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PubMed1998

Legal and ethical responsibilities of gamete banks.

In the UK, following many years of consultation and debate, Parliament passed the Human Fertilisation and Embryology Act in 1990. This introduced a system of detailed regulation of banks and clinics undertaking the storage and use of gametes and embryos in the UK. The law established the framework for the system and set up the Human Fertilisation and Embryology Authority (HFEA) to implement it from 1991. The HFEA is required to license and monitor centres which store or use donated gametes, and to provide them with guidelines in a Code of Practice. The Code of Practice contains guidance on practical clinical matters and also the HFEA's policy on a number of social and ethical issues. The regulatory system was set up to reassure the public, to protect the interests of potential children, patients and donors, and to promote good practice in fertility research and treatment. It works by consultation and cooperation between the HFEA and the scientists and clinicians being regulated, although sanctions do exist for use where needed. The HFEA is notable in regulating an area of medical practice in such a detailed way. It has established itself as an effective regulator and adviser, and has provided a basis for the development of policy in the field of fertility treatment.

Biological Specimen Banks↗
PubMed1995

Similarities and differences between anonymous and directed candidates for oocyte donation.

PURPOSE: To compare anonymous and directed candidates for oocyte donation within a single program. METHODS: 75 consecutive candidates for oocyte donation (49 anonymous and 26 directed) were studied using a semistructured interview to collect data on demographics, psychosocial history, motivation, and candidate views on disclosure to a potential child. RESULTS: Donor groups were similar with regard to race, religion and education. Anonymous donors (mean age 27.33 years, SD 4.17) were significantly younger than directed donors (mean age 37.54 years, SD 4.94), (t = -4.83, df = 73, p < 0.001). Marital duration was significantly longer for directed donors (6.92 years, SD 5.64) versus (2.57 years, SD 3.96) for anonymous donors (t = -3.50, df = 38.47, p = .001). Forty-one percent of anonymous and 69% of directed donors had previous pregnancies (X2 = 4.60, p < .05). A greater percentage of anonymous donors (34.7%) felt that the potential child should be informed of his or her origins, compared to 19% of directed donors, but this difference fell short of statistical significance. CONCLUSIONS: There were more similarities than differences among groups of potential donors with the exception of age, marital status, and previous pregnancies. Differing views about disclosure were suggested in both groups with anonymous donors tending to opt for disclosure.

Adult↗
PubMed1992

Mt. St. Anonymous; the adolescent living-related donor.

Seventeen-year-old David is a perfect organ match for his younger brother, Ken, who has kidney failure. David understands that the procedure presents some risk for him and that after surgery he may no longer be able to continue playing football. His idols all have been football players and he now plays on his high school's team. Nevertheless, he wants to donate a kidney to his brother and agrees to being a donor as soon as the option is mentioned. He never displays any ambivalence and says, "I want to donate my kidney because then I'll be a hero to my family." This close family--of two parents and five older siblings--strongly supports the seventeen-year-old's decision, especially after an older brother, who was also a perfect organ match, is found medically (anatomically) unsuitable. The parents and two of the older siblings could still be medically acceptable donors: their organs are likely to be better grafts (one haplotype matches) than a non-related cadaveric kidney would be, but less compatible than the perfect organ match (haploidentical) that could be provided by David, the adolescent brother. Studies have shown that in the short run there is little difference in the survivability of organs from different classes of donors. After several years, however, there is a significant difference with perfectly matched kidneys being much less prone to rejection than the less ideally matched organs.

Adolescent↗
PubMed2004

Disclosure decisions among known and anonymous oocyte donation recipients.

