{"id":12000,"date":"2020-07-28T19:40:00","date_gmt":"2020-07-28T23:40:00","guid":{"rendered":"https:\/\/www.shortform.com\/blog\/?p=12000"},"modified":"2022-04-01T16:04:17","modified_gmt":"2022-04-01T20:04:17","slug":"voluntary-consent-informed-consent","status":"publish","type":"post","link":"https:\/\/www.shortform.com\/blog\/voluntary-consent-informed-consent\/","title":{"rendered":"Voluntary Consent in Medical Research: The Murky Situation"},"content":{"rendered":"\n<p>What makes it ethical to perform experiments on people? How does a doctor get permission to take blood or tissue samples from a patient? What type of voluntary consent or informed consent is needed?<\/p>\n\n\n\n<p>Voluntary consent is when a person willingly participates in a procedure or experiment. Informed consent in research requires the person to know what they&#8217;re agreeing to as opposed to just agreeing to do something.<\/p>\n\n\n\n<p>Read more about the issue of voluntary consent for Henrietta Lacks and informed consent in research using her cells.<\/p>\n\n\n\n<!--more-->\n\n\n\n<h2 class=\"wp-block-heading\">Discovering a Lack of Voluntary Consent<\/h2>\n\n\n\n<p>In 1975, a <em>Rolling Stone <\/em>reporter writing a story on the widespread contamination of cell lines with HeLa reached out to the family. The article alluded to commercial businesses that sold vials of HeLa cells. (As of 2009, a company called Invitrogen was selling HeLa-derived products for anywhere from $100 to $10,000 per unit.)<br><\/p>\n\n\n\n<p>When the article appeared in 1976, it had a major impact in the wider culture. It was the era of the Black Panthers, and scholars and activists had uncovered widespread abuses of research subjects and medical patients on the basis of their race. <strong>The cultivation of Henrietta\u2019s cells without her or her family\u2019s voluntary consent\u2014and the economic difficulties of her kin\u2014became a testament to the persistent power disparities between Blacks and Whites in the U.S.<\/strong><br><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Informed Consent in Research<\/h3>\n\n\n\n<p>In terms of voluntary consent, the Federal Policy for the Protection of Human Subjects\u2014more commonly known as the \u201cCommon Rule\u201d\u2014mandates that researchers must have informed consent before conducting studies or experiments on human subjects. <strong>The problem is that most <a href=\"https:\/\/www.shortform.com\/blog\/human-tissue-ownership-tissue-research\/\">tissue research<\/a> isn\u2019t federally funded and the researcher never comes into contact with the actual human who provided the samples: the subject is the <em>sample<\/em>, not the <em>human<\/em><\/strong>. Doctors must get informed consent from a potential subject if they want to remove tissue for research, but if they want to conduct research on already-removed tissue, they don\u2019t.<br><\/p>\n\n\n\n<p>While the medical establishment believes there are sufficient mechanisms and rules in place for informed consent in research\u2014institutional review boards, various guidelines, and ethical codes\u2014tissue-rights activists argue that actual legislation is necessary to protect people\u2019s tissue. <strong>These activists believe that donors should have a say in who gets access to those tissues and what kinds of research their tissues are used for<\/strong>.<br><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Gray Areas in Voluntary Consent<\/h3>\n\n\n\n<p>Some unwitting tissue donors have tested these theories in the courts. In 2005, 6,000 patients sued Washington University to have their tissue samples removed from the institution\u2019s cell bank. The patients lost their initial lawsuit as well as their appeal; the judges in both cases argued that patient ownership of tissue samples would stifle scientific research. In 2008, the patients appealed to the Supreme Court, which refused to hear the case.<br><\/p>\n\n\n\n<p><strong>Hopkins\u2019s release of Henrietta\u2019s name and medical records, however, <\/strong><strong><em>would <\/em><\/strong><strong>be illegal now: HIPAA protects patients\u2019 privacy<\/strong>. And the Common Rule features guidelines for naming and\/or coding samples that renders them anonymous (i.e., samples are no longer named, like HeLa, using the subject\u2019s real name).<br><\/p>\n\n\n\n<p><strong>Contemporary bioethicists and scientists are divided on the issue of informed consent in research<\/strong>. Some believe patients should have complete knowledge of and control over how their tissues are used, whereas others argue the complexity of a robust consent regime would have significant negative consequences for the advance of science.&nbsp;<br><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Voluntary Consent With Commercial Uses<\/h3>\n\n\n\n<p>In terms of the <em>patient\u2019s <\/em>interests in commercial science, the scientists Skloot interviews believe patients should have ownership of their tissues. Wayne Grody, a lab director at UCLA, argues that if patients can leverage their tissues to make a profit, more power to them.