Asunto(s)
Epidermis/trasplante , Agencias de los Sistemas de Salud/economía , Medicina Regenerativa/tendencias , Células Madre/fisiología , Ingeniería de Tejidos/tendencias , Adulto , Animales , Trasplante de Médula Ósea/legislación & jurisprudencia , Trasplante de Médula Ósea/métodos , Quemaduras/cirugía , Quemaduras/terapia , Ensayos Clínicos como Asunto , Análisis Costo-Beneficio/estadística & datos numéricos , Células Madre Embrionarias/trasplante , Terapia Genética/economía , Terapia Genética/métodos , Accesibilidad a los Servicios de Salud/normas , Agencias de los Sistemas de Salud/legislación & jurisprudencia , Enfermedades Hematológicas/cirugía , Enfermedades Hematológicas/terapia , Humanos , Células Madre Pluripotentes Inducidas/trasplante , Modelos Animales , Medicina Regenerativa/economía , Medicina Regenerativa/legislación & jurisprudencia , Investigación con Células Madre/ética , Terapias en Investigación/ética , Ingeniería de Tejidos/economía , Ingeniería de Tejidos/legislación & jurisprudenciaRESUMEN
Bone marrow donation between siblings is a common medical procedure. In some instances, the donor will be a young child incapable of providing either consent or assent, and the intervention is made lawful through the consent of the parent(s). Although a number of justifications have been formulated to cover this act with legitimacy, these fail to describe accurately the transaction that takes place. In the absence of the child authorising his parents to act as his proxy, it is unclear why parental consent is sufficient to permit the redistribution of his biological wealth. Instead, where the donor is such a young child, the whole procedure may be construed as the appropriation of bodily tissue from one unconsenting human and its conveyance to a third, albeit related, party. This paper argues that if the parentally authorised transfer of biological material from an unconsenting human to another is legally permissible, it must be on the basis of an implicitly acknowledged property right in the child.
Asunto(s)
Trasplante de Médula Ósea/legislación & jurisprudencia , Propiedad/legislación & jurisprudencia , Consentimiento Paterno/legislación & jurisprudencia , Preescolar , Humanos , Reino UnidoRESUMEN
JACIE (Joint Accreditation Committee ISTC EBMT) regulations and standards impose a quality and safety requirement for graft reinjection by nurses. However, the standards do not provide a step-by-step graft reinjection procedure. Because of high medical team turnover, the opening of new transplant centers, and continual questions from colleagues trying to decipher the JACIE standards, the need for a specific procedure goes without saying. We collected graft reinjection procedures from each SFGM-TC center that participated in our survey, thus creating an inventory of the different steps that make up graft reinjection. In addition to reviewing the main regulatory texts and JACIE standards, we sought advice from medical and cellular therapy experts. We observed that most centers use a mix of practices and some unjustified practices. In some transplant units, it is still standard practice to defrost cell therapy products in the transplant unit. Caregivers are aware of the need for a rigorous application of the regulatory requirements and are willing to administer a procedure that provides specific steps for each stage of the process. In this workshop, we questioned each stage of the graft reinjection procedure, which helped us define clear methods of implementation. In the form of a checklist, we offer bone marrow and stem cell transplant units a step-by-step procedure.
