{"id":1141,"date":"2021-10-19T16:24:14","date_gmt":"2021-10-19T20:24:14","guid":{"rendered":"https:\/\/mrctcenter.org\/return-of-individual-results\/?page_id=1141"},"modified":"2021-10-19T16:24:14","modified_gmt":"2021-10-19T20:24:14","slug":"legal-old","status":"publish","type":"page","link":"https:\/\/mrctcenter.org\/return-of-individual-results\/topics\/legal-old\/","title":{"rendered":"Legal"},"content":{"rendered":"<section class=\"wpb-content-wrapper\"><p>[vc_row][vc_column][vc_column_text]<strong>While there exist a variety of concerns that may fall under the purview of a legal department, we have grouped concepts below under <\/strong><\/p>\n<ul>\n<li><strong>Liability<\/strong><\/li>\n<li><strong>Regulations<\/strong><\/li>\n<li><strong>Privacy<\/strong><\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_custom_heading text=&#8221;Liability&#8221; use_theme_fonts=&#8221;yes&#8221;][vc_column_text]<strong>Liability<\/strong><\/p>\n<ul>\n<li>Is re-interpretation required? No.<\/li>\n<li>Duty to warn<\/li>\n<li>Risk of patients interpreting their results for themselves incorrectly and making bad decisions because of that\n<ul>\n<li>Address: add disclaimer to not use this ad medical advice and consult doc with questions or concerns. Can also pass on PI contact info.<\/li>\n<\/ul>\n<\/li>\n<li>\u201cnever say never\u201d in ICF \u2013 even if pt doesn\u2019t want other results, should leave door open for urgent results\/duty to care<\/li>\n<li>Sharing with minors \u2013 what are some approaches?<\/li>\n<li>Do sponsors use data that they don\u2019t \u201cown\u201d (eg RWE) and can they share results from that?<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_custom_heading text=&#8221;Regulations&#8221; use_theme_fonts=&#8221;yes&#8221;][vc_column_text]<strong>Regulations<\/strong><\/p>\n<p>Laws, regulations, and guidance (including Ethics Committee and regulatory guidance or position papers) vary considerably across countries on the issue of return of individual research results to study participants.<\/p>\n<p>In general, two types of regulations need to be considered:<\/p>\n<ol>\n<li>regulations for the return of results by researchers<\/li>\n<li>rules governing the individual\u2019s right of access to personal information.<\/li>\n<\/ol>\n<p>In some countries, laws grant study participants broad access to their individual research results upon request; in other countries, laws may place restrictions on access.<\/p>\n<p>If you are pursuing the return of IRR at your organization, make sure to identify local individuals who know and can represent the relevant laws and regulations, and their interpretation. Remember, laws and regulations are constantly evolving.<\/p>\n<ul>\n<li>Regs:\n<ul>\n<li>US:\n<ul>\n<li>HIPAA<\/li>\n<li>CLIA<\/li>\n<li>Common Rule<\/li>\n<li>Genetic Information Nondiscrimination Act<\/li>\n<li>Genetic Privacy Laws \u2013 50 state survey (link)<\/li>\n<\/ul>\n<\/li>\n<li>International:\n<ul>\n<li>GDPR<\/li>\n<li>Link to HHS International Compilation of Human Research Standards<\/li>\n<\/ul>\n<\/li>\n<li>Review HIPAA\/CLIA clash<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_custom_heading text=&#8221;Privacy&#8221; use_theme_fonts=&#8221;yes&#8221;][vc_column_text]<strong>Privacy<\/strong><\/p>\n<ul>\n<li>Address medical record stuff<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n<\/section>","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column][vc_column_text]While there exist a variety of concerns that may fall under the purview of a legal department, we have grouped concepts below under Liability Regulations Privacy [\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_custom_heading text=&#8221;Liability&#8221; use_theme_fonts=&#8221;yes&#8221;][vc_column_text]Liability Is re-interpretation required? No. Duty to warn Risk of patients interpreting their results for themselves incorrectly and making bad decisions because of that Address: add disclaimer [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":0,"parent":854,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"template-sub.php","meta":{"footnotes":""},"class_list":["post-1141","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>Legal - 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\/topics\/legal-old\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Legal\" \/>\n<meta property=\"og:description\" content=\"[vc_row][vc_column][vc_column_text]While there exist a variety of concerns that may fall under the purview of a legal department, we have grouped concepts below under Liability Regulations Privacy [\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_custom_heading text=&#8221;Liability&#8221; use_theme_fonts=&#8221;yes&#8221;][vc_column_text]Liability Is re-interpretation required? 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