{"id":12005,"date":"2020-08-02T14:29:00","date_gmt":"2020-08-02T18:29:00","guid":{"rendered":"https:\/\/www.shortform.com\/blog\/?p=12005"},"modified":"2022-04-01T16:06:43","modified_gmt":"2022-04-01T20:06:43","slug":"protecting-human-subjects-remuneration","status":"publish","type":"post","link":"https:\/\/www.shortform.com\/blog\/protecting-human-subjects-remuneration\/","title":{"rendered":"Remuneration: Exploiting or Protecting Human Subjects?"},"content":{"rendered":"\n

What do clinical trial regulations say about paying research participants? How do researchers go about protecting human subjects? What bioethical issues arise from the remuneration of research subjects that donate tissues?<\/p>\n\n\n\n

Rules for protecting human subjects generally prohibit paying research participants to donate their tissues or other body parts. But there are some bioethical issues that arise from profiting from research without paying research participants.<\/p>\n\n\n\n

Learn more about the issues related to protecting human subjects.<\/p>\n\n\n\n\n\n\n\n

Protecting Human Subjects<\/strong>: Is Paying Research Participants Okay?<\/h2>\n\n\n\n

The other facet of the debate concerns money\u2014whether patients should be informed if their tissues will be used in commercial enterprise and whether they should be compensated<\/strong>.
<\/p>\n\n\n\n

Under current law and clinical trial regulations, it is illegal to sell human organs and tissues for research or transplants. However, companies turn profits processing those organs and tissues that humans donate freely. 
<\/p>\n\n\n\n

Support for Paying Research Participants<\/h3>\n\n\n\n

Analysts in favor of compensating research subjects that are donating tissues have proposed various systems for paying patients back: direct payments for donations, royalties on future earnings from donated samples, and tax write-offs are just a few.  With a fair exchange, it is protecting human subjects instead of taking advantage.
<\/p>\n\n\n\n

Arguments Against Compensation<\/h3>\n\n\n\n

Those arguing against<\/em> compensating patients fear that, if patients can sell their tissues, they will begin to withhold samples to achieve better financial terms, thereby stifling research. But Skloot finds that very few tissue-rights activists seek cash awards for themselves<\/strong>. Rather, they want to ensure that whatever treatments or medicines are derived from their tissues are freely available to all (rather than patented for profit). This is protecting human subjects by giving them some power.
<\/p>\n\n\n\n

Bioethical Issues Around Gene Patenting<\/h3>\n\n\n\n

When Skloot was writing, the most contentious area of commercial science was gene patenting<\/strong>. As of 2005, the use of approximately 20% of known human genes had been patented. This meant that laboratories or institutions that wanted to conduct research on those genes had to pay a licensing fee. For example, to study the gene that caused hereditary hemochromatosis, a blood disorder, academic institutions were required to pay a $25,000 licensing fee to the company that had patented it<\/strong> (commercial enterprises had to pay $250,000). Myriad Genetics, which held patents on two genes responsible for breast cancer, had a monopoly on the test for those genes (which cost $3,000 per patient) and charged peer companies and institutions to research those genes. 
<\/p>\n\n\n\n

(Shortform note: The ACLU sued Myriad Genetics in 2009, arguing, ironically, that instead of spurring research, patenting discrete strands of DNA stifled research. After a number of appeals and a remand from the Supreme Court, the case was finally heard by the Supreme Court and decided in favor of the ACLU: The Court held that companies couldn\u2019t patent isolated strands of DNA found in nature<\/strong>.)
<\/p>\n\n\n\n

Members of the scientific community, as they are on the topic of a far-reaching consent regime, are divided on the topic of commercializing science. More capitalistic scientists believe that the possibility of profit incentivizes research and innovation, whereas less profit-driven researchers believe patents undermine the spirit and mission of science\u2014to increase the world\u2019s store of knowledge<\/strong>.
<\/p>\n\n\n\n

Researchers’ Views on Protecting Human Subjects and Paying Research Participants<\/h3>\n\n\n\n

In terms of the patient\u2019s <\/em>interests in commercial science, the scientists Skloot interviews believe research subjects should have ownership of their tissues. This helps in protecting human subjects. Wayne Grody, a lab director at UCLA, argues that if patients can leverage their tissues to make a profit, more power to them. 
<\/p>\n\n\n\n

The problem, though, is that the majority of research subjects don\u2019t know their tissues are valuable until 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\n\n\n

John Moore\u2019s lawsuit against David Golde<\/a> and UCLA resulted in case law that recommended patients be notified if their tissues have commercial value. No legislation resulted from the judge\u2019s decision, however, so institutions have no obligation to inform their patients about the potential for commercial use<\/strong>. And despite congressional hearings and federal reports on bioethics, no clear policy has emerged.
<\/p>\n\n\n\n

Bioethical Issues and Complications With HeLa<\/h2>\n\n\n\n

Although Lawrence and Zakariyya have expressed interest intermittently in suing Hopkins, no Lacks family<\/a> member has actually filed suit. There are merits to their case\u2014since HeLa cells are anything but anonymous, the family ought to be covered by the Common Rule; and since Henrietta\u2019s descendants share DNA with HeLa cells, they ought, under the Common Rule, to be able to remove HeLa cells from circulation\u2014but given the disruption a ruling like this would cause, legal experts are skeptical the suit would succeed. According to Sonny, the Lackses aren\u2019t eager to keep HeLa cells from being used in research anyway. He believes Deborah would want their mother\u2019s cells to continue helping people<\/strong>. HeLa\u2019s miraculous role in 20th-century science is a source of pride for the family. <\/p>\n","protected":false},"excerpt":{"rendered":"

What do clinical trial regulations say about paying research participants? How do researchers go about protecting human subjects? What bioethical issues arise from the remuneration of research subjects that donate tissues? Rules for protecting human subjects generally prohibit paying research participants to donate their tissues or other body parts. But there are some bioethical issues that arise from profiting from research without paying research participants. Learn more about the issues related to protecting human subjects.<\/p>\n","protected":false},"author":6,"featured_media":12120,"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-12005","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":"\nRemuneration: Exploiting or Protecting Human Subjects? - Shortform Books<\/title>\n<meta name=\"description\" content=\"Rules for protecting human subjects generally prohibit paying research participants to donate their tissues or other body parts. 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