{"id":864,"date":"2021-04-05T00:42:25","date_gmt":"2021-04-05T04:42:25","guid":{"rendered":"https:\/\/mrctcenter.org\/individual-return-of-results\/?page_id=864"},"modified":"2021-04-05T00:42:25","modified_gmt":"2021-04-05T04:42:25","slug":"sponsors","status":"publish","type":"page","link":"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/roadmap-by-role\/sponsors\/","title":{"rendered":"Sponsors"},"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_1641835529465{padding-right: 20px !important;padding-left: 20px !important;background-color: #f4f4f4 !important;border-radius: 20px !important;}&#8221;][vc_column css=&#8221;.vc_custom_1641835555007{margin-bottom: -10px !important;}&#8221;][vc_column_text css=&#8221;.vc_custom_1641835834091{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\/sponsors\/#preparation\">Preparation<\/a><\/li>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/roadmap-by-role\/sponsors\/#on-study\">On Study<\/a><\/li>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/roadmap-by-role\/sponsors\/#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_1641835623852{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_1647971889386{margin-top: 14px !important;margin-bottom: 14px !important;}&#8221;]<\/p>\n<h2>Organizational Buy-In<\/h2>\n<p><strong>Addressing Key Topics<\/strong><\/p>\n<ul>\n<li>Prepare yourself and your organization to address common topics (e.g., relevant regulations or privacy considerations) to initiate a return of results program\n<ul>\n<li>See our topic-specific pages on <a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/topics\/informed-consent\/\">informed consent<\/a>, <a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/topics\/liability\/\">liability<\/a>, <a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/topics\/regulations\/\">regulations<\/a>, <a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/topics\/study-integrity\/\">study integrity<\/a>, <a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/topics\/funders\/\">funders<\/a>, and <a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/topics\/genetics\/\">genetics<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><strong>Why to get started<\/strong><\/p>\n<ul>\n<li>Highlighting key points on why to get started (e.g., ethical reasons, meeting participant expectations) will help you advocate for return of results at your organization\n<ul>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/getting-started\/why\/\">Click here for more on why to get started<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><strong>How to get started<\/strong><\/p>\n<ul>\n<li>Getting started returning results may seem overwhelming. It may help to start small, returning a handful of results and\/or starting a small pilot. Our guide on how to start, plus a proposed progression of returning results helps get the program, or pilot, off the ground\n<ul>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/getting-started\/how\/\">Click here for more on how to get started<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Funding&#8221; tab_id=&#8221;1641526386508-6bf3c829-dd24&#8243;][vc_column_text css=&#8221;.vc_custom_1644772317605{margin-top: 14px !important;margin-bottom: 14px !important;}&#8221;]<\/p>\n<h2>Funding Results Return<\/h2>\n<p>A common question around returning IRR is how it will be funded. These decisions and the associated costs will vary significantly between organizations, but here are some considerations to start with:<\/p>\n<p><strong>Identify financial resources<\/strong><\/p>\n<ul>\n<li>Different funding resources may be applicable to returning IRR (e.g., innovation, patient engagement, etc.). Explore what\u2019s available at your organization<\/li>\n<\/ul>\n<p><strong>Develop a budget<\/strong><\/p>\n<ul>\n<li>A detailed plan for returning IRR, considering the points listed here, will lend itself to a clear and thought-out budget. The budget should be feasible given the constraints and resources available<\/li>\n<\/ul>\n<p><strong>Good plans save resources<\/strong><\/p>\n<ul>\n<li>A robust plan is necessary regardless of the intention to return results given the possibility for urgent\/incidental results that must be returned. Early planning will reduce the resources needed in a reactive response while the study is ongoing. CROs or data management vendors could be leveraged to support return of IRR.<\/li>\n<\/ul>\n<p><strong>Start Small<\/strong><\/p>\n<ul>\n<li>Consider whether the costs will vary according to the quantity and\/or types of results that are returned. One strategy is to start small by returning results that are familiar to participants or require less interpretation, and slowly add to the practice once processes are established and positive impacts are realized\n<ul>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/getting-started\/how\/#proposed-progression\">Click here for a proposed progression on how to get started<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><strong>Consult participants and return what matters<\/strong><\/p>\n<ul>\n<li>It is also important to discuss your plans with participants or patient advocates to understand which results are most meaningful to them. This could maximize the impact of a Return of Results program while still narrowing its scope<\/li>\n<\/ul>\n<p><strong>Consider your options<\/strong><\/p>\n<ul>\n<li>Some methods of return may be more costly than others. Consider low-cost solutions, particularly while the IRR program is being established. Once there is buy-in, consider investments in website portals or decision-tracking systems\n<ul>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/how-to-return\/#how\">Click here for more considerations on different ways to return results<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><strong>Run a pilot<\/strong><\/p>\n<ul>\n<li>It is often advantageous to run a pilot as a proof of concept, to learn what works, and to better understand what the funding needs will be\n<ul>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/getting-started\/how\/#pilot\">Click here for more on running a pilot<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>[\/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_1647971933360{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 regulations. Sponsors (and study teams) should rely on legal counsel and Regulatory Affairs departments 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><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 (see