Investigator A conducts research on emphysema using biospecimens from human subjects. The consent form indicates that the research will focus exclusively on emphysema. Investigator B wishes to use the biospecimens for research on lung cancer. Can Investigator B use the specimens for cancer research without re-consent if the specimens are de-identified?<\/p>\n\n\n\n
Yes, because research with biospecimens is minimal risk.<\/p>\n\n\n\n
Yes, if the biospecimens are de-identified then the research is no longer considered human subjects research.<\/p>\n\n\n\n
No, because it would be unethical to conduct research that is not consistent with the consent form the subjects originally signed.<\/p>\n\n\n\n
No, the original research subjects must be re-consented for the cancer research.<\/p>\n\n\n\n
The Correct Answer and Explanation is:<\/mark><\/strong><\/p>\n\n\n\n Correct Answer: Yes, if the biospecimens are de-identified then the research is no longer considered human subjects research.<\/strong><\/p>\n\n\n\n According to the U.S. Department of Health and Human Services (HHS) regulations under the Common Rule<\/strong> (45 CFR 46), research involving biospecimens may not be considered human subjects research if the specimens are de-identified<\/strong>. De-identified means that all personally identifiable information (PII)<\/strong> has been removed such that the identities of the individuals cannot be readily ascertained by the investigator or linked to the specimens.<\/p>\n\n\n\n In this scenario, Investigator A<\/strong> originally obtained informed consent from participants to use biospecimens solely for research on emphysema. While this limits the scope of use under the consent<\/strong>, the crucial distinction arises when Investigator B<\/strong> wants to use these specimens for lung cancer research<\/strong>\u2014a different disease focus.<\/p>\n\n\n\n If Investigator B uses de-identified specimens<\/strong>, this type of research is not considered human subjects research<\/strong> under the Common Rule, because it does not involve interaction or intervention with living individuals and does not involve identifiable private information. Since the biospecimens are stripped of identifiers<\/strong> and cannot be traced back to individual subjects, no re-consent is legally required<\/strong>, and the research can proceed ethically and legally under current federal guidelines.<\/p>\n\n\n\n However, it is important to recognize that this applies only when the specimens are truly de-identified<\/strong>. If there is any link<\/strong>\u2014such as a code that allows the researcher to re-identify the subjects\u2014then the research may still be considered human subjects research, and re-consent could be necessary.<\/p>\n\n\n\n Thus, while there may be ethical nuances<\/strong> surrounding participant expectations, current regulations clearly allow such research without re-consent<\/strong> if the biospecimens are fully de-identified<\/strong>, as they no longer fall under the scope of human subjects research.<\/p>\n","protected":false},"excerpt":{"rendered":" Investigator A conducts research on emphysema using biospecimens from human subjects. The consent form indicates that the research will focus exclusively on emphysema. Investigator B wishes to use the biospecimens for research on lung cancer. Can Investigator B use the specimens for cancer research without re-consent if the specimens are de-identified? Yes, because research with […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[25],"tags":[],"class_list":["post-215508","post","type-post","status-publish","format-standard","hentry","category-exams-certification"],"_links":{"self":[{"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/posts\/215508","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/comments?post=215508"}],"version-history":[{"count":0,"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/posts\/215508\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/media?parent=215508"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/categories?post=215508"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/tags?post=215508"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Explanation:<\/h3>\n\n\n\n