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Abstract

The donation, procurement, processing, distribution, and transplantation of various human tissues and body parts have increased tremendously around the world in recent decades. This topic raises some complex ethical questions. The reasons for this include the partnering of altruistic donations and the processing, commercialization, and distribution of these resources, often involving for-proﬁt companies. While human tissues and body parts are generally used for the therapeutic beneﬁt of recipients, they can also be used for other purposes such as research and cosmetic enhancement. The main ethical issues concern voluntary and informed consent, the value of the human body and its parts, the gift of life, stewardship, safety, allocation, transparency, and anonymity.

Introduction

This entry focuses on ethical issues related to the donation and various uses of human tissues such as the skin and bone marrow and body parts such as the bone, tendons, blood vessels, and heart valves. “Musculoskeletal tissues” constitute “the majority of tissues, procured, processed, and transplanted” (Youngner et al. 2004, p. 14). Other entries in this encyclopedia treat the donation of the whole human body, complete human organs such as kidneys, and human blood, gametes, and embryos. While tissues and body parts are usually taken from the recently deceased, certain tissues such as bone marrow, which are regenerative, can involve living donors.

History And Development

Tissues of the human body have been studied at least since ancient Greece. In 287 C.E. Saints Cosmas and Damian reportedly transplanted a leg from a deceased to a living person. In the ﬁfteenth century medical schools in Europe began studying the human body and tissues. Specimens for study come not only from cadavers but also from tissues obtained for diagnosis or treatment. In 1878 MacEwan ﬁrst documented successful transplants of musculoskeletal tissue. While a surgical bone bank was established in Cuba in 1942, the US Navy Tissue Bank established in Maryland in 1949 “marked the emergence of the modern tissue bank.” The World Medical Association in 1964 ﬁrst presented ethical principles related to research in its Declaration of Helsinki. These were implemented in the regulations of many countries (Youngner et al. 2004, pp. 14–15; Allen et al. 2010).

In the 1960s and 1970s, many hospitals maintained their own surgical discard bone banks, mainly freezing bone removed during hip replacement surgery. Developments in orthopedic oncological surgery in the 1970s led to the development of cadaveric tissue banks. In the 1980s tissue banks began to proliferate. These were started by blood banks, eye banks, universities, hospitals, and entrepreneurs who saw a need or opportunity in tissue banking. Over time tissue banks began distributing tissues in high demand beyond their local areas and also to other countries. In the 1980s and 1990s, there was a dramatic expansion of the types of tissues used including sports medicine surgeons using increasingly larger amounts of “soft tissues,” for example, to repair damaged knee ligaments. In the 1980s for-proﬁt tissue processors entered into the ﬁeld. These used traditional business activities such as advertising, sales, and marketing. They also improved the quality of transplantable tissues, for example, introducing clean-room technology.

Many of the “new tissue forms currently in high demand” would not “have been developed without the capital provided by their investors.” These partnerships of for-proﬁt businesses with nonproﬁt tissue banks prompted ethical concerns in an area that had involved altruistic donors for the beneﬁt of recipients. “The 1990s saw the development of proprietary processing technologies, patented tissue conﬁgurations, and advanced processing systems that result in tissue grafts with very speciﬁc dimensions and shapes designed by biomechanical engineers that are used primarily in spinal fusion surgery and sports medicine” (Youngner et al. 2004, pp. 15–19).

Beginning in 1991 reports of several cases of disease transmission from organ and tissue donors focused attention on donor screening and tissue processing techniques. This led both to tissue banks implementing voluntary standards and to more government regulations and oversight. In 1992 in the United States, the National Donor Family Council (NDFC) was organized. This gave a home and voice to donor families who gained signiﬁcant inﬂuence. As a result tissue banks, as well as Organ Procurement Organizations (OPOs), “began to provide better aftercare bereavement services to donor families, ranging from a follow-up thank-you letter to providing recipient information, donor family recognition events and commemoratives, bereavement counseling services, and peer support groups staffed by grief and counseling specialists” (Youngner et al. 2004, pp. 23–28 and 72–73). In 1994 the European Association of Tissue Banks published an ethical code.

