{"id":706,"date":"2023-12-22T13:05:44","date_gmt":"2023-12-22T18:05:44","guid":{"rendered":"https:\/\/www.rochester.edu\/ohsp\/?page_id=706"},"modified":"2026-09-11T15:21:26","modified_gmt":"2026-09-11T19:21:26","slug":"policies","status":"publish","type":"page","link":"https:\/\/www.rochester.edu\/ohsp\/policies\/","title":{"rendered":"Policies"},"content":{"rendered":"","protected":false},"excerpt":{"rendered":"","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-706","page","type-page","status-publish","hentry"],"acf":{"lead_in":"","display_title":"","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":"accordion_new","anchor_id":"","classes":"pt-0 pb-0","title":"","description":"Explore policy documents and guideline documents for all OHSP policies in the drop-downs below, organized by policy topic.\r\n\r\n<hr \/>\r\n\r\n<h2>General administration<\/h2>","background":"plain","background_color":"#ffffff","style":"row_blank","expand":"yes","accordions":[{"acf_fc_layout":"accordion","accordion_title":"Policy 101: Maintenance of Policies","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_101_Maintenance_of_Policies.pdf\">Download Policy 101<\/a><\/li>\r\n \t<li><strong>Purpose: <\/strong>Outlines the process for creating and maintaining OHSP policies.<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Policy 102: 糖心传媒\u2019s (UR) Human Research Protection Program (HRPP)","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_102_UofR_Human_Research_Program.pdf\">Download Policy 102<\/a><\/li>\r\n \t<li><strong>Purpose:\u00a0<\/strong>Describes the UR-HRPP program.<\/li>\r\n \t<li><strong>Related resources:<\/strong>\r\n<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/hrpp\/\">UR-HRPP Overview page<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/training\/hrpp-training\/\">UR-HRPP Training Requirements page<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Policy 103: Organizational Structure of the HRPP","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_103_Org_Structure_of_HRPP.pdf\">Download Policy 103<\/a><\/li>\r\n \t<li><strong>Purpose:\u00a0<\/strong>Describes the administrative structure to support the UR-HRPP.<\/li>\r\n \t<li><strong>Related resources:<\/strong>\r\n<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/hrpp\/\">UR-HRPP Overview page<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/09\/OHSPOrgChart.pdf\">OHSP Organizational Chart<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Policy 104: Institutional Conflict of Interest","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_104_Institutional_Conflict_of_Interest.pdf\">Download Policy 104<\/a><\/li>\r\n \t<li><strong>Purpose:\u00a0<\/strong>Ensures institutional conflicts of interest are identified and managed or eliminated as appropriate within the online IRB review system.<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Policy 105: HRPP Emergency Preparedness","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/12\/Policy_105_Emergency_Preparedness.pdf\">Download Policy 105<\/a><\/li>\r\n \t<li><strong>Purpose: <\/strong>Establishes an HRPP emergency preparedness process within the UR to ensure the protection of the rights and welfare of human subject research subjects in the event of an emergency or disaster situation.<\/li>\r\n<\/ul>","accordion_anchor":""}]},{"acf_fc_layout":"text","anchor":"","css_class":"pb-0 pt-0","title":"<hr \/>","content":"","background_color":"#ffffff","width":"width-medium"},{"acf_fc_layout":"accordion_new","anchor_id":"training","classes":"pt-30 pb-0","title":"<h2>Training and education<\/h2>","description":"","background":"plain","background_color":"#ffffff","style":"row_blank","expand":"yes","accordions":[{"acf_fc_layout":"accordion","accordion_title":"Policy 201: Education Program","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_201_Education_Program.pdf\">Download Policy 201<\/a><\/li>\r\n \t<li><strong>Purpose:\u00a0<\/strong>Describes institutional training requirements and educational opportunities for individuals within the UR-HRPP.