{"id":1230,"date":"2021-11-01T16:25:37","date_gmt":"2021-11-01T20:25:37","guid":{"rendered":"https:\/\/mrctcenter.org\/return-of-individual-results\/?page_id=1230"},"modified":"2021-11-01T16:25:37","modified_gmt":"2021-11-01T20:25:37","slug":"determining-what-to-return","status":"publish","type":"page","link":"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/determining-what-to-return\/","title":{"rendered":"Determining what to return"},"content":{"rendered":"<section class=\"wpb-content-wrapper\"><p>[vc_row][vc_column][vc_empty_space][vc_column_text]<\/p>\n<h3><span style=\"color: #910532\">Step 1: During the study, when are you collecting data?<\/span><\/h3>\n<p><strong>Consider the entire clinical trial lifecycle for a participant:<\/strong>[\/vc_column_text][vc_single_image image=&#8221;1123&#8243; img_size=&#8221;full&#8221;][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text]<span style=\"color: #a80532;font-size: 21px;font-weight: bold\">Step 2: What kinds of data will be generated during each period?<\/span><\/p>\n<p><strong>Think about the kinds of tests you will perform during each of the above periods:<\/strong><\/p>\n<ul>\n<li>Study arm assignment<\/li>\n<li>Laboratory tests<\/li>\n<li>Diagnostic Imaging<\/li>\n<li>Genetic sequencing<\/li>\n<li>Physical or visual examinations<\/li>\n<li>Socio-behavioral<\/li>\n<li>Surveys and questionnaires<\/li>\n<li>Digital or mobile health results<\/li>\n<li>Patient-reported outcomes (PROs)<\/li>\n<li>Exploratory results<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text]<\/p>\n<h3><span style=\"color: #910532\">Step 3: Consider the following questions\/domains for <em>each<\/em> data type during <em>each<\/em> study period to determine whether to return and what plans must be made to return:<\/span><\/h3>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row el_id=&#8221;urgent&#8221;][vc_column][vc_row_inner][vc_column_inner][vc_custom_heading text=&#8221;A. URGENCY&#8221; font_container=&#8221;tag:h2|text_align:left|color:%230c598c&#8221; use_theme_fonts=&#8221;yes&#8221;][vc_column_text]<\/p>\n<ul>\n<li><strong>Is there a possibility for a result to require urgent medical attention?<\/strong>\n<ul>\n<li><strong>Example:<\/strong> A &#8220;routine&#8221; blood pressure found to be 220\/120 mmHg<\/li>\n<li><strong>Example:<\/strong> A participant reports suicidal ideation<\/li>\n<\/ul>\n<\/li>\n<li><strong>Is there a possibility for an urgent unanticipated finding to be identified while testing for something else?<\/strong>\n<ul>\n<li><strong>Example:<\/strong> A mass is discovered on a routine Chest X-ray<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner content_placement=&#8221;top&#8221;][vc_column_inner width=&#8221;1\/3&#8243;][vc_cta h2=&#8221;NO&#8221; h2_font_container=&#8221;tag:h2|text_align:left|color:%23002b38&#8243; h2_use_theme_fonts=&#8221;yes&#8221; style=&#8221;custom&#8221; add_icon=&#8221;left&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-down&#8221; i_color=&#8221;mulled_wine&#8221; i_size=&#8221;lg&#8221; use_custom_fonts_h2=&#8221;true&#8221; custom_background=&#8221;#ffffff&#8221; i_link=&#8221;url:https%3A%2F%2Fmrctcenter.org%2Freturn-of-individual-results%2Fhow-to-return-irr%2Fdetermining-what-to-return%2F%23actionable&#8221;]Next data type[\/vc_cta][\/vc_column_inner][vc_column_inner width=&#8221;2\/3&#8243; css=&#8221;.vc_custom_1633366209037{margin-top: -34px !important;border-radius: 20px !important;}&#8221;][vc_cta h2=&#8221;YES&#8221; add_icon=&#8221;left&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; i_color=&#8221;peacoc&#8221; i_background_style=&#8221;rounded&#8221; i_background_color=&#8221;white&#8221; i_size=&#8221;lg&#8221; i_link=&#8221;url:https%3A%2F%2Fmrctcenter.org%2Freturn-of-individual-results%2Fhow-to-return-irr%2Fhow-to-return%2Furgent-results%2F&#8221;]<\/p>\n<ul>\n<li><strong>This result should be returned ASAP<\/strong><\/li>\n<li>A plan must be made <em>ahead of time<\/em> for how to return this result, especially regarding:\n<ul>\n<li>how the study team will ensure compliance with necessary regulations (e.g. CLIA)<\/li>\n<li>whether the result will be returned to the participant or a medical provider\/other appropriate person<\/li>\n<\/ul>\n<\/li>\n<li>See more here about returning<strong> <a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/how-to-return\/urgent-results\/\">urgent results.