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PubMed2004

Ethical issues in the collection, storage, and research use of human biological materials.

Human biological materials (HBMs) are samples of blood, DNA, organs and tissues commonly obtained during routine surgical procedures or through direct donation by an individual. This article reviews four of the most pressing issues arising from the collection, storage, and use of HBMs in research: current regulations governing research with human subjects, misuse of genetic information, economic factors, and public knowledge.

Blood↗
PubMed1993

Characterization of cholecystokinin receptors on the human sphincter of Oddi.

BACKGROUND: The present in vitro study investigated the interaction between cholecystokinin (CCK) and receptors on human sphincter of Oddi tissue obtained from donated human livers that were being transplanted. METHODS: Radiolabeled ligands with cholecystokinin receptor specificity, autoradiography, and crystal scintillation counting were used to directly characterize cholecystokinin receptors on tissue sections. RESULTS: The binding of 125I-BH-CCK-8 to the tissue was saturable, specific, and dependent on time, pH, and temperature. Saturable binding of 125I-BH-CCK-8 was localized on the smooth muscle layer, and binding was inhibited only by cholecystokinin-related peptides. Computer analysis of 125I-BH-CCK-8 binding indicated the presence of two classes of binding sites, one with a high affinity and the other with a low affinity for CCK-8. CCK-8 caused relaxation (half-maximal concentration, 6 nmol/L) and carbachol caused contraction (half-maximal concentration, 10 nmol/L) of circular, cross-sectional strips of the tissue. Longitudinal strips were less responsive. The relative 125I-BH-CCK-8 binding inhibition potency of CCK-8 agreed closely with its relative ability to cause sphincter relaxation. Tetrodotoxin (1 mumol/L) and atropine (1 mumol/L) caused a rightward shift of the dose-response curve for CCK-8-stimulated sphincter relaxation. CONCLUSIONS: The present results indicate that cholecystokinin receptors on the human sphincter of Oddi are sulfate dependent and mediate sphincter relaxation.

Atropine↗
PubMed2003

Transplantation of porcine umbilical cord matrix cells into the rat brain.

Immune rejection of transplanted material is a potential complication of organ donation. In response to tissue transplantation, immune rejection has two components: a host defense directed against the grafted tissue and an immune response from the grafted tissue against the host (graft vs host disease). To treat immune rejection, transplant recipients are typically put on immunosuppression therapy. Complications may arise from immune suppression or from secondary effects of immunosuppression drugs. Our preliminary work indicated that stem cells may be xenotransplanted without immunosuppression therapy. Here, we investigated the survival of pig stem cells derived from umbilical cord mucous connective tissue (UCM) after transplantation into rats. Our data demonstrate that UCM cells survive at least 6 weeks without immune suppression of the host animals after transplantation into either the brain or the periphery. In the first experiment, UCM cells were transplanted into the rat brain and recovered in that tissue 2-6 weeks posttransplantation. At 4 weeks posttransplantation, the UCM cells engrafted into the brain along the injection tract. The cells were small and roughly spherical. The transplanted cells were positively immunostained using a pig-specific antibody for neuronal filament 70 (NF70). In contrast, 6 weeks posttransplantation, about 10% of the UCM cells that were recovered had migrated away from the injection site into the region just ventral to the corpus callosum; these cells also stained positively for NF70. In our second experiment, UCM cells that were engineered to constitutively express enhanced green fluorescent protein (eGFP) were transplanted. These cells were recovered 2-4 weeks after brain transplantation. Engrafted cells expressing eGFP and positively staining for NF70 were recovered. This finding indicates a potential for gene therapy. In the third experiment, to determine whether depositing the graft into the brain protected UCM cells from immune detection/clearance, UCM cells were injected into the tail vein and/or the semitendinosis muscle in a group of animals. UCM cells were recovered from the muscle or within the kidney 3 weeks posttransplantation. In control experiments, rat brains were injected with PKH 26-labeled UCM cells that had been lysed by repeated sonic disruption. One and 2 weeks following injection, no PKH 26-labeled neurons or glia were observed. Taken together, these data indicate that UCM cells can survive xenotransplantation and that a subset of the UCM cells respond to local signals to differentiate along a neural lineage.

Animals↗
PubMed1998

Religion and the body in medical research.

Religious discussion of human organs and tissues has concentrated largely on donation for therapeutic purposes. The retrieval and use of human tissue samples in diagnostic, research, and education contexts have, by contrast, received very little direct theological attention. Initially undertaken at the behest of the National Bioethics Advisory Commission, this essay seeks to explore the theological and religious questions embedded in nontherapeutic use of human tissue. It finds that the "donation paradigm" typically invoked in religious discourse to justify uses of the body for therapeutic reasons is inadequate in the context of nontherapeutic research, while the "resource paradigm" implicit in scientific discourse presumes a reductionist account of the body that runs contrary to important religious values about embodiment. The essay proposes a "contribution paradigm" that provides a religious perspective within which research on human tissue can be both justified and limited.

