{"id":1049,"date":"2021-09-15T00:34:49","date_gmt":"2021-09-15T04:34:49","guid":{"rendered":"https:\/\/dev.mrctcenter.org\/return-of-individual-results\/?page_id=1049"},"modified":"2021-09-15T00:34:49","modified_gmt":"2021-09-15T04:34:49","slug":"urgent-results","status":"publish","type":"page","link":"https:\/\/dev.mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/how-to-return\/urgent-results\/","title":{"rendered":"Urgent Results"},"content":{"rendered":"<section class=\"wpb-content-wrapper\"><p>[vc_row][vc_column][vc_empty_space height=&#8221;24px&#8221;][\/vc_column][\/vc_row][vc_row css=&#8221;.vc_custom_1637003722770{padding-right: 20px !important;padding-left: 20px !important;background-color: #f4f4f4 !important;border-radius: 20px !important;}&#8221;][vc_column width=&#8221;10\/12&#8243;][vc_column_text css=&#8221;.vc_custom_1637004188115{margin-right: -130px !important;}&#8221;]<\/p>\n<h2><strong>HOW WE DEFINE URGENT RESULTS<\/strong><\/h2>\n<p><strong>An urgent result is any result that requires immediate follow-up, typically by a healthcare professional. This result could have been anticipated due to the research and condition under study, or it may be unanticipated and\/or related to a previously undiagnosed condition.<\/strong><\/p>\n<p>Examples:<\/p>\n<ul>\n<li>A \u201croutine\u201d blood pressure found to be 220\/120 mmHg<\/li>\n<li>A participant reports suicidal ideation<\/li>\n<li>A mass is discovered on a routine Chest Xray<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column][vc_column width=&#8221;2\/12&#8243;][vc_icon icon_fontawesome=&#8221;fas fa-exclamation-circle&#8221; color=&#8221;custom&#8221; size=&#8221;lg&#8221; align=&#8221;right&#8221; custom_color=&#8221;#68184b&#8221; css=&#8221;.vc_custom_1637004074612{margin-top: -26px !important;}&#8221;][\/vc_column][\/vc_row][vc_row][vc_column][vc_row_inner][vc_column_inner][vc_custom_heading text=&#8221;Review the Basics for Returning Urgent Results:&#8221; font_container=&#8221;tag:h2|text_align:left|color:%23152736&#8243; use_theme_fonts=&#8221;yes&#8221;][\/vc_column_inner][\/vc_row_inner][vc_row_inner gap=&#8221;35&#8243;][vc_column_inner width=&#8221;1\/4&#8243;][vc_cta h2=&#8221;&#8221; txt_align=&#8221;center&#8221; style=&#8221;outline&#8221; color=&#8221;peacoc&#8221; add_icon=&#8221;top&#8221; i_icon_fontawesome=&#8221;fas fa-user-md&#8221; i_color=&#8221;custom&#8221; i_background_style=&#8221;rounded&#8221; i_size=&#8221;sm&#8221; i_on_border=&#8221;true&#8221; i_link=&#8221;url:https%3A%2F%2Fdev.mrctcenter.org%2Freturn-of-individual-results%2Fhow-to-return-irr%2Fhow-to-return%2F%231634222001646-b7a37063-8227&#8243;]<\/p>\n<h2 style=\"text-align: center\"><a href=\"https:\/\/dev.mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/how-to-return\/#1634222001646-b7a37063-8227\">Who<\/a><\/h2>\n<p>[\/vc_cta][\/vc_column_inner][vc_column_inner width=&#8221;1\/4&#8243;][vc_cta h2=&#8221;&#8221; txt_align=&#8221;center&#8221; style=&#8221;outline&#8221; color=&#8221;peacoc&#8221; add_icon=&#8221;top&#8221; i_icon_fontawesome=&#8221;fas fa-clock&#8221; i_color=&#8221;custom&#8221; i_background_style=&#8221;rounded&#8221; i_size=&#8221;sm&#8221; i_on_border=&#8221;true&#8221; i_link=&#8221;url:https%3A%2F%2Fdev.mrctcenter.org%2Freturn-of-individual-results%2Fhow-to-return-irr%2Fhow-to-return%2F%231634224992429-98d5b7e9-ac42&#8243;]<\/p>\n<h2 style=\"text-align: center\"><a href=\"https:\/\/dev.mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/how-to-return\/#1634224992429-98d5b7e9-ac42\">When<\/a><\/h2>\n<p>[\/vc_cta][\/vc_column_inner][vc_column_inner width=&#8221;1\/4&#8243;][vc_cta h2=&#8221;&#8221; txt_align=&#8221;center&#8221; style=&#8221;outline&#8221; color=&#8221;peacoc&#8221; add_icon=&#8221;top&#8221; i_icon_fontawesome=&#8221;fas fa-file-medical-alt&#8221; i_color=&#8221;custom&#8221; i_background_style=&#8221;rounded&#8221; i_size=&#8221;sm&#8221; i_on_border=&#8221;true&#8221; i_link=&#8221;url:https%3A%2F%2Fdev.mrctcenter.org%2Freturn-of-individual-results%2Fhow-to-return-irr%2Fhow-to-return%2F%231634227831478-43b9e961-aef7&#8243;]<\/p>\n<h2 style=\"text-align: center\"><a href=\"https:\/\/dev.mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/how-to-return\/#1634227831478-43b9e961-aef7\">How<\/a><\/h2>\n<p>[\/vc_cta][\/vc_column_inner][vc_column_inner width=&#8221;1\/4&#8243;][vc_cta h2=&#8221;&#8221; txt_align=&#8221;center&#8221; style=&#8221;outline&#8221; color=&#8221;peacoc&#8221; add_icon=&#8221;top&#8221; i_icon_fontawesome=&#8221;fas fa-check-square&#8221; i_color=&#8221;custom&#8221; i_background_style=&#8221;rounded&#8221; i_size=&#8221;sm&#8221; i_on_border=&#8221;true&#8221;]<\/p>\n<h2 