Assuntos
Comparação Transcultural , Transplante de Células-Tronco Hematopoéticas/ética , França , Transplante de Células-Tronco Hematopoéticas/legislação & jurisprudência , Transplante de Células-Tronco Hematopoéticas/psicologia , Humanos , Índia , Menores de Idade , Doadores de Tecidos/psicologia , Obtenção de Tecidos e Órgãos/ética , Obtenção de Tecidos e Órgãos/métodos , Transplantados/psicologiaAssuntos
Publicidade Direta ao Consumidor/ética , Células-Tronco Hematopoéticas , Células-Tronco Mesenquimais , Células-Tronco Adultas , Instituições de Assistência Ambulatorial/ética , Instituições de Assistência Ambulatorial/legislação & jurisprudência , Qualidade de Produtos para o Consumidor , Publicidade Direta ao Consumidor/economia , Ética Médica , Setor de Assistência à Saúde/ética , Transplante de Células-Tronco Hematopoéticas/economia , Transplante de Células-Tronco Hematopoéticas/legislação & jurisprudência , Humanos , Transplante de Células-Tronco Mesenquimais/economia , Transplante de Células-Tronco Mesenquimais/legislação & jurisprudência , Doenças Musculoesqueléticas/terapia , Coleta de Tecidos e Órgãos/ética , Estados UnidosRESUMO
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.
Assuntos
Transplante de Medula Óssea/normas , Transplante de Células-Tronco Hematopoéticas/normas , Retratamento/normas , Transplante de Medula Óssea/legislação & jurisprudência , Transplante de Medula Óssea/métodos , Criopreservação , França , Transplante de Células-Tronco Hematopoéticas/efeitos adversos , Transplante de Células-Tronco Hematopoéticas/legislação & jurisprudência , Transplante de Células-Tronco Hematopoéticas/métodos , Humanos , Sistemas de Identificação de Pacientes/métodos , Pré-Medicação/métodos , Pré-Medicação/normas , Retratamento/efeitos adversos , Retratamento/métodos , Sociedades Médicas , TemperaturaAssuntos
Produtos Biológicos/uso terapêutico , Terapia Baseada em Transplante de Células e Tecidos , Regulamentação Governamental , Transplante de Células-Tronco Hematopoéticas/legislação & jurisprudência , Medicina Regenerativa/legislação & jurisprudência , Qualidade de Produtos para o Consumidor/legislação & jurisprudência , Transplante de Células-Tronco Hematopoéticas/efeitos adversos , Humanos , Estados Unidos , United States Food and Drug AdministrationRESUMO
One of the significant modifications to the Common Rule is the requirement that prospective participants be given information sufficient for a "reasonable person." However, research is limited on what types of information patients, caregivers, and providers consider "key information." Although certain aspects of informed consent (IC) may be considered standard, considering the individualized needs and preferences of patients is necessary for patient-centered consent. In this study, we qualitatively examined the specific types of information that patients and caregivers involved in hematopoietic cell transplantation (HCT), as well as their providers, believe to be important and necessary as part of the IC process to make a decision about participating in clinical research; and further, how these perspectives are aligned. Our findings suggest opportunities for improving the IC document and process by emphasizing information of importance to patients, such as the benefits to others and contributions to science that are associated with participation in clinical research. Furthermore, increasing patient engagement during the IC process may allow providers to streamline information that is aligned with patient information needs and preferences.
Assuntos
Transplante de Células-Tronco Hematopoéticas/legislação & jurisprudência , Consentimento Livre e Esclarecido/normas , Melhoria de Qualidade , Adulto , Cuidadores , Tomada de Decisões , Feminino , Humanos , Consentimento Livre e Esclarecido/legislação & jurisprudência , Masculino , Pessoa de Meia-Idade , Educação de Pacientes como Assunto , Participação do Paciente , Inquéritos e Questionários , Adulto JovemRESUMO
Providing information to living donors is first and foremost a legal obligation as well as an ethical one, not to mention necessary to health care provision. It's been shown that quality of information concerning the procedure's practical aspects, scheduling of clinical tests and examinations, withdrawing stem cells for the donation, post-donation symptoms, and support provided by healthcare teams, directly impacts the donor's quality of experience. Taking this into consideration our group decided it was essential to create an informational support for donors in the form of a booklet to be provided in different hematopoietic stem cell transplant centers across France. In September 2016 in Lille, France, the Francophone Society of Bone Marrow Transplantation and Cellular Therapy (SFGM-TC) organized the 7th allergenic hematopoietic stem cell transplantation clinical practices harmonization workshops. As part of these workshops, our group worked collectively to develop a basis of indispensable information to be included in the booklet and presented using clear and accessible language.