OBJECTIVE: The purpose of this study was to compare anonymous and known donor mothers' demographics, knowledge about the donor, and disclosure attitudes. DESIGN: Cross-sectional survey of oocyte donation parents. SETTING: Academic medical centers. PATIENT(S): Women having a child through oocyte donation in the past 12 years. INTERVENTION(S): Subjects completed a survey regarding their oocyte donation experience. MAIN OUTCOME MEASURE(S): Donor characteristics and disclosure behavior. RESULT(S): Questionnaires were sent to 524 individuals (262 couples); 157 (92 women and 65 men) were returned yielding a response rate of 31.4% (157/500). The average age of the women was 44.7 years and the average age of the child was 2.89 years. Seventy women used anonymous donors and 20 women used known donors. Significantly more known recipients knew their donors' religion, number of children, hobbies, profession, and photograph. Eighty percent of both groups told others about using a donor to conceive. Regarding telling the child, there were also no significant differences with approximately 10% who have told, 49% plan to tell, 31% are not telling, and 10% are unsure. CONCLUSION(S): Contrary to conventional wisdom we found no differences in plans to inform the child based on the use of a known or an anonymous donor.

Adult↗
PubMedDate not supplied

Recipients of oocyte donation: an integrative review.

OBJECTIVE: To conduct a systematic review of published research to provide a synthesis of the psychosocial characteristics of donor oocyte recipient women. DATA SOURCES: The sample of published studies was selected from 1983 to September 2002. Retrieval of the studies used online computer searches from CINAHL, MEDLINE, PsycINFO, and Wilson's Social Science Abstracts using the terms reproduction techniques, in vitro fertilization, oocyte donation, oocyte recipients, and egg donation; citations from references and bibliographies of previously located articles; and two 60-minute retrieval sessions with a librarian specializing in health science literature. STUDY SELECTION: The majority of studies retrieved were completed in the natural sciences. The final sample resulted in 16 studies. DATA EXTRACTION: Each study was read and the data were extracted using a survey instrument developed by the investigator. DATA SYNTHESIS: Multiple methodologies were used in the sample; most were exploratory, retrospective, and descriptive studies. Thus, the data were analyzed using a qualitative discursive approach. A total of 827 donor oocyte recipient women participated in the studies. CONCLUSIONS: Published research investigating the psychosocial characteristics of donor recipient women was categorized into six focused areas: motivation; desired donor characteristics; selection of a known versus an anonymous donor; demographic, educational, and psychosocial profiles; disclosure of the method of conception to family members, friends, and the resulting child; and the relationship between the oocyte recipient and her resulting offspring. Research involving the psychosocial aspects of donor oocyte recipient women is in the infancy stage.

Attitude to Health↗
PubMed2003

Gamete donation - where is the evidence that there are benefits in removing the anonymity of donors? A patient's viewpoint.

The Department of Health has recently initiated a consultation exercise seeking input on the subject of removing gamete donor anonymity. This paper examines the case for disclosure alongside that of providing additional non-identifying information. The author questions the availability of scientifically based research to demonstrate that children's best interests can only be served by the provision of identifying information. The author also questions whether all the possible implications of legislative change have been identified and debated. The paper states that the harmful effects of disclosure on the lives of other interested parties, an inevitable downward trend on donor numbers, and a negative emotional impact in the event of a mismatch in expectations between donors and donor offspring guard against the identification of gamete donors. It is proposed that egg share schemes without anonymity, possibly the only reliable source of donor eggs, would become impractical in the UK. It concludes that given the far-reaching and irreversible impact of disclosure, the removal of anonymity should be considered only when research provides unequivocal proof that improved levels of non-identifying information are insufficient for the well-being of donor offspring.

Adult↗
PubMed2006

Long-term graft outcome with mycophenolate mofetil and azathioprine: A paired kidney analysis.

BACKGROUND: Randomized controlled trials and U.S. Registry data have demonstrated that mycophenolate mofetil (MMF) reduces acute rejection rates and improves graft survival. We undertook the first paired kidney analysis comparing the effects of MMF and azathioprine on graft outcome in the United Kingdom. METHODS: In all, 238 deceased donors from 1999 to 2002 who donated one kidney to a patient treated with MMF and the other kidney to a patient treated with azathioprine were identified from the national transplant database held by U.K. Transplant. Graft function and rates of change of graft function were compared using multiple linear regression analyses adjusting for covariates on an intention-to-treat basis. Incidence of acute rejection and delayed graft function were studied using logistic regression. Patient and graft survival censored for death were evaluated with Cox regression analyses. RESULTS: The MMF-treated patients exhibited a nonsignificant trend towards improved graft function but with increased rejection rates (44% versus 31%, P < 0.01). Treatment with MMF did not reduce delayed graft function rates. Univariate analysis showed that graft survival was inferior in MMF-treated patients (90% versus 95%, log-rank, P = 0.02) but in multivariate Cox regression models, MMF treatment was not a significant factor. Surprisingly, in the first year 32% of patients achieved daily doses of less than 2 g of MMF compared to 18% of patients who received less than 100 mg of azathioprine (P < 0.01). CONCLUSION: In this real-life study, there was no difference in patient or graft outcome between MMF and azathioprine treated groups despite increased rejection rates in patients receiving MMF therapy.