<\/a><\/strong><\/li>\n<\/ul>\n<p>[\/vc_cta][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row el_id=&#8221;actionable&#8221;][vc_column][vc_row_inner][vc_column_inner][vc_custom_heading text=&#8221;B. ACTIONABILITY&#8221; font_container=&#8221;tag:h2|text_align:left|color:%230c598c&#8221; use_theme_fonts=&#8221;yes&#8221;][vc_column_text]<strong>Does the result have established health or other personal implications and is actionable, but not urgent?<\/strong><\/p>\n<ul>\n<li><strong>Example: <\/strong>A Hemoglobin AIC (or HbA1c) blood test, a measure of average blood sugar, is above normal, and may indicate diabetes or pre-diabetes.<\/li>\n<li><strong>Example: <\/strong>Genetic screening of an individual who has been personally unaffected by cancer returns the presence of BRCA1, a breast cancer susceptibility gene.<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner content_placement=&#8221;top&#8221;][vc_column_inner width=&#8221;1\/3&#8243;][vc_cta h2=&#8221;NO&#8221; h2_font_container=&#8221;tag:h2|text_align:left|color:%23002b38&#8243; h2_use_theme_fonts=&#8221;yes&#8221; style=&#8221;custom&#8221; add_icon=&#8221;left&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-down&#8221; i_color=&#8221;mulled_wine&#8221; i_size=&#8221;lg&#8221; use_custom_fonts_h2=&#8221;true&#8221; custom_background=&#8221;#ffffff&#8221; i_link=&#8221;url:https%3A%2F%2Fmrctcenter.org%2Freturn-of-individual-results%2Fhow-to-return-irr%2Fdetermining-what-to-return%2F%23personally-valuable&#8221;]Next data type[\/vc_cta][\/vc_column_inner][vc_column_inner width=&#8221;2\/3&#8243; css=&#8221;.vc_custom_1633366209037{margin-top: -34px !important;border-radius: 20px !important;}&#8221;][vc_cta h2=&#8221;YES&#8221; add_icon=&#8221;left&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; i_color=&#8221;peacoc&#8221; i_background_style=&#8221;rounded&#8221; i_background_color=&#8221;white&#8221; i_size=&#8221;lg&#8221; i_link=&#8221;url:https%3A%2F%2Fmrctcenter.org%2Freturn-of-individual-results%2Fhow-to-return-irr%2Fhow-to-return%2Factionable%2F&#8221;]<\/p>\n<ul>\n<li><strong>This result should be returned to participants<\/strong><\/li>\n<li>A plan should be made <em>ahead of time<\/em> for how and when to return this result &#8211; see more here about returning <strong><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/how-to-return\/actionable\/\">actionable results.<\/a><\/strong><\/li>\n<\/ul>\n<p>[\/vc_cta][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row el_id=&#8221;personally-valuable&#8221;][vc_column][vc_row_inner][vc_column_inner][vc_custom_heading text=&#8221;C. PERSONAL VALUE&#8221; font_container=&#8221;tag:h2|text_align:left|color:%230c598c&#8221; use_theme_fonts=&#8221;yes&#8221;][vc_column_text]<strong>Is the result something that could be considered meaningful or valuable to the participant despite not being currently actionable?<\/strong><\/p>\n<ul>\n<li><strong>Example:<\/strong> Genetic screening of a normal individual returns cystic fibrosis carrier status.<\/li>\n<li><strong>Example:<\/strong> The participant is found to have Gilbert\u2019s syndrome with an abnormal bilirubin secondary to a variant of a gene but one that does not cause liver disease. It is important to know, however, so that unnecessary tests are not performed.<\/li>\n<li><strong>Example:<\/strong> The participant is found to have a rare blood type.