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COPYRIGHT 2005 Health Law Institute
Promising discoveries about the lifesaving attributes of umbilical cord blood (UCB) stem cells have led to the emergence of public and private cord blood banks throughout Canada. UCB cells are currently used in the treatment of a variety of malignant and non-malignant diseases and for research purposes. (1) There is also much talk of their potential use for the treatment of a broad range of degenerative, hereditary, post-traumatic and central nervous system related conditions. (2)
The primary purpose of public UCB banks is to create an inventory of UCB units for unrelated allogeneic hematopoietic stem cell transplants. The UCB is donated to the bank and the units are made available to suitably matched recipients regionally, nationally or internationally. In contrast, private banks allow parents to store their newborn's cord blood for autologous (use by donor) or familial use. Thus, for a fee, the UCB is stored as a form of 'insurance' in case the child or a matched family member should have a need for it in the future. In Canada, two public banks and at least nine private banks have been established to date. (3)
At present, the role that Canada should play in UCB banking remains unclear. Because Canada has a universally accessible healthcare system, public policy makers will soon be confronted with the difficult task of deliberating the merits and economics of establishing a national network of public cord blood banks, as well as deciding on the place of private banking of UCB for autologous use. A policy framework is necessary to guide this decision making.
On a regulatory level, the Canadian Standards Association has published standards which are applicable to UCB banking for transplantation: Cells, Tissues, and Organs for Transplantation and Assisted Reproduction: General Requirements, and Lymphohematopoietic Cells for Transplantation. (4) These national standards will be incorporated into Health Canada's new regulations regarding the safety of cells, tissues, and organs for transplantation which are currently being elaborated. (5) In the meantime, Health Canada has released a Directive and a Guidance Document to encourage adherence to basic safety standards. (6) The standards set by accreditation bodies also help to promote the safety of UCB banking practices, although the accreditation process remains voluntary and therefore cannot be relied upon to protect the public]
UCB banking in Canada is still in its early stages, and there are many regulatory and policy issues that have yet to be addressed. It is during this period of development that it is crucial to prospectively address the socio-ethical and legal issues surrounding cord blood banking. In this manner, an ethical framework can be elaborated to provide guidance to policy makers seeking to effectively regulate cord blood banking in Canada. This paper aims to provide a selective overview of some of the key socio-ethical and legal issues involved. Four main topics will be broached: 1) public awareness and perceptions relating to UCB banking, 2) the process of informed consent for the collection, donation, processing, storage, and future use of UCB, 3) issues related to ethnic diversity, and 4) the possibility of a national UCB program in Canada.
The discussion would be incomplete however, without a brief review of the ethics of private cord blood banking for autologous use. Policymakers cannot chart the future of UCB banking in Canada without taking into account the existence of private banks and their potential role in meeting future clinical needs, as well as their actual and potential contribution to research in this domain.
A number of organizations have taken the position that UCB banking for autologous use should be discouraged. (8) The Society of Obstetricians and Gynaecologists of Canada Clinical Practice Guidelines, for example, state that "[c]ollection and long-term storage of umbilical cord blood for autologous donation is not recommended because of the limited indications and lack of scientific evidence to support the practice." (9) The clinical utility of autologous storage is said to be limited because of the very low probability that an autologous hematopoietic stem cell transplant will be required by the individual in his/her lifetime, the uncertain shelf life of stored UCB, and the fact that autologous transplants are not recommended for inherited disorders or blood cancers. (10) Furthermore, should the need for a hematopoeitic stem cell transplant arise, allogeneic UCB or bone marrow and, in some cases, autologous peripheral blood might provide an alternative source of stem cells, depending on the circumstances. (11) It is hoped that autologous UCB stem cells will prove to be of particular value for cellular therapy and regenerative medicine, but at present these uses remain speculative. (12)
Aside from the limited clinical utility of autologous UCB, private banking also raises concerns about social inequities. If UCB does ultimately prove to be useful for cellular therapy and regenerative medicine, then issues of equitable access to health care arise since the costs of private storage may be prohibitive for many parents. (13) In cases where there is a family member suffering from a condition which is treatable by hematopoietic stem cell transplant, it has been suggested that storage should be done by public banks. (14) Directed donations are in fact possible in a many public banks to address this identifiable need. (15) It has also been suggested that private storage of cord blood may be supplanting donations to public banks. This idea has been refuted by some on the grounds that the collection of UCB for public banks is usually restricted to a limited network of hospitals and that women outside these areas would generally be precluded from making a donation even if they were so inclined. J6
While these concerns need to be kept in mind, it is important to recognize the contribution that private banks could potentially make in this area. (17) As will be discussed in the section on 'the possibility of a national UCB program', private banks may be able to assist in meeting the UCB needs of Canadians while decreasing the strain on the public purse. They may be instrumental in progressing research in this area as well. Indeed, many private banks accept donations of UCB for research purposes and have a vested interest in developing therapeutic applications for privately banked units. (18)
Having set out the context for UCB banking in Canada, let us now turn to an in depth analysis of the key socio-ethical and legal issues: public awareness and perceptions relating to UCB banking (A); the process of informed consent for the collection, donation, processing, storage, and future use of UCB (B); issues related to ethnic diversity (C); and the possibility of a national UCB program (D).