Asunto(s)
Trasplante de Médula Ósea/normas , Trasplante de Células Madre Hematopoyéticas/normas , Retratamiento/normas , Trasplante de Médula Ósea/legislación & jurisprudencia , Trasplante de Médula Ósea/métodos , Criopreservación , Francia , Trasplante de Células Madre Hematopoyéticas/efectos adversos , Trasplante de Células Madre Hematopoyéticas/legislación & jurisprudencia , Trasplante de Células Madre Hematopoyéticas/métodos , Humanos , Sistemas de Identificación de Pacientes/métodos , Premedicación/métodos , Premedicación/normas , Retratamiento/efectos adversos , Retratamiento/métodos , Sociedades Médicas , TemperaturaRESUMEN
INTRODUCTION: Bone marrow transplants primarily depend on people who previously registered to be donors. From then on, the search for compatibility between donor and recipient begins. OBJECTIVE: To describe the historical landmarks and the legal apparatus of bone marrow donor banks in Brazil based on an integrative review. METHODS: LILACS database and PubMed and SciELO journals were used. The term bone marrow transplantation was the descriptor. Eligibility criteria were: articles with the theme of Bone Marrow Transplantation (BMT) and studies carried out on the national territory. RESULTS: A total of 88,855 articles were identified, among which 185 met the eligibility criteria. After they were thoroughly read, 14 articles were selected. The studies pointed out fragments that dealt with important historical landmarks for the establishment of bone marrow transplantation as a conventional treatment for oncohematological diseases. CONCLUSION: The use of BMT has a history of more than thirty years in Brazil. However, none of the articles identified specifically addresses the historical content of bone marrow transplantation.
Asunto(s)
Donantes de Tejidos , Trasplante de Médula Ósea/historia , Trasplante de Médula Ósea/legislación & jurisprudencia , Trasplante de Células Madre , BrasilRESUMEN
OBJECTIVE: Obtaining informed consent from hematopoietic stem cell recipients and donors is a critical step in the transplantation process. Anxiety may affect their understanding of the provided information. However, use of audiovisual methods may facilitate understanding. In this prospective randomized study, we investigated the effectiveness of using an audiovisual method of providing information to patients and donors in combination with the standard model. MATERIALS AND METHODS: A 10-min informational animation was prepared for this purpose. In total, 82 participants were randomly assigned to two groups: group 1 received the additional audiovisual information and group 2 received standard information. A 20-item questionnaire was administered to participants at the end of the informational session. RESULTS: A reliability test and factor analysis showed that the questionnaire was reliable and valid. For all participants, the mean overall satisfaction score was 184.8±19.8 (maximum possible score of 200). However, for satisfaction with information about written informed consent, group 1 scored significantly higher than group 2 (p=0.039). Satisfaction level was not affected by age, education level, or differences between the physicians conducting the informative session. CONCLUSION: This study shows that using audiovisual tools may contribute to a better understanding of the informed consent procedure and potential risks of stem cell transplantation.
Asunto(s)
Trasplante de Células Madre , Donantes de Tejidos/educación , Receptores de Trasplantes/educación , Grabación en Video , Adolescente , Adulto , Anciano , Trasplante de Médula Ósea/legislación & jurisprudencia , Femenino , Trasplante de Células Madre Hematopoyéticas/legislación & jurisprudencia , Humanos , Consentimiento Informado/legislación & jurisprudencia , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Trasplante de Células Madre/legislación & jurisprudencia , Encuestas y Cuestionarios , Donantes de Tejidos/legislación & jurisprudencia , Receptores de Trasplantes/legislación & jurisprudencia , Adulto JovenAsunto(s)
Células Madre Adultas/metabolismo , Trasplante de Médula Ósea , Células Endoteliales/metabolismo , Infarto del Miocardio/terapia , Enfermedad Arterial Periférica/terapia , Células Madre Adultas/patología , Células Madre Adultas/trasplante , Animales , Médula Ósea/patología , Trasplante de Médula Ósea/ética , Trasplante de Médula Ósea/legislación & jurisprudencia , Separación Celular/métodos , Ensayos Clínicos como Asunto , Células Endoteliales/patología , Células Endoteliales/trasplante , Humanos , Infarto del Miocardio/patología , Infarto del Miocardio/fisiopatología , Neovascularización Fisiológica , Enfermedad Arterial Periférica/patología , Enfermedad Arterial Periférica/fisiopatología , Recuperación de la Función , Regeneración , Trasplante Autólogo , Cicatrización de HeridasRESUMEN
It is widely accepted that younger children can act as saviour siblings by donating cord blood or bone marrow to their gravely-ill brothers or sisters. However, it is under dispute whether these procedures are in the best interests of the child. This article suggests that parents may be relying on a thinly-veiled interfamilial approach, where the wider benefit to the whole family is used to justify the procedure to the Human Tissue Authority in the United Kingdom. This article suggests that the merging of familial interests to validate a non-therapeutic bone marrow harvest on a child forces altruism in a patient too young to understand, rendering the harvests unlawful under current law.
