https://docshare.wps.com/thumbnails/ugahrp-010a-3-purpose-definitions-and-single-irb-of-record-guidance/307145.png","ImageObject",442,249,{"name":42,"@type":43},"Well Done","Person",{"url":19,"name":45,"@type":46},"DocShare","Organization","application/pdf","2026-10-23","2026-09-19",true,{"@type":52,"interactionType":53,"userInteractionCount":55},"InteractionCounter",{"@type":54},"ViewAction",8,{"@type":57,"mainEntity":58},"FAQPage",[59,65,69],{"name":60,"@type":61,"acceptedAnswer":62},"When must cooperative research rely on a single IRB for U.S. domestic portions?","Question",{"text":63,"@type":64},"For research covered by the Revised Common Rule, a U.S. institution engaged in cooperative research must rely on approval by a single IRB for the portion conducted in the United States. The reviewing IRB is identified by the supporting/ conducting federal department or agency or by the lead institution subject to federal acceptance.","Answer",{"name":66,"@type":61,"acceptedAnswer":67},"What is required under the NIH Single IRB (sIRB) Policy for multi-site research?",{"text":68,"@type":64},"For most NIH grants and contracts submitted on or after January 25, 2018 involving multi-site non-exempt human subjects research, the policy requires use of a single IRB to accomplish IRB review and approval for all domestic sites. The requirement does not apply to sites outside the United States.",{"name":70,"@type":61,"acceptedAnswer":71},"What documents and roles are defined to support reliance-based review?",{"text":72,"@type":64},"The guidance defines an IRB Authorization Agreement (IAA) / Reliance Agreement, explains what external and collaborating sites are, and clarifies roles such as lead institution, IRB of record (central/sIRB), relying site, reviewing IRB, and corresponding lead/relying PIs.","https://schema.org",{"og:url":32,"og:type":75,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":77,"canonical":32},"index,follow",{"doc_id":79,"site_id":7},307145,1790412513,{"code":4,"msg":82,"data":83},"success",[84,89,94,99,104,109,113,118,123],{"id":85,"doc_module":22,"doc_module_name":25,"category_name":86,"show_sort_weight":87,"slug":88},11,"Presentations",90,"presentations",{"id":90,"doc_module":22,"doc_module_name":25,"category_name":91,"show_sort_weight":92,"slug":93},12,"Resumes",80,"resumes",{"id":95,"doc_module":22,"doc_module_name":25,"category_name":96,"show_sort_weight":97,"slug":98},14,"Invoices",70,"invoices",{"id":100,"doc_module":22,"doc_module_name":25,"category_name":101,"show_sort_weight":102,"slug":103},15,"Posters",60,"posters",{"id":105,"doc_module":22,"doc_module_name":25,"category_name":106,"show_sort_weight":107,"slug":108},16,"Social Media",50,"social-media",{"id":110,"doc_module":22,"doc_module_name":25,"category_name":29,"show_sort_weight":111,"slug":112},17,40,"forms",{"id":114,"doc_module":22,"doc_module_name":25,"category_name":115,"show_sort_weight":116,"slug":117},18,"Letters",30,"letters",{"id":119,"doc_module":22,"doc_module_name":25,"category_name":120,"show_sort_weight":121,"slug":122},21,"Paper Templates",5,"papers-templates",{"id":124,"doc_module":22,"doc_module_name":25,"category_name":125,"show_sort_weight":4,"slug":126},158,"General","general-158",{"code":4,"msg":82,"data":128},{"doc_id":79,"user_id":129,"nickname":42,"user_avatar":130,"doc_module":22,"category_id":110,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":131,"file_id":132,"file_url":133,"file_type":134,"file_size":135,"view_count":55,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":136,"language":137,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":138,"faqs":139,"seo_title":140,"seo_description":12,"update_tm":141,"read_time":30},5909892210082,"https://ap-avatar.wpscdn.com/avatar/56001069da27c9f41e8?x-image-process=image/resize,m_fixed,w_180,h_180&k=1789614185077863061","|  |  |  |  |  |\n| --- | --- | --- | --- | --- |\n| UGAHRP-010a-3 | 5/24/2021 | HSO | HSO Director (HRPP Policy Committee notified) | Page 1 of 7 |\n\n1. PURPOSE  \n1.1. It is common for University of Georgia (UGA) researchers to be involved in multi-site studies or collaborative work with researchers from other institutions. Two recent federal mandates have altered the way IRBs are required to review multi-site and cooperative research.  \n• The Federal Policy for the Protection of Human Subjects (the Common Rule) was revised effective July 19, 2018. The Revised Common Rule includes a requirement that,“Any institution located in the United States that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States. The reviewing IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research”(45 CFR 46. 