{"id":711,"date":"2014-09-25T18:18:42","date_gmt":"2014-09-25T18:18:42","guid":{"rendered":"https:\/\/psi2030.wpengine.com\/?page_id=711"},"modified":"2021-07-20T12:05:20","modified_gmt":"2021-07-20T12:05:20","slug":"research-ethics-board","status":"publish","type":"page","link":"https:\/\/www.psi.org\/fr\/research-ethics\/research-ethics-board\/","title":{"rendered":"Research Ethics Board"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"711\" class=\"elementor elementor-711\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-ecd4118 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"ecd4118\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-0b8bb33\" data-id=\"0b8bb33\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-6165b08 elementor-widget elementor-widget-spacer\" data-id=\"6165b08\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-09d9036 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"09d9036\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-04ae3a7\" data-id=\"04ae3a7\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4b971e4 elementor-widget elementor-widget-heading\" data-id=\"4b971e4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Research Ethics Board<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-46b9faee elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"46b9faee\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-50871d6f\" data-id=\"50871d6f\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-27d01dc elementor-widget elementor-widget-text-editor\" data-id=\"27d01dc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Our\u00a0Research Ethics Program is responsible for the ethical and regulatory compliance of research that involves human subjects. We are\u00a0committed to protecting the rights and welfare of subjects enrolled in its research activities.<\/p><p>As a result, in 2009 the PSI Board of Directors established a Research Ethics Board (REB) to review all human subjects research conducted by us or under our direction.<\/p><p>PSI maintains a Federalwide Assurance (FWA) with the U.S. Department of Health and Human Services\u2019 Office for Human Research Protections (OHRP), and our REB is registered with OHRP. <\/p><h2>Submission\u00a0Information<\/h2><p>Our REB accepts complete submissions on a rolling basis.\u00a0A submission determined to be minimal risk will be reviewed immediately. Those determined to be more than minimal risk will be reviewed by the full board.<\/p><p>Since the overwhelming majority of the submissions to the REB meet the regulatory criteria for expedited approval, our REB convenes on an as-needed basis. If a submission is found to require a full board review, the REB Manager will convene the board within four weeks of submission.<\/p><h2>Determining if an activity requires ethical review<\/h2><p><em>Is my activity research? Does my activity require ethical review? We\u00a0is involved in activity X, but we\u2019re not recruiting participants, do we need ethical review? <\/em><\/p><p>These are common questions posed by our\u00a0staff and researchers. Our\u00a0Research Ethics Program has developed the following guidance to help staff determine when activities are required to receive ethical review and guidance on questions to consider at this stage of the process.<\/p><ul><li><a title=\"PSI Guidelines for Deciding Whether an Activity Requires REB Review\" href=\"https:\/\/www.psi.org\/fr\/publication\/psi-guidelines-for-deciding-whether-an-activity-requires-reb-review\/\" target=\"_blank\" rel=\"noopener\">Our\u00a0guidelines for deciding whether an activity requires REB review<\/a><\/li><li><a title=\"PSI Research vs. Non-Research Decision Tree\" href=\"https:\/\/www.psi.org\/fr\/publication\/psi-research-vs-non-research-decision-tree\/\" target=\"_blank\" rel=\"noopener\">Is my activity research? A decision tree<\/a><\/li><li><a title=\"Request for Determination of Research or Non-Research\" href=\"https:\/\/www.psi.org\/fr\/publication\/request-for-determination-of-research-or-non-research\/\" target=\"_blank\" rel=\"noopener\">Request for determination of research or non research<\/a><\/li><li><a title=\"Questions to Answer Before Developing a Submission for Ethical Review\" href=\"https:\/\/www.psi.org\/fr\/publication\/questions-to-answer-before-developing-a-submission-for-ethical-review\/\" target=\"_blank\" rel=\"noopener\">Questions to answer before developing a submission for ethical review<\/a><\/li><\/ul><h2>Pre-submission: Understanding the REB review process and preparing a complete package<\/h2><p>Understanding our\u00a0REB review process and elements of a complete submission are key to an efficient and quality review. Our\u00a0Research Ethics Program developed the following documents to provide detailed explanation on the review process, training requirements for key personnel and how to prepare a complete packet for our\u00a0REB.