<\/li>\r\n \t<li><strong>Related resources:<\/strong>\r\n<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/training\/\">Training Overview page<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/training\/required-human-subject-protection-training\/\">Required HSP Training page<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","accordion_anchor":""}]},{"acf_fc_layout":"text","anchor":"","css_class":"pb-0 pt-0","title":"<hr \/>","content":"","background_color":"#ffffff","width":"width-medium"},{"acf_fc_layout":"accordion_new","anchor_id":"scope","classes":"pt-30 pb-0","title":"<h2>IRB scope and organization<\/h2>","description":"","background":"plain","background_color":"#ffffff","style":"row_blank","expand":"yes","accordions":[{"acf_fc_layout":"accordion","accordion_title":"Policy 301: RSRB Scope and Authority","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_301_RSRB_Scope_and_Authority.pdf\">Download Policy 301<\/a><\/li>\r\n \t<li><strong>Purpose:\u00a0<\/strong>Defines the role and responsibilities of the University\u2019s Institutional Review Board (IRB).<\/li>\r\n \t<li><strong>Supporting guidelines:<\/strong>\r\n<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/301a_GDL_for_Determining_Engagement_in_Research.pdf\">Determining Engagement in Research<\/a><\/li>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/301b_GDL_for_Determining_Human_Subj_Research.pdf\">Determining Human Subject Research<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li><strong>Related resources:<\/strong>\r\n<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/irb-review\/\">Overview of the IRB page<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/irb-review\/scope\/\">Scope of the IRB page<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/DeterminationFormChecklist.pdf\">Research vs QI Determination Checklist<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Policy 302: RSRB Membership and Composition","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_302_RSRB_Membership_and_Composition.pdf\">Download Policy 302<\/a><\/li>\r\n \t<li><strong>Purpose:\u00a0<\/strong>Describes the composition of the IRB and the role\/responsibilities of the IRB members.<\/li>\r\n \t<li><strong>Supporting guidelines:<\/strong>\r\n<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/302_GDL_for_Board_Member_Terms_of_Appt.pdf\">Board Member Terms of Appointment, Evaluation and Re-Appointment<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li><strong>Related resources:<\/strong>\r\n<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/irb-review\/membership\/\">Membership of the IRB page<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Policy 303: Board Member Conflict of Interest ","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_303_Board_Member_COI.pdf\">Download Policy 303<\/a><\/li>\r\n \t<li><strong>Purpose:\u00a0<\/strong>Ensures real or perceived conflicts of interest of IRB Chairs, Vice Chairs, and Members are identified and managed.<\/li>\r\n<\/ul>","accordion_anchor":""}]},{"acf_fc_layout":"text","anchor":"","css_class":"pb-0 pt-0","title":"<hr \/>","content":"","background_color":"#ffffff","width":"width-medium"},{"acf_fc_layout":"accordion_new","anchor_id":"functions","classes":"pt-30 pb-0","title":"<h2>IRB function and operations<\/h2>","description":"","background":"plain","background_color":"#ffffff","style":"row_blank","expand":"yes","accordions":[{"acf_fc_layout":"accordion","accordion_title":"Policy 401: Functions of the RSRB Office","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_401_Functions_of_the_RSRB_Office.pdf\">Download Policy 401<\/a><\/li>\r\n \t<li><strong>Purpose:\u00a0<\/strong>Describes the operations of the IRB administrative office.<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Policy 402: RSRB Meetings","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_402_RSRB_Meetings.pdf\">Download Policy 402<\/a><\/li>\r\n \t<li><strong>Purpose: <\/strong>Describes the procedures for preparation, conduct and review determinations of IRB meetings.<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Policy 403: Notification of RSRB Determinations","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_403_Notification_of_RSRB_Determinations.pdf\">Download Policy 403<\/a><\/li>\r\n \t<li><strong>Purpose:\u00a0<\/strong>Describes the process for communicating IRB determinations to Investigators, University personnel, and regulatory bodies.