Assuntos
Transplante de Células-Tronco Hematopoéticas , Doadores Vivos/educação , Folhetos , França , Transplante de Células-Tronco Hematopoéticas/efeitos adversos , Transplante de Células-Tronco Hematopoéticas/ética , Transplante de Células-Tronco Hematopoéticas/legislação & jurisprudência , Humanos , Sociedades MédicasRESUMO
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.
Assuntos
Transplante de Células-Tronco , Doadores de Tecidos/educação , Transplantados/educação , Gravação em Vídeo , Adolescente , Adulto , Idoso , Transplante de Medula Óssea/legislação & jurisprudência , Feminino , Transplante de Células-Tronco Hematopoéticas/legislação & jurisprudência , Humanos , Consentimento Livre e Esclarecido/legislação & jurisprudência , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Transplante de Células-Tronco/legislação & jurisprudência , Inquéritos e Questionários , Doadores de Tecidos/legislação & jurisprudência , Transplantados/legislação & jurisprudência , Adulto JovemRESUMO
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.
Assuntos
Transplante de Medula Óssea , Terapia Baseada em Transplante de Células e Tecidos , Conferências de Consenso como Assunto , Consentimento Livre e Esclarecido , Temas Bioéticos , Transplante de Medula Óssea/ética , Transplante de Medula Óssea/legislação & jurisprudência , Terapia Baseada em Transplante de Células e Tecidos/ética , Comunicação , França , Transplante de Células-Tronco Hematopoéticas/ética , Transplante de Células-Tronco Hematopoéticas/legislação & jurisprudência , Humanos , Consentimento Livre e Esclarecido/ética , Consentimento Livre e Esclarecido/legislação & jurisprudência , Relações Médico-Paciente/ética , Sociedades Médicas , Doadores de Tecidos/ética , Doadores de Tecidos/legislação & jurisprudênciaRESUMO
The most suitable donor for younger patients who undergo hematopoietic stem cell transplantation in the research setting is frequently a minor sibling. These cases raise the question of whether minors who serve as stem cell donors for research subjects should be regarded as research subjects themselves. Regarding pediatric donors as research subjects ensures that an Institutional Review Boards reviews their involvement and determines whether it is appropriate. Yet, Institutional Review Boards must follow the US regulations for pediatric research, which were designed for patients and healthy volunteers, not for healthy donors. As a result, regarding pediatric donors as research subjects also can pose unnecessary obstacles to appropriate and potentially life-saving research. This article considers a new way to address this dilemma. The federal research regulations allow for waiver of some or all of the included requirements when they are unnecessary for a study or a class of studies. We argue that this option offers a way to ensure that the involvement of pediatric donors receives sufficient review and approval without inadvertently undermining valuable and potentially life-saving research.
Assuntos
Transplante de Células-Tronco Hematopoéticas/ética , Pesquisa com Células-Tronco/ética , Obtenção de Tecidos e Órgãos/ética , Adolescente , Pesquisa Biomédica/ética , Pesquisa Biomédica/legislação & jurisprudência , Criança , Pré-Escolar , Comitês de Ética em Pesquisa , Transplante de Células-Tronco Hematopoéticas/legislação & jurisprudência , Humanos , Lactente , Sujeitos da Pesquisa , Pesquisa com Células-Tronco/legislação & jurisprudência , Obtenção de Tecidos e Órgãos/legislação & jurisprudência , Estados UnidosRESUMO
In order to address the European Directive 2004/23 on human tissues and cells, the authorization obligation for tissue and blood stem cell preparations was introduced (§ 21a AMG) in the year 2007 in the German medicinal products act. Stem cell transplantation for hematopoietic reconstitution has been in use for decades and is well established for the treatment of many malignancies. The manufacture of stem cell preparations varies, but in terms of hematopoietic reconstitution, different products are intended for the same indication. Taking these aspects into account, it was considered inappropriate that every single applicant should provide their own documentation, including an expert report on clinical and nonclinical data. Consequently, the idea came up to create a central expert report, to which all applicants could refer and would include relevant clinical and nonclinical data according to current knowledge. A central expert report was therefore generated, called the "Gemeinsame Stellungnahme der Fachgesellschaften Deutsche Gesellschaft für Transfusionsmedizin und Immunhämatologie (DGTI), Deutsche Gesellschaft für Hämatologie und Onkologie (DGH) und Gesellschaft für Pädiatrische Onkologie und Hämatologie (GPOH)". Applicants are allowed to refer to this central expert report provided their stem cell product is comparable with the cell preparations included in the report. In order to represent current knowledge, the content of the central expert report was already reworked once, but should be updated regularly.