<\/p><ul><li><a title=\"Description of REB Review Process and Timeline\" href=\"https:\/\/www.psi.org\/fr\/publication\/description-of-reb-review-process-and-timeline\/\" target=\"_blank\" rel=\"noopener\">Research ethics board review process and timeline<\/a><\/li><li><a title=\"Human Subjects Training for Key Research Personnel\" href=\"https:\/\/www.psi.org\/fr\/publication\/human-subjects-training-for-key-research-personnel\/\" target=\"_blank\" rel=\"noopener\">Training requirements for key personnel<\/a><\/li><li><a title=\"Preparing a Complete Packet for the PSI\/REB\" href=\"https:\/\/www.psi.org\/fr\/publication\/preparing-a-complete-packet-for-the-psireb\/\" target=\"_blank\" rel=\"noopener\">Preparing a complete packet for the REB<\/a><\/li><\/ul><h2>REB forms and instructions<\/h2><p>The REB requires the completion of the appropriate forms for new submissions, modification requests and continuing review applications.<\/p><ul><li><a title=\"Cover sheet: Application for review of a new research study\" href=\"https:\/\/www.psi.org\/fr\/publication\/cover-sheet-application-for-review-of-a-new-research-study\/\" target=\"_blank\" rel=\"noopener\">Cover sheet for new submission<\/a><\/li><li><a title=\"Instructions for Completing the Application Cover Sheet for a New Research Study\" href=\"https:\/\/www.psi.org\/fr\/publication\/instructions-for-completing-the-application-cover-sheet-for-a-new-research-study\/\" target=\"_blank\" rel=\"noopener\">Instructions for completing the REB cover sheet for\u00a0new\u00a0submission<\/a><\/li><li><a title=\"Application for Review of a Study Modification\" href=\"https:\/\/www.psi.org\/fr\/publication\/application-for-review-of-a-study-modification\/\" target=\"_blank\" rel=\"noopener\">Modification form<\/a><\/li><li><a title=\"Modification Requests: Submission Procedures and Form Instructions\" href=\"https:\/\/www.psi.org\/fr\/publication\/modification-requests-submission-procedures-and-form-instructions\/\" target=\"_blank\" rel=\"noopener\">Modification procedures and submission instructions<\/a><\/li><li><a title=\"Application for Continuing Review\" href=\"https:\/\/www.psi.org\/fr\/publication\/application-for-continuing-review\/\" target=\"_blank\" rel=\"noopener\">Continuing review form<\/a><\/li><li><a title=\"Continuing Review: Submission Procedures and Form Instructions\" href=\"https:\/\/www.psi.org\/fr\/publication\/continuing-review-submission-procedures-and-form-instructions\/\" target=\"_blank\" rel=\"noopener\">Continuing review procedures and submission instructions<\/a><\/li><li><a title=\"Reportable Events Form\" href=\"https:\/\/www.psi.org\/fr\/publication\/reportable-events-form\/\" target=\"_blank\" rel=\"noopener\">Reportable event form<\/a><\/li><li><a title=\"Reportable Event Form: Submission Procedures and Instructions\" href=\"https:\/\/www.psi.org\/fr\/publication\/reportable-event-form-submission-procedures-and-instructions\/\" target=\"_blank\" rel=\"noopener\">Reportable event procedures and submission instructions<\/a><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Research Ethics Board Our\u00a0Research Ethics Program is responsible for the ethical and regulatory compliance of research that involves human subjects. We are\u00a0committed to protecting the rights and welfare of subjects enrolled in its research activities. As a result, in 2009 the PSI Board of Directors established a Research Ethics Board (REB) to review all human [&hellip;]<\/p>\n","protected":false},"author":89,"featured_media":0,"parent":649,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-711","page","type-page","status-publish","hentry"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.psi.org\/fr\/wp-json\/wp\/v2\/pages\/711","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.psi.org\/fr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.psi.org\/fr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.psi.org\/fr\/wp-json\/wp\/v2\/users\/89"}],"replies":[{"embeddable":true,"href":"https:\/\/www.psi.org\/fr\/wp-json\/wp\/v2\/comments?post=711"}],"version-history":[{"count":0,"href":"https:\/\/www.psi.org\/fr\/wp-json\/wp\/v2\/pages\/711\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.psi.org\/fr\/wp-json\/wp\/v2\/pages\/649"}],"wp:attachment":[{"href":"https:\/\/www.psi.org\/fr\/wp-json\/wp\/v2\/media?parent=711"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}