[Organ donation after determination of brain death : Legal aspects and practical approach]. / Organspende nach irreversiblem Hirnfunktionsausfall : Rechtliche Aspekte und praktisches Vorgehen.

The prerequisites for post-mortem organ donation in Germany include the determination of irreversible loss of brain function, consent to organ donation, and the exclusion of medical contraindications. In addition, mainly because of the shortage of donor organs in Germany and the sometimes controversial social and media discussions on the topic of organ donation, all physicians involved in the donation process must be familiar with the relevant laws, guidelines, and procedural instructions. This applies especially to those who are to carry out the verification of irreversible brain death. Only then, can they act safely in this challenging situation and serve as competent consultants for all involved.

Current status of liver transplantation in Asia.

In spite of early adoption of the brain death legislation, and all efforts at promoting deceased donation, various social, economic and cultural factors have acted as road blocks to the furthering of deceased donor liver transplantation (DDLT) in most Asian societies. On the other hand, Asian liver transplant centers have been the pioneers, innovators, and technical advancement catalysts for the world to follow, especially with regards to living donor liver transplantation (LDLT). With some high volume centers performing more than 200 LDLTs a year with good outcomes in the donor and recipient, techniques to expand the living donor pool have also been adopted like ABO-incompatible, paired exchange and dual lobe living donor liver transplants. Although large multicenter, and registry data as regards safety and outcomes of minimally invasive donor hepatectomy are awaited, expert centers have pioneered, and now regularly perform purely laparoscopic and robotic living donor hepatectomies, especially in Korea.

Where do these cadavers come from?

Cadaveric surgical courses are highly useful in developing operative skills, however, the provenance of the cadavers themselves remains opaque. Trade in cadaveric parts is an important source of material for courses, and this has spawned the unique service of body brokerage. Body brokers, however, operate in an unregulated market and obtain bodies by exploiting family members' altruistic instincts and financial concerns. Unethical and illegal sale of body parts has been well-documented, while the use of cadavers for uses other than that consented by donors is also a key concern. Undoubtedly, cadaveric surgical courses would have used bodies sourced from brokers, and questions remain about the moral and ethical implications of this. We discuss this issue using an ethical and historical context as well as offering solutions to ensure the ethical sourcing of cadavers for surgical training.

Allograft for knee ligament surgery: an American perspective.

PURPOSE: Allografts are frequently use for ligamentous reconstruction at the knee. In the United States, tissue donation and distribution are highly regulated processes with thorough oversight from private and government entities. Allograft is widely available in the United States and allograft procurement is a large industry with varying procurement, sterilization, processing, and distribution procedures. It is important to understand allograft regulation and processing which may affect graft mechanical properties and biological graft integration. METHODS: English-language literature, United States government and regulatory agency statues pertaining to allograft procurement, distribution, and usage were reviewed and the findings summarized. RESULTS: During the processing of allograft, multiple factors including sterilization procedures, irradiation, storage conditions, and graft type all affect the biomechanical properties of the allograft tissue. Biological incorporation and ligamentization of allograft does occur, but at a slower rate compared with autograft. For ligamentous reconstruction around the knee, allograft offers shorter operative time, no donor-site morbidity, but has shown an increased risk for graft failure compared to autograft. CONCLUSION: This article reviews the regulations on graft tissue within the United States, factors affecting the biomechanics of allograft tissue, differences in allograft tissue choices, and the use of allograft for anterior cruciate ligament reconstruction and multiligamentous knee injury reconstruction. LEVEL OF EVIDENCE: V.

Uncontrolled DCD: When Should We Stop Trying to Save the Patient and Focus on Saving the Organs?

Uncontrolled donation after circulatory death, which occurs when an individual has experienced unexpected cardiac arrest, usually not in a hospital, generates both excitement and concern. On the one hand, uDCD programs have the capacity to significantly increase organ donation rates, with good transplant outcomes-mainly for kidneys, but also for livers and lungs. On the other hand, uDCD raises a number of ethical challenges. In this essay, we focus on an issue that is central to all uDCD protocols: When should we cease resuscitation and shift to organ preservation? Do current uDCD protocols prematurely consider as potential donors patients who could still have some chances of meaningful survival? Can the best interest of patients be fostered once they are considered and treated as potential donors?

Regulatory aspects of tissue donation, banking and transplantation in India.

