ABSTRACT
It now seems technically feasible to culture human embryos beyond the "fourteen-day limit," which has the potential to increase scientific understanding of human development and perhaps improve infertility treatments. The fourteen-day limit was adopted as a compromise but subsequently has been considered an ethical line. Does it remain relevant in light of technological advances permitting embryo maturation beyond it? Should it be changed and, if so, how and why? What justifications would be necessary to expand the limit, particularly given that doing so would violate some people's moral commitments regarding human embryos? Robust stakeholder engagement preceded adoption of the fourteen-day limit and should arguably be part of efforts to reassess it. Such engagement could also consider the need for enhanced oversight of human embryo research. In the meantime, developing and implementing reliable oversight systems should help foster high-quality research and public confidence in it.
Subject(s)
Embryo Research , Humans , Morals , PolicyABSTRACT
In view of the globally evolving coronavirus disease (COVID-19) pandemic, German hospitals rapidly expanded their intensive care capacities. However, it is possible that even with an optimal use of the increased resources, these will not suffice for all patients in need. Therefore, recommendations for the allocation of intensive care resources in the context of the COVID-19 pandemic have been developed by a multidisciplinary group of authors with the support of eight scientific medical societies. The recommendations for procedures and criteria for prioritisations in case of resource scarcity are based on scientific evidence, ethicolegal considerations and practical experience. Medical decisions must always be based on the need and the treatment preferences of the individual patient. In addition to this patient-centred approach, prioritisations in case of resource scarcity require a supraindividual perspective. In such situations, prioritisations should be based on the criterion of clinical prospect of success in order to minimize the number of preventable deaths due to resource scarcity and to avoid discrimination based on age, disabilities or social factors. The assessment of the clinical prospect of success should take into account the severity of the current illness, severe comorbidities and the patient's general health status prior to the current illness.
Subject(s)
COVID-19 , Coronavirus , Critical Care , Humans , Methacrylates , Pandemics , Resource Allocation , SARS-CoV-2ABSTRACT
In view of the globally evolving Coronavirus Disease (COVID-19) pandemic, German hospitals rapidly expanded their intensive care capacities. However, it is possible that even with an optimal use of the increased resources, these will not suffice for all patients in need. Therefore, recommendations for the allocation of intensive care resources in the context of the COVID-19 pandemic have been developed by a multidisciplinary authors group with support of eight scientific medical societies. The recommendations for procedures and criteria for prioritisations in case of resource scarcity are based on scientific evidence, ethico-legal considerations and practical experience. Medical decisions must always be based on the need and the treatment preferences of the individual patient. In addition to this patient-centred approach, prioritisations in case of resource scarcity require a supra-individual perspective. In such situations, prioritisations should be based on the criterion of clinical prospect of success in order to minimize the number of preventable deaths due to resource scarcity and to avoid discrimination based on age, disabilities or social factors. Assessment of the clinical prospect of success should take into account the severity of the current illness, severe comorbidities and the patient's general health status prior to the current illness.
Subject(s)
Coronavirus Infections/epidemiology , Critical Care/ethics , Health Care Rationing/ethics , Pneumonia, Viral/epidemiology , Betacoronavirus , COVID-19 , Clinical Decision-Making , Humans , Pandemics/ethics , Practice Guidelines as Topic , SARS-CoV-2 , Societies, MedicalABSTRACT
The discovery of new methods of genetic engineering has revolutionized genetic research and opens up new ways of gene therapies. The molecular tool known as CRISPR/Cas9 in particular allows researchers to alter the human genome with unprecedented precision. This new method is referred to as "genome editing," since the procedure is reminiscent of the correction of a text: "false" letters of the DNA can simply be replaced. Due to the precision and the simple application of this method, the focus is now on a field of application that was previously considered an absolute taboo: germline interventions. Any interference with the human germline causes the corresponding genetic changes to be passed on from generation to generation. The issue is highly controversial, and the arguments for and against interventions are diverse. Their proponents argue that future descendants will thus be freed from serious genetic diseases. Opponents, on the other hand, believe that this path must always remain off limits in order to prevent the conception of "designer children." It is clear that such interventions should not yet take place at the moment: more research is needed in order to allow for a more precise risk-benefit-assessment. In fact, the research community seemed to agree that the techniques are not yet sufficiently developed. However, the rumoured birth of two genetically modified children in China at the end of November 2018 shows that such a consensus either does not exist or, at least, that we cannot trust rely on all researchers acting in accordance with the scientific consensus. This news therefore highlights yet again how urgently we must discuss the issue: it is high time, also given the possibility of rapid improvements in the techniques' safety, to deliberate on the justifiability of germline interventions and to set clear limits. This article is intended to contribute to this debate and to sketch the main arguments