<\/li>\r\n \t<li><strong>Supporting guidelines:<\/strong>\r\n<ul>\r\n \t<li style=\"list-style-type: none;\">\r\n<ul>\r\n \t<li><a class=\"u-link-external u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/403a_GDL_for_Notification_of_RSRB_Determinations.pdf\">Notification of RSRB Determinations<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li><strong>Related resources:<\/strong>\r\n<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/irb-review\/process\/\">IRB Review Process page<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Policy 404: Criteria for RSRB Approval of Research","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_404_Criteria_for_Approval.pdf\">Download Policy 404<\/a><\/li>\r\n \t<li><strong>Purpose:\u00a0<\/strong>Describes the criteria for approval of research that will be followed by the IRB.<\/li>\r\n \t<li><strong>Related resources:<\/strong>\r\n<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/irb-review\/process\/\">IRB Review Process page<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/irb-review\/approval-criteria\/\">Criteria for IRB Approval Guide<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Policy 405: HRPP Maintenance of Records","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_405_Maintenance_of_Records.pdf\">Download Policy 405<\/a><\/li>\r\n \t<li><strong>Purpose:\u00a0<\/strong>Describes the requirements and procedures for maintaining adequate documentation of IRB activities.<\/li>\r\n<\/ul>","accordion_anchor":""}]},{"acf_fc_layout":"text","anchor":"","css_class":"pb-0 pt-0","title":"<hr \/>","content":"","background_color":"#ffffff","width":"width-medium"},{"acf_fc_layout":"accordion_new","anchor_id":"review","classes":"pt-30 pb-0","title":"<h2>Reviews of research<\/h2>","description":"","background":"plain","background_color":"#ffffff","style":"row_blank","expand":"yes","accordions":[{"acf_fc_layout":"accordion","accordion_title":"Policy 501: Levels of RSRB Review","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_501_Levels_of_RSRB_Review.pdf\">Download Policy 501<\/a><\/li>\r\n \t<li><strong>Purpose:\u00a0<\/strong>Describes the review levels assigned to an application by the IRB based on risks posed to the subjects by research activities.<\/li>\r\n \t<li><strong>Supporting guidelines:<\/strong>\r\n<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/501a_GDL_Exempt_Status_Determination.pdf\">Exempt Status Determination<\/a><\/li>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/501b_GDL_Expedited_Review.pdf\">Expedited Review of Research<\/a><\/li>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/501c_GDL_Convened_Review.pdf\">Convened Board Review of Research<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li><strong>Related resources:<\/strong>\r\n<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/irb-review\/process\/\">IRB Review Process page<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Policy 502: Types of RSRB Submissions","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_502_Types_of_RSRB_Submissions.pdf\">Download Policy 502<\/a><\/li>\r\n \t<li><strong>Purpose:\u00a0<\/strong>Describes the types of submissions received and reviewed by the IRB and the materials required for review.<\/li>\r\n \t<li><strong>Related resources:<\/strong>\r\n<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/click-irb\/\">Click IRB Resources page<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/irb-review\/process\/\">IRB Review Process page<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Policy 503: Ancillary Committee Reviews","icon":"","row_content":"<ul>\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\">Download Policy 503<\/a><\/li>\r\n \t<li><strong>Purpose:\u00a0<\/strong>Describes the institutional committees that review research activities, in addition to the IRB.<\/li>\r\n \t<li><strong>Supporting guidelines:<\/strong>\r\n<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/503a_GDL_Ancillary_Committee_Contact_Information.pdf\">Ancillary Committee Contacts<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Policy 504: IRB Reliance and Collaborative Research","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_504_RSRB_Reliance_Review.pdf\">Download Policy 504<\/a><\/li>\r\n \t<li><strong>Purpose:\u00a0<\/strong>Establishes the requirements when 糖心传媒 (URochester) researchers collaborate with an unaffiliated institution(s) or Investigator(s) to ensure URochester ethical, regulatory and institutional requirements for the protection of human subjects are met.