{"id":1438,"date":"2021-12-30T17:04:07","date_gmt":"2021-12-30T22:04:07","guid":{"rendered":"https:\/\/mrctcenter.org\/return-of-individual-results\/?page_id=1438"},"modified":"2021-12-30T17:04:07","modified_gmt":"2021-12-30T22:04:07","slug":"research-site-study-staff-and-pis","status":"publish","type":"page","link":"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/roadmap-by-role\/research-site-study-staff-and-pis\/","title":{"rendered":"PI, Study Team, and Site Staff"},"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_1641836302869{padding-right: 20px !important;padding-left: 20px !important;background-color: #f4f4f4 !important;border-radius: 20px !important;}&#8221;][vc_column css=&#8221;.vc_custom_1641836309176{margin-bottom: -10px !important;}&#8221;][vc_column_text css=&#8221;.vc_custom_1641836315467{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\/research-site-study-staff-and-pis\/#preparation\">Preparation<\/a><\/li>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/roadmap-by-role\/research-site-study-staff-and-pis\/#on-study\">On Study<\/a><\/li>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/roadmap-by-role\/research-site-study-staff-and-pis\/#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_1641836331130{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_1641833918740{margin-top: 14px !important;margin-bottom: 14px !important;}&#8221;]<\/p>\n<h2>Organizational Buy-In<\/h2>\n<p>Investigators and their study teams should be included as key stakeholders if an organization is initiating a Return of Results program to allow for their expertise and perspectives to be incorporated[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Protocol Writing&#8221; tab_id=&#8221;1640898601629-495f6cee-3b27&#8243;][vc_column_text css=&#8221;.vc_custom_1647972985115{margin-top: 14px !important;margin-bottom: 14px !important;}&#8221;]<\/p>\n<h2>Protocol Writing<\/h2>\n<p><strong>Planning<\/strong><\/p>\n<ul>\n<li>It is essential to plan for the return of IRR during protocol writing, similar to plans for recruitment, data collection and storage, and analysis. While an organizational policy may be helpful, each study will require a tailored plan\n<ul>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/determining-what-to-return\/\">Click here for a tool on determining what to return<\/a><\/li>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/how-to-return\/\">Click here for guidance on how to return different data types<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><strong>Stakeholder collaboration<\/strong><\/p>\n<ul>\n<li>Make sure that key stakeholders have the opportunity to provide input on a study\u2019s plans for IRR. This will enable a better plan and will clarify responsibilities among the investigator, site staff, sponsor, and even a participant\u2019s healthcare provider if they are involved in communication. This is also an opportunity to solicit feedback from patients or patient advocates about which results are most meaningful to them and how best to return them<\/li>\n<\/ul>\n<p><strong>Regulations<\/strong><\/p>\n<ul>\n<li>Different countries and even states will have varied legal, ethical, and clinical frameworks. Investigators and their study teams should rely on their HRPPs and general counsel for guidance in these areas\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_section title=&#8221;IRB\/Ethics Review&#8221; tab_id=&#8221;1640898601652-1143dd6d-1ff3&#8243;][vc_column_text css=&#8221;.vc_custom_1644772783511{margin-top: 14px !important;margin-bottom: 14px !important;}&#8221;]<\/p>\n<h2>IRB\/Ethics Review<\/h2>\n<p><strong>IRB Review Expectations<\/strong><\/p>\n<ul>\n<li>There should be clear expectations set and communicated around what should be included in IRB review as it pertains to IRR. Make sure to communicate with your IRB\/HRPP and\/or sponsor as to their expectations and\/or any resources, policies, or guidance they can provide<\/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_1641836340647{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;Screening &amp; Enrollment&#8221; tab_id=&#8221;1616447363389-e31dd8a3-bafd&#8221;][vc_column_text css=&#8221;.vc_custom_1641834104556{margin-top: 14px !important;margin-bottom: 14px !important;}&#8221;]<\/p>\n<h2>Screening\/Enrollment<\/h2>\n<ul>\n<li>It is possible that screening data will be returned to participants, particularly for screen-failures or participants who have urgent incidental findings during screening. This return, including requisite referral, should be included in the IRR Plan. In some cases, it will be appropriate to prepare a referral pathway for the participant\n<ul>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/determining-what-to-return\/\">Click here for a tool on determining what to return, which helps you think through what data will be generated throughout your study<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Informed Consent&#8221; tab_id=&#8221;1616447363411-d7fa3648-245b&#8221;][vc_column_text css=&#8221;.vc_custom_1644772837393{margin-top: 14px !important;margin-bottom: 14px !important;}&#8221;]<\/p>\n<h2>Informed Consent<\/h2>\n<p><strong>Decision making<\/strong><\/p>\n<ul>\n<li>Participants should have the option to decide whether to receive their results, be able to review this decision and\/or change their mind later during the study, and receive support to make that decision. Investigators and their study staff can facilitate these decisions in a variety of ways\n<ul>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/resources\/for-participants\/#deciding\">Click here for resources to support the decision-making process<\/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<\/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_1647973025949{margin-top: 14px !important;margin-bottom: 14px !important;}&#8221;]<\/p>\n<h2>Early and Mid-Study<\/h2>\n<p><strong>Reviewing participant decisions<\/strong><\/p>\n<ul>\n<li>Participants should be able to review their decision to receive results and\/or change their mind during the study. Clear processes should be planned and established to maintain and update participant decisions\n<ul>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/download\/1581\/\">Click here for a template to support and guide this process<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><strong>Returning results during the study<\/strong><\/p>\n<ul>\n<li>Results may be