style=\"text-align: center\"><a href=\"https:\/\/dev.mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/how-to-return\/#opt-in-opt-out\">Choice<\/a><\/h2>\n<p>[\/vc_cta][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1637121802127{background-color: #68184b !important;}&#8221; el_id=&#8221;prep&#8221;][vc_column css=&#8221;.vc_custom_1635544316400{margin-top: -20px !important;}&#8221;][vc_custom_heading text=&#8221;How to Prepare and Additional Points to Consider&#8221; font_container=&#8221;tag:h1|text_align:left|color:%23ffffff&#8221; use_theme_fonts=&#8221;yes&#8221;][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; el_id=&#8221;consent&#8221; css=&#8221;.vc_custom_1636753435778{background-color: #f7f7f7 !important;}&#8221;][vc_column][vc_custom_heading text=&#8221;Informed Consent&#8221; font_container=&#8221;tag:h1|text_align:left|color:%2368184b&#8221; use_theme_fonts=&#8221;yes&#8221;][vc_row_inner][vc_column_inner][vc_column_text]The informed consent form should state that there is a possibility for the study to generate an urgent result or urgent incidental finding (hereafter &#8220;urgent result&#8221;), and that any urgent result will be returned promptly to the participant and\/or their healthcare provider. In some cases, this means that the participant must consent to sharing data with the healthcare provide, even if the participant does not wish to receive other results.<\/p>\n<p><strong>Sample language: <\/strong><\/p>\n<p><em>Sample: We will [draw blood] [perform tests] that may result in medical information that requires immediate action. We will share this information with you [and your healthcare provider] so that you can get further medical care. <\/em><\/p>\n<p><em>If you agree to take part in the study, you are agreeing to sharing this information with you [and your healthcare provider]. [We will also need your healthcare provider\u2019s contact information]<\/em><\/p>\n<p><em>[If you do not agree with allowing this information to be shared with your healthcare provider, you cannot participate in this study. This is for your safety.<\/em><\/p>\n<p><em>If you do not have a healthcare provider, then\u2026]<\/em><\/p>\n<p><em>[If we cannot reach you to tell you about the result, please provide the name and contact information of someone you trust with whom we can share this information. If we cannot reach you after X attempts by (phone\/email\/text), we will contact this person.]<\/em><\/p>\n<p><strong><a href=\"https:\/\/dev.mrctcenter.org\/return-of-individual-results\/topics\/informed-consent\/\">See more here about informed consent.<\/a><\/strong>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row el_id=&#8221;HCP&#8221;][vc_column][vc_custom_heading text=&#8221;Healthcare provider contact information&#8221; font_container=&#8221;tag:h1|text_align:left|color:%2368184b&#8221; use_theme_fonts=&#8221;yes&#8221;][vc_row_inner][vc_column_inner][vc_column_text]If the involvement of the healthcare provider is necessary, the provider\u2019s contact information should be collected as early in the study as possible, ideally during enrollment (<a href=\"https:\/\/dev.mrctcenter.org\/return-of-individual-results\/download\/1579\/\">see template here<\/a>). Requesting this information can also facilitate a conversation with the research participant not only about their preferences for whom to include but also to establish realistic expectations should an urgent result arise.<\/p>\n<p>Note that, along with the urgent result, any other data that might inform the healthcare provider\u2019s action\/interpretation of the urgent result should also be returned.<\/p>\n<p>It should be anticipated that a potential participant without health insurance or a HCP may wish to join the study. A plan should be made for how their participation will or will not be accommodated and, if participating, how any urgent result will be handled.<\/p>\n<p>This plan will vary depending on the study. For example, a\u00a0PI may be asked to assist the patient to follow up locally for appropriate next steps and care. In some instances, additional funds can be made available if safety follow-up is needed[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; el_id=&#8221;regs&#8221; css=&#8221;.vc_custom_1636753448208{background-color: #f7f7f7 !important;}&#8221;][vc_column][vc_custom_heading text=&#8221;Regulatory Requirements &amp; CLIA Confirmation&#8221; font_container=&#8221;tag:h1|text_align:left|color:%2368184b&#8221; use_theme_fonts=&#8221;yes&#8221;][vc_row_inner][vc_column_inner][vc_column_text]If an urgent result complies with necessary regulatory requirements for return (e.g., the test was performed in a CLIA lab), it should be returned to the participant ASAP.