Amendments to India's Transplantation of Human Organs Act, 1994, have established the legality of tissue donation and transplantation from deceased donors and the conditions under which they are permitted. The amended Act, now known as The Transplantation of Human Organs and Tissues Act, 1994, seeks to prevent the commercialization of tissue donation and to guarantee the safety of indigenous allografts. Registration of tissue banks, compliance with national standards and the appointment of transplant co-ordinators in hospitals registered under the Act are now mandatory. A national registry and Regional and State networks for donation and transplantation of tissues have been introduced. Despite the amendments a few anomalies of the principal Act persist as some of the differences between tissue and organ donation and transplantation have been overlooked. These include the possibility of skin donation in locations other than hospitals; the donation of medical and surgical tissue residues which does not pose any risk to the living donor; the non-requirement for compatibility between donor and recipient; the delayed time factor between tissue donation and transplantation which makes identification of a recipient at the time of donation impossible; and the easy availability of alternatives to tissues which make waiting lists redundant for many tissues. Rules for the implementation of the amended Act were framed in 2014 but like the Act must be adopted by the State health assemblies to become universally applicable in the country.

Considerations pertaining to cell collection and administration of industry-manufactured autologous CAR-T cells, in relation to French healthcare organization and regulations.

Access to treatment with CAR-T Cells at European hospitals in general and at French hospitals in particular remains limited, when compared with the situation that prevails in the USA or in certain Asian countries. Multiple reasons explain why European investigators lag behind their US or Chinese colleagues in this clinical research area. Some of these reasons are related to the European and French regulatory landscapes that hamper the design and rapid implementation of organizational solutions needed for safe and efficient administration of CAR-T Cells. We here identify some of these pressing issues and propose some possible paths to move forward.

Compulsory Organ Retrieval: Morally, But Not Socially, Justified.

The number of patients with organ failure who could potentially benefit from transplantation continues to exceed the available supply of organs. Despite numerous efforts to increase the number of donors, there remains an enormous mismatch between demand and supply. Large numbers of people still die with potentially transplantable organs remaining in situ, most frequently as a result of family objections. I argue that there are no persuasive moral arguments against mandated organ retrieval from all dead individuals who meet clinical criteria. However, because of continuing endemic prejudice in United States society and its healthcare system and the distrust this engenders, I conclude that proceeding with a policy of compulsory organ retrieval, even if morally unobjectionable, would not be warranted.

Choice, pressure and markets in kidneys.

We do not always benefit from the expansion of our choice sets. This is because some options change the context in which we must make decisions in ways that render us worse off than we would have been otherwise. One promising argument against paid living kidney donation holds that having the option of selling a 'spare' kidney would impact people facing financial pressures in precisely this way. I defend this argument from two related criticisms: first, that having the option to sell one's kidney would only be harmful if one is pressured or coerced to take this specific course of action; and second, that such forms of pressure are unlikely to feature in a legal market.

Organ donation in India: Scarcity in abundance.

In modern era, India witnessed its first successful corneal, kidney and cardiac transplant in the year 1960, 1967 and 1994 though the reverberations for organ donation and transplantation (ODT) existed since time-memorial with roots existing in Hindu mythology along with vivid example of Guru Dadheech and lord Ganesha. No country in the world is able to meets its organ requirement. Government of India promulgated Transplantation of Human Organ and Tissues Act in 1994 and with the view to enlarge its scope and promote organ donation government has brought new amendments as of year 2014 and 2017. In the background of this journey many new developmental milestones have been achieved in the country however organ donation which has assumed public health significance has been consistently lower than expectations. This manuscript highlights the current status of ODT in the country; legislative environment, limitations, challenges, health education activities, and newer initiatives.

Nivel de conocimiento del concepto de muerte encefálica entre estudiantes de grado de la Universitat de Lleida / The level of knowledge regarding the concept of brain death among undergraduates at the Universitat de Lleida