<\/li>\n<li><\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner content_placement=&#8221;top&#8221;][vc_column_inner width=&#8221;1\/3&#8243;][vc_cta h2=&#8221;NO&#8221; h2_font_container=&#8221;tag:h2|text_align:left|color:%23002b38&#8243; h2_use_theme_fonts=&#8221;yes&#8221; style=&#8221;custom&#8221; add_icon=&#8221;left&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-down&#8221; i_color=&#8221;mulled_wine&#8221; i_size=&#8221;lg&#8221; use_custom_fonts_h2=&#8221;true&#8221; custom_background=&#8221;#ffffff&#8221; i_link=&#8221;url:https%3A%2F%2Fmrctcenter.org%2Freturn-of-individual-results%2Fhow-to-return-irr%2Fdetermining-what-to-return%2F%23no-known-implications&#8221;]Next data type[\/vc_cta][\/vc_column_inner][vc_column_inner width=&#8221;2\/3&#8243; css=&#8221;.vc_custom_1633366209037{margin-top: -34px !important;border-radius: 20px !important;}&#8221;][vc_cta h2=&#8221;YES&#8221; add_icon=&#8221;left&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; i_color=&#8221;peacoc&#8221; i_background_style=&#8221;rounded&#8221; i_background_color=&#8221;white&#8221; i_size=&#8221;lg&#8221; i_link=&#8221;url:https%3A%2F%2Fmrctcenter.org%2Freturn-of-individual-results%2Fhow-to-return-irr%2Fhow-to-return%2Fpersonally-valuable%2F&#8221;]<\/p>\n<ul>\n<li><strong>This result should be returned to participants if feasible<\/strong><\/li>\n<li>Feasibility is dependent on the study and the priorities of the study population, and should be considered on a study-by-study basis.<\/li>\n<li>A plan should be made <em>ahead of time<\/em> for how and when to return this result &#8211; see more here about returning <strong><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/how-to-return\/personally-valuable\/\">personally valuable results.<\/a><\/strong><\/li>\n<\/ul>\n<p>[\/vc_cta][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row el_id=&#8221;no-known-implications&#8221;][vc_column][vc_row_inner][vc_column_inner][vc_custom_heading text=&#8221;D. INTERPRETATION LIMITATIONS&#8221; font_container=&#8221;tag:h2|text_align:left|color:%230c598c&#8221; use_theme_fonts=&#8221;yes&#8221;][vc_column_text]<strong>Is the result not known to have any health implications?<\/strong><\/p>\n<ul>\n<li><strong>Example: <\/strong>A minimally high-density lipoprotein (HDL) of uncertain significance.<\/li>\n<li><strong>Example:<\/strong> Initial genetic research studies that are trying to uncover associations between differences in our DNA and response to an investigational drug.<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner content_placement=&#8221;top&#8221;][vc_column_inner width=&#8221;2\/3&#8243; css=&#8221;.vc_custom_1633366209037{margin-top: -34px !important;border-radius: 20px !important;}&#8221;][vc_cta h2=&#8221;YES&#8221; add_icon=&#8221;left&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; i_color=&#8221;peacoc&#8221; i_background_style=&#8221;rounded&#8221; i_background_color=&#8221;white&#8221; i_size=&#8221;lg&#8221; i_link=&#8221;url:https%3A%2F%2Fmrctcenter.org%2Freturn-of-individual-results%2Fhow-to-return-irr%2Fhow-to-return%2Fno-known-implications%2F&#8221;]<\/p>\n<ul>\n<li><strong>If returning this result, do so with adequate explanation of the limits of current knowledge.<\/strong><\/li>\n<li>See more here about returning results with <strong><a href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/how-to-return\/no-known-implications\/\">no known implications<\/a>.<\/strong><\/li>\n<\/ul>\n<p>[\/vc_cta][\/vc_column_inner][vc_column_inner width=&#8221;1\/3&#8243;][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row]<\/p>\n<\/section>","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column][vc_empty_space][vc_column_text] Step 1: During the study, when are you collecting data? Consider the entire clinical trial lifecycle for a participant:[\/vc_column_text][vc_single_image image=&#8221;1123&#8243; img_size=&#8221;full&#8221;][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text]Step 2: What kinds of data will be generated during each period? Think about the kinds of tests you will perform during each of the above periods: Study arm assignment Laboratory tests Diagnostic Imaging [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":0,"parent":986,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"template-sub.php","meta":{"footnotes":""},"class_list":["post-1230","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>Determining what to return - 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\/determining-what-to-return\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Determining what to return\" \/>\n<meta property=\"og:description\" content=\"[vc_row][vc_column][vc_empty_space][vc_column_text] Step 1: During the study, when are you collecting data? 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