<\/li>\r\n \t<li><strong>Supporting guidelines and forms\r\n<\/strong>\r\n<ul>\r\n \t<li style=\"list-style-type: none;\">\r\n<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/irb-review\/fees\/\">IRB Fee Structure<\/a><\/li>\r\n \t<li><a class=\"u-link-external\" href=\"https:\/\/redcap.urmc.rochester.edu\/redcap\/surveys\/?s=YFNMF798AR\">IRB Reliance Request Form<\/a><\/li>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/504b_GDL_UR_Reviewing_IRB.pdf\">When the University of Rochester is the Reviewing IRB<\/a><\/li>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/GDL_NIH_Grant_sIRB_Language.pdf\">Single IRB Plan in a NIH Grant Application<\/a><\/li>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/504c_GDL_PI_Oversight_Plans.pdf\">PI Oversight for Multi-Site Research<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2026\/03\/HRP-Review-Questions-When-UR-Relying.pdf\"><span data-olk-copy-source=\"MessageBody\">HRP Review Form When Relying on External IRB<\/span><\/a><\/li>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/504a_GDL_UR_Relying_IRB.pdf\">When the University of Rochester Relies on a Non-糖心传媒 IRB<\/a><\/li>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2025\/03\/504d-Guideline-External-Investigator.pdf\">Guideline for Review of External (Non-UR) Investigators<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Policy 505: Departmental Scientific and Resource Review","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Scientific_Review_Standards_Policy_and_Appendices.pdf\">Download Policy 505<\/a><\/li>\r\n \t<li><strong>Purpose:\u00a0<\/strong>Establishes the requirements and process for departmental scientific review of research protocols.\u00a0 Includes a link to the \u201cScientific Review Standards Checklist\u201d that may be used for documenting scientific review determinations.<\/li>\r\n \t<li><strong>Supporting guidelines and forms<\/strong>\r\n<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/505_GDL_Scientific_Review.pdf\">Scientific and Resource Review of Human Subject Research<\/a><\/li>\r\n \t<li><strong><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Scientific_Review_Checklist_template.pdf\">Scientific and Resource Review Checklist<\/a><\/strong><\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Policy 506: Data and Safety Monitoring","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_506_Data_Safety_Monitoring.pdf\">Download Policy 506<\/a><\/li>\r\n \t<li><strong>Purpose:\u00a0<\/strong>Establishes the requirements for a Data and Safety Monitoring Plan in research involving human subjects.<\/li>\r\n \t<li><strong>Related resources:<\/strong>\r\n<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/resources\/data-safety-monitoring-plans\/\">Data and Safety Monitoring Plan page<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","accordion_anchor":""}]},{"acf_fc_layout":"text","anchor":"","css_class":"pb-0 pt-0","title":"<hr \/>","content":"","background_color":"#ffffff","width":"width-medium"},{"acf_fc_layout":"accordion_new","anchor_id":"specialconsiderations","classes":"pt-30 pb-0","title":"<h2>Reviews requiring special consideration<\/h2>","description":"","background":"plain","background_color":"#ffffff","style":"row_blank","expand":"yes","accordions":[{"acf_fc_layout":"accordion","accordion_title":"Policy 601: Research Involving Children","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_601_Research_Involving_Children.pdf\">Download Policy 601<\/a><\/li>\r\n \t<li><strong>Purpose:\u00a0<\/strong>Defines the ethical and regulatory considerations required by the IRB when reviewing research involving children, and to indicate when consent, permission and assent of the subject is required.<\/li>\r\n \t<li><strong>Supporting guidelines:<\/strong>\r\n<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/601a_GDL_Assessing_Capacity_to_Consent_in_Children.pdf\">Assessing Capacity to Consent in Children<\/a><\/li>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/601b_GDL_for_SADCR_Review.pdf\">SADCR Review of Research Involving Children<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Policy 602: Research Involving Pregnant Women, Human Fetuses and Neonates","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_602_Research_Involving_Pregnant_Woman.pdf\">Download Policy 602<\/a><\/li>\r\n \t<li><strong>Purpose:\u00a0<\/strong>Defines the ethical and regulatory considerations required by the IRB when reviewing research involving pregnant women, human fetuses, and neonates.<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Policy 603: Research Involving Prisoners","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_603_Research_Involving_Prisoners.pdf\">Download Policy 603<\/a><\/li>\r\n \t<li><strong>Purpose:\u00a0<\/strong>Defines the ethical and regulatory considerations required by the IRB when reviewing research involving prisoners.