Assuntos
Terapia Baseada em Transplante de Células e Tecidos/normas , Coleta de Dados/legislação & jurisprudência , Coleta de Dados/normas , Documentação/normas , Prova Pericial/legislação & jurisprudência , Transplante de Células-Tronco Hematopoéticas/legislação & jurisprudência , Transplante de Células-Tronco Hematopoéticas/normas , Programas Nacionais de Saúde/legislação & jurisprudência , Garantia da Qualidade dos Cuidados de Saúde/legislação & jurisprudência , Europa (Continente) , Humanos , Segurança do Paciente , Controle de QualidadeRESUMO
The Human Tissue Authority can authorise a bone marrow harvest on a child of any age if a person with parental responsibility consents to the procedure. Older children have the legal capacity to consent to medical procedures under Gillick, but it is unclear if Gillick can be applied to non-therapeutic medical procedures. The relevant donation guidelines state that the High Court shall be consulted in the event of a disagreement, but what is in the best interests of the teenage donor under s.1 of the Children Act 1989? There are no legal authorities on child bone marrow harvests in the United Kingdom. This article considers the best interests of the older saviour sibling and questions whether, for the purposes of welfare, the speculative benefits could outweigh the physical burdens.
Assuntos
Transplante de Células-Tronco Hematopoéticas/legislação & jurisprudência , Doadores Vivos , Menores de Idade/legislação & jurisprudência , Consentimento dos Pais/legislação & jurisprudência , Irmãos , Coleta de Tecidos e Órgãos/legislação & jurisprudência , Adolescente , Criança , Humanos , Reino UnidoRESUMO
With increasing frequency, allogeneic hematopoietic cell transplantation involving children is being performed in the research setting. Allogeneic hematopoietic cell transplantation, however, cannot be performed without a hematopoietic stem cell (HSC) donor. This donor is often a sibling of the recipient and may also be a child. In such circumstances, it is unclear whether or how the federal regulations for pediatric research apply to the minor donors. This introductory paper reviews the issues to be considered while evaluating studies that use HSCs obtained from minor donors and identifies areas where further research is needed. In the era of increasing applicability for donor-derived cellular therapies, we provide a suggested framework for determining when minor donors qualify as human research subjects and when their participation can be approved under the federal regulations.
Assuntos
Transplante de Células-Tronco Hematopoéticas , Células-Tronco Hematopoéticas , Doadores Vivos , Adolescente , Criança , Pré-Escolar , Feminino , Transplante de Células-Tronco Hematopoéticas/ética , Transplante de Células-Tronco Hematopoéticas/legislação & jurisprudência , Humanos , Doadores Vivos/ética , Doadores Vivos/legislação & jurisprudência , MasculinoRESUMO
BACKGROUND: Autologous stem cell transplantation (ASCT) requires collection and cryopreservation of hematopoietic progenitor cells (HPCs), which in turn may be partially or never reinfused. Thus, HPC storage has become a logistic, ethical, and economic issue. SIDEM, GITMO, and CNT/ISS endorsed a project aimed to define national criteria for HPC disposal aimed to guarantee appropriateness and equity. STUDY DESIGN AND METHODS: A multidisciplinary panel was convened including HPC harvest and manipulation experts from apheresis units, hematologists with clinical expertise in ASCT, a representative of the national health authority, and a bioethicist. An analytic hierarchy process (AHP) was carried out to select disposal criteria. RESULTS: The AHP selected two criteria for prompt disposal of freshly collected HPCs: an abnormal freezing procedure causing highly reduced viability or major microbiology contamination. Moreover, AHP selected six major criteria, each one of them allowing for the disposal of stored HPC units: patient death, withdrawal of consent to ASCT, contraindications or loss of indications to ASCT, a damaged label that prevents correct identification of the unit, and time elapsed since harvest longer than 10 years. Three minor criteria were additionally identified that allowed to anticipate disposal only provided that viability levels are below the limit of acceptance: a documented cold chain interruption, loss of bag integrity, and total amount of stored CD34+ cells lower than 1 × 10(6) /kg or lower than 2 × 10(6)/kg in patients with a successfully completed stem cell transplantation program. CONCLUSIONS: A formal consensus process allowed SIDEM and GITMO to propose a policy for autologous HPC disposal that fulfills clinical, ethical, and economic criteria.