114) . The policy applies to research initially approved by an IRB on or after January 20, 2020. Federal departments and agencies that have signed onto the Revised Common Rule are listed at [https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common](https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common)rule/index. html  \n• The Single IRB (sIRB) Policy for Multi-site Research is a NIH policy that applies to most grants and contracts submitted to NIH on or after January 25, 2018 that involve multi-site non-exempt human subjects research. The policy requires the use of a single IRB to accomplish IRB review and approval for all domestic sites. The requirement for single IRB review does not apply to awardees or research sites outside the United States.  \no Awardee institutions are responsible for ensuring reliance agreements are complete and documented.  \no Participating sites are expected to rely on the single IRB unless an exception is granted by NIH in accordance with NIH policy on exceptions from single IRB review.  \n1.2. For research not subject to these requirements, Department of Health and Human Services (DHHS) regulations allow institutions conducting cooperative research projects to “enter into a joint review arrangement, rely upon the review of another qualified Institutional Review Board (IRB), or make similar arrangements for avoiding duplication of effort”(45 CFR 46 . 114) . UGA IRB may serve as a single IRB (the “IRB of record” or “sIRB”) for review and continuing oversight of the research in order to comply with the new federal requirement, or to avoid duplication of review and facilitate the review process. The purpose of this policy is to provide guidance on the requirements and procedures that the UGA IRB follows when serving as the single IRB.  \n\n|  |  |  |  |  |\n| --- | --- | --- | --- | --- |\n| UGAHRP-010a-3 | 5/24/2021 | HSO | HSO Director (HRPP Policy Committee notified) | Page 2 of 7 |\n\n2. DEFINITIONS  \n2.1. IRB Authorization Agreement (IAA): a written agreement between two institutions collaborating in non-exempt research that describes each institution’s authority, roles, and responsibilities for review and oversight of the research and communication between thereviewing and the relying IRBs. The IAA is usually for a single project. Also known as: Reliance Agreement.  \n2.2. External IRB: is the local IRB at an external site.  \n2.3. Collaborating site: refers to an institution or organization with which a non-UGA investigator or collaborating organization is affiliated.  \n2.4. Cooperative research: is human subjects research that involves more than one institution.  \nAlso known as: Collaborative research.  \n2.5. Lead institution: is one that initiates or manages a research study involving multiple sites that conduct research procedures for the study.  \n2.6. IRB of record: refers to the IRB that conducts the review of and provides oversight for multisite or","cbCaibP7ZL47C2cx","https://ap.wps.com/l/cbCaibP7ZL47C2cx","pdf",678065,7,"English","# Purpose\n## Federal requirements for cooperative research\n## Single IRB (sIRB) policy for multi-site research\n## Joint review arrangements for non-applicable studies\n# Definitions\n## IRB authorization and reliance agreements\n## Roles: lead/relying/reviewing IRBs and PIs\n## Study types and key terms","[{\"question\":\"When must cooperative research rely on a single IRB for U.S. domestic portions?\",\"answer\":\"For research covered by the Revised Common Rule, a U.S. institution engaged in cooperative research must rely on approval by a single IRB for the portion conducted in the United States. The reviewing IRB is identified by the supporting/ conducting federal department or agency or by the lead institution subject to federal acceptance.\"},{\"question\":\"What is required under the NIH Single IRB (sIRB) Policy for multi-site research?\",\"answer\":\"For most NIH grants and contracts submitted on or after January 25, 2018 involving multi-site non-exempt human subjects research, the policy requires use of a single IRB to accomplish IRB review and approval for all domestic sites. The requirement does not apply to sites outside the United States.\"},{\"question\":\"What documents and roles are defined to support reliance-based review?\",\"answer\":\"The guidance defines an IRB Authorization Agreement (IAA) / Reliance Agreement, explains what external and collaborating sites are, and clarifies roles such as lead institution, IRB of record (central/sIRB), relying site, reviewing IRB, and corresponding lead/relying PIs.\"}]","UGAHRP-010a-3 - Purpose, Definitions and Single IRB of Record Guidance | PDF",1789844831]