{"id":1437,"date":"2021-12-30T17:03:59","date_gmt":"2021-12-30T22:03:59","guid":{"rendered":"https:\/\/mrctcenter.org\/return-of-individual-results\/?page_id=1437"},"modified":"2021-12-30T17:03:59","modified_gmt":"2021-12-30T22:03:59","slug":"irb-hrpp","status":"publish","type":"page","link":"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/roadmap-by-role\/irb-hrpp\/","title":{"rendered":"IRB\/HRPP"},"content":{"rendered":"<section class=\"wpb-content-wrapper\"><p>[vc_section][vc_row][vc_column][vc_empty_space height=&#8221;24px&#8221;][\/vc_column][\/vc_row][vc_row css=&#8221;.vc_custom_1641835993076{padding-right: 20px !important;padding-left: 20px !important;background-color: #f4f4f4 !important;border-radius: 20px !important;}&#8221;][vc_column css=&#8221;.vc_custom_1641835999103{margin-bottom: -10px !important;}&#8221;][vc_column_text css=&#8221;.vc_custom_1641836006776{margin-top: -10px !important;}&#8221;]<\/p>\n<h2>HOW TO USE THIS PAGE<\/h2>\n<p><strong>The overall study roadmap has been divided into three sections:<\/strong><\/p>\n<ol>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/roadmap-by-role\/irb-hrpp\/#preparation\">Preparation<\/a><\/li>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/roadmap-by-role\/irb-hrpp\/#on-study\">On Study<\/a><\/li>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/roadmap-by-role\/irb-hrpp\/#end-of-study\">End of Study<\/a><\/li>\n<\/ol>\n<p><strong>Within each section, click through the considerations at the left to view relevant guidance and links to additional information or resources.<\/strong>[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_empty_space height=&#8221;24px&#8221;][\/vc_column][\/vc_row][vc_row css=&#8221;.vc_custom_1641836121337{background-color: #005565 !important;}&#8221; el_id=&#8221;preparation&#8221;][vc_column][vc_custom_heading text=&#8221;Preparation&#8221; font_container=&#8221;tag:h1|text_align:left|color:%23ffffff&#8221; use_theme_fonts=&#8221;yes&#8221; css=&#8221;.vc_custom_1640898971334{margin-top: -28px !important;margin-bottom: 8px !important;}&#8221;][\/vc_column][\/vc_row][vc_row][vc_column][vc_tta_tour style=&#8221;flat&#8221; shape=&#8221;square&#8221; controls_size=&#8221;sm&#8221; active_section=&#8221;1&#8243; no_fill_content_area=&#8221;true&#8221; el_class=&#8221;preparation&#8221; css=&#8221;.vc_custom_1640898879085{margin-top: -20px !important;}&#8221;][vc_tta_section title=&#8221;Organizational Buy-In&#8221; tab_id=&#8221;1640898601604-39e66b56-2fdb&#8221;][vc_column_text css=&#8221;.vc_custom_1641833617448{margin-top: 14px !important;margin-bottom: 14px !important;}&#8221;]<\/p>\n<h2>Organizational Buy-In<\/h2>\n<p>IRBs and HRPPs are important stakeholders and advisors throughout IRR, particularly during initiation of an IRR pilot or program, at any organization or institution<\/p>\n<p>Make sure to stay involved to both guide practices towards those that are beneficial to participants, and to establish appropriate expectations for what should be included to enable appropriate IRB review[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Establishing a Policy&#8221; tab_id=&#8221;1640898601678-71b2fa48-9563&#8243;][vc_column_text css=&#8221;.vc_custom_1641833850414{margin-top: 14px !important;margin-bottom: 14px !important;}&#8221;]<\/p>\n<h2>Establishing a Policy<\/h2>\n<p>IRBs are encouraged to create policies or guidelines for what they will require and review relating to return of individual results. This will help standardize the review process as programs evolve and enable return of results plans to be better formulated before IRB review takes place<\/p>\n<ul>\n<li><a href=\"https:\/\/research.iu.edu\/compliance\/human-subjects\/guidance\/returning-research-results.html\">Click here for an example of one IRB\u2019s policy on IRR<\/a><\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Protocol Review&#8221; tab_id=&#8221;1640898601629-495f6cee-3b27&#8243;][vc_column_text css=&#8221;.vc_custom_1647972699868{margin-top: 14px !important;margin-bottom: 14px !important;}&#8221;]<\/p>\n<h2>Protocol Writing<\/h2>\n<p><strong>Setting Expectations<\/strong><\/p>\n<ul>\n<li>There should be clarity around what should be included in IRB review as it pertains to IRR. Make sure expectations are communicated to study teams so that needed information is provided\n<ul>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/download\/1577\/\">Click here for an IRB Review Checklist for IRR<\/a><\/li>\n<\/ul>\n<\/li>\n<li>Note that If you return