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Regulating Tissue Donation Consent

April 12, 2018
It is estimated that one individual organ, eye, and tissue donor can save up to 75 lives [1]. Currently an average of 22 individuals die each day waiting to be matched for a transplant [2]. Donated tissues and organs both have lifesaving potential, but unlike donated organs, donated tissue is also purchased by biotechnology and cosmetic companies for research purposes. Most donors, however, are not aware of the differences between organ and tissue donation, including how it is removed, used, and regulated [3]. Even fewer are aware that by registering for organ donation, they have become tissue donors by default and that their tissues can be sold for up to $80,000 to profitable companies [4]. In order to increase transparency and not lose informed consent of donors, registration for tissue donation and organ donation in the United States should be separate processes.

Differences Between Organ and Tissue Donation

Despite their similarities, organ donation is much more widely understood than tissue donation. Tissue donation recovers the parts of the body besides organs, including tendons, skin, and bones [5]. Individuals can choose to donate tissue after their death, or living individuals can choose to donate tissue removed during surgeries, such as bone after a hip replacement or placental tissue after giving birth [6]. Unlike organ donation, which must take place immediately, the process of tissue removal can begin 24 hours after death [7]. While organ donation procedures require surgeons to remove the donated organs, tissue donation does not. Notably, the comparative lack of medical protocol in tissue removal could explain some of the difference between the highly regulated procedures involving donor organs and the lack of regulation over donated tissue. However, the tissue transplant industry still calls for the use of “trained technicians using aseptic techniques in a controlled environment” to adequately recover donated tissue, establishing voluntary guidelines to direct the safe, respectful handling of donated tissue by tissue facilities [8].

Donated tissue can be used to treat severe burns, torn ligaments and tendons, and injuries affecting bones, joints, teeth, and the spine [9]. Corneal tissue can be used to restore sight from several diseases and is one of the most commonly transplanted tissues with 44,000 corneal transplants reported annually [10].

(Image: Donated organs, shown in blue, and tissues, shown in green, can serve many important functions. Source: Donate Life.)(Image: Donated organs, shown in blue, and tissues, shown in green, can serve many important functions. Source: Donate Life.)

The main difference between organ and tissue donation is that the recovered tissue can also be used by for-profit biotech and cosmetic companies. While this use of donated tissue helps to advance research, it is unclear how payment for tissue should be handled, especially since donors themselves are not paid for their tissue despite the economic benefit their tissue provides [11]. Many research hospitals have partnered with biotechnology companies to provide human tissue samples for research, treatment, and drug development uses [12]. This tissue is often left over from procedures and stored anonymously to protect donor privacy. Tissue banks and databases are established for specific illnesses, and some donated tissue stored in tissue banks can also be bought by groups interested in researching specific illnesses [13]. In addition to medical, pharmaceutical, and research groups, cosmetic companies also purchase tissue samples, especially preserved skin samples [14]. The use of donated and preserved skin by the cosmetic industry is considered an ethical alternative to testing on animals for products like makeup and sunscreen [15]. Finally, donated tissue is used for cosmetic procedures including, rhinoplasties, breast augmentations, and face lifts [16]. The human tissue industry brings in profits of approximately $1 billion annually [17]. The fact that private industry is profiting off of donations may be troublesome to some donors.

Differences in Regulation

Tissue and organ donation are regulated differently, despite the fact that they are presented to donors as the same. Donor tissue has a much wider legal use compared to donor organs. While donated organs are highly regulated in the United States, donated tissue is largely unregulated [18]. In 1984, Congress passed the National Organ Transplant Act (NOTA), which established the Organ Procurement and Transplantation Network, a private non-profit that matches donors to individuals on the national waitlist [19]. NOTA also made it illegal to buy or sell human organs, explaining that “human body parts should not be viewed as commodities” [20].

Unlike organ donation, tissue donation regulation varies between states. Nationally the Food and Drug Administration regulates tissue donor screening as part of its category of human cell and tissue-based products, establishing that that tissue banks must submit and keep records of donor health information [21]. The American Association of Tissue Banks provides a code of ethics and good practice standards, including conduct for communicating with donor families and ways to distribute tissue in a nondiscriminatory manner [22]. These standards, which are referenced in legislation by more than 20 states, are the only private tissue-banking standards in the country and have served as a model for federal regulation [23]. However, the standards are phrased as an abstract pledge of values as opposed to direct legislation and notably omit any reference to the profitable uses of tissue. Beyond the FDA screening regulations and AATB guidelines, there is a variety of differing regulation between states. The separate aspects of tissue donation, including donor screening, procurement, and designation, are regulated differently and often by separate governing organizations. Laws regulating tissue banks are often inconsistent even within the same state [24]. Clearly there is room for improvement both in regulation and education.