The discovery of new methods of genetic engineering has revolutionized genetic research and opens up new ways of gene therapies. The molecular tool known as CRISPR/Cas9 in particular allows researchers to alter the human genome with unprecedented precision. This new method is referred to as "genome editing," since the procedure is reminiscent of the correction of a text: "false" letters of the DNA can simply be replaced. Due to the precision and the simple application of this method, the focus is now on a field of application that was previously considered an absolute taboo: germline interventions. Any interference with the human germline causes the corresponding genetic changes to be passed on from generation to generation. The issue is highly controversial, and the arguments for and against interventions are diverse. Their proponents argue that future descendants will thus be freed from serious genetic diseases. Opponents, on the other hand, believe that this path must always remain off limits in order to prevent the conception of "designer children." It is clear that such interventions should not yet take place at the moment: more research is needed in order to allow for a more precise risk-benefit-assessment. In fact, the research community seemed to agree that the techniques are not yet sufficiently developed. However, the rumoured birth of two genetically modified children in China at the end of November 2018 shows that such a consensus either does not exist or, at least, that we cannot trust rely on all researchers acting in accordance with the scientific consensus. This news therefore highlights yet again how urgently we must discuss the issue: it is high time, also given the possibility of rapid improvements in the techniques' safety, to deliberate on the justifiability of germline interventions and to set clear limits. This article is intended to contribute to this debate and to sketch the main arguments
Subject(s)
Humans , Germ-Line Mutation/ethics , Gene Editing/ethics , Personhood , Genetic Engineering/legislation & jurisprudence , Value of Life , Genetic Enhancement/legislation & jurisprudence , Ethics, Research , Genetic Diseases, Inborn/geneticsABSTRACT
The establishment and operation of research biobanks are still not regulated by special laws. As a consequence, the acquisition, storage and use of biobank materials and data are only covered by quite general legal regulations. The way in which these rules are to be interpreted in relation to the specific problems of biobanks is rather controversial. The central question revolves around the tense relationship between the right to privacy of the donor and the academic freedom of the researchers. This article gives an overview of the current discussion and suggestions for practice.
Subject(s)
Biological Specimen Banks/legislation & jurisprudence , Biomedical Research/legislation & jurisprudence , Confidentiality/legislation & jurisprudence , Government Regulation , Informed Consent/legislation & jurisprudence , Tissue Donors/legislation & jurisprudence , Freedom , Germany , Humans , Internationality , Tissue and Organ ProcurementABSTRACT
Governance, underlying general ICT (Information and Communication Technology) architecture, and workflow of the Central Research Infrastructure for molecular Pathology (CRIP) are discussed as a model enabling biobank networks to form operational "meta biobanks" whilst respecting the donors' privacy, biobank autonomy and confidentiality, and the researchers' needs for appropriate biospecimens and information, as well as confidentiality. Tailored to these needs, CRIP efficiently accelerates and facilitates research with human biospecimens and data.
Subject(s)
Confidentiality , Tissue Banks/organization & administration , Tissue Donors , Confidentiality/ethics , Humans , Information Services/ethics , Information Services/organization & administration , Tissue Banks/ethics , Tissue Donors/ethics , WorkflowABSTRACT
In transplantation medicine there is neither fair organ allocation per se, nor a specific organ distribution required by the German law. The constitution primarily provides a restrictive framework, and it is the parliamentary legislator's task to fill in the details. Following the principle of division of labour, the involvement of medicine in solution finding is permitted and deemed to be justified. Nevertheless, these basic decisions should have been made by the German legislator in much more detail.
Subject(s)
Organ Transplantation/legislation & jurisprudence , Resource Allocation/legislation & jurisprudence , Germany , Humans , Organ Transplantation/standards , Social JusticeABSTRACT
The German constitution contains no easy answers to the question of whether and under what circumstances an altering of the current embryo protection law might lead to the therapeutic or even reproductive cloning of human beings being allowed. Due to the fact that guiding fundamental research does not exist, the time for a decision has surely not yet come. But should concrete opportunities for therapy based on therapeutic cloning begin to emerge or it become clear that reproductively cloned humans are not genetically disadvantaged when compared with human beings engendered through impregnation (an unrealistic prospect from a present-day perspective), then the legislator himself will have to come to a decision, openly and by taking a balanced account of his social responsibilities. Hiding behind the constitution by, for instance, simply alluding to human dignity will then no longer be an option.