results you must have full board IRB review (and cannot, e.g., use the broad consent exemption for minimized review) (45 CFR 46.104(d)(8))<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Regulations&#8221; tab_id=&#8221;1640898601652-1143dd6d-1ff3&#8243;][vc_column_text css=&#8221;.vc_custom_1641833690516{margin-top: 14px !important;margin-bottom: 14px !important;}&#8221;]<\/p>\n<h2>Regulations<\/h2>\n<ul>\n<li>Ensuring compliance with local, regional, or country-level regulations will often fall within the role of the HRPP\n<ul>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/topics\/regulations\/\">Click here for a limited review of regulations that apply to returning IRR<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][\/vc_tta_tour][vc_empty_space][\/vc_column][\/vc_row][\/vc_section][vc_row css=&#8221;.vc_custom_1641836132634{background-color: #68184b !important;}&#8221; el_id=&#8221;on-study&#8221;][vc_column][vc_custom_heading text=&#8221;On Study&#8221; font_container=&#8221;tag:h1|text_align:left|color:%23ffffff&#8221; use_theme_fonts=&#8221;yes&#8221; css=&#8221;.vc_custom_1640899011965{margin-top: -28px !important;margin-bottom: 8px !important;}&#8221;][\/vc_column][\/vc_row][vc_row][vc_column][vc_tta_tour style=&#8221;flat&#8221; shape=&#8221;square&#8221; controls_size=&#8221;sm&#8221; active_section=&#8221;1&#8243; no_fill_content_area=&#8221;true&#8221; el_class=&#8221;mid-study&#8221; css=&#8221;.vc_custom_1640899057360{margin-top: -20px !important;}&#8221;][vc_tta_section title=&#8221;Informed Consent&#8221; tab_id=&#8221;1616447363411-d7fa3648-245b&#8221;][vc_column_text css=&#8221;.vc_custom_1647972745505{margin-top: 14px !important;margin-bottom: 14px !important;}&#8221;]<\/p>\n<h2>Informed Consent<\/h2>\n<p><strong>Informed Consent Form<\/strong><\/p>\n<ul>\n<li>Plans for IRR should be made during protocol development to enable all relevant details around IRR to be given to the participant during the informed consent process. The IRB should determine which details need to be included in the Informed Consent Form, and which can be communicated in other ways\n<ul>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/topics\/informed-consent\/\">Click here for more on informed consent<\/a><\/li>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/how-to-return\/#opt-in-opt-out\">Click here for considerations around participant choice<\/a><\/li>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/download\/1581\/\">Click here for a template to support and guide the informed consent process<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><strong>Decision making<\/strong><\/p>\n<ul>\n<li>The participant\u2019s decision must be made carefully so that they understand what will or will not be returned, and why, and to avoid upsetting experiences from receiving results (to the extent that is possible). This process will require preparation before and time during the informed consent process\n<ul>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/resources\/for-participants\/#deciding\">Click here for decision-making resources for participants<\/a><\/li>\n<li><a href=\"https:\/\/mrctcenter.org\/health-literacy\/trial-life-cycle\/overview\/consent\/\">Click here for our work on health literacy in informed consent<\/a><\/li>\n<li>Note that decisions around receiving results should be reviewed as needed throughout study participation, and there should be opportunities to update those decisions as appropriate<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Early and Mid-Study&#8221; tab_id=&#8221;1616447363435-394caedd-2630&#8243;][vc_column_text css=&#8221;.vc_custom_1644772690687{margin-top: 14px !important;margin-bottom: 14px !important;}&#8221;]<\/p>\n<h2>Early and Mid-Study<\/h2>\n<p><strong>Providing mid-study consultation<\/strong><\/p>\n<ul>\n<li>An IRB consult may be needed during the study in the event of urgent or incidental results. Ideally, a thought-out plan for handling urgent results will have been anticipated, included in the protocol, and reviewed by the IRB before the study begins, and thus consult would not be needed\n<ul>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/how-to-return\/#1634224992429-98d5b7e9-ac42\">Click here for more on handling an urgent result during a study and determining whether an IRB should be consulted<\/a><\/li>\n<\/ul>\n<\/li>\n<li>Note that IRBs should not be expected to interpret results or provide any medical opinion or advice. It may help to involve a