<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Policy 604: Research Involving Adults with Decisional Impairment","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_604_Research_Involving_Decisionally_Impaired_Adults.pdf\">Download Policy 604<\/a><\/li>\r\n \t<li><strong>Purpose:\u00a0<\/strong>Defines the ethical and regulatory considerations required by the IRB when reviewing research involving adult subjects who may be decisionally impaired and unable to make an informed decision regarding participation in research, and to identify the circumstances when the IRB may permit use of a legally authorized representative.\u00a0 Includes a link to the \u201cResearch Proxy Template\u201d.<\/li>\r\n \t<li><strong>Supporting guidelines and forms:<\/strong>\r\n<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/604a_GDL_Assess_Consent_Capacity_Decisional_Impaired.pdf\">Assessing Consent Capacity in Adults with Decisional Impairment<\/a><\/li>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/documents\/ohsp\/pdf\/policiesAndGuidance\/604b_GDL_Inst_Review_Impaired_Adults.pdf\">Institutional Review of Research Involving Adults with Decisional Impairment<\/a><\/li>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Research_Proxy_Template.pdf\">Research Proxy Form<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Policy 605: Research Involving FDA Regulated Drugs, Biologics, and Supplements","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_605_Research_Involving_FDA_Regulated_Drugs_Biologics.pdf\">Download Policy 605<\/a><\/li>\r\n \t<li><strong>Purpose:\u00a0<\/strong>Outlines the responsibilities and regulatory requirements when conducting FDA regulated research that involves the use of drugs, agents, biological products, or nutritional products.<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Policy 606: Research Involving FDA Regulated Devices","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_606_Research_Involving_FDA_Regulated_Devices.pdf\">Download Policy 606<\/a><\/li>\r\n \t<li><strong>Purpose:\u00a0<\/strong>Outlines the responsibilities and regulatory requirements when conducting FDA regulated research that involves the use of devices.<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Policy 607: Emergency Use of Investigational Drugs, Biologics and Medical Devices","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_607_Emergency_Use_of_Test_Article.pdf\">Download Policy 607<\/a><\/li>\r\n \t<li><strong>Purpose:\u00a0<\/strong>Establishes the requirements for the emergency use of investigational products. See additional links for emergency use checklists and reporting forms.<\/li>\r\n \t<li><strong>Supporting guidelines and forms:<\/strong>\r\n<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/01_Emergency_Use_Physician_Checklist.doc\">Emergency Use Physician Checklist<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/02_Emergency_Use_Report_to_RSRB.doc\">Emergency Use Report to IRB<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/04_Emergency_Use_Follow_Up_Report.doc\">Emergency Use Follow-Up Report to IRB<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Policy 608: Research Involving Genetic Testing and Gene Transfer","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_608_Genetic_Testing.pdf\">Download Policy 608<\/a><\/li>\r\n \t<li><strong>Purpose:\u00a0<\/strong>Outlines additional protections required by New York State when research involves genetic testing (as defined by NYS), and the additional requirements when conducting research involving gene transfer.<\/li>\r\n \t<li><strong>Supporting guidelines and forms:<\/strong>\r\n<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2026\/04\/608c-Guideline-Genetic-Testing.pdf\"> Guideline on Requirements for Genetic Testing Research<\/a><\/li>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/608_GDL_Gene_Transfer_Research.pdf\">Internal Review of Human Gene Transfer Research<\/a><\/li>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/608b_GDL_Genomic_Data_Sharing.pdf\">Human Genomic Data Sharing and Institutional Certification<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Policy 609: Research Supported by the Department of Defense","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_609_Research_Supported_by_DOD.pdf\">Download Policy 609<\/a><\/li>\r\n \t<li><strong>Purpose:\u00a0<\/strong>Outlines additional federal regulatory requirements when conducting Department of Defense supported research.