A. Public Awareness
The Data Available
Very little research has been done on the knowledge and attitudes of the public with respect to UCB banking. But there are a small number of studies that have sought to address this issue and which begin to give us an indication of public perceptions of the purpose and need for UCB banks for clinical and research use, and the distinction between public and private banks. All but one of these studies were conducted outside of Canada, and a couple of them may be outdated since attitudes concerning UCB banking are likely to change over time and with scientific progress. Nevertheless, they will be reviewed here for lack of more relevant and recent data.
The one Canadian study involved a survey of pregnant women attending antenatal clinics at a regional hospital in Halifax. (19) Of the four hundred and forty-three women who completed the questionnaire, 70% rated their knowledge about cord blood banking as poor or very poor. Despite this lack of knowledge, 86% of women indicated that they would chose to donate to a public bank, whereas 14% of women would opt for private banking. The most common reasons cited by those who preferred public banks were altruism and the costs of private banking. Most women who gave preference to private banks felt that it would be a good investment to protect their child's health and wished to avoid feelings of guilt should the child eventually require the cord blood. Interestingly, level of knowledge was not associated with the choice between public and private banking. In terms of future use of the donated cord blood, 30% felt that it should only be used for transplantation whereas 67% supported use for research purposes, 39% for gene therapy, and 33% for drug manufacturing. Other interesting findings were that 68% of the women indicated that physicians should talk to pregnant women about the collection of cord blood. Many wished to receive information on the subject directly from a health care professional (66%) or in a prenatal class (70%). Finally, 25% of respondents overestimated the risk of a child needing a bone marrow transplant by his or her 10th birthday.
Although this survey was conducted amongst Canadian women, the results of this study cannot be generalized to the Canadian population as a whole since the sample was not representative of this population. Specifically, the women surveyed had above average education (72% had a university or college degree) and were not very ethnically diverse (85% were white). The region also had no established private or public cord blood banks, which is a factor that would likely affect knowledge and attitudes. Surveys conducted in different geographic regions of Canada would likely yield differing results.
Two other studies may assist in deciphering public perceptions of cord blood banks even though they were not conducted within Canada. A 1998 Swiss study looked at the acceptance of umbilical cord blood donation by pregnant patients. (20) The questionnaire provided concise information on the use of cord blood for transplantation and was distributed to women of different ethnic backgrounds attending the University of Basel Women's Hospital pregnancy outpatient clinic. Of the 245 responses analysed, 95% were in support of umbilical cord blood banking for future transplantation. Along similar lines, 93% of respondents stated that they would be willing to donate cord blood from their own child. Previous knowledge and ethnic background were not significant predictors of willingness to donate. The authors speculated that the absence of significant differences between women of different ethnic backgrounds was an indication that a high degree of HLA diversity could be expected for donated cord blood.
Another, more recent, Swiss study investigated the attitudes of Swiss mothers toward unrelated cord blood banking 6 months after donation. (21) The questionnaire was distributed to 131 women who had donated cord blood for unrelated banking. Of the 78 women who responded, 96.1% stated that they would donate UCB again, 100% continued to believe that their decision to donate was ethical and 74.8% were emotionally satisfied about UCB donation. Only 5.6 % of respondents had slightly negative feelings toward CB donation which included fear, worry and doubt. The reasons why these negative feelings developed were not clear. Many women (63%) indicated that they were concerned about improper use of donated UCB for genetic testing or experimentation. The authors conclude that there is a high degree of satisfaction concerning unrelated umbilical CB donation among women six months after delivery, and, in light of concerns about improper use of donated CB, specify that accurate and detailed counselling should maximize willingness to donate.
Finally, a 1998 article documents pregnant women's perspectives on umbilical cord blood banking based on three focus group discussions conducted in the south-eastern United States. (22) A total of 19 women with diverse socio-demographic characteristics participated. The authors reported...
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