{"id":4676,"date":"2024-01-08T15:49:03","date_gmt":"2024-01-08T20:49:03","guid":{"rendered":"https:\/\/www.rochester.edu\/ohsp\/?page_id=4676"},"modified":"2026-09-09T17:10:55","modified_gmt":"2026-09-09T21:10:55","slug":"hrpp","status":"publish","type":"page","link":"https:\/\/www.rochester.edu\/ohsp\/hrpp\/","title":{"rendered":"Human Research Protection Program"},"content":{"rendered":"<p>The purpose of the University\u2019s Human Research Protection Program (UR-HRPP) is to ensure that individuals involved with human subject research understand and apply their obligations to protect the rights, dignity, welfare and privacy of research subjects at the University of Rochester (and its affiliates) by adhering to the highest ethical standards and by complying with applicable federal and state regulations, as well as institutional policies.<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The purpose of the University\u2019s Human Research Protection Program (UR-HRPP) is to ensure that individuals involved with human subject research understand and apply their obligations to protect the rights, dignity,&hellip;<\/p>\n","protected":false},"author":36,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":"","_members_access_role":[],"_members_access_error":""},"class_list":["post-4676","page","type-page","status-publish","hentry"],"acf":{"lead_in":"University of Rochester ","display_title":"Human Research Protection Program (UR-HRPP)","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":"","title":"<h2>Administration of the UR-HRPP<\/h2>","content":"The President of the University, with concurrence of the Board of Trustees, has appointed the University\u2019s <strong>Institutional Official (IO)<\/strong> with the responsibility to oversee the implementation and maintenance of the UR-HRPP. At the University of Rochester, the IO role is delegated to the <a href=\"https:\/\/www.rochester.edu\/university-research\/\"><strong>Vice President for Research<\/strong><\/a>. Daily administration of the UR-HRPP is charged to the <a href=\"http:\/\/www.rochester.edu\/ohsp\"><strong>Office for Human Subject Protection (OHSP)<\/strong><\/a>.\r\n\r\nTo meet the needs of the UR-HRPP, the IO and OHSP coordinate efforts and collaborate with several other departments and institutional committees that provide a variety of oversight, support, and educational opportunities for investigators, study coordinators and research staff conducting human subject research. This includes, but is not limited to:\r\n<ul>\r\n \t<li><a href=\"https:\/\/www.urmc.rochester.edu\/clinical-translational-science-institute.aspx\">Clinical &amp; Translational Science Institute<\/a> (CTSI)<\/li>\r\n \t<li>Conflict of Interest (COI) Advisory Committees<\/li>\r\n \t<li><a href=\"https:\/\/www.urmc.rochester.edu\/clinical-ethics\/ethics-committee.aspx\">Ethics Committee<\/a><\/li>\r\n \t<li><a href=\"http:\/\/internal.rochester.edu\/counsel\/\">Office of Counsel<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.urmc.rochester.edu\/clinical-translational-science-institute\/clinical-research\/office-of-clinical-research.aspx\">Office of Clinical Research<\/a> (OCR)<\/li>\r\n \t<li><a href=\"https:\/\/www.urmc.rochester.edu\/clinical-translational-science-institute\/about\/research-services-branch\/regulatory-support.aspx\">Office of Regulatory Support<\/a> (ORS)<\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/adminfinance\/finance\/office-of-research-accounting-and-costing-standards-oracs\/\">Office of Research Accounting &amp; Costing Standards<\/a> (ORACS)<\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/orpa\/\">Office of Research &amp; Project Administration<\/a> (ORPA)<\/li>\r\n \t<li>Research Compliance Committee<\/li>\r\n \t<li><a href=\"https:\/\/tech.rochester.edu\/\">University Information Technology<\/a> (IT)<\/li>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_503_Ancillary_Committee_Reviews.pdf\">UR-HRPP Ancillary Committees<\/a><\/li>\r\n \t<li><a href=\"https:\/\/sites.mc.rochester.edu\/departments\/hipaa\">URMC &amp; Affiliates Privacy &amp; Security Office<\/a><\/li>\r\n<\/ul>","background_color":"#f4f4f4","width":"width-medium"},{"acf_fc_layout":"card_grid","anchor":"","css_class":"","title":"","description":"","background_color":"#FFFFFF","width":"width-large","columns":"1","cards":[{"card_title":"<h2>Accreditation<\/h2>","card_text":"As a result of the UR-HRPP\u2019s collaborative efforts, and the commitment of the University of Rochester research community at-large, the UR-HRPP has maintained accreditation through the Association for the Accreditation of Human Research Protection Programs (<a class=\"u-link-external\" href=\"http:\/\/www.aahrpp.org\/\">AAHRPP<\/a>) since 2007.","card_background_color":"#FFFFFF","card_hover_color":"transparent","card_link":"","card_hover_arrow":"","card_image":3236,"card_image_size":"image_thumbnail","card_image_placement":"image_left","card_image_hover_state":"","card_image_link":""}]},{"acf_fc_layout":"accordion_new","anchor_id":"","classes":"","title":"<h2>Basic UR-HRPP requirements<\/h2>","description":"Navigating the ethical, regulatory, and institutional standards and requirements within the UR-HRPP can be complicated. Below is a summary of basic \u2018need-to-know\u2019 information for conducting human subject research at the University, with corresponding resources.","background":"decorative","background_color":"#ffffff","style":"row_blank","expand":"yes","accordions":[{"acf_fc_layout":"accordion","accordion_title":"Departmental and Institutional Review Board (IRB) Review ","icon":"","row_content":"All human subject research requires<a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Scientific_Review_Standards_Policy_and_Appendices.pdf\"> Departmental<\/a> and <a href=\"https:\/\/www.rochester.edu\/ohsp\/irb-review\/\">Institutional Review Board (IRB) review<\/a>. Reference our <a href=\"https:\/\/www.rochester.edu\/ohsp\/getting-started\/\">Getting Started with Human Subject Research page<\/a> for more information.<em>\r\n<\/em>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"UR-HRPP Training Requirements","icon":"","row_content":"All study team members engaged in the conduct of human subject research are minimally required to complete and maintain <a href=\"https:\/\/www.rochester.edu\/ohsp\/training\/required-human-subject-protection-training\/\">Human Subject Protection (HSP) training<\/a>. Further training <em>may<\/em> be required based on the nature of the research; reference our <a href=\"https:\/\/www.rochester.edu\/ohsp\/training\/hrpp-training\/\">UR-HRPP Training Requirements page<\/a> for more details.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Principal Investigator Eligibility","icon":"","row_content":"With the exception of research confirmed to be not human subject research or <a href=\"https:\/\/www.rochester.edu\/ohsp\/irb-review\/exemptions\/\">determined to be exempt<\/a>, Principal Investigators (PIs) must meet <a href=\"http:\/\/www.rochester.edu\/orpa\/_assets\/pdf\/policy_pieligib.pdf\">University PI eligibility<\/a> requirements.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Grants and Agreements","icon":"","row_content":"All research-related contracts, grants and agreements are administered by the <a href=\"http:\/\/rochester.edu\/orpa\/\">Office of Research &amp; Project Administration<\/a> (ORPA).\r\n\r\n<strong>Only ORPA representatives are permitted to execute (sign) contracts and communicate post-award administrative requests (e.g., project period extensions, budget modifications, programmatic changes) to funding sponsors on behalf of the University<\/strong>. This includes:\r\n<ul>\r\n \t<li>proposals submitted to external entities for financial support;<\/li>\r\n \t<li>confidentiality agreements (aka non-disclosure agreements);<\/li>\r\n \t<li>clinical trial agreements;<\/li>\r\n \t<li>sponsored research agreements;<\/li>\r\n \t<li>data use agreements;<\/li>\r\n \t<li>data transfer agreements; and<\/li>\r\n \t<li>material transfer agreements.<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Clinical Research Billing Compliance","icon":"","row_content":"All clinical research (i.e., research involving a test article [drug, device, or biologic] or clinical procedure) must comply with the <a href=\"http:\/\/www.rochester.edu\/orpa\/compliance\/clinical\/\">Clinical Research Billing Policy<\/a>, ensuring that clinical procedures, items or tests that are experimental are <a href=\"https:\/\/www.rochester.edu\/orpa\/training\/facportal\/page_19box1.html\">budgeted<\/a> for (and subsequently will be billed for) appropriately. To facilitate this, all research involving billable clinical services must conduct a Coverage Analysis during the study development process. Following IRB approval and throughout research conduct, these studies must be entered to and tracked via the <a href=\"https:\/\/www.urmc.rochester.edu\/clinical-translational-science-institute\/services-and-support\/oncore.aspx\">OnCore Clinical Trial Management System<\/a>.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Financial Interests","icon":"","row_content":"All faculty and research staff with the ability to influence the design, conduct and reporting of research are required to report annually all external <a href=\"http:\/\/www.rochester.edu\/orpa\/compliance\/#fcoi\">financial interests<\/a> for review. New or revised financial interests should be reported within 30 days of discovery or acquisition.