<\/li>\r\n \t<li><strong>Supporting guidelines and forms:<\/strong>\r\n<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/12\/609a-_Checklist_RSRBReview_DOD.pdf\">Checklist for IRB Review of Research Supported by the DoD<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","accordion_anchor":""}]},{"acf_fc_layout":"text","anchor":"","css_class":"pb-0 pt-0","title":"<hr \/>","content":"","background_color":"#ffffff","width":"width-medium"},{"acf_fc_layout":"accordion_new","anchor_id":"consent","classes":"pt-30 pb-0","title":"<h2><strong>Informed consent, recruitment, and privacy<\/strong><\/h2>","description":"","background":"plain","background_color":"#ffffff","style":"row_blank","expand":"yes","accordions":[{"acf_fc_layout":"accordion","accordion_title":"Policy 701: Informed Consent","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_701_Informed_Consent.pdf\">Download Policy 701<\/a><\/li>\r\n \t<li><strong>Purpose:\u00a0<\/strong>Describes requirements for Investigators to obtain informed consent and to document the consent process, including requests for waivers or alterations of consent, and the requirements for the IRB to evaluate the consent process.<\/li>\r\n \t<li><strong>Supporting guidelines:<\/strong>\r\n<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/701_GDL_Informed_Consent.pdf\">Informed Consent<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li><strong>Related resources:<\/strong>\r\n<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/resources\/consent\/\">Consent Overview page<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/resources\/consent\/documentation\/\">Documentation of Consent page<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/resources\/non-english-speaking-subjects\/\">Enrolling Non-English Speaking Subjects page<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Policy 702: HIPAA Privacy Rule","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_702_HIPAA.pdf\">Download Policy 702<\/a><\/li>\r\n \t<li><strong>Purpose:\u00a0<\/strong>Ensures 糖心传媒 research activities comply with the standards for protection of health information under the HIPAA Privacy Rule.<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Policy 703: Recruitment Materials and Subject Payment","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_703_Recruitment_Payment.pdf\">Download Policy 703<\/a><\/li>\r\n \t<li><strong>Purpose:\u00a0<\/strong>Describes the requirements and mechanism for IRB review and approval of research recruitment materials, as well as methods for subject payment.<\/li>\r\n \t<li><strong>Supporting guidelines<\/strong>\r\n<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/703a_GDL_Recruitment_Methods_Materials.pdf\">Recruitment Methods and Materials<\/a><\/li>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/GDL_Payment_Peer_Recruiters.pdf\">Payment to Subjects to Recruit Other Subjects (Peer Recruiters)<\/a><\/li>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/703c_GDL_Subject_Payment.pdf\">Subject Payment<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/adminfinance\/finance\/accounts-payable\/policies-and-procedures\/\">Accounts Payable Research Subject Payments Policy &amp; Procedures<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.urmc.rochester.edu\/clinical-translational-science-institute\/services-and-support\/participant-payments.aspx\">Participant Payments Website<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Policy 704: FERPA and PPRA in Human Subject Research","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_704_FERPA_and_PPRA.pdf\">Download Policy 704<\/a><\/li>\r\n \t<li><strong>Purpose:\u00a0<\/strong>Describes the requirements for research involving students and\/or is conducted in an educational setting; applies to all research conducted within local Pre-Kindergarten - grade 12 schools \/school districts, undergraduate, and graduate education.