In 2000 and 2001, a number of newspaper and television reports began to bring public attention to tissue banks. Some newspaper reports treated controversial aspects such as using certain tissues such as the skin for cosmetic purposes. These reports as well as the NDFC’s development of guidelines on informed consent for tissue donation led to changes in the consent process and how tissue banks and OPOs operate. Tissue production and distribution has dramatically increased in recent decades and is now in many countries although it is still the most developed in the United States. Much of the public still lacks awareness of tissue transplants. The future no doubt will involve new processing technologies, expanded government involvement, and increased awareness by the public (Youngner et al. 2004, pp. 23–30).

In 2004 from Nov. 29 to Dec. 1, the ﬁrst World Health Organization (WHO) Global Consultation on the Regulatory Requirements for Human Cells and Tissues for Transplantation was held. There were updates from representatives of many member states concerning developments related to human tissues and cells as well as developments related to regulations, laws, and oversight. This meeting acknowledged the special status of human cells and tissues for transplantation as a speciﬁc class of health product. It noted that international circulation of many tissues and cells is widespread but that many areas did not have regulations and laws. It stressed the importance of national and global oversight and surveillance to ensure optimal practice. Harmonizing of safety and quality standards was considered an achievable goal. Scientiﬁc professional societies should provide guidance in their specialist ﬁelds and work together to provide international harmonized standards. There is a need for consultation and collaboration between health authorities and scientiﬁc professional societies to optimize regulations and enforcement to guarantee real improvement in safety, quality, and access. There is also a need for consultation and collaboration across national and regional boundaries to take action to minimize risk to patients. Among other things, representatives made a commitment to develop one global coding system for cellular therapy products (WHO 2006). In 1991 and 2010, WHO published a number of international guidelines and universal principles (WHO 2010).

Conceptual Clarification

Donation following death may be by oneself via an organ donor card or living will or by one’s family, for example, a spouse, parents, or adult children. Types of transplants include autograft (from one part to another part of the same living person), allograft (from the body of one person to another person), and xenograft (from one species to another).

Ethical Dimension

Professional scientiﬁc societies often took the lead in developing ethical and professional regulations related to the use of human tissues (WHO 2006). In 1991 the World Health Organization (WHO) ﬁrst published some guiding principles on transplantation which greatly inﬂuenced professional codes and practices as well as legislation around the world. In 2010 WHO published an update of its principles due in part to the increasing use of tissues. These principles are meant to provide an ethical and acceptable framework for the acquisition and transplantation of human cells, tissues, and organs for therapeutic purposes. It is left to individual jurisdictions to determine the means of implementation. Here these principles will provide a framework for discussing the ethics related to the donation and various usages of human tissues and body parts.

Consent

Tissues may be removed from the bodies of deceased persons if the consent required by law has been obtained and the deceased did not express an objection before they died. Some countries require explicit consent either of the donor before he or she died or of his or her family or surrogate. Since most people favor such donations, some other countries presume consent unless the deceased while alive registered an objection. In any case, it is recommended that approval be sought of the family. Physicians determining death should not be involved in transplants to avoid a conﬂict of interest. While donations from living people are acceptable if they are voluntary, informed, and competent, donations from the deceased for therapeutic purposes should be maximized since they do not pose any risk to the donor. Donations of tissues from living minors and incompetent persons should not be done if they object, and their assent should be obtained if possible as well as that of their guardian. Such donations are only acceptable for regenerative cells such as bone marrow when no suitable competent person is available (WHO 2010, Principles 1–4).

Concerning consent there are some differences regarding whole organs as compared to tissues. Organs are transplanted “fresh” very soon after removal, are not processed, and have a clear purpose – to save the lives or signiﬁcantly improve the quality of lives of recipients. Consent concerning tissues is more complex since these tissues are often processed and stored for considerable time before being used and can be used for various purposes, sometimes to save life as in the case of skin tissue for some severe burn victims, most often to improve the quality of life such as with the bone, blood vessels, tendons, and cornea, but also for cosmetic and research purposes. Regarding the latter, the use of human tissues can reduce the use of animals in research and for some purposes may be better scientiﬁcally. Related to the processing, storage, and distribution of tissues, there is often a link between the donation and commercialization including the involvement of for-proﬁt companies (Youngner et al. 2004; NCOB 2010).