Advisory Committees↗
PubMed1996

Attitudes of emergency nurses toward organ and tissue donation.

OBJECTIVE: Organ and tissue transplantation has gained increased acceptance as a medical procedure. Costs for most transplantations are reimbursed by insurance companies, and the list of transplantable tissues and organs has doubled during the past 10 years. To meet this resulting increased demand, more organs and tissues need to be recovered from potential donors. The purpose of this study was to examine the relationship between emergency nurses' attitudes and their intention to ask potential donor families if they will donate their family member's organs and tissues. METHODS: Thirty hospitals were sent a letter inviting them to participate in this descriptive survey research design. Survey packets were sent to the 17 hospitals that responded positively to the request. Surveys contained a cover letter to the participants with directions and assurance that anonymity would be maintained. Completed surveys were returned directly to the researcher. RESULTS: We found a relationship between the nurses' attitudes and the frequency with which they approached families regarding donation. Further analysis revealed that nurses' attitudes about organ and tissue donation were related to their confidence in asking families about donation. The study also demonstrated that emergency nurses want educational programs that offer information on how to approach donor families. DISCUSSION: These results can be used to develop educational programs for emergency nurses to provide them information that can increase their confidence in asking families about donation and subsequently increase the number of families they approach regarding donation.

Adult↗
PubMed1996

Risks and benefits of pediatric bone marrow donation: a critical need for research.

Healthcare providers assume that there are minimal risks and potential psychosocial benefits for children who undergo a bone marrow harvest for the benefit of their critically ill siblings. Ethical justifications for the use of children as donors rely on there being minimal risks since donors receive no direct medical benefits from the intervention. There is little empirical research regarding psychosocial consequences. This article review relevant research in three contexts: a) psychosocial outcomes for adults and children who donate tissue and organs; b) psychosocial impacts on a sibling of a pediatric cancer patient; and c) children's decision-making regarding medical decisions. The relevant research literature supports the belief that the psychosocial impact on a child bone marrow donor will be influenced by the survival of the recipient, the age of the donor, and the donor's participation in the decision to donate. In order to empirically validate the actual psychosocial risks (and benefits) for donors, it is argued that direct research is needed so that a donor's well-being can be protected.

Bone Marrow Transplantation↗
PubMed1994

Overview of the organ donation process.

Organ transplantation has become a viable treatment option for end-stage organ disease. With the advent of immunosuppressive medication and vastly improved preservation practices and surgical techniques, it is now possible to transplant an increasing number and variety of organs. In their role as direct care givers to patients and their families, critical care nurses must be attuned to the need for donor organs and tissues, and to the benefits of donation for the donor family, the potential organ recipients, and to themselves as health care professionals.

Brain Death↗
PubMedDate not supplied

[Precocious menopause after antimitotic therapy. Is in vitro fertilization with oocyte donation the only appropriate response?].

Advances in antimitotic treatments have improved the prognosis of cancer in young subjects. The resulting increase in life expectancy raises the question of the subject's future fertility, a question that should be posed before beginning any anticancer therapy which could lead to a gonadal failure. If oocyte donation remains the alternative indication proposed for these patients desiring a child, it is important to assess the tissue alterations in the uterus, to verify its vascularization under suitable treatment and appreciate the other alternative directions.

Antineoplastic Agents↗
PubMed2005

Ethics, transplantation, and the changing role of anatomists.