<\/li>\r\n<\/ul>","accordion_anchor":""}]},{"acf_fc_layout":"text","anchor":"","css_class":"pb-0 pt-0","title":"<hr \/>","content":"","background_color":"#ffffff","width":"width-medium"},{"acf_fc_layout":"accordion_new","anchor_id":"reporting","classes":"pt-30 pb-0","title":"<h2><strong>Reporting to IRB\r\n<\/strong><\/h2>","description":"","background":"plain","background_color":"#ffffff","style":"row_blank","expand":"yes","accordions":[{"acf_fc_layout":"accordion","accordion_title":"Policy 801: Unanticipated Problems Involving Risks to Subjects or Others","icon":"","row_content":"<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/policies\/policy-801-upirtso\/\">Policy 801: Unanticipated Problems Involving Risks to Subjects or Others<\/a><\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Policy 802: Deviations","icon":"","row_content":"<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/policies\/policy-802-deviations\/\">Policy 802: Deviations<\/a><\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Policy 803: HRPP and Non-Compliance","icon":"","row_content":"<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/policies\/policy-803-hrpp-and-non-compliance\/\">Policy 803: HRPP and Non-Compliance<\/a><\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Policy 804: Administrative Hold, Suspension, and Termination of Research","icon":"","row_content":"<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/policies\/policy-804-administrative-hold-suspension-and-termination-of-research\/\">Policy 804: Administrative Hold, Suspension, and Termination of Research<\/a><\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Policy 805: Institutional Reporting Procedures","icon":"","row_content":"<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/policies\/policy-805-institutional-reporting-procedures\/\">Policy 805: Institutional Reporting Procedures<\/a><\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Policy 806: Protection of Research Participants","icon":"","row_content":"<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/policies\/policy-806-protection-of-research-participants\/\">Policy 806: Protection of Research Participants<\/a><\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Policy 807: Research Complaints and Concerns","icon":"","row_content":"<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/policies\/policy-807-research-complaints-and-concerns\/\">Policy 807: Research Complaints and Concerns<\/a><\/li>\r\n<\/ul>","accordion_anchor":""}]},{"acf_fc_layout":"text","anchor":"","css_class":"pb-0 pt-0","title":"<hr \/>","content":"","background_color":"#ffffff","width":"width-medium"},{"acf_fc_layout":"accordion_new","anchor_id":"responsibilities","classes":"pt-30 pb-0","title":"<h2><strong>Responsibilities of investigators<\/strong><\/h2>","description":"","background":"plain","background_color":"#ffffff","style":"row_blank","expand":"yes","accordions":[{"acf_fc_layout":"accordion","accordion_title":"Policy 901: Investigator Responsibilities","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_901_Investigator_Responsibilities.pdf\">Download Policy 901<\/a><\/li>\r\n \t<li><strong>Purpose:\u00a0<\/strong>Describes the responsibilities and requirements of the Principal Investigator to ensure research is conducted in accordance with federal regulations and University policies and guidelines. Includes links to related summary sheets of responsibilities.<\/li>\r\n \t<li><strong>Supporting guidelines:<\/strong>\r\n<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/901_EXEMPT_PI_Responsiblities_Summary.pdf\">Exempt Responsibilities Summary Sheet<\/a><\/li>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/901_NONFDA_Regulated_PI_Responsiblities_Summary.pdf\">Non-FDA Regulated Responsibilities Summary Sheet<\/a><\/li>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/901_FDA_Regulated_PI_Responsiblities_Summary.pdf\">FDA-Regulated Responsibilities Summary Sheet<\/a><\/li>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/901_GDL_Investigators_Leaving_Institution.pdf\">Investigators Leaving the Institution<\/a><\/li>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/901b_GDL_Deidentification_Data_Publishing.pdf\">De-Identification of Data for Publishing\/Presentation<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Policy 902: Investigator Conflict of Interest","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_902_Investigator_Conflict_of_Interest.pdf\">Download Policy 902<\/a><\/li>\r\n \t<li><strong>Purpose:\u00a0<\/strong>Ensures Investigator financial interests and financial conflicts of interest are identified and managed or eliminated, as appropriate, within the RSRB review system.