{"id":376,"date":"2023-12-22T12:50:51","date_gmt":"2023-12-22T17:50:51","guid":{"rendered":"https:\/\/www.rochester.edu\/ohsp\/?page_id=376"},"modified":"2026-09-09T18:08:59","modified_gmt":"2026-09-09T22:08:59","slug":"scope","status":"publish","type":"page","link":"https:\/\/www.rochester.edu\/ohsp\/irb-review\/scope\/","title":{"rendered":"Scope"},"content":{"rendered":"<p><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_301_RSRB_Scope_and_Authority.pdf\">OHSP policy<\/a> requires <strong>all human subject research<\/strong> conducted or supported by employees or agents of the University of Rochester to undergo Institutional Review Board (IRB) review.<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>OHSP policy requires all human subject research conducted or supported by employees or agents of the University of Rochester to undergo Institutional Review Board (IRB) review. &nbsp;<\/p>\n","protected":false},"author":36,"featured_media":0,"parent":356,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":"","_members_access_role":[],"_members_access_error":""},"class_list":["post-376","page","type-page","status-publish","hentry"],"acf":{"lead_in":"","display_title":"When Do You Need RSRB (IRB) Approval?","subtitle":"","call_to_action":"","hero_image_placement":"no_image","hero_media":"images","hero_pattern_option":"","hero_video":"","hero_image_landing":"","hero_image_landing_two":"","hero_image_landing_three":"","content_modules":[{"acf_fc_layout":"text","anchor":"","css_class":"pb-30","title":"<h2>What is 'human subject research'?<\/h2>","content":"To be considered \u2018human subject research\u2019, a proposal needs to meet the definition of \u2018research\u2019 <strong>and<\/strong> involve \u2018human subjects\u2019 (as defined by Department of Health and Human Service regulation, <a class=\"u-link-external\" href=\"https:\/\/www.ecfr.gov\/on\/2018-07-19\/title-45\/subtitle-A\/subchapter-A\/part-46#46.102\">45 CFR 46.102<\/a>):\r\n<ul>\r\n \t<li><strong>Research:<\/strong> A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.<\/li>\r\n \t<li><strong>Human Subject: <\/strong>A living individual about whom an investigator conducting research: a) obtains information or biospecimens through intervention or interactions with the individual and uses, studies, or analyzes the information or biospecimens or b) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.<\/li>\r\n<\/ul>\r\nNote: The Food &amp; Drug Administration's (FDA) definition of 'research' and 'human subject' differs from the Department of Health and Human Service, based on the involvement of a test article. Reference our <a href=\"#definition\">definitions FAQ<\/a> for more information.","background_color":"#f4f4f4","width":"width-medium"},{"acf_fc_layout":"card_grid","anchor":"","css_class":"pt-0","title":"","description":"","background_color":"#f4f4f4","width":"width-large","columns":"3","cards":[{"card_title":"<h5>Prepare your submission<\/h5>","card_text":"If a proposal meets the definition of \u2018research\u2019 <strong>and<\/strong> \u2018human subjects\u2019, IRB review and approval is required.","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"Preparing your IRB Submission","url":"https:\/\/www.rochester.edu\/ohsp\/irb-review\/submission-preparation\/","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""},{"card_title":"<h5>Unsure if your research qualifies?<\/h5>","card_text":"If you aren't sure whether your proposal is \u2018human subject research\u2019, reference our Determination Checklist","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"","url":"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/DeterminationFormChecklist.pdf","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""},{"card_title":"<h5>Additional guidance<\/h5>","card_text":"For additional information, reference the OHSP Guideline for Determining Human Subject Research","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"","url":"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/301b_GDL_for_Determining_Human_Subj_Research.pdf","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""}]},{"acf_fc_layout":"accordion_new","anchor_id":"faq","classes":"","title":"<h2>IRB scope FAQs<\/h2>","description":"","background":"plain","background_color":"#ffffff","style":"row_blank","expand":"no","accordions":[{"acf_fc_layout":"accordion","accordion_title":"What is the difference between research, clinical research, and a clinical trial?","icon":"","row_content":"It depends on who you\u2019re speaking with and the context of the conversation\u2026 Consider the following regulatory definitions:\r\n<ul>\r\n \t<li>Research (HHS): A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (<a class=\"u-link-external\" href=\"https:\/\/www.ecfr.gov\/cgi-bin\/retrieveECFR?gp=&amp;SID=83cd09e1c0f5c6937cd9d7513160fc3f&amp;pitd=20180719&amp;n=pt45.1.46&amp;r=PART&amp;ty=HTML#se45.1.46_1102\">45 CFR 46.102(l)<\/a>)<\/li>\r\n \t<li>Clinical Trial (HHS): A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes (<a class=\"u-link-external\" href=\"https:\/\/www.ecfr.gov\/cgi-bin\/retrieveECFR?gp=&amp;SID=83cd09e1c0f5c6937cd9d7513160fc3f&amp;pitd=20180719&amp;n=pt45.1.46&amp;r=PART&amp;ty=HTML#se45.1.46_1102\">45 CFR 46.102(b)<\/a>)<\/li>\r\n \t<li>Clinical Investigation (FDA \u2013 Part 50 Protection of Human Subjects): Any experiment that involves a test article and one or more human subjects\u2026 (<a class=\"u-link-external\" href=\"https:\/\/www.ecfr.gov\/cgi-bin\/text-idx?SID=d5f70c40db402a0845529d323748e599&amp;mc=true&amp;node=pt21.1.50&amp;rgn=div5#se21.1.50_13\">21 CFR 50.3(c)<\/a>)<\/li>\r\n \t<li>Clinical Investigation (FDA \u2013 Part 312 Investigation New Drug): Any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects (<a class=\"u-link-external\" href=\"https:\/\/www.ecfr.gov\/cgi-bin\/text-idx?SID=2f5375cbd5ae389f31575edcab881d41&amp;mc=true&amp;node=pt21.5.312&amp;rgn=div5#se21.5.312_13\">21 CFR 50.312.3(b)<\/a>)<\/li>\r\n \t<li>Clinical Investigation (FDA \u2013 Part 812 Investigational Device Exemption): A clinical investigation or research involving one or more subjects to determine the safety or effectiveness of a device (<a class=\"u-link-external\" href=\"https:\/\/www.ecfr.gov\/cgi-bin\/text-idx?SID=2f5375cbd5ae389f31575edcab881d41&amp;mc=true&amp;node=pt21.8.812&amp;rgn=div5#se21.8.812_13\">21 CFR 50.812.3(b)<\/a>)<\/li>\r\n<\/ul>\r\nGenerally, the term \u2018clinical\u2019 relates to the observation of a patient in a health-related setting. And the term \u2018trial\u2019, in the context of research, relates to the use of an intervention. So, \u2018clinical research\u2019 commonly refers to research that is patient or health-oriented and \u2018clinical trial\u2019 commonly refers to a type of clinical research that involves some type of intervention (e.g., a drug, device or behavioral intervention).\r\n\r\nThat said, these terms are often used interchangeably. Definitions may depend on the context, funding agency, and applicable regulations\/policies.","accordion_anchor":"definition"},{"acf_fc_layout":"accordion","accordion_title":"I reviewed the determination checklist and I'm still not sure if I need to get IRB approval?","icon":"","row_content":"(<a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/DeterminationFormChecklist.pdf\">Determination Checklist for reference<\/a>)\r\n\r\nConsult with your <a href=\"https:\/\/www.rochester.edu\/ohsp\/irb-review\/coordinator\/\">IRB Coordinator<\/a>. Verify whether your project requires IRB review <strong>prior<\/strong> to initiating the project.","accordion_anchor":"notsure"},{"acf_fc_layout":"accordion","accordion_title":"My funding agency requires documentation from the IRB confirming a proposal does not involve human subject research. How does this get reviewed?","icon":"","row_content":"If a study sponsor or funding agency requires formal IRB review and determination, submit the proposal for IRB review via <a href=\"https:\/\/www.rochester.edu\/ohsp\/click-irb\/\">Click IRB<\/a>.","accordion_anchor":"funding"},{"acf_fc_layout":"accordion","accordion_title":"Do proposals that qualify for IRB exemption need IRB review?","icon":"","row_content":"Yes. It is the responsibility of the IRB to determine whether a proposal qualifies for IRB exemption. For more information on this process, visit our <a href=\"https:\/\/www.rochester.edu\/ohsp\/irb-review\/exemptions\/\">IRB Exemptions page<\/a>.","accordion_anchor":"exemption"}]},{"acf_fc_layout":"card_grid","anchor":"","css_class":"","title":"<h2 style=\"text-align: center;\">Additional resources<\/h2>","description":"","background_color":"#f4f4f4","width":"width-large","columns":"3","cards":[{"card_title":"<h5>Getting started guide<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"Getting Started Guide","url":"https:\/\/www.rochester.edu\/ohsp\/getting-started\/","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""},{"card_title":"<h5>Preparing your IRB submission<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"Preparing your IRB Submission","url":"https:\/\/www.rochester.edu\/ohsp\/irb-review\/submission-preparation\/","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""},{"card_title":"<h5>Who's my IRB coordinator?<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"Who\u2019s My IRB Coordinator?","url":"https:\/\/www.rochester.edu\/ohsp\/irb-review\/coordinator\/","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""},{"card_title":"<h5>Click IRB resources<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"Click IRB Resources","url":"https:\/\/www.rochester.edu\/ohsp\/click-irb\/","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""},{"card_title":"<h5>OHSP Policy 301: RSRB scope and authority<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"","url":"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_301_RSRB_Scope_and_Authority.pdf","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""},{"card_title":"<h5>OHSP Policy 901: Investigator responsibilities<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"","url":"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_901_Investigator_Responsibilities.pdf","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""}]}]},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>IRB (RSRB) Scope - Office for Human Subject Protection - 糖心传媒<\/title>\n<meta name=\"description\" content=\"Understand when you need Institutional Review Board (IRB) approval for human subject research. 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