Introducción. La muerte encefálica es una situación de muerte que se diagnostica a través de criterios neurológicos y es la situación ideal para donar los órganos, ya que, gracias a los cuidados intensivos, los órganos mantienen su viabilidad. Muy pocos estudios previos han analizado el conocimiento de la población sobre esta situación. Objetivo. Determinar el grado de conocimiento del concepto de muerte encefálica entre estudiantes universitarios, comparando resultados entre Medicina y otros estudios de grado. Sujetos y métodos. Se realizó una encuesta electrónica cerrada a estudiantes de la Universitat de Lleida sobre el conocimiento del concepto de muerte encefálica, la legislación de donante y la voluntad de donar. Resultados. Respondieron un total de 488 personas, 192 (39,3%) del grado de Medicina. Sólo 164 (33,6%) eran hombres. La edad media fue de 22,1 ± 4,4 años. Sólo 63 (12,9%) encuestados definieron la muerte encefálica como muerte. Un 19,1% contestó correctamente a la pregunta de la legislación de órganos, aunque un 79,7% mostró voluntad para donar sus órganos. El grado de conocimiento fue significativamente mayor en los cursos más elevados del grado de Medicina, pero con un margen de mejoría importante. Sólo el 31,7% de los estudiantes de sexto curso tuvo un buen conocimiento del concepto de muerte encefálica. Conclusión. El grado de conocimiento de la muerte encefálica y la legislación de donante es pobre entre la población universitaria, incluso en el grado de Medicina. Sería conveniente diseñar estrategias para mejorar el conocimiento, sobre todo en los futuros profesionales sanitarios (AU)

Introduction. Brain death is a death situation which is diagnosed by means of neurological criteria and is the ideal situation for organ donation, as, thanks to intensive care, the organs maintain their viability. Very few studies have analysed the knowledge that the population has about this situation. Aim. To determine how much university students know about brain death by comparing the results between undergraduates pursuing a degree in medicine and those on other bachelor’s degree courses. Subjects and methods. A closed on-line survey was administered to undergraduate students at the Universitat de Lleida about their knowledge regarding the concept of brain death, donor legislation and willingness to donate. Results. The survey was answered by a total of 488 people, 192 (39.3%) from the degree in medicine. Only 164 (33.6%) were males. The mean age was 22.1 ± 4.4 years. Only 63 (12.9%) respondents defined brain death as death. While 19.1% replied correctly to the question about organ donation legislation, 79.7% said they would be willing to donate their organs. The level of knowledge was significantly higher in the later courses of the degree in medicine, although there was still plenty of room for improvement in this respect. Only 31.7% of sixth-year students had a good idea of the concept of brain death. Conclusion. The extent of knowledge about brain death and legislation on organ donation is poor among university students, even in the degree in medicine. It would be advisable to design strategies aimed at improving this knowledge, especially among future healthcare professionals (AU)

A critical analysis of the Recommendation CM/Rec(2016)6 of the Committee of Ministers to member States on research on biological materials of human origin on the basis of the comments made by the experts participating in its public consultation process

On 11 May 2016, the Council of Europe adopted the Recommendation CM/Rec(2016)6 of the Committee of Ministers to Member States on research on biological materials of human origin. This new legal tool is meant to play a key role in the harmonization of the regulation of the topic addressed in the Council of Europe geographical scope, and even beyond. This paper develops a critical analysis of the new Recommendation on the basis of the comments made by academics, representatives of the biotechnology industry, members of the ethics committees, professional and patient associations, national agencies, etc. in a public consultation organized to refine the preliminary draft of the document. It offers a detailed account of its main clauses while comparing them with the suggestions made by the participants in the consultation, highlighting the main disagreements that remained in its final version. In this way, it contributes to the most recent stage of development, both by performing a valuable analysis of the document and by including a critical comment on the utility of the public consultation made during the process

El 11 de mayo de 2016, el Consejo de Europa aprobó la Recomendación CM/Rec(2016)6 del Comité de Ministros a los Estados Miembros sobre investigación con materiales biológicos de origen humano. Este nuevo instrumento jurídico está destinado a desempeñar un papel clave en la armonización de la regulación del tema abordado en el ámbito geográfico del Consejo de Europa, e incluso más allá. En este documento se desarrolla un análisis crítico de la nueva Recomendación sobre la base de las observaciones formuladas por académicos, representantes de la industria biotecnológica, miembros de los comités de ética, asociaciones profesionales y de pacientes, agencias nacionales, etc. en la consulta preliminar sobre el documento realizada por el Consejo. Ofrece una descripción detallada de sus prin.cipales cláusulas, comparándolas con las sugerencias de los participantes en la consulta y destacando los principales desacuerdos que quedaron en su versión final. De esta manera, contribuye al estado de la cuestión a través de una doble vía, tanto realizando un valioso análisis del documento como incluyendo un comentario crítico sobre la utilidad de la consulta pública realizada durante el proceso

Global lessons in graft type and pediatric liver allocation: A path toward improving outcomes and eliminating wait-list mortality.