Asunto(s)
Trasplante de Médula Ósea/legislación & jurisprudencia , Protección a la Infancia/legislación & jurisprudencia , Trasplante de Células Madre de Sangre del Cordón Umbilical/legislación & jurisprudencia , Hermanos , Recolección de Tejidos y Órganos/legislación & jurisprudencia , Trasplante de Médula Ósea/ética , Niño , Trasplante de Células Madre de Sangre del Cordón Umbilical/ética , Humanos , Reino UnidoRESUMEN
Informed consent is not restricted to clinical research and must be applied to high-risk care such as hematopoietic stem cell transplantation. If standardized informed consent might improve inequalities in medical practices between different transplantation centers, it is strongly recommended that it be adapted with an honest dialogue between physicians and patients and physicians and donors. In an attempt to harmonize clinical practices among French hematopoietic stem cell transplantation centers, the Francophone Society of Bone Marrow Transplantation and Cellular Therapy (SFGM-TC) held its sixth annual workshop series in September 2015 in Lille. This event brought together practitioners from across the country. The purpose of this paper is to highlight the French law concerning patients' rights and ethical practices for an informed consent process to be applied to care or research.
Asunto(s)
Trasplante de Médula Ósea , Tratamiento Basado en Trasplante de Células y Tejidos , Conferencias de Consenso como Asunto , Consentimiento Informado , Discusiones Bioéticas , Trasplante de Médula Ósea/ética , Trasplante de Médula Ósea/legislación & jurisprudencia , Tratamiento Basado en Trasplante de Células y Tejidos/ética , Comunicación , Francia , Trasplante de Células Madre Hematopoyéticas/ética , Trasplante de Células Madre Hematopoyéticas/legislación & jurisprudencia , Humanos , Consentimiento Informado/ética , Consentimiento Informado/legislación & jurisprudencia , Relaciones Médico-Paciente/ética , Sociedades Médicas , Donantes de Tejidos/ética , Donantes de Tejidos/legislación & jurisprudenciaAsunto(s)
Trasplante de Células Madre de Sangre del Cordón Umbilical/ética , Consentimiento Informado/ética , Trasplante de Médula Ósea/ética , Trasplante de Médula Ósea/legislación & jurisprudencia , Trasplante de Células Madre de Sangre del Cordón Umbilical/legislación & jurisprudencia , Ética Médica , Humanos , Consentimiento Informado/legislación & jurisprudencia , Responsabilidad Legal , Medición de Riesgo , Medicina Estatal , Reino UnidoRESUMEN
The medical staff caring for children with hematological or oncological diseases is often faced with delicate ethical and, at times, legal problems. Although many of these are common to other branches of pediatrics where patients are children lacking decision-making capacity, others, such as bone marrow transplantation (BMT), are peculiar to this specialty. This is a vanguard treatment for a wide range of diseases that are either incurable or resistant to conventional therapies. If the patient does not have a related donor, ethical and legal problems can occur: profound emotional dilemmas arise both because of the fretful search for a donor and because of the limited period the patient can be transplanted with good expectations of success. National and International Registries are linked to all BMT Units for the identification of compatible donors with the recipient. Hospitals hosting a BMT Unit must fulfill several requirements which are crucial to guaranteeing the best results when faced with the complexity and aggressiveness of transplantation and possible complications, such as a blood bank, an infectious diseases department, a rehabilitation unit, the availability of consultants, as well as playworkers, teachers, psychologists and social workers. Any trial carried out in a Center without sufficient experience, simply pleading the concept of "last hope" is not ethical, even considering possible late effects and sequelae. For allogeneic bone marrow transplantation it is necessary to obtain both the Consent of the donor and the Consent of parents of the recipient. Often the donor is a child sibling of the patient, lacking decision-making capacity as well. Information to parents of both children must be detailed. In reality, there are practically no risks for the child donor and, if any, they are linked to the general anaesthesia. The text of the Informed Consent is usually deliberated and accepted in advance by the Ethics Committee of the Institution where the patient is followed. Voluntary donor's Consent is required at different steps: at the entry in the Registry, when typing of major histocompatibility complex, at bone marrow harvesting under general anaesthesia. In Italy, Article No. 3, Law No. 107 of May 4, 1990 allows parents or legal guardians to consent to the bone marrow donation of a minor.