Informed consent, the primary moral and legal principle guiding medical decision making and human subjects participating in research, nurtures the autonomy of persons, protects them from undue harm, and reinforces public trust in these areas. The context of informed consent for tissue donation where there is no risk of harm to the deceased differs in signiﬁcant ways from medical and research situations where there are often risks, for example, to the person having surgery or the living research subject. With tissue donation consent is often obtained from the family who is in the crisis of the death of a loved one. The request for tissues is often made over the phone by strangers. Some question whether a “presumed consent” policy to increase the supply of organs and tissues violates personal autonomy (Youngner et al. 2004, Ch. 12).

Tissue banks “have a ﬁduciary relationship with prospective donor families, they have an obligation to put the interests of those families before their own …. [I]nformation should be provided at the level wanted by a reasonable or ‘typical’ donor family.” Donor families need sensitive support in their bereavement and adequate information to make an informed decision but should not be overwhelmed by too much information – the amount beyond the basic information should be tailored to the family’s needs. Donating tissues and body parts can help families deal with their grief. They often “report feeling better that something good (help for the recipient) came out of a tragedy (the death of their loved one).” Many feel that “in some way the dead loved one ‘lives on’ or would have wanted this to happen.” Potential harms “include disﬁgurement of the body, or dishonouring the gift and its givers by using it in an unworthy manner .. . which … could cause considerable upset to surviving family members who agreed to donate” (Youngner et al. 2004, Ch. 12).

Information should be relevant, accurate, and sufﬁcient to allow genuine choice and so that a donor family is not later surprised or upset. Factors such as coercion, deception, conﬂict of interest, and misinformation could defeat genuine consent. Since one cannot foresee every possible legitimate use of human tissues, fully “informed” consent is an unattainable ideal that could prevent using tissues for later-developed therapeutic uses or valuable research. It is thus permissible for donors or their families and patients to give broad consent to acceptable uses of their tissues according to professional, ethical, and legal standards (NCOB 2010, pp. 10–16).

The tissue industry should attempt to improve the informed-consent process and “demonstrate that it is a good steward of the precious gifts it has been entrusted with.” Many tissue banks now offer educational and informational brochures to donor families related to many speciﬁcs of tissue donation. Efforts to improve the consent process should be systematically evaluated to determine their effectiveness (Youngner et al. 2004, Ch. 12).

Donated Freely Without Monetary Payment

Human tissues and body parts should be donated freely without monetary payment to the donor or next of kin. The sale of body parts takes advantage of the poor and vulnerable, undermines altruistic donation, and treats certain people as “objects” to be used by others. The donation of tissues and body parts should be motivated by need and community beneﬁt. Public appeals and advertising related to education about needs and beneﬁts can be acceptable. While the sale of human body parts is banned, this “does not preclude reimbursing reasonable and veriﬁable expenses incurred by … [a living] donor … or paying the costs of recovering, processing, preserving and supplying human cells, tissues or organs for transplantation.” Health professionals are not to engage in transplants where the cells, tissues, and organs have been obtained by coercion, exploitation, or payment to the donor or next of kin. Facilities and professionals are not to receive excessive fees (WHO 2010, Principles 5–8). The public is not well informed about the organization and ﬁnancing of the tissue industry. “… [A] better informed public will be less apt to react negatively to information about the business practices in the ﬁeld” (Youngner et al. 2004, p. 186).