Assuntos
Transplante de Células-Tronco Hematopoéticas/legislação & jurisprudência , Células-Tronco Hematopoéticas/citologia , Transplante Autólogo/legislação & jurisprudência , HumanosAssuntos
Doenças Hematológicas/terapia , Transplante de Células-Tronco Hematopoéticas , Doença Enxerto-Hospedeiro/prevenção & controle , Antígenos HLA/genética , Haplótipos , Transplante de Células-Tronco Hematopoéticas/legislação & jurisprudência , Transplante de Células-Tronco Hematopoéticas/tendências , Histocompatibilidade/genética , HumanosRESUMO
BACKGROUND: With a view to addressing the moral concerns about the use of donor siblings, the Policy Statement of the American Academy of Pediatrics - Children as Hematopoietic Stem Cell Donors (the Policy) has laid out the criteria upon which tissue harvest from a minor would be permissible. DISCUSSION: Although tissue harvest serves the best interests of recipient siblings, parents are also obliged to act in the best interests of the donor sibling in the UK. Tissue harvest should proceed if and only if it serves the best interests of both the donor and recipient. Parents should be forbidden, and they are by UK law, to consent to tissue harvest unless there are substantial benefits for an incompetent minor that can outweigh the potential harm. There is no basis to subject a minor to the medical risks of tissue harvest if the recipient sibling can wait without significant risks of complications until the donor becomes Gillick competent. We also argue that the Policy fails to take into account recent advances in haematopoietic transplantation from haploidentical donors or related tissue-matched donors. SUMMARY: Unless a recipient sibling will suffer from serious complications or die without the transplantation and no other medically equivalent donors are available, there is no moral or legal basis to violate the donor sibling's right to bodily integrity. Accordingly, we propose that the Policy should be modified in order to fully satisfy the legal requirements for application in the UK and other commonwealth jurisdictions with similar statute laws protecting minors.
Assuntos
Transplante de Células-Tronco Hematopoéticas , Doadores Vivos , Menores de Idade , Consentimento dos Pais/ética , Guias de Prática Clínica como Assunto/normas , Irmãos , Coleta de Tecidos e Órgãos/ética , Criança , Haplótipos , Transplante de Células-Tronco Hematopoéticas/ética , Transplante de Células-Tronco Hematopoéticas/legislação & jurisprudência , Transplante de Células-Tronco Hematopoéticas/normas , Humanos , Consentimento dos Pais/legislação & jurisprudência , Sociedades Médicas , Reino Unido , Estados UnidosRESUMO
⢠Type 1 diabetes results from the loss of normal immunological self-tolerance, which may be attributable to the failure of Foxp3+ regulatory T cells (Tregs). Umbilical cord blood is rich in Tregs and therefore has the potential to prevent or delay the onset of type 1 diabetes. A pilot trial is currently underway in Australia to examine whether infusion of autologous cord blood can prevent type 1 diabetes in high-risk children with serum antibodies to multiple ß-cell antigens. ⢠A number of other potential therapeutic indications for autologous cord blood have been proposed, including cerebral palsy and hypoxic-ischaemic encephalopathy. ⢠Recruitment to clinical trials using cord blood is influenced by divergent public and private cord blood banking policy in Australia. The burgeoning consumer demand for storage of cord blood highlights the need for regulatory bodies to develop and adapt policies to facilitate research that may extend the use of cord blood beyond currently recognised indications. ⢠Consumers, researchers and policymakers must also recognise specific ethical issues associated with collection and storage of cord blood, including storage in public and private banks, informed consent, ownership, access and the principle of beneficence.
Assuntos
Bancos de Sangue/legislação & jurisprudência , Diabetes Mellitus Tipo 1/terapia , Sangue Fetal , Política de Saúde/legislação & jurisprudência , Transplante de Células-Tronco Hematopoéticas/legislação & jurisprudência , Transplante Autólogo/legislação & jurisprudência , Austrália , Diabetes Mellitus Tipo 1/prevenção & controle , Humanos , Propriedade/legislação & jurisprudência , RegeneraçãoRESUMO
⢠Cord blood banking raises ethical and legal issues which highlight the need for careful regulatory approaches to the emerging bioeconomy. ⢠Consent processes for both private and public banking should be inclusive and representative of the different familial interests in the cord blood. ⢠Property law is a potentially useful way of understanding the mechanisms for donation to both public and private banks. ⢠Increasing tensions between public and private models of banking may require the adoption of hybrid forms of banking.