Asunto(s)
Trasplante de Médula Ósea/psicología , Ética Médica , Trasplante de Médula Ósea/legislación & jurisprudencia , Niño , Preescolar , Humanos , LactanteAsunto(s)
Regulación Gubernamental , Medición de Riesgo , Experimentación Humana Terapéutica , Trasplante Heterólogo , Síndrome de Inmunodeficiencia Adquirida/terapia , Animales , Trasplante de Médula Ósea/efectos adversos , Trasplante de Médula Ósea/legislación & jurisprudencia , Comités de Ética en Investigación , Gobierno Federal , Humanos , Papio , Donantes de Tejidos , Obtención de Tejidos y Órganos , Trasplante Heterólogo/efectos adversos , Estados Unidos , United States Food and Drug Administration , Virosis/transmisión , Virosis/veterinariaRESUMEN
The paper reports the normative rules and the Italian Ministry of Health administrative instructions concerning the bone marrow unrelated donor (MUD) search in the Italian Bone Marrow Donor Registry (IBMDR) and in international registries from the preliminary activation to a MUD bone marrow transplant (BMT), when a volunteer donor, perfectly compatible with a recipient lacking a HLA identical sibling, is found. The article describes all the expenses pertinent to the different stages of search and the documents necessary to obtain the reimbursement of these expenses. A very recent Ministry Decree establishing that all the search costs will be charged to the competent local sanitary authority is added.
Asunto(s)
Trasplante de Médula Ósea/legislación & jurisprudencia , Obtención de Tejidos y Órganos/legislación & jurisprudencia , Trasplante de Médula Ósea/economía , Humanos , Italia , Sistema de Registros , Obtención de Tejidos y Órganos/economíaRESUMEN
From a legislative point of view, the allograft of bone marrow is considered as an organ transplant. It consists in "replacing a diseased or deficient marrow with a healthy marrow removed on a compatible living donor." This treatment has significant repercussions for the patient. Will he find, in his circle, the resources which will enable him to face the changes imposed by the marrow graft? The information can then be a way to meet the needs of the patient. Our study is based on questionnaires sent to 55 adults who underwent an allograft. Thanks to the results, we could highlight the most favourable moment for information, the person most capable of giving it, the precise content and the way best suited to the needs of the patient.
Asunto(s)
Adaptación Psicológica , Actitud Frente a la Salud , Trasplante de Médula Ósea/enfermería , Trasplante de Médula Ósea/psicología , Evaluación de Necesidades , Educación del Paciente como Asunto/métodos , Adulto , Trasplante de Médula Ósea/efectos adversos , Trasplante de Médula Ósea/legislación & jurisprudencia , Femenino , Francia , Humanos , Masculino , Evaluación en Enfermería , Investigación Metodológica en Enfermería , Registros de Enfermería , Encuestas y CuestionariosRESUMEN
Many U.S. states have passed legislation providing leave to organ and bone marrow donors and/or tax benefits for live and deceased organ and bone marrow donations and to employers of donors. We exploit cross-state variation in the timing of such legislation to analyze its impact on organ donations by living and deceased persons, on measures of the quality of the transplants, and on the number of bone marrow donations. We find that these provisions do not have a significant impact on the quantity of organs donated. The leave laws, however, do have a positive impact on bone marrow donations, and the effect increases with the size of the population of beneficiaries and with the generosity of the legislative provisions. Our results suggest that this legislation works for moderately invasive procedures such as bone marrow donation, but these incentives may be too low for organ donation, which is riskier and more burdensome.