Views Of The Human Body And Its Tissues

What is the status of a human body, corpse, tissues, and body parts? Perspectives on the human body range from considering it to be a machine to personal property to a temple and in the image of the divine. Human tissues from the body of a recently deceased human person are generally seen as distinct from other resources from nonhuman sources including animals. Some ﬁnd the attitude of treating human tissue as a “commodity” to be distressing, involving a depersonalizing language and objectiﬁcation. A prominent view is to see the body as a gift involving not only a transfer of a good but also the donor giving a part of himself or herself, conveying a self that is “caring, thoughtful, generous, and so forth.” If the recipient accepts the gift, is grateful, and uses the gift in line with the intention of the giver, this creates a moral relationship (Youngner et al. 2004, pp. 139–141). While the tendency in Europe is to consider the cadaver as “community property,” many disagree considering the cadaver, while no longer a person, to be sacred related to emotional ties on the part of the survivors (Sgreccia 2012). Respect for the human body and its parts is widely acknowledged (NCOB 2010, p. 4).

Some think the language of tissue as a resource or property is appropriate related to the whole process of tissue transplants since resources and property can be both given and sold. However, many think that tissues, also as modiﬁed and processed, should not be treated as a “product” but always seen as “a gift of life” that either saves life or enhances the life of the human recipients. Should we think of tissues as a gift like a charitable contribution? While there are some similarities, donating to charity does not have the profound symbolism of donating body parts of a loved one or oneself (Youngner et al. 2004, pp. 170–2).

Human tissues and body parts concern not only those from the deceased or living donors for therapeutic purposes but also such as hair to make wigs and specimens for diagnostic or treatment purposes. Due to a number of recent legal settlements, millions of specimens of patient tissue have been destroyed. In most of these cases, which involved “tissue excised for clinical purposes and tissue donated for research,” courts have concluded that “patients and other research study participants do not retain ownership rights of the excised tissue. Contrary rulings have been reached in cases in which the evidence showed that there was a clear understanding that the patient would retain ownership of the excised tissue.” The law regarding “donor control over excised tissue samples is still evolving.” There are ongoing efforts, however, to address “questions about the donors’ right to control the future use of that tissue” (Allen et al. 2010).

The Gift Of Life And Stewardship

Related to the view that the human body is a gift, the ban on buying the body and its parts from donors or their families, and the importance of altruistic donation in the area of transplants, many think that the principle of “stewardship” must play a central role in human tissue and other transplants. The model of stewardship for tissue banks “would respect the intent of the original donation, ensure that the technological transformation undergone by the gift does not erode the donative intent, and facilitate a distribution process that embodies both equity and efﬁciency.” Altruistic donations seek “to elicit the best from human beings” and “to ensure the perpetuation of both love and justice in tissue transplantation.” This can help promote a culture of giving. Some recommend that the tissue industry should insist that all packaged tissue prominently reveal its origins as an altruistic gift and make sure that patients who receive tissue also know that it came as a precious gift. The model of good stewardship already characteristic of much of the behavior of the tissue transplant industry needs to be strengthened, recognizing, preserving, and nurturing the caring instinct (Youngner et al. 2004, Chs. 10, 12 & 13; Sgreccia 2012, Ch. 14).

Allocation

When the need for certain human cells, tissues, and organs exceeds the supply, according to the World Health Organization, allocation criteria should be determined by a multidisciplinary committee that includes experts in the relevant medical specialties, bioethics, and public health. Such committees should consider clinical factors, community values, and ethical norms. Criteria should be in accord with human rights and not related to the recipient’s racial, gender, religious, or economic condition. They should not be determined by ﬁnancial or other considerations but be equitable, justiﬁable, and transparent (WHO 2010, Principle 9).

Concerning allocation there are generally differences comparing organs and tissues. For example, in the United States, “in 2000, 6081 cadaver donors provided 17,255 organs, while more than 20,000 donors provided cadaveric tissue for more than 750,000 allografts.” While there is often a shortage of organs, which makes allocation criteria very important, for most tissues there is not a shortage since procurement is not limited to brain-dead patients maintained on ventilators. Organs need to be removed fairly quickly and transplanted “fresh,” whereas certain tissues and bones can be removed up to several hours later. Also some tissues can be processed for various uses. The situation is not the same in all countries – some export tissues and others import, while some countries do some of both (Youngner et al. 2004, p. 169; WHO 2006).