Anatomists are regarded as custodians of cadaveric material donated to science. Almost every facet of medical science has experienced explosive advances. This has impacted directly on anatomists and their role. Increasingly, anatomists are raising concerns with regard to the treatment of human tissue (Jones,2002, Clin. Anat. 15:436-440). The Korperwelten (Bodyworlds) of Gunther von Hagens et al. (1987, Anat. Embryol. 175:411-421) has evoked considerable debate about the treatment of human cadavers. Thus far clinical anatomists have had little role to play in policy formulation, legislation, and ethical imperatives as applied to cadaveric donation for organ transplantation. Anatomists play an even more negligible role in the raging ethical controversy around live related/unrelated organ transplantation. Due to the critical international shortage of cadaveric donors, boundaries are being pushed to meet the needs of potential recipients (Ohler,2001, Prog. Transplant. 11:160-161). Constant reappraisal of these ethical and moral issues is therefore appropriate. Issues that relate to cultural and economic imperialism and pronouncements of international transplant societies may also require re-evaluation. The legislature governing the donation of human tissue in various countries is usually governed by a Human Tissue Act or its equivalent. In general, such acts are congruent with the Human Tissue Act (South Africa: Government Gazette 9, November 2001; No. 22824) that states "It is an offense to charge a fee in relation to the donation of human organs." In many countries, however, various lay press report that "the sale of body parts is now coming of age." Terms such as "rewarded gifting" and "donors" being transformed into "vendors" are opening a Pandora's Box (Nelson et al.,1993, "Financial incentives for organ donation: a report on the UNOS ethics committee payment subcommittee"). Cameron and Hoffenberg (1999, Kidney Int. 55:724-732) feel strongly that arguments in favour of the sale of organs are sufficiently cogent to warrant further discussion. Equally disturbing is the use of executed prisoners as organ donors. In the developing world there are additional socio-economic, indigenous and cultural, religious, and ethical issues to consider. In addition, strategies that are ethically sound and morally acceptable to expand the pool of living donors must keep pace with recent advances in medicine. A paradigm shift is required for anatomists to contribute to the international ethical debate, not only as custodians of the dead but also as protectors of the living. Their voices should be heard in transplantation and other forums, and contribute to the ethical debate as well as relevant evolving legislature.

Anatomy↗
PubMed2003

Nonaltruistic kidney donations in contemporary Jewish law and ethics.

BACKGROUND: In 2000, the Consensus Statement on the Live Organ Donor reported that "direct financial compensation for an organ from a living donor remains controversial and illegal in the United States" and took note of the position of the Transplantation Society that "Organs and tissue should be given without commercial consideration or commercial profit." Christian authorities insist that organ donors must not accrue economic advantage, and "selling" organs deprives the donation of its ethical quality. METHODS: The writings of major contemporary authorities of Jewish law and ethics whose halakhic positions on bioethical issues are regularly considered by Orthodox, Conservative, and Reform ethicists were reviewed. Their positions on this issue were contrasted with those of various contemporary secular and religious authorities. RESULTS: These Jewish authorities reject the notion that generosity and charity, rather than monetary gain and greed, must serve as the exclusive basis for donation of functioning organs. CONCLUSION: Although nonaltruistic sale of kidneys may be theoretically ethical, ultimately its ethical status in Jewish ethics and law is inextricably connected to solving a series of pragmatic programs, such as creating a system that ensures that potential vendors and donors are properly informed and not exploited. Lacking such arrangements, ethical nonaltruistic kidney donations remain but a theoretical possibility.

Bioethical Issues↗
PubMed2006

Number of deaths by neurological criteria, and organ and tissue donation rates at three critical care centres in Canada.

PURPOSE: Comparative organ donation rates are expressed per million population and by this measurement, Canada lags behind other countries. These estimates do not account for differing demographics and health patterns of populations which can result in different rates of death by neurological criteria and subsequent donation rates. We sought to measure directly the number of deaths by neurological criteria, the associated donation rates, and the reasons for the differences. METHODS: A prospective evaluation of deaths by neurological and cardiorespiratory criteria in the critical care areas of three major adult Canadian tertiary care centres over a seven month period was undertaken. Patients were assessed for eligibility for organ and tissue donation and ultimate disposition. RESULTS: Annualized rates of death by neurological criteria varied from 2.3%-7.5% (8.6-28 patients) of all deaths. Conversion to actual donors ranged from 20-86%, with family refusal rates accounting for most of this variation. There were only three cases of suspected death by neurological criteria where a complete examination was not performed. CONCLUSIONS: There is substantial geographic variability in the rate of neurological death and actual organ donation rates in these Canadian tertiary care centres. These variations are principally related to regional differences in demographics of brain injury, referral patterns and donation consent rates, rather than lack of identification of potential donors.

Adult↗
PubMed2005

[Consequence of European Directive 2004/23/EC for bone banks in Germany].

Allogenic bone grafting is an established method in revision surgery of artificial joint replacement and spinal surgery in case of bone defects. In Germany, femoral heads from living donors undergoing total hip replacement are frequently used. These grafts are processed according to the "Guidelines for the management of bone banking" issued by the Federal Medical Board. Bone grafts are drugs according to German law. Local bone banks are excluded from the regulations of the federal law on drugs [Arzneimittelgesetz (AMG) section sign 4a (4)] if certain requirements are fulfilled. The Directive 2004/23/EC of the European Parliament and of The Council on Setting Standards of Quality and Safety for the Donation, Procurement, Testing, Processing, Preservation, Storage and Distribution of Human Tissues and Cells has to be implemented into national law within 2 years. The exception of section sign 4a (4) will no longer be possible. Thus a legal construction has to be found which allows running local bone banks in compliance with the new legal settings. Three conditions will be possible: (1) a single physician procures a graft for another patient of his, (2) grafts are procured in one hospital and are used exclusively in this hospital: a license from the local authorities and a strict quality assessment according to GMP-rules is required, (3) if the grafts are distributed to other hospitals, a license from the local authorities and registration as a drug by the federal authorities are necessary.

