{"id":1298,"date":"2021-11-12T17:19:40","date_gmt":"2021-11-12T22:19:40","guid":{"rendered":"https:\/\/dev.mrctcenter.org\/return-of-individual-results\/?page_id=1298"},"modified":"2021-11-12T17:19:40","modified_gmt":"2021-11-12T22:19:40","slug":"no-known-implications","status":"publish","type":"page","link":"https:\/\/dev.mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/how-to-return\/no-known-implications\/","title":{"rendered":"No known implications"},"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_1637124426994{padding-right: 20px !important;padding-left: 20px !important;background-color: #f4f4f4 !important;border-radius: 20px !important;}&#8221;][vc_column width=&#8221;5\/6&#8243;][vc_column_text css=&#8221;.vc_custom_1639586443628{margin-right: -130px !important;}&#8221;]<\/p>\n<h2><strong>HOW WE DEFINE RESULTS WITH NO KNOWN IMPLICATIONS<\/strong><\/h2>\n<p><strong>A result with no known utility or value has unclear significance to a participant\u2019s current or future health, at least as is currently known.\u00a0 These data include but are not limited to exploratory endpoints and may be generated during or after the study.<\/strong><\/p>\n<p>Examples:<\/p>\n<ul>\n<li>A minimally high-density lipoprotein (HDL) of uncertain significance.<\/li>\n<li>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][vc_column width=&#8221;1\/6&#8243;][vc_icon icon_fontawesome=&#8221;fas fa-question-circle&#8221; color=&#8221;custom&#8221; size=&#8221;lg&#8221; align=&#8221;right&#8221; custom_color=&#8221;#005565&#8243; css=&#8221;.vc_custom_1637124473562{margin-top: -26px !important;}&#8221;][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221;][vc_column css=&#8221;.vc_custom_1635544316400{margin-top: -20px !important;}&#8221;][vc_custom_heading text=&#8221;Review the Basics for Returning Results with No Known Implications:&#8221; font_container=&#8221;tag:h2|text_align:left|color:%23152736&#8243; use_theme_fonts=&#8221;yes&#8221; css=&#8221;.vc_custom_1637125220819{margin-top: 12px !important;}&#8221;][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%231634222002112-6b1c6a67-fc87&#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\/#1634222002112-6b1c6a67-fc87\">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%231634224992818-479edf63-a38e&#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\/#1634224992818-479edf63-a38e\">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%231634227831888-63f5ccf8-e6ef&#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\/#1634227831888-63f5ccf8-e6ef\">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; i_link=&#8221;url:https%3A%2F%2Fdev.mrctcenter.org%2Freturn-of-individual-results%2Fhow-to-return-irr%2Fhow-to-return%2F%23opt-in-opt-out&#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;][vc_column css=&#8221;.vc_custom_1635544316400{margin-top: -20px !important;}&#8221;][vc_empty_space][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1637124521544{background-color: #005565 !important;}&#8221;][vc_column css=&#8221;.vc_custom_1635544316400{margin-top: -20px !important;}&#8221;][vc_custom_heading text=&#8221;Points to Consider &amp; the Decision to Return or Not&#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;][vc_column][vc_row_inner][vc_column_inner][vc_custom_heading text=&#8221;The return of these types of results should be done with caution and care.&#8221; font_container=&#8221;tag:h3|text_align:left|color:%23152736&#8243; use_theme_fonts=&#8221;yes&#8221; css=&#8221;.vc_custom_1637124687781{padding-bottom: 12px !important;}&#8221;][vc_column_text]These results may be confusing to participants and\/or their healthcare provider and may cause stress to participants from not knowing how or when to act upon their results.<\/p>\n<p>That being said, participants may still want to have this information for the future. These results can be returned if logistically feasible and if the participant chooses to receive them, unless there is a specific reason to withhold the information. It is important to communicate the quality and validity of any data returned particularly those data with no known utility or value, and document that communication. The limitations of the interpretation of the data should be made clear.<\/p>\n<p>Returning exploratory results encourages continuing engagement in research as well as responsible stewardship of personal and family health. If it is decided not to return these data, it should be made clear to the participant for transparency.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1636755442178{background-color: #f7f7f7 !important;}&#8221;][vc_column][vc_custom_heading text=&#8221;Participant Choice&#8221; font_container=&#8221;tag:h1|text_align:left|color:%23005565&#8243; use_theme_fonts=&#8221;yes&#8221;][vc_row_inner][vc_column_inner][vc_column_text]It is especially important to offer participants a choice as to whether or not to receive these types of individual research results, as they carry a risk of confusion, dissatisfaction, and unpleasant reactions.<\/p>\n<p>There are 4 ways outlined to obtain this choice from participants \u2013 depending on the nature of your results the risk\/benefit ratio may not warrant return.<\/p>\n<p><strong><a href=\"https:\/\/dev.mrctcenter.org\/return-of-individual-results\/how-to-return-irr\/how-to-return\/#opt-in-opt-out\">See more here about participant choice.<\/a><\/strong>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221;][vc_column][vc_custom_heading text=&#8221;Informed Consent&#8221; font_container=&#8221;tag:h1|text_align:left|color:%23005565&#8243; use_theme_fonts=&#8221;yes&#8221;][vc_row_inner][vc_column_inner][vc_column_text]If offering to return this information, it is important that<strong> participants understand its limitations, the absence of current and future interpretation, and that they have a choice whether or not to receive it.<\/strong><\/p>\n<p><strong>Sample language: <\/strong><\/p>\n<p><em>During this study, we may learn things about you that you may find interesting but probably will not help you. Health care providers may not know what the information means or what to do about it. Examples include [describe]. <\/em><\/p>\n<p><em>Some people find this kind of information confusing or stressful. You can choose whether to receive this information. [<\/em><em>Include appropriate language for participants to indicate whether they want to receive information, per your plan.]<\/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]<\/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_1637124426994{padding-right: 20px !important;padding-left: 20px !important;background-color: #f4f4f4 !important;border-radius: 20px !important;}&#8221;][vc_column width=&#8221;5\/6&#8243;][vc_column_text css=&#8221;.vc_custom_1639586443628{margin-right: -130px !important;}&#8221;] HOW WE DEFINE RESULTS WITH NO KNOWN IMPLICATIONS A result with no known utility or value has unclear significance to a participant\u2019s current or future health, at least as is currently known.\u00a0 These data include but are not limited to [&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-1298","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.mrctcenter.org\/return-of-individual-results\/wp-json\/wp\/v2\/pages\/1298"}],"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=1298"}],"version-history":[{"count":0,"href":"https:\/\/dev.mrctcenter.org\/return-of-individual-results\/wp-json\/wp\/v2\/pages\/1298\/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=1298"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}