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The Revised Uniform Anatomical Gift Act (2006)

1/15/2008

January 15, 2008. The National Conference of Commissioners on Uniform State Laws approved in July 2006 and revised in 2007 The Revised Uniform Anatomical Gift Act (UAGA). The purpose of the UAGA is, in part, to address the critical organ shortage for transplantation by providing additional ways for making organ, eye, and tissue donations. Since the original UAGA was promulgated in 1968, and updated in 1987 with only 26 states adopting that version, the diversity of laws is seen as an impediment to transplantation. Thus, there has been a state-by-state effort to encourage the adoption of this most recent revision of the UAGA. At the same time, there is a need to educate the public to the provisions contained in the UAGA to ensure the protection of donors, especially the most vulnerable, while also encouraging this act of charity.  
 
A section by section analysis of the UAGA will follow, however, the overall concerns relate to: the authority for anatomical donations of the person who has “jurisdiction” over the body and has the authority to dispose of the body or anatomical parts and tissue, such as a coroner or medical examiner (perhaps equating to “presumed consent” of the homeless); the difficulty which exists for removing one’s name from a donor registry (See Section, 5 (c) and (d), Page 20, and bullets, attached, pertaining to Sections 5, 7, and 8 ); the ability to use tissue from aborted fetuses (Section 2 (4), Pages 11-12) for such purposes (not a new provision); and the provision to recognize donor consent documents executed in other countries or pertaining to the domicile of a donor (See Section 19 (a) (2) and (3), page 45). One new wrinkle is that in this age of public funding of cloning as well as assisted reproductive technologies, it is not unreasonable to have one’s gametes taken, literally to create one’s offspring for reproductive therapies or for research purposes through in vitro fertilization or somatic cell nuclear transfer. It should be noted that the “Comment” to Section 2 indicates that the UAGA is silent on the donation of blastocysts and embryos (See Page 15). All that means is that use of donations for such research purposes are not prohibited. 
 
There are protections included in these provisions. There is no “presumed” consent, as in Europe. The separation of the role of the transplant physician from the attending who pronounces death is clear. Organs and tissue cannot be sold. Death must be documented, although the standards for Non Heart Beating Death are not specified sufficiently. Dispute resolution methods among prioritized classes of those who can give consent are provided. Provisions for the donor to document refusals of consent are included. However, family members are precluded from overriding a written document of consent by the donor. Specificity is given as to how organs and tissue will be used when a donor only specifies that he will be an “organ donor;” transplant and therapy uses are all that is allowed. Specific consent is required for research and education uses. The ability to use tissue from aborted fetuses has not changed.  
 
For these reasons, the National Catholic Bioethics Center recommends that attempts should be made at the state level to amend proposed legislation, rather than an all out opposition. It is recognized that this is a “uniform” act, intended not to be modified at the state level. However, the vulnerability of the homeless who become the property of coroners is of concern. State Catholic Conferences and diocesan Pro-Life Offices may find that advocates for the homeless will collaborate in opposition to this provision. Also, the recognition of documents executed in other countries or pertaining to the domicile of a donor may open the door to allowing the sale of organs, or assisted suicide. The other concerns that are addressed can be remedied by good public education to assist persons in declaring, affirmatively, to what they are refusing. One overall practical concern may be that proposals such as those contained in this document are likely to cause hardship and dissatisfaction among families, thus leading more patients to refuse to become organ donors in the first place. The section by section analyses are contained in the attached pages.

 

Analysis of the Uniform Anatomical Gift Act of 2006
(Revised 2007)

• Prefatory Note, Page 5: The 2006 Act preserves the prohibition against the sale and purchase of organs, which is not true in some other countries (see provision, below, recognizing legal parameters of other countries; perhaps this needs to be incorporated in that section, also). 
• History of 1968 and 1987 Acts, Page 5: The 2006 Act preserves the donor requirement of irreversible cessation of circulatory and respiratory function, or irreversible cessation of all function of the entire brain, including the brain stem. However, what is not defined are the criteria for determining irreversible cessation of circulatory and respiratory function (e.g., not able to be resumed, naturally, after five minutes; in fact some advocate for a two minute rule, which is problematic). Furthermore, what is not delineated is what interventions, such as high dose heparin and vasodilators, are licit/illicit to be applied to the donor, if they will be detrimental to the donor’s health, before the donor is declared dead. ,  
• History of 1968 and 1987 Acts, Page 6: The “opt in” criterion is maintained, except for the person whose remains for disposal are the jurisdiction of such persons as a medical examiner or corner, which is very problematic.  
• Summary of the Changes in the Revised Act, Pages 7-11: The list of those who can make a donation on one’s behalf, and what to do if there is a conflict among them is explained well. However, the effort to contact such persons for consent is minimal (“‘Reasonably available’ means able to be contacted by a procurement organization without undue effort and willing and able to act in a timely manner consistent with existing medical criteria necessary for the making of an anatomical gift;” this would equate to being able to reach them by phone, which is nebulous, at best; see Section 2 (23), Page13, and “Comment,” Page 17). One could be declared not “reasonably available” by being unwilling to make a decision for the decedent. Thus, an adult grandchild could have the authority to consent to an anatomical donation when those others listed in priority in Section 9 (Page 30) are “reasonably unavailable.”  
 