Issues in Current Policy

Currently, the process of registering to be a tissue donor in the United States is not well defined and varies from state to state [25]. Organ donation and tissue donation consent are often conjoined, and organ donors are often unaware that they are also tissue donors. Donors are also unaware that their tissue could be used for profit, such as cosmetic surgery [26]. Increased transparency is necessary to reduce the ambiguity among organ donors about their status as tissue donors and increase awareness among current and potential donors about the uses of harvested tissue. Policy can be restructured in three primary ways that will alleviate these concerns.

Policy Proposal

Adopting a national policy would make tissue donation regulation easier. National legislation would make the policy clearer and more widely known. This would have the added benefit of simplifying relocation within the United States. Organ and tissue donation should be clearly separated on donation consent forms such that both could be completed concurrently, but there would be would clearly be separate choices, with separate consents given for each type of donation. This “separate but linked” consent would make tissue donation forms as accessible as the more common organ donation forms. The separation would also make clear to the prospective donor that tissue and organ donation are distinct. Finally tissue donors should be allowed to limit their consent to not-for-profit use. This would allow people who would like to refrain from donating tissues for use in for-profit industries to still be donors for medical uses. Furthermore, separate donation categories would make clear that tissue is currently used for profit. Adoption of such a policy proposal would create a more transparent process allowing for truly informed consent.

Costs of A More Regulated Policy

Further regulation may result in tissue scarcity if donors are deterred by the new information they receive. Reducing the supply of human tissue available would increase cost of obtaining tissue for research. Currently, human tissue purposed for biomedical research is valued at approximately $500 per gram [27]. Furthermore, decreased availability of tissue could also increase the price of cosmetic surgery in the United States, which as mentioned previously, relies on tissue donation for routine procedures such as facelifts and rhinoplasty. Introducing tissue donation regulation that separates for-profit and not-for-profit tissue usage and allows donors to choose one over the other could create substantial obstacles for the cosmetic procedures. Decreased tissue availability could also make it more difficult for patients in need of tissue donations for skin grafts or corneal implantations to receive treatment [28].

Tissue donation in the United States is in need of a clearly delineated, consistent, and national policy. This will reduce any ambiguity that exists among organ donors about whether they are tissue donors as well and will allow donors to exercise more control over what their tissues are purposed for. However, a policy that inadvertently decreases the tissue availability could potentially prompt the cosmetic surgery or biomedical research industries, which rely on donated tissues, to move overseas.

Student Blog Disclaimer
  • The views expressed on the Student Blog are the author’s opinions and don’t necessarily represent the Penn Wharton Public Policy Initiative’s strategies, recommendations, or opinions.

References

  [1] https://www.donatelife.net

  [2] Ibid.

  [3] https://www.npr.org/2012/07/17/156876476/calculating-the-value-of-human-tissue-donation

  [4] Ibid.

  [5] https://www.donatelife.net/types-of-donation/tissue-donation/

  [6] http://www.donors1.org/learn2/faqs/

  [7] https://www.npr.org/2012/07/17/156876476/calculating-the-value-of-human-tissue-donation

  [8] https://www.aatb.org/sites/default/files/AATBCodeofEthics19June2012.pdf

  [9] https://www.organdonation.nhs.uk/about-donation/what-is-tissue-donation/

  [10] https://uihc.org/health-library/eye-donor-awareness-frequently-asked-questions

  [11] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1071143/

  [12] Ibid.

  [13] Ibid.

  [14] http://allograftpossibilities.org/about-tissue-transplant/

  [15] https://www.genoskin.com/en/tissue-samples/

  [15] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1071143/

  [16] http://nymag.com/thejob/2017/04/the-human-tissue-saleswoman-who-advises-surgeons-in-the-o-r.html

  [17] https://www.npr.org/2012/07/17/156876476/calculating-the-value-of-human-tissue-donation

  [18] https://organdonor.gov/about-dot/laws.html

  [19] https://optn.transplant.hrsa.gov/governance/about-the-optn/history-nota/

  [20] https://history.nih.gov/research/downloads/PL98-507.pdf

  [21] https://www.fda.gov/ohrms/dockets/ac/01/briefing/3736b2_01.pdf

  [22] https://www.aatb.org/sites/default/files/AATBCodeofEthics19June2012.pdf

  [23] https://www.aatb.org/sites/default/files/AATBCodeofEthics19June2012.pdf

  [24] 50-State Survey of Laws Regulating the Collection … - Drexel University

  [25] https://www.huffingtonpost.com/icij/tissue-donation_b_1676671.html

  [26] https://www.npr.org/2012/07/18/156968033/am-i-a-tissue-donor-too

  [27] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4428037/

  [28] https://uihc.org/health-library/eye-donor-awareness-frequently-asked-questions