<\/p>\n<p>If the urgent result will NOT comply with all necessary regulatory requirements for return, a plan should be made in advance for a medically responsible course of action (e.g., the study team will rerun the test in a compliant, clinically reliable manner and return it to the participant ASAP.)<\/p>\n<p>See more here about <strong><a href=\"https:\/\/dev.mrctcenter.org\/return-of-individual-results\/topics\/regulations\/\">regulations that pertain to IRR<\/a><\/strong>.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row el_id=&#8221;expertise&#8221;][vc_column][vc_custom_heading text=&#8221;Access to appropriate expertise&#8221; font_container=&#8221;tag:h1|text_align:left|color:%2368184b&#8221; use_theme_fonts=&#8221;yes&#8221;][vc_row_inner][vc_column_inner][vc_column_text]Some results are challenging to interpret for actionability or validity, and\/or difficult to explain to participants. A responsible medical professional, listed on the study protocol IRB application, should be identified before the study begins, to advise as needed.<\/p>\n<p>If needed, referral to or provision of support (e.g., genetic counseling) should also be considered when appropriate.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; el_id=&#8221;IRB&#8221; css=&#8221;.vc_custom_1636753461669{background-color: #f7f7f7 !important;}&#8221;][vc_column][vc_custom_heading text=&#8221;Role of the IRB or Ethics Review Committee&#8221; font_container=&#8221;tag:h1|text_align:left|color:%2368184b&#8221; use_theme_fonts=&#8221;yes&#8221;][vc_row_inner][vc_column_inner][vc_column_text]The IRB should not be expected to interpret a medical or clinical result nor to determine actionability.<\/p>\n<p>The IRB should review and decide whether the urgent finding will be considered an adverse event or unanticipated problem requiring reporting to the IRB, and if so, whether there is flexibility in timing of the report and\/or other obligations to be considered.<\/p>\n<p>See more here about\u00a0the <strong><a href=\"https:\/\/dev.mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/roadmap-by-role\/irb-hrpp\/\">role of IRBs.<\/a><\/strong>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row el_id=&#8221;process&#8221;][vc_column][vc_custom_heading text=&#8221;Process Flow&#8221; font_container=&#8221;tag:h1|text_align:left|color:%2368184b&#8221; use_theme_fonts=&#8221;yes&#8221;][vc_single_image image=&#8221;1676&#8243; img_size=&#8221;full&#8221;][\/vc_column][\/vc_row]<\/p>\n<\/section>","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column][vc_empty_space height=&#8221;24px&#8221;][\/vc_column][\/vc_row][vc_row css=&#8221;.vc_custom_1637003722770{padding-right: 20px !important;padding-left: 20px !important;background-color: #f4f4f4 !important;border-radius: 20px !important;}&#8221;][vc_column width=&#8221;10\/12&#8243;][vc_column_text css=&#8221;.vc_custom_1637004188115{margin-right: -130px !important;}&#8221;] HOW WE DEFINE URGENT RESULTS An urgent result is any result that requires immediate follow-up, typically by a healthcare professional. This result could have been anticipated due to the research and condition under study, or it may be unanticipated and\/or [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":0,"parent":992,"menu_order":1,"comment_status":"closed","ping_status":"closed","template":"template-sub.php","meta":{"footnotes":""},"class_list":["post-1049","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.mrctcenter.org\/return-of-individual-results\/wp-json\/wp\/v2\/pages\/1049"}],"collection":[{"href":"https:\/\/dev.mrctcenter.org\/return-of-individual-results\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/dev.mrctcenter.org\/return-of-individual-results\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/dev.mrctcenter.org\/return-of-individual-results\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/dev.mrctcenter.org\/return-of-individual-results\/wp-json\/wp\/v2\/comments?post=1049"}],"version-history":[{"count":0,"href":"https:\/\/dev.mrctcenter.org\/return-of-individual-results\/wp-json\/wp\/v2\/pages\/1049\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/dev.mrctcenter.org\/return-of-individual-results\/wp-json\/wp\/v2\/pages\/992"}],"wp:attachment":[{"href":"https:\/\/dev.mrctcenter.org\/return-of-individual-results\/wp-json\/wp\/v2\/media?parent=1049"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}