There is a provision for a donor to sign a refusal statement which is intended to bar all other persons (other than his/herself) from making an anatomical gift on one’s part (See Section 2 (26), Page 13, and Section 7, Pages 24-26). No one can override a written declaration of the decedent to be a donor of anatomical parts. Family members cannot contravene the written requests of the donor. However, unless the donor specifies to the contrary, the health care agent (and those listed in priority on Page 30) have all such powers to consent to anatomical donations (See “Comment,” Section 4, Page 19). Furthermore, what one “opts in” for can be expanded by those empowered to consent for the decedent if one has not been specific about exclusions. However, how well promulgated these refusal/exclusion provisions are, remains a question. The major ethical concern related to who can consent rests with those who have jurisdiction over remains, as presented above. However, it should be noted that this revision of the UAGA prevents what was permitted in earlier Acts: previously, those having jurisdiction over the body (e.g., coroner, medical examiner) did not need to have authority over the disposal of the body to make a donation of the eyes. Another new provision is that specific consent must be documented for the donation of the total body or anatomical part for research or education. This is not intended to be protective of individual rights, as much as to make the first priority organ donations for transplant.  
 
The last revision of concern is that there is a “default” provision to provide advanced life support despite the Advanced Directive of the donor, to ensure the medical suitability of the organs, until the conflict can be solved pursuant to Section 21(b), Pages 47-48; Section 14 (c), Page 40 and Section 21, Pages 47-49. This could allow for care of the organs (e.g., high doses of heparin) to the detriment of the donor before death. There are those who argue that any interventions must benefit the person to whom they are being administered, if that person has not been pronounced dead (i.e., not declared brain dead). It also is important to note that, by its own admission, the UAGA does not define “transplantation,” “therapy,” “research,” and “education.” The major concerns herein can be addressed by good public education as to what is being given consent. Perhaps if adopted at the state level, there could be a provision for regulations to be promulgated for education of the public. 
• Section 5, (c) and (d) (Page 20) indicate how difficult it is to revoke one’s donor status. Any form of cancellation of an identification card does not revoke consent to be a donor. Furthermore, invalidation of a will providing for a donation does not revoke the consent to be a donor. Such a revocation must be in writing, or communicated to two witnesses, one of which must be a disinterested witness. Again, if adopted at the state level, there could be a provision for regulations to be promulgated for education of the public. 
• Section 6,”Comment,” Pages 23-24, explains, further the problem in revoking donor status once on a registry. Again, if adopted at the state level, there could be a provision for regulations to be promulgated for education of the public. 
• Section 8, (d) and (e), Page 27, indicate further how a revocation of consent by an authorized party does not bar another authorized party from authorizing that gift, or of authorizing the gift of another anatomical part. Relevant “Comment(s)” related to this section are as follows: “For example, suppose an individual who had donated a kidney by a donor card later destroys that card with the intent to revoke the anatomical gift. This revocation will not prevent another person acting under either Section 5 or 10 from making an anatomical gift. A donor who wishes both to revoke and bind others not to make a gift must sign a refusal.” (Page 28); And, “Section 8(e), consistent with prior law, provides that, absent express, contrary indications by the person making an anatomical gift, the gift of a part is neither a refusal to give other parts nor a limitation on the making of gifts of other parts.” (Page 29); and “For example, suppose a donor donates “all organs, eyes, and tissue for transplantation or therapy.” That gift would not bar a gift under Section 10 of the organs, eyes, or tissue for research. The donor can bar an expansion of the gift’s purposes by an express contrary direction. For example a donor’s gift of “organs, eyes, and tissue only for transplantation” would bar others from expanding the purpose of the gift to include research.” (Page 29) Again, if adopted at the state level, there could be a provision for regulations to be promulgated for education of the public. 
• Section 9 (Page 30) lists the persons who may make an anatomical gift for a decedent. They appear to be listed in level of priority. However, the issue of “reasonably available” is raised, again. If a spouse is unavailable, an adult child is authorized to make a donation on behalf of the decedent, barring no predetermined exclusions. Recall that reasonably unavailable includes not being able or willing to make the decision once contacted. Furthermore, last on the list of priority persons is “any other person having the authority to dispose of the decedent’s body,” which would include the medical examiner or coroner. 
• Section 10 (Page 33) indicates that consent to donate cannot be revoked once invasive procedures have begun to prepare the recipient. Perhaps “life threatening” invasive procedures should be the standard.  
• Section 11 (See “Comment,” Pages 36-37) states that an anatomical gift designated for a specific person, if unused, is relegated to an organ procurement agency, unless specified to the contrary. Furthermore, if anatomical parts are not used for transplantation, therapy, research or education, custody of those parts rests in the person who has an obligation to dispose of them. Thus, if a person has designated anatomical tissue for transplantation and it is not used, the anatomical part is under the jurisdiction of the person who is to dispose of it. He could determine it should be used for research, barring specific refusal of the donor. Again, this is an area that could be addressed through good public education. 
• Section 14 (i) separates the roles of the transplant physician from the pronouncer of death (Page 41), which is an advisable position.  
• Section 19 (Page 45) provides extensive latitude to follow the laws of other countries of donor domicile or where the document was executed. This has significant implications pertaining to the wellbeing of the donor, particularly in countries that allow assisted suicide and sale of organs. For example, the Philippines allows the sale of organs. If the donor is domiciled in the Philippines, would this allow a transplant team in Hawaii to use organs from such a sale? 
• Sections 22 and 23 (Pages 49-53) allow the anatomical gifting from a decedent by those who have jurisdiction of the body. This includes a coroner or medical examiner. This means that those who have no one to speak for them at the end of life only will have the state, with an interest in organ and tissue procurement, to decide the fate of their remains. Furthermore, if an organ or tissue is not deemed suitable for a purpose designated by the donor, and the donor has not specifically indicated a refusal provision for use, those who are to dispose of the anatomical gift have the authority to gift it for another purpose.