next)<\/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_1647972535555{margin-top: 14px !important;margin-bottom: 14px !important;}&#8221;]<\/p>\n<h2>IRB\/Ethics Review<\/h2>\n<p><strong>Collaboration and Preparation<\/strong><\/p>\n<ul>\n<li>Collaborating and\/or soliciting advice from an IRB\/HRPP\/Ethics committee while establishing an IRR program will enable its long-term success. Their input can help you to craft IRR policies, procedures, and justifications for when results will be returned and will not be returned. This will support your study teams in creating IRR plans that are adequately thought-out before they reach the IRB for review\n<ul>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/roadmap-by-role\/irb-hrpp\/\">Click here for a roadmap of an IRB\u2019s role with IRR<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Kick Off Meetings&#8221; tab_id=&#8221;1644772403114-ecba0836-d664&#8243;][vc_column_text]<\/p>\n<h2>Study\/Site Kick Off Meetings<\/h2>\n<p><strong>Clarifying plans and expectations<\/strong><\/p>\n<ul>\n<li>Study kick off\/ Investigator meetings are key opportunities to ensure PIs are aware of expectations and plans for IRR, and to answer any questions early on<\/li>\n<li>Site kick off meetings can also be used to clarify plans and procedures for IRR, provide training for the actual return of results, etc.<\/li>\n<\/ul>\n<p>[\/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_1641832903475{margin-top: 14px !important;margin-bottom: 14px !important;}&#8221;]<\/p>\n<h2>Establishing a Policy<\/h2>\n<ul>\n<li>In time, it will be beneficial to establish an organizational policy regarding IRR. It is important to involve all stakeholders, including participants, in the creation of an IRR policy\n<ul>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/getting-started\/how\/#policy\">Click here for more considerations around IRR policies<\/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_1641835774042{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_1641833006313{margin-top: 14px !important;margin-bottom: 14px !important;}&#8221;]<\/p>\n<h2>Screening\/Enrollment<\/h2>\n<ul>\n<li>Sponsors can provide supportive instructions to study teams on how to handle return of screening data. 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_1647972298242{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. Sponsors can support investigators and their study staff to facilitate these decisions in a variety of ways\n<ul>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/download\/1581\/\">Click here for an IRR Information Sheet template<\/a><\/li>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/topics\/informed-consent\/\">Click here for more details around informed consent<\/a><\/li>\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<\/ul>\n<\/li>\n<\/ul>\n<p><strong>ICF Details<\/strong><\/p>\n<ul>\n<li>Some details will need to be in the Informed Consent Form, and some can be communicated outside of that form. Sponsors (and investigators) should work with the IRBs to determine what is needed in the ICF\n<ul>\n<li><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/topics\/informed-consent\/\">Click here for more details around 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<\/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_1647972196093{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. Sponsors should anticipate this and establish processes 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\u00a0<\/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 or may have more of an active role in results return 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 during a study<\/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. Sponsors can provide this guidance and\/or policy to study teams<\/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_1641835785303{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_1647972214164{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>Make sure the investigator and their site staff have the information and resources needed to explain expectations around IRR to participants, including what will be returned and the timing of that return\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>[\/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_1647972244913{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, or may have more of an active role in results return 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>Study Close Out Visits<\/strong><\/p>\n<ul>\n<li>Close out visits are a good time to check that all results were already returned that were supposed to be returned, and to reiterate plans and expectations around returning any results after the study has ended\/data is locked (e.g., study are assignment)<\/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 an 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_section title=&#8221;Analysis &amp; Reporting&#8221; tab_id=&#8221;1640898554140-d9b8a0b2-e93d&#8221;][vc_column_text css=&#8221;.vc_custom_1641833391053{margin-top: 14px !important;margin-bottom: 14px !important;}&#8221;]<\/p>\n<h2>Analysis &amp; Reporting<\/h2>\n<p><strong>Aggregate Results<\/strong><\/p>\n<ul>\n<li>If a participant has consented to receive aggregate results, it can be helpful or interesting to share those in the context of the participant\u2019s individual results<\/li>\n<li><a href=\"https:\/\/mrctcenter.org\/blog\/projects\/return-of-aggregate-results-to-participants\/\" target=\"_blank\" rel=\"noopener\"><span style=\"color: #910532\">Click here for our work on Return of Aggregate Results<\/span><\/a><\/li>\n<\/ul>\n<p><strong>Publication<\/strong><\/p>\n<ul>\n<li>It can also be seen as a courtesy to share publication information with participants about research in which they participated<\/li>\n<\/ul>\n<p>This communication, along with the return of individual results, can contribute to trust and transparency in research, and can convey respect and appreciation for research participation[\/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_1641835529465{padding-right: 20px !important;padding-left: 20px !important;background-color: #f4f4f4 !important;border-radius: 20px !important;}&#8221;][vc_column css=&#8221;.vc_custom_1641835555007{margin-bottom: -10px !important;}&#8221;][vc_column_text css=&#8221;.vc_custom_1641835834091{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-864","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) - 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