Bone Banks↗
PubMed1997

Pharmacological actions of melatonin in oxygen radical pathophysiology.

Melatonin, the chief secretory product of the pineal gland, was recently found to be a free radical scavenger and antioxidant. This review briefly summarizes the published reports supporting this conclusion. Melatonin is believed to work via electron donation to directly detoxify free radicals such as the highly toxic hydroxyl radical. Additionally, in both in vitro and in vivo experiments, melatonin has been found to protect cells, tissues and organs against oxidative damage induced by a variety of free radical generating agents and processes, e.g., the carcinogen safrole, lipopolysaccharide, kainic acid, Fenton reagents, potassium cyanide, L-cysteine, excessive exercise, glutathione depletion, carbon tetrachloride, ischemia-reperfusion, MPTP, amyloid beta (25-35 amino acid residue) protein, and ionizing radiation. Melatonin as an antioxidant is effective in protecting nuclear DNA, membrane lipids and possibly cytosolic proteins from oxidative damage. Also, melatonin has been reported to alter the activities of enzymes which improve the total antioxidative defense capacity of the organism, i.e., superoxide dimutase, glutathione peroxidase, glutathione reductase, glucose-6-phosphate dehydrogenase, and nitric oxide synthase. Most studies have used pharmacological concentrations or doses of melatonin to protect against free radical damage; in a few studies physiological levels of the indole have been shown to be beneficial against oxidative stress. Melatonin's function as a free radical scavenger and antioxidant is likely assisted by the ease with which it crosses morphophysiological barriers, e.g., the blood-brain barrier, and enters cells and subcellular compartments. Whether the quantity of melatonin produced in vertebrate species is sufficient to significantly influence the total antioxidative defense capacity of the organism remains unknown, but its pharmacological benefits seem assured considering the low toxicity of the molecule.

Animals↗
PubMed2005

The acceptability of posthumous human ovarian tissue donation in Utah.

BACKGROUND: Infertility due to accelerated loss of ovarian follicles/oocytes may occur through numerous mechanisms. As a result, posthumous human oocyte donation, banking and maturation protocols for research and fertility restoration are current interests in reproductive medicine. METHODS: A computer-generated sample of Utah residents (n = 704) were surveyed regarding demographics, willingness to donate organs, IVF acceptability and posthumous follicle/oocyte donation for: research, fertilization with monitoring to the preembryo stage (eight cells), and fertilization and subsequent transfer of embryos derived from themselves, their partner or non-spousal relative for whom they act as guardian. RESULTS: Ovarian tissue donation for follicle/oocyte retrieval, maturation and scientific investigation without fertilization was acceptable (>or=70%) to a majority of the Utah population. However, fertilization of oocytes or fertilization and transfer of resulting preembyos derived from such donations to cause a pregnancy was less acceptable (58.3% and 57.4%, respectively) in the population responding for their own or partner's oocytes, and more so when the donation was guardian-directed (54.8% and 52.1%, respectively). Similar declines in the level of acceptance were noted when those who had an express interest in such donations (ovarian failure or surgical castration) were surveyed (n = 50). CONCLUSIONS: This study substantiates the ethical recommendation that explicit prior written consent of the donor be obtained when ovarian tissue donations are procured for fertilization, or transfer of a preembryo to cause a pregnancy. In light of the rapid technological advancements in ovarian follicle/oocyte cryopreservation and maturation, the time may have come to provide potential organ donors the opportunity to specify their desires regarding ovarian tissues when registering for organ donation.

Adolescent↗
PubMed2003

Factors influencing the adaptation of the Spanish Model of organ donation.

Spain is the only existing example of a large country (40 million inhabitants) with a continuous increase in cadaveric organ donation for a period of over 10 years, and, in parallel, with an increase in the overall number of solid organ transplantations. A proactive donor detection program performed by well-trained transplant coordinators, the introduction of systematic death audits in the hospitals combined with a positive social atmosphere, adequate management of mass media relations, and adequate economic reimbursement for the hospitals accounted for this success. Some regions of Italy, for example Tuscany, have successfully adapted this approach with excellent results. We can conclude that the "Spanish Model" can be partially or totally adapted to other countries or regions if basic conditions are guaranteed. An adequate and careful study of the local characteristics that influence organ donation directly or indirectly should be carried out before planning any specific action to improve organ donor rates.

Cadaver↗