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Notes: 
1. The National Conference of Commissioners on Uniform State Laws, The Revised Uniform Anatomical Gift Act, 2007, http://www.anatomicalgiftact.org/DesktopDefault.aspx?tabindex=1&tabid=63. 
2. NCCB/USCC, Ethical and Religious Directives for Catholic Health Care Services (Washington, DC: USCCB, June 15, 2001). Specifically, ERD nn. 30 and 63, addressing consent: “30. The transplantation of organs from living donors is morally permissible when such a donation will not sacrifice or seriously impair any essential bodily function and the anticipated benefit to the recipient is proportionate to the harm done to the donor. Furthermore, the freedom of the prospective donor must be respected, and economic advantages should not accrue to the donor;” and “63. Catholic health care institutions should encourage and provide the means whereby those who wish to do so may arrange for the donation of their organs and bodily tissue, for ethically legitimate purposes, so that they may be used for donation and research after death.” 
3. Ibid. 
4. Ibid, nn. 65 and 66: “65. The use of tissue or organs from an infant may be permitted after death has been determined and with the informed consent of the parents or guardians;” and “66. Catholic health care institutions should not make use of human tissue obtained by direct abortions even for research and therapeutic purposes.” 
5. Ibid, nn 38 through 43: “38. When the marital act of sexual intercourse is not able to attain its procreative purpose, assistance that does not separate the unitive and procreative ends of the act, and does not substitute for the marital act itself, may be used to help married couples conceive; 39. Those techniques of assisted conception that respect the unitive and procreative meanings of sexual intercourse and do not involve the destruction of human embryos, or their deliberate generation in such numbers that it is clearly envisaged that all cannot implant and some are simply being used to maximize the chances of others implanting, may be used as therapies for infertility; 40. Heterologous fertilization (that is, any technique used to achieve conception by the use of gametes coming from at least one donor other than the spouses) is prohibited because it is contrary to the covenant of marriage, the unity of the spouses, and the dignity proper to parents and the child; 41 Homologous artificial fertilization (that is, any technique used to achieve conception using the gametes of the two spouses joined in marriage) is prohibited when it separates procreation from the marital act in its unitive significance (e.g., any technique used to achieve extra-corporeal conception); 42 Because of the dignity of the child and of marriage, and because of the uniqueness of the mother-child relationship, participation in contracts or arrangements for surrogate motherhood is not permitted. Moreover, the commercialization of such surrogacy denigrates the dignity of women, especially the poor; and 43. A Catholic health care institution that provides treatment for infertility should offer not only technical assistance to infertile couples but also should help couples pursue other solutions (e.g., counseling, adoption).” 
6. Greg Burke, “A Non-Heart Beating Donor Protocol as a Physician,” Ethics and Medics (April 2000, VOL 25 NO 4). 
7. Ibid. 
8. NCCB/USCC, n 33: “33. The well-being of the whole person must be taken into account in deciding about any therapeutic intervention or use of technology. Therapeutic procedures that are likely to cause harm or undesirable side-effects can be justified only by a proportionate benefit to the patient.” 
9. Burke.