Azathioprine↗
PubMed2006

Increasing the opportunity of live kidney donation by matching for two- and three-way exchanges.

BACKGROUND: To expand the opportunity for paired live donor kidney transplantation, computerized matching algorithms have been designed to identify maximal sets of compatible donor/recipient pairs from a registry of incompatible pairs submitted as candidates for transplantation. METHODS: Demographic data of patients who had been evaluated for live donor kidney transplantation but found to be incompatible with their potential donor (because of ABO blood group or positive crossmatch) were submitted for computer analysis and matching. Data included ABO and HLA types of donor and recipient, %PRA and specificity of recipient alloantibody, donor/recipient relationship, and the reason the donor was incompatible. The data set used for the initial simulation included 29 patients with one donor each and 16 patients with multiple donors for a total of 45 patients and 68 donor/patient pairs. In addition, a simulation based on OPTN/SRTR data was used to further assess the practical importance of multiple exchange combinations. RESULTS: If only exchanges involving two patient-donor pairs were allowed, a maximum of 8 patient-donor pairs in the data set could exchange kidneys. If three-way exchanges were also allowed, a maximum of 11 pairs could exchange kidneys. Simulations with OPTN/SRTR data demonstrate that the increase in the number of potential transplants if three-way exchanges are allowed is robust, and does not depend on the particular patients in our sample. CONCLUSIONS: A computerized matching protocol can be used to identify donor/recipient pairs from a registry of incompatible pairs who can potentially enter into donor exchanges that otherwise would not readily occur.

Algorithms↗
PubMed2004

Preimplantation HLA testing.

CONTEXT: Preimplantation genetic diagnosis (PGD) has become an option for couples for whom termination of an affected pregnancy identified by traditional prenatal diagnosis is unacceptable and is applicable to indications beyond those of prenatal diagnosis, such as HLA matching to affected siblings to provide stem cell transplantation. OBJECTIVE: To describe preimplantation HLA typing, not involving identification of a causative gene, for couples who had children with bone marrow disorders at need for HLA-matched stem cell transplantation. DESIGN, SETTING, AND PARTICIPANTS: HLA matching procedures conducted at a single site during 2002-2003 in an in vitro fertilization program for 9 couples with children affected by acute lymphoid leukemia, acute myeloid leukemia, or Diamond-Blackfan anemia requiring HLA-matched stem cell transplantation. In 13 clinical cycles, DNA in single blastomeres removed from 8-cell embryos following in vitro fertilization was analyzed for HLA genes simultaneously with analysis for short tandem repeats in the HLA region to select and transfer only those embryos that were HLA matched to affected siblings. MAIN OUTCOME MEASURES: Results of HLA matching and pregnancy outcome. RESULTS: As a result of testing a total of 199 embryos, 45 (23%) HLA-matched embryos were selected, of which 28 were transferred in 12 clinical cycles, resulting in 5 singleton pregnancies and birth of 5 HLA-matched healthy children. CONCLUSION: This is the first known experience of preimplantation HLA typing performed without PGD for a causative gene, providing couples with a realistic option of having HLA-matched offspring to serve as potential donors of stem cells for their affected siblings.

Anemia, Diamond-Blackfan↗
PubMed1990

The ethical assessment of innovative therapies: liver transplantation using living donors.