<\/li>\r\n<\/ul>","accordion_anchor":""}]},{"acf_fc_layout":"text","anchor":"","css_class":"pb-0 pt-0","title":"<hr \/>","content":"","background_color":"#ffffff","width":"width-medium"},{"acf_fc_layout":"accordion_new","anchor_id":"quality","classes":"pt-30","title":"<h2><strong>Quality improvement\r\n<\/strong><\/h2>","description":"","background":"plain","background_color":"#ffffff","style":"row_blank","expand":"yes","accordions":[{"acf_fc_layout":"accordion","accordion_title":"Policy 1001: Quality Improvement Program","icon":"","row_content":"<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_1001_QI_Program.pdf\">Download Policy 1001<\/a><\/li>\r\n \t<li><strong>Purpose:\u00a0<\/strong>Describes the Quality Improvement program established under the University of Rochester\u2019s HRPP.<\/li>\r\n \t<li><strong>Related resources:<\/strong>\r\n<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/quality-improvement\/\">Quality Improvement Overview page<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","accordion_anchor":""}]},{"acf_fc_layout":"text","anchor":"additional","css_class":"","title":"<h2>Additional guidance<\/h2>","content":"<h4>OHSP guidance<\/h4>\r\n<ul>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Guideline_for_Internet_Based_Research.pdf\">Computer and Internet-Based Research<\/a><\/li>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Guideline_for_Home_Visits.pdf\">Conducting Home Visits<\/a><\/li>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Guideline_Coordinating_Center_Studies.pdf\">Coordinating Center Studies<\/a><\/li>\r\n \t<li><a class=\"u-link-external u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/GDL_HIV_Research.pdf\">HIV Testing<\/a><\/li>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Guideline_Conducting_International_Research.pdf\">International Research<\/a>\r\n<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2026\/01\/International-Research-Worksheet.docx\">International Research Worksheet<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li><a class=\"u-link-external u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/GDL_for_Use_of_Placebo_in_Research.pdf\">Placebo in Clinical Research<\/a><\/li>\r\n \t<li><a class=\"u-link-external u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Guideline_Research_Involving_Repositories.pdf\">Repositories (Databases, Repositories &amp; Registries)<\/a><\/li>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/GDL_Resident_Interns_Study_Coordinator.pdf\">Residents, Interns, ACMGE-Approved Fellowships as Study Coordinator<\/a><\/li>\r\n \t<li><a class=\"u-link-external u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/GDL_NIH_Grant_sIRB_Language.pdf\">Single IRB Plan in a NIH Grant Application<\/a><\/li>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Guideline_for_Research_Using_Social_Media.pdf\">Social Media<\/a><\/li>\r\n<\/ul>\r\n<h4>University policies and guidance<\/h4>\r\n<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/adminfinance\/finance\/accounts-payable\/policies-and-procedures\/\">Accounts Payable Policies &amp; Procedures<\/a> (Research Subject Payments Policy &amp; Procedures)<\/li>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Guideline_on_HSR_Research_Data_Security_Requirements.pdf\">Data Security Requirements<\/a>\r\n<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Guideline_on_HSR_Research_Electronic_Data_Security_Assessment_Form.doc\">Data Security Assessment Form [icon name=\"file-word\" prefix=\"fas\"]<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li><a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/UR_Policy_Enrollment_Incentive_Payments.pdf\">Enrollment Incentive Payments By or To University Clinical Trial Researchers<\/a><\/li>\r\n \t<li><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\">EU General Data Protection Regulation (GDPR)<\/a><\/li>\r\n \t<li><a class=\"u-link-external\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Guideline_REDCap_eConsent.pdf\">REDCap for Electronic Informed Consent<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/policies\/\">University\u2019s Policies website<\/a><\/li>\r\n<\/ul>","background_color":"#f4f4f4","width":"width-medium"}]},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>OHSP Policies - Office for Human Subject Protection - 糖心传媒<\/title>\n<meta name=\"description\" content=\"Policies and formal guidelines for human subject research at the University of Rochester. 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