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  • <h3>Internal Revenue Service: Tax Statistics</h3><p><img width="155" height="200" alt="" src="/live/image/gid/4/width/155/height/200/486_irs_logo.rev.1407789424.jpg" class="lw_image lw_image486 lw_align_left" srcset="/live/image/scale/2x/gid/4/width/155/height/200/486_irs_logo.rev.1407789424.jpg 2x" data-max-w="463" data-max-h="596"/>Find statistics on business tax, individual tax, charitable and exempt organizations, IRS operations and budget, and income (SOI), as well as statistics by form, products, publications, papers, and other IRS data.</p><p> Quick link to <strong>Tax Statistics, where you will find a wide range of tables, articles, and data</strong> that describe and measure elements of the U.S. tax system: <a href="http://www.irs.gov/uac/Tax-Stats-2" target="_blank">http://www.irs.gov/uac/Tax-Stats-2</a></p><p>See all <a href="/data-resources/">data and resources</a> »</p>
  • <h3>Congressional Budget Office</h3><p><img width="180" height="180" alt="" src="/live/image/gid/4/width/180/height/180/380_cbo-logo.rev.1406822035.jpg" class="lw_image lw_image380 lw_align_right" data-max-w="180" data-max-h="180"/>Since its founding in 1974, the Congressional Budget Office (CBO) has produced independent analyses of budgetary and economic issues to support the Congressional budget process.</p><p> The agency is strictly nonpartisan and conducts objective, impartial analysis, which is evident in each of the dozens of reports and hundreds of cost estimates that its economists and policy analysts produce each year. CBO does not make policy recommendations, and each report and cost estimate discloses the agency’s assumptions and methodologies. <strong>CBO provides budgetary and economic information in a variety of ways and at various points in the legislative process.</strong> Products include baseline budget projections and economic forecasts, analysis of the President’s budget, cost estimates, analysis of federal mandates, working papers, and more.</p><p> Quick link to Products page: <a href="http://www.cbo.gov/about/our-products" target="_blank">http://www.cbo.gov/about/our-products</a></p><p> Quick link to Topics: <a href="http://www.cbo.gov/topics" target="_blank">http://www.cbo.gov/topics</a></p><p>See all <a href="/data-resources/">data and resources</a> »</p>
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  • <h3>National Center for Education Statistics</h3><p><strong><img width="400" height="80" alt="" src="/live/image/gid/4/width/400/height/80/479_nces.rev.1407787656.jpg" class="lw_image lw_image479 lw_align_right" data-max-w="400" data-max-h="80"/>The National Center for Education Statistics (NCES) is the primary federal entity for collecting and analyzing data related to education in the U.S. and other nations.</strong> NCES is located within the U.S. Department of Education and the Institute of Education Sciences. NCES has an extensive Statistical Standards Program that consults and advises on methodological and statistical aspects involved in the design, collection, and analysis of data collections in the Center. To learn more about the NCES, <a href="http://nces.ed.gov/about/" target="_blank">click here</a>.</p><p> Quick link to NCES Data Tools: <a href="http://nces.ed.gov/datatools/index.asp?DataToolSectionID=4" target="_blank">http://nces.ed.gov/datatools/index.asp?DataToolSectionID=4</a></p><p> Quick link to Quick Tables and Figures: <a href="http://nces.ed.gov/quicktables/" target="_blank">http://nces.ed.gov/quicktables/</a></p><p> Quick link to NCES Fast Facts (Note: The primary purpose of the Fast Facts website is to provide users with concise information on a range of educational issues, from early childhood to adult learning.): <a href="http://nces.ed.gov/fastfacts/" target="_blank">http://nces.ed.gov/fastfacts/#</a></p><p>See all <a href="/data-resources/">data and resources</a> »</p>
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  • <h3>The Penn World Table</h3><p> The Penn World Table provides purchasing power parity and national income accounts converted to international prices for 189 countries/territories for some or all of the years 1950-2010.</p><p><a href="https://pwt.sas.upenn.edu/php_site/pwt71/pwt71_form.php" target="_blank">Quick link.</a> </p><p>See all <a href="/data-resources/">data and resources</a> »</p>
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