\r\n\r\nIn the event a financial conflict of interest is identified, the Dean will take action to eliminate, reduce, or manage the conflict through a Conflict of Interest Management Plan; these plans <em>must<\/em> be followed.\r\n\r\nInvestigators with funding through Public Health Service are also required to complete conflict of interest training every 4 years, and report reimbursed or sponsored travel related to their institutional responsibilities.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"HIPAA Compliance","icon":"","row_content":"All research utilizing protected health information (PHI) conducted under the University of Rochester Medical Center (URMC) &amp; Affiliates covered entity or with study team members that are part of the URMC &amp; Affiliates covered entity must with comply the <a class=\"u-link-external\" href=\"https:\/\/www.hhs.gov\/hipaa\/index.html\">Health Insurance Portability and Accountability Act (HIPAA)<\/a> and URMC HIPAA <a href=\"https:\/\/sharepoint19.mc.rochester.edu\/sites\/HIPAA\/Privacy\/P25.pdf\">Policies<\/a> and <a href=\"https:\/\/sharepoint19.mc.rochester.edu\/sites\/HIPAA\/Privacy\/P25_Procedure.pdf\">Procedures<\/a>.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Data Security","icon":"","row_content":"All human subject research that involves collecting, transmitting or storing electronic data are required to complete the University\u2019s <a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Guideline_on_HSR_Research_Electronic_Data_Security_Assessment_Form.doc\">Human Subject Research Electronic Data Security Assessment Form<\/a>. The form must be included with all IRB submissions and the research may be subject to further review by Data Security.\u00a0 For additional information, see the <a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Guideline_on_HSR_Research_Data_Security_Requirements.pdf\">Guideline for Human Subject Research Data Security Requirements<\/a>.\r\n\r\nAll research that is potentially subject to the <a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Guideline_for_GDPR_QA_for_researchers_with_graphics.pdf\">European Union\u2019s General Data Protection Regulations (GDPR)<\/a> and\/or China\u2019s Personal Information Protection Law (PIPL) must undergo review by the Privacy Office and Counsel.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Ancillary Committee Review","icon":"","row_content":"Additional review and approval by applicable UR-HRPP <a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_503_Ancillary_Committee_Reviews.pdf\">Ancillary Committees<\/a> is required for human subject research involving specific types of subject populations, procedures or research services.\r\n\r\nThis review ensures:\r\n<ul>\r\n \t<li>appropriate expertise is applied to the review of a human subject research proposal;<\/li>\r\n \t<li>applicable regulatory requirements that fall beyond the scope of IRB review are met; and<\/li>\r\n \t<li>adequate resources are available for the conduct of the specific type of research.<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Data and\/or Biospecimen Sharing","icon":"","row_content":"All data and\/or biospecimen shared outside of the institution require the execution of clinical trial agreement, data use or material transfer agreement via ORPA, regardless of the identifiability of the data\/biospecimens. This is includes identifiable, coded, de-identified, anonymized, and\/or anonymous data\/biospecimens.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"ClinicalTrials.gov","icon":"","row_content":"All research meeting the definition of an \u2018<a class=\"u-link-external\" href=\"https:\/\/prsinfo.clinicaltrials.gov\/ACT_Checklist.pdf\">applicable clinical trial<\/a>\u2019 must meet <a href=\"https:\/\/www.urmc.rochester.edu\/clinical-translational-science-institute\/services-and-support\/clinical-trials-registration.aspx\">ClinicalTrials.gov registration and reporting requirements<\/a> in accordance with funding, Food &amp; Drug Administration, and the <a href=\"https:\/\/www.urmc.rochester.edu\/MediaLibraries\/URMCMedia\/ctsi\/about\/images\/Policy-on-Public-Dislcosure-of-Clinical-Trial-Information_V2_102419.pdf\">Office of Clinical Research\u2019s Policy 001 Public Disclosure of Clinical Trial Information<\/a>.","accordion_anchor":""}]}]},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.6 - 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