Liver transplantation is the treatment of choice for many forms of liver disease. Unfortunately, the scarcity of cadaveric donor livers limits the availability of this technique. To improve the availability of liver transplantation, surgeons have developed the capability of removing a portion of liver from a live donor and transplanting it into a recipient. A few liver transplants using living donors have been performed worldwide. Our purpose was to analyze the ethics of liver transplants using living donors and to propose guidelines for the procedure before it was introduced in the United States. We used a process of "research ethics consultation" that involves a collaboration between clinical investigators and clinical ethicists. We concluded that it was ethically appropriate to perform liver transplantation using living donors in a small series of patients on a trial basis, and we published our ethical guidelines in a medical journal before the procedure was introduced. We recommend this prospective, public approach for the introduction of other innovative therapies in medicine and surgery.

Directed Tissue Donation↗
PubMed1990

Anencephalic infants and special relationships.

This paper investigates the scope and limits of parents' and physicians' obligations to anencephalic newborns. Special attention is paid to the permissibility of harvesting anencephalic organs for transplant. My starting point is to identify the general justification for treating patients in order to benefit third parties. This analysis reveals that the presence of a close relationship between patients and beneficiaries is often crucial to justifying treating in these cases. In particular, the proper interpretation of the Kantian injunction against treating persons as means only takes on a different light in the context of special relationships. The implications of this analysis for our responsibilities to anencephalic infants is clarified.

Anencephaly↗
PubMed1994

Ethical guidelines for the use of human embryonic or fetal tissue for experimental and clinical neurotransplantation and research. Network of European CNS Transplantation and Restoration (NECTAR).

Recently a Network of European CNS Transplantation And Restoration (NECTAR) has been founded, aimed at a concerted effort to develop efficient, reliable, safe and ethically acceptable transplantation therapies for neurodegenerative diseases, in particular Parkinson's and Huntington's disease. Owing to the use of human fetal brain tissue in such studies, usually obtained from elective abortions, ethical concerns have been focused on the relationship between abortion and transplantation activities. There is no uniform code on the retrieval and use of human embryonal or fetal material for experimental and clinical research or application in Europe. NECTAR has therefore formulated self-restraining ethical guidelines for its European member groups. These guidelines consist of a series of restrictions intended to prevent the use of grafts from encouraging induced abortions and to maintain high standards of respect for life and human dignity. In order to support applications for human embryonal or fetal neurotransplantation studies of NECTAR member groups to local or national medico-ethical committees, and to stimulate the goal of obtaining European legislation on this issue, the guidelines are here presented. They are followed by extensive explanatory notes. Only in this public manner can the lines of thought behind these NECTAR guidelines be addressed critically by those working in the fields of biomedical ethics and legislation as well by politicians and the general public.

Aborted Fetus↗
PubMed2003

Tissue typing for bone marrow transplantation: an ethical examination of some arguments concerning harm to the child.

Tissue typing (TT) is a recent and controversial scientific advance. Whilst its current applications can easily be described as pro-therapeutic and within the realms of preventative medicine, its specificity and potential are often characterized as the tip of the eugenic iceberg: undermining the very basis of individual autonomy and identity in an inevitable march towards the perfect society. In addition to arguments concerning societal harms flowing from TT, significant concerns have also been raised concerning harms to the future child born as a result. In the context of current legislation and policy, this article examines two aspects of arguments concerning harm to the future child: those relating to psychological harms, and those arguing that TT is contrary to the future child's best interests. The article examines the moral basis for arguments concerning harm to the future child. It proposes that arguments concerning psychological harm may overlook or minimise the potential benefits flowing from the broader social, familial context into which the child is born. These arguments may be countered, or at least balanced, by considering the future child in this context. In relation to arguments that TT is contrary to the future child's best interests, the paper examines a non-standard consideration of best interests. It argues that this standard should be used in considering whether or not TT for bone marrow transplant is harmful to the future child, thereby extending moral consideration of interests to intra-familial interests and outcomes. On this basis, it can be argued that TT is not contrary to the interests of the future child. The paper concludes by noting a potential tension between the first guiding principle of the Infertility Treatment Act 1995 (Vic) and the current Victorian policy on TT.

Bone Marrow Transplantation↗