returned during the study. Sponsors may need to support investigators and their study teams with this if results will not be returned through a portal or other external vendor\n<ul>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/determining-what-to-return\/\">Click here for a tool on determining what results will be generated and what to return<\/a><\/li>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/how-to-return\/urgent-results\/\">Click here for more on returning urgent results<\/a><\/li>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/getting-started\/how\/#routine-results\">Click here for more on returning routine results during a study<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><strong>Changing plans during the study<\/strong><\/p>\n<ul>\n<li>Plans for IRR should be made during protocol development. If the plan for IRR changes mid-study, make sure to consult with your IRB, re-consent participants as necessary, and gather all of the requisite contact information for participants and\/or their healthcare provider<\/li>\n<\/ul>\n<p><strong>Returning IRR to withdrawn\/discontinued participants<\/strong><\/p>\n<ul>\n<li>Plans should include whether, which, and how results will be returned to participants who withdraw from a study before it ends. Investigators and study teams should be able to look to sponsors to provide this guidance<\/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_1641836354726{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;Participant&#8217;s Last Visit&#8221; tab_id=&#8221;1640898554093-ace1dc8b-debe&#8221;][vc_column_text css=&#8221;.vc_custom_1647974034618{margin-top: 14px !important;margin-bottom: 14px !important;}&#8221;]<\/p>\n<h2>Participant&#8217;s Last Visit<\/h2>\n<p><strong>Managing expectations<\/strong><\/p>\n<ul>\n<li>A participant\u2019s last visit is an important time to revisit and manage expectations. This could include reviewing:\n<ul>\n<li>Which results will or will not be returned<\/li>\n<li>When results will be returned<\/li>\n<li>The participant\u2019s decisions to receive their results, updated if necessary<\/li>\n<li>The participant\u2019s (and, if necessary, their healthcare provider\u2019s) contact information<\/li>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/download\/1579\/\">Click here for a template to gather a participant&#8217;s healthcare provider&#8217;s contact info<\/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 IRR process\u00a0<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;End of Study&#8221; tab_id=&#8221;1640898554114-b7f266e0-56b0&#8243;][vc_column_text css=&#8221;.vc_custom_1647974115388{margin-top: 14px !important;margin-bottom: 14px !important;}&#8221;]<\/p>\n<h2>End of Study<\/h2>\n<p><strong>Planning for return<\/strong><\/p>\n<ul>\n<li>Results from a study are often returned at the end of or after the study. During protocol development, plans should be made for who will return results, and how. Sponsors may need to support the investigator and their study teams in returning results if results will not be returned through a portal or other external vendor\n<ul>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/how-to-return\/#who\">Click here for considerations about who returns results<\/a><\/li>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/how-to-return\/#how\">Click here for considerations about how results are returned<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><strong>Stakeholder responsibilities<\/strong><\/p>\n<ul>\n<li>As a study ends, it is important to reinforce how responsibilities are separated between the investigator, site staff, sponsor, and participant\u2019s healthcare provider (HCP) and who is or will be involved in communication<\/li>\n<\/ul>\n<p><strong>Connecting to HCP or follow-up care<\/strong><\/p>\n<ul>\n<li>It may be necessary to connect with a participant\u2019s HCP or another medical provider for follow-up care. It is often best to make these plans before returning results to participants\n<ul>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/download\/1579\/\">Click here to for a HCP contact form template<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><strong>Supporting results communication<\/strong><\/p>\n<ul>\n<li>Whoever is explaining the results to participants will likely need guidance. This could include an information sheet about the results that will be returned and how they can be interpreted, a script or answers to frequently asked questions, plain-language take-home documentation for the participant, health literacy training, translated documents or translator services, and more\n<ul>\n<li><a href=\"https:\/\/mrctcenter.org\/health-literacy\/\" target=\"_blank\" rel=\"noopener\">Click here for our work on Health Literacy<\/a><\/li>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/resources\/for-participants\/\" target=\"_blank\" rel=\"noopener\">Click here for resources for participants<\/a><\/li>\n<\/ul>\n<\/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_1641836302869{padding-right: 20px !important;padding-left: 20px !important;background-color: #f4f4f4 !important;border-radius: 20px !important;}&#8221;][vc_column css=&#8221;.vc_custom_1641836309176{margin-bottom: -10px !important;}&#8221;][vc_column_text css=&#8221;.vc_custom_1641836315467{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-1438","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>PI, Study Team, and Site Staff - 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\/research-site-study-staff-and-pis\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"PI, Study Team, and Site Staff\" \/>\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_1641836302869{padding-right: 20px !important;padding-left: 20px !important;background-color: #f4f4f4 !important;border-radius: 20px !important;}&#8221;][vc_column css=&#8221;.vc_custom_1641836309176{margin-bottom: -10px !important;}&#8221;][vc_column_text css=&#8221;.vc_custom_1641836315467{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\/research-site-study-staff-and-pis\/\" \/>\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=\"5 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\/research-site-study-staff-and-pis\/\",\"url\":\"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/roadmap-by-role\/research-site-study-staff-and-pis\/\",\"name\":\"PI, Study Team, and Site Staff - 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