specialist in the area of return when the protocol and consent is being reviewed if expert insight is helpful to advise the study team regarding data return (e.g., genomic test results)\n<ul>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/how-to-return\/urgent-results\/#expertise\">Click here for more on identifying medical expertise for urgent results<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][\/vc_tta_tour][vc_empty_space][\/vc_column][\/vc_row][vc_row css=&#8221;.vc_custom_1641836143953{background-color: #4f7523 !important;}&#8221; el_id=&#8221;end-of-study&#8221;][vc_column][vc_custom_heading text=&#8221;End of Study&#8221; font_container=&#8221;tag:h1|text_align:left|color:%23ffffff&#8221; use_theme_fonts=&#8221;yes&#8221; css=&#8221;.vc_custom_1640899089997{margin-top: -28px !important;margin-bottom: 8px !important;}&#8221;][\/vc_column][\/vc_row][vc_row][vc_column][vc_tta_tour style=&#8221;flat&#8221; shape=&#8221;square&#8221; controls_size=&#8221;sm&#8221; active_section=&#8221;1&#8243; no_fill_content_area=&#8221;true&#8221; el_class=&#8221;end-of-study&#8221; css=&#8221;.vc_custom_1640899115579{margin-top: -20px !important;}&#8221;][vc_tta_section title=&#8221;Maintaining Oversight&#8221; tab_id=&#8221;1640898554093-ace1dc8b-debe&#8221;][vc_column_text css=&#8221;.vc_custom_1641527296666{margin-top: 14px !important;margin-bottom: 14px !important;}&#8221;]<\/p>\n<h2>Maintaining oversight<\/h2>\n<ul>\n<li>IRBs will need to think through whether the return of IRR warrants a study to remain open until all results have been returned, and\/or what their level of oversight will be.<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][\/vc_tta_tour][\/vc_column][\/vc_row][vc_row][vc_column][vc_raw_js]JTNDc2NyaXB0JTIwdHlwZSUzRCUyMnRleHQlMkZqYXZhc2NyaXB0JTIyJTNFJTIwalF1ZXJ5JTI4JTIwZnVuY3Rpb24lMjglMjQlMjklMjAlN0IlMEElMEElMjAlMjAlMjQlMjhkb2N1bWVudCUyOS5vbiUyOCUyN3RvdWNoc3RhcnQlMjBjbGljayUyNyUyQyUyMCUyN2xpLnZjX3R0YS10YWIlMjBhJTJDbGkudmNfdHRhLXRhYiUyQy52Y190dGEtcGFuZWwtdGl0bGUlMjclMkMlMjBmdW5jdGlvbiUyOCUyOSU3QiUwQSUyMCUyMCUyMCUyMCUyMCUyNCUyOCUyN2h0bWwlMkMlMjBib2R5JTI3JTI5LnN0b3AlMjglMjklM0IlMEElMjAlMjAlN0QlMjklM0IlMEElMEElMEElN0QlMjklM0IlMjAlM0MlMkZzY3JpcHQlM0U=[\/vc_raw_js][\/vc_column][\/vc_row]<\/p>\n<\/section>","protected":false},"excerpt":{"rendered":"<p>[vc_section][vc_row][vc_column][vc_empty_space height=&#8221;24px&#8221;][\/vc_column][\/vc_row][vc_row css=&#8221;.vc_custom_1641835993076{padding-right: 20px !important;padding-left: 20px !important;background-color: #f4f4f4 !important;border-radius: 20px !important;}&#8221;][vc_column css=&#8221;.vc_custom_1641835999103{margin-bottom: -10px !important;}&#8221;][vc_column_text css=&#8221;.vc_custom_1641836006776{margin-top: -10px !important;}&#8221;] HOW TO USE THIS PAGE The overall study roadmap has been divided into three sections: Preparation On Study End of Study Within each section, click through the considerations at the left to view relevant guidance and links to [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":0,"parent":817,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"template-sub.php","meta":{"footnotes":""},"class_list":["post-1437","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.0 (Yoast SEO v25.0) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>IRB\/HRPP - Return of Individual Research Results<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/roadmap-by-role\/irb-hrpp\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"IRB\/HRPP\" \/>\n<meta property=\"og:description\" content=\"[vc_section][vc_row][vc_column][vc_empty_space height=&#8221;24px&#8221;][\/vc_column][\/vc_row][vc_row css=&#8221;.vc_custom_1641835993076{padding-right: 20px !important;padding-left: 20px !important;background-color: #f4f4f4 !important;border-radius: 20px !important;}&#8221;][vc_column css=&#8221;.vc_custom_1641835999103{margin-bottom: -10px !important;}&#8221;][vc_column_text css=&#8221;.vc_custom_1641836006776{margin-top: -10px !important;}&#8221;] HOW TO USE THIS PAGE The overall study roadmap has been divided into three sections: Preparation On Study End of Study Within each section, click through the considerations at the left to view relevant guidance and links to [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/roadmap-by-role\/irb-hrpp\/\" \/>\n<meta property=\"og:site_name\" content=\"Return of Individual Research Results\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/roadmap-by-role\/irb-hrpp\/\",\"url\":\"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/roadmap-by-role\/irb-hrpp\/\",\"name\":\"IRB\/HRPP - Return of Individual Research Results\",\"isPartOf\":{\"@id\":\"https:\/\/mrctcenter.org\/return-of-individual-results\/#website\"},\"datePublished\":\"2021-12-30T22:03:59+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/roadmap-by-role\/irb-hrpp\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/roadmap-by-role\/irb-hrpp\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/roadmap-by-role\/irb-hrpp\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/mrctcenter.org\/return-of-individual-results\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"IRR Roadmap By Role\",\"item\":\"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/roadmap-by-role\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"IRB\/HRPP\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/mrctcenter.org\/return-of-individual-results\/#website\",\"url\":\"https:\/\/mrctcenter.org\/return-of-individual-results\/\",\"name\":\"Return of Individual Research Results\",\"description\":\"\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/mrctcenter.org\/return-of-individual-results\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"IRB\/HRPP - Return of Individual Research Results","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/roadmap-by-role\/irb-hrpp\/","og_locale":"en_US","og_type":"article","og_title":"IRB\/HRPP","og_description":"[vc_section][vc_row][vc_column][vc_empty_space height=&#8221;24px&#8221;][\/vc_column][\/vc_row][vc_row css=&#8221;.vc_custom_1641835993076{padding-right: 20px !important;padding-left: 20px !important;background-color: #f4f4f4 !important;border-radius: 20px !important;}&#8221;][vc_column css=&#8221;.vc_custom_1641835999103{margin-bottom: -10px !important;}&#8221;][vc_column_text css=&#8221;.vc_custom_1641836006776{margin-top: -10px !important;}&#8221;] HOW TO USE THIS PAGE The overall study roadmap has been divided into three sections: Preparation On Study End of Study Within each section, click through the considerations at the left to view relevant guidance and links to [&hellip;]","og_url":"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/roadmap-by-role\/irb-hrpp\/","og_site_name":"Return of Individual Research Results","twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/roadmap-by-role\/irb-hrpp\/","url":"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/roadmap-by-role\/irb-hrpp\/","name":"IRB\/HRPP - Return of Individual Research Results","isPartOf":{"@id":"https:\/\/mrctcenter.org\/return-of-individual-results\/#website"},"datePublished":"2021-12-30T22:03:59+00:00","breadcrumb":{"@id":"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/roadmap-by-role\/irb-hrpp\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/roadmap-by-role\/irb-hrpp\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/roadmap-by-role\/irb-hrpp\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/mrctcenter.org\/return-of-individual-results\/"},{"@type":"ListItem","position":2,"name":"IRR Roadmap By Role","item":"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/roadmap-by-role\/"},{"@type":"ListItem","position":3,"name":"IRB\/HRPP"}]},{"@type":"WebSite","@id":"https:\/\/mrctcenter.org\/return-of-individual-results\/#website","url":"https:\/\/mrctcenter.org\/return-of-individual-results\/","name":"Return of Individual Research Results","description":"","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/mrctcenter.org\/return-of-individual-results\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"}]}},"_links":{"self":[{"href":"https:\/\/mrctcenter.org\/return-of-individual-results\/wp-json\/wp\/v2\/pages\/1437"}],"collection":[{"href":"https:\/\/mrctcenter.org\/return-of-individual-results\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/mrctcenter.org\/return-of-individual-results\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/mrctcenter.org\/return-of-individual-results\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/mrctcenter.org\/return-of-individual-results\/wp-json\/wp\/v2\/comments?post=1437"}],"version-history":[{"count":0,"href":"https:\/\/mrctcenter.org\/return-of-individual-results\/wp-json\/wp\/v2\/pages\/1437\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/mrctcenter.org\/return-of-individual-results\/wp-json\/wp\/v2\/pages\/817"}],"wp:attachment":[{"href":"https:\/\/mrctcenter.org\/return-of-individual-results\/wp-json\/wp\/v2\/media?parent=1437"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}