Regarding allocation Youngner et al. recommend that industry set standards of responsible prioritization. For example, skin tissues will only be used for cosmetic enhancement when needs such as treating burn victims are ﬁrst met. Informing prospective donors and donor families of these priorities could simplify the consent process. Rules for the allocation and distribution of tissues should be discussed and debated in public (2004, pp. 183–188).

Safety

Tissue banks “have two primary missions or interests: to procure safe tissue for transplantation into needy recipients and to respect the donors. In addition they have secondary interests—their own job security, salary levels, and recognition and inﬂuence with the ﬁeld.” Conﬂicts of interest “may adversely affect the informed-consent process by inﬂuencing clinicians or investigators to minimize or avoid disclosure of potential harms. Few … would argue that respect for donors or donor families should be sacriﬁced .. . to promote the welfare of potential recipients and certainly not for the personal or institutional welfare of those asking for the tissue” (Youngner et al. 2004, p. 179).

To ensure the safety of recipients of human tissues, due to the risks of transmission of certain diseases, there is a need to interview family members and signiﬁcant others concerning the deceased donor’s medical and behavioral history. Tissue transplants have a relatively good safety record. Absolute safety is impossible since we do not have complete knowledge about all infectious agents (Youngner et al. 2004, p. 187). The long-term beneﬁts and risks of tissue transplants should be documented and evaluated. The beneﬁts must outweigh the risks. There need to be vigilance and the use of internationally agreed means of coding to ensure the full traceability of human tissues. Any adverse events need to be reported. “Highquality, safe and efﬁcacious procedures are essential for donors and recipients alike” (WHO 2010, Principle 10).

Transparency And Anonymity

All donation and transplant activities must be transparent. Data needs to be comprehensive, updated regularly, and accessible to the public, scholars, and government oversight while protecting the anonymity of donors and recipients (WHO 2010, Principle 11).

Conclusion

The donation, processing, distribution, and various uses of human tissues and body parts raise a number of ethical questions. This is because they involve important human values including respect for persons; the dignity of human persons, bodies, and parts; autonomy; anonymity; the care and meeting of human needs; saving life and quality of life; fair compensation, equity, and nondiscrimination; giving and altruism; health and safety; and public trust.

Bibliography :

Allen, M. J., Powers, M. L. E., Gronowski, K. S., & Gronowski, A. M. (2010). Human Tissue Ownership and Use in Research: What Laboratorians and Researchers Should Know. Clinical Chemistry, 56 (11), 1675–1682. Available: http://www.clinchem.org/ content/56/11/1675.full. Accessed 23 June 2014.
Nufﬁeld Council on Bioethics (NCOB). (2010). Human tissue: Ethical and legal issues. Available: http://www. nufﬁeldbioethics.org/sites/default/ﬁles/ﬁles/NCOB%20response%20-%20HT%20bill.pdf. Accessed 23 June 2014.
Sgreccia, E. (2012). Personalist bioethics. Philadelphia: The National Catholic Bioethics Center. [Translated from Manuele di Bioetica (Milan: Vita e Pensiero, 2007) by John Di Camillo and Michael Miller].
World Health Organization (WHO). (2006). Second global consultation on regulatory requirements for human cells and tissues for transplantation: Towards global harmonization through graduated standards: Report. Available: http://www.who.int/transplantation/2dHTTGHreport.pdf?ua=1. Accessed 29 May 2014.
World Health Organization (WHO). (2010), WHO guiding principles on human cell, tissue and organ transplantation. Available: http://www.who.int/transplantation/ Guiding_PrinciplesTransplantation_WHA63.22en.pdf. Accessed 30 May 2014.
Youngner, S. J., Anderson, M. W., & Schampiro, R. (Eds.). (2004). Transplanting human tissue: Ethics, policy, and practice. New York: Oxford University Press.
World Health Organization (WHO). (2010), WHO guiding principles on human cell, tissue and organ transplantation. Available: http://www.who.int/transplantation/ Guiding_PrinciplesTransplantation_WHA63.22en.pdf. Accessed 30 May 2014.
Youngner, S. J., Anderson, M. W., & Schampiro, R. (Eds.). (2004). Transplanting human tissue: Ethics, policy, and practice. New York: Oxford University Press.