Current literature and policy in pediatric liver allocation and organ procurement are reviewed here in narrative fashion, highlighting historical context, ethical framework, technical/procurement considerations, and support for a logical way forward to an equitable pediatric liver allocation system that will improve pediatric wait-list and posttransplant outcomes without adversely affecting adults. Where available, varying examples of successful international pediatric liver allocation and split-liver policy will be compared to current US policy to highlight potential strategies that can be considered globally. Liver Transplantation 23:86-95 2017 AASLD.

Impact of donor-recipient genetic relationship on outcome of living donor liver transplantation.

Living donor liver transplantation (LDLT) is a valuable option for expanding the donor pool, especially in localities where deceased organ harvesting is not allowed. In addition, rejection rates were found to be lower in LDLT, which is attributed to the fact that LDLT is usually performed between relatives. However, the impact of genetic relation on the outcome of LDLT has not been studied. In this study, we examined the difference in rejection rates between LDLT from genetically related (GR) donors and genetically unrelated (GUR) donors. All cases that underwent LDLT during the period from May 2004 until May 2014 were included in the study. The study group was divided into 2 groups: LDLT from GR donors and LDLT from GUR donors. A total of 308 patients were included in the study: 212 from GR donors and 96 from GUR donors. Human leukocyte antigen (HLA) typing was not included in the workup for matching donors and recipients. GUR donors were wives (36; 11.7%), sons-in-law (7; 2.3%), brothers-in-law (12; 3.9%), sisters-in-law (1; 0.3%), and unrelated (38; 12.3%). The incidence of acute rejection in the GR group was 17.4% and 26.3% in the GUR group (P value = 0.07). However, there was a significant difference in the incidence of chronic rejection (CR) between the 2 groups: 7% in GR group and 14.7% in the GUR group (P value = 0.03). In terms of overall survival, there was no significant difference between both groups. LDLT from the GUR donors is not associated with a higher incidence of acute cellular rejection. However, CR was significantly lower when grafts were procured from GR donors. HLA matching may be recommended before LDLT from GUR donors. Liver Transplantation 23:43-49 2017 AASLD.

Crimes against Public Health in Croatia and Bosnia and Herzegovina.

The criminal protection of human health, public health is based on the punishment procedures doctor, pharmacist, ordinary citizen, manufacturers and merchants. It is justified to singleout these crimes in a special group of criminal offenses within the particular part, which is particularly true for those offenses where the focus is not on false threats to the health of a particular individual, but when it may lead to more people lose their lives or get to poor health of more people. This paper will point out the fundamental characteristics of these criminal offenses, their justification to identify a separate chapter in the criminal law, the importance of respect ethical standards in scientific activity, the criminal liability of doctors as fundamental carriers of health activities with regard to the offenses for which the perpetrators appear primary doctor.

Towards a standardised informed consent procedure for live donor nephrectomy: the PRINCE (Process of Informed Consent Evaluation) project-study protocol for a nationwide prospective cohort study.

INTRODUCTION: Informed consent is mandatory for all (surgical) procedures, but it is even more important when it comes to living kidney donors undergoing surgery for the benefit of others. Donor education, leading to informed consent, needs to be carried out according to certain standards. Informed consent procedures for live donor nephrectomy vary per centre, and even per individual healthcare professional. The basis for a standardised, uniform surgical informed consent procedure for live donor nephrectomy can be created by assessing what information donors need to hear to prepare them for the operation and convalescence. METHODS AND ANALYSIS: The PRINCE (Process of Informed Consent Evaluation) project is a prospective, multicentre cohort study, to be carried out in all eight Dutch kidney transplant centres. Donor knowledge of the procedure and postoperative course will be evaluated by means of pop quizzes. A baseline cohort (prior to receiving any information from a member of the transplant team in one of the transplant centres) will be compared with a control group, the members of which receive the pop quiz on the day of admission for donor nephrectomy. Donor satisfaction will be evaluated for all donors who completed the admission pop-quiz. The primary end point is donor knowledge. In addition, those elements that have to be included in the standardised format informed consent procedure will be identified. Secondary end points are donor satisfaction, current informed consent practices in the different centres (eg, how many visits, which personnel, what kind of information is disclosed, in which format, etc) and correlation of donor knowledge with surgeons' estimation thereof. ETHICS AND DISSEMINATION: Approval for this study was obtained from the medical ethical committee of the Erasmus MC, University Medical Center, Rotterdam, on 18 February 2015. Secondary approval has been obtained from the local ethics committees in six participating centres. Approval in the last centre has been sought. RESULTS: Outcome will be published in a scientific journal. TRIAL REGISTRATION NUMBER: NTR5374; Pre-results.