&nbsp;<\/p>\n\n\n\n<p><strong>The problem, though, is that the majority of patients don\u2019t know their tissues are valuable until <em>after<\/em> they\u2019ve already been (legally) taken<\/strong>. Thus the only way they can reap the benefits of their tissues is if doctors and researchers voluntarily include them in any commercial venture\u2014or if those doctors and researchers must get their consent. <\/p>\n","protected":false},"excerpt":{"rendered":"<p>What makes it ethical to perform experiments on people? How does a doctor get permission to take blood or tissue samples from a patient? What type of voluntary consent or informed consent is needed? Voluntary consent is when a person willingly participates in a procedure or experiment. Informed consent in research requires the person to know what they&#8217;re agreeing to as opposed to just agreeing to do something. Read more about the issue of voluntary consent for Henrietta Lacks and informed consent in research using her cells.<\/p>\n","protected":false},"author":6,"featured_media":12081,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[20,16],"tags":[111],"class_list":["post-12000","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-ethics","category-health","tag-the-immortal-life-of-henrietta-lacks","","tg-column-two"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v24.3 (Yoast SEO v24.3) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Voluntary Consent in Medical Research: The Murky Situation - Shortform Books<\/title>\n<meta name=\"description\" content=\"Voluntary consent is willing participation in something. Informed consent in research requires the person to know what they&#039;re agreeing to. Read about both.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.shortform.com\/blog\/voluntary-consent-informed-consent\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Voluntary Consent in Medical Research: The Murky Situation\" \/>\n<meta property=\"og:description\" content=\"Voluntary consent is willing participation in something. Informed consent in research requires the person to know what they&#039;re agreeing to. Read about both.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.shortform.com\/blog\/voluntary-consent-informed-consent\/\" \/>\n<meta property=\"og:site_name\" content=\"Shortform Books\" \/>\n<meta property=\"article:published_time\" content=\"2020-07-28T23:40:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-04-01T20:04:17+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/s3.amazonaws.com\/wordpress.shortform.com\/blog\/wp-content\/uploads\/2020\/07\/the-immortal-life-of-henrietta-lacks-voluntary-consent-scaled.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1708\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Rina Shah\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Rina Shah\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.shortform.com\/blog\/voluntary-consent-informed-consent\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.shortform.com\/blog\/voluntary-consent-informed-consent\/\"},\"author\":{\"name\":\"Rina Shah\",\"@id\":\"https:\/\/www.shortform.com\/blog\/#\/schema\/person\/d07435826f13a8f422d5d333dceac287\"},\"headline\":\"Voluntary Consent in Medical Research: The Murky Situation\",\"datePublished\":\"2020-07-28T23:40:00+00:00\",\"dateModified\":\"2022-04-01T20:04:17+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.shortform.com\/blog\/voluntary-consent-informed-consent\/\"},\"wordCount\":684,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/www.shortform.com\/blog\/#organization\"},\"image\":{\"@id\":\"https:\/\/www.shortform.com\/blog\/voluntary-consent-informed-consent\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.shortform.com\/blog\/wp-content\/uploads\/2020\/07\/the-immortal-life-of-henrietta-lacks-voluntary-consent-scaled.jpg\",\"keywords\":[\"The Immortal Life of Henrietta Lacks\"],\"articleSection\":[\"Ethics\",\"Health\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/www.shortform.com\/blog\/voluntary-consent-informed-consent\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.shortform.com\/blog\/voluntary-consent-informed-consent\/\",\"url\":\"https:\/\/www.shortform.com\/blog\/voluntary-consent-informed-consent\/\",\"name\":\"Voluntary Consent in Medical Research: The Murky Situation - Shortform Books\",\"isPartOf\":{\"@id\":\"https:\/\/www.shortform.com\/blog\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.shortform.com\/blog\/voluntary-consent-informed-consent\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.shortform.com\/blog\/voluntary-consent-informed-consent\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.shortform.com\/blog\/wp-content\/uploads\/2020\/07\/the-immortal-life-of-henrietta-lacks-voluntary-consent-scaled.jpg\",\"datePublished\":\"2020-07-28T23:40:00+00:00\",\"dateModified\":\"2022-04-01T20:04:17+00:00\",\"description\":\"Voluntary consent is willing participation in something. 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