Australian human research ethics committee members' confidence in reviewing genomic research applications.

Human research ethics committees (HRECs) are evaluating increasing quantities of genomic research applications with complex ethical considerations. Genomic confidence is reportedly low amongst many non-genetics-experts; however, no studies have evaluated genomic confidence levels in HREC members specifically. This study used online surveys to explore genomic confidence levels, predictors of confidence, and genomics resource needs of members from 185 HRECs across Australia. Surveys were fully or partially completed by 145 members. All reported having postgraduate 94 (86%) and/or bachelor 15 (14%) degrees. Participants consisted mainly of researchers (n = 45, 33%) and lay members (n = 41, 30%), affiliated with either public health services (n = 73, 51%) or public universities (n = 31, 22%). Over half had served their HREC [Formula: see text]3 years. Fifty (44%) reviewed genomic studies [Formula: see text]3 times annually. Seventy (60%) had undertaken some form of genomic education. While most (94/103, 91%) had high genomic literacy based on familiarity with genomic terms, average genomic confidence scores (GCS) were moderate (5.7/10, n = 119). Simple linear regression showed that GCS was positively associated with years of HREC service, frequency of reviewing genomic applications, undertaking self-reported genomic education, and familiarity with genomic terms (p < 0.05 for all). Conversely, lay members and/or those relying on others when reviewing genomic studies had lower GCSs (p < 0.05 for both). Most members (n = 83, 76%) agreed further resources would be valuable when reviewing genomic research applications, and online courses and printed materials were preferred. In conclusion, even well-educated HREC members familiar with genomic terms lack genomic confidence, which could be enhanced with additional genomic education and/or resources.

Declaración de conflictos de interés y revisión por comités de ética en publicaciones con sede en el norte de Perú / No disponible

No disponible

¿Modificar o no modificar el genoma de nuestra descendencia? Algunos comentarios a raiz de la Declaración del Comité de Bioética de España sobre la edición genómica en humanos / To modify or not to modify the genome of our offspring? Some comments following the Declaration of the Spanish Bioethics Committee on genomic editing in humans / Modificar o no modificar el genoma de la nostra descendència?. Alguns comentaris arran de la Declaració del Comitè de Bioètica d'Espanya sobre l'edició genòmica en humans

La modificación genética de la línea germinal humana presenta grandes problemas de carácter ético y jurídico. El Comité de Bioética de España ha publicado una Declaración ofreciendo una respuesta a estos retos. Este artículo analiza críticamente su postura, subrayando la escasa consistencia de cualquier argumento que pretenda censurar cualquier forma de mejora en la salud humana. Con tal fin, se exponen cuestiones como la relación entre dignidad humana y modificación genética o la inconsistencia de la apelación al argumento de la pendiente resbaladiza en este contexto. Asimismo, se afirma la necesidad de trazar distinciones entre las intervenciones que afectan a bienes absolutos, como la salud, y los que no lo son

Genetic modification of the human germline presents major ethical and legal problems. The Spanish Bioethics Committee has published a Declaration offering a response to these challenges. This article critically analyzes its position, underlining the scarce consistency of any argument that attempts to censor any form of improvement in human health. To this end, questions such as the relationship between human dignity and genetic modification or the inconsistency of the appeal to the argument of the slippery slope in this context are raised. At the same time, this paper highlights the need to draw distinctions between interventions that affect absolute goods, such as health, and those that are not

La modificació genètica de la línia germinal humana presenta enormes problemes de caràcter ètic i jurídic. El Comitè de Bioètica d'Espanya ha publicat una Declaració oferint una resposta a aquests reptes. Aquest article analitza críticament la seva postura, subratllant l'escassa consistència de qualsevol argument que pretengui censurar qualsevol forma de millora en la salut humana. Amb tal fi, s'exposen qüestions com la relació entre dignitat humana i modificació genètica o la inconsistència de l'apel·lació a l'argument del pendent relliscós en aquest context. Així mateix, s'afirma la necessitat de traçar distincions entre les intervencions que afecten béns absoluts, com la salut, i els que no ho són

Manejo nutricional de la demencia avanzada: resumen de recomendaciones del Grupo de Trabajo de Ética de la SENPE / Nutritional management of advanced dementia: summary of recommendations of the SENPE Ethic Group

No disponible

Institutional Ethics Committees.

In hospitals throughout the United States, institutional ethics committees (IECs) have become a standard vehicle for the education of health professionals about biomedical ethics, for the drafting and review of hospital policy, and for clinical ethics case consultation. In addition, there is increasing interest in a role for the IEC in organizational ethics. Recommendations are made about the membership and structure of an IEC, and guidance is provided for those serving on an IEC.

Declaración sobre: Ética y Responsabilidad en la Sostenibilidad del Sistema Nacional de Salud / Declaration on ethics and responsibility in the sustainability of the Spanish National Heatlh System

Representantes de Comités de Bioética autonómicos y del Comité de Bioética de España reunidos en Zaragoza con fecha de 16 de noviembre de 2016 elaboraron una declaración para contribuir a la reflexión pública sobre la sostenibilidad del Sistema Nacional de Salud a partir de los valores éticos que deben impulsar la responsabilidad de todos los agentes implicados en su desarrollo. Manteniéndose la vigencia de las circunstancias concurrentes en su redacción inicial, la reunión de la "Red de Consejos, Comisiones y Comités autonómicos de Bioética y del Comité de Bioética de España" (REDECABE) celebrada en Logroño el día 26 de octubre de 2018 ratificó su plena vigencia como herramienta para la sostenibilidad del Sistema Nacional de Salud, instando su máxima difusión tanto en lengua española como inglesa

Representatives from Autonomous Communities' Bioethics Committees and the National Bioethics Committee met in Zaragoza on 16 November 2016 to draft a joint statement to contribute to publicly reflecting upon the sustainable nature of the National Health System, taking into consideration the ethical values that should promote the responsibility of all actors involved in their development. Since circumstances of the first draft remain, the meeting of the Network of Bioethics Councils, Commissions and Committees of Autonomous Regions (REDCABE), held Logroño on 26 October 2018, ratified the full validity of the declaration as a tool for sustainability of the National Health System, aiming for its dissemination in as many fields as possible, both in Spanish and English language

Content review of pediatric ethics consultations at a cancer center.

BACKGROUND/OBJECTIVES: Ethical challenges in pediatric oncology arise at every stage of illness. However, there are sparse data on the content of and reason for ethics consultations in the field. We sought to evaluate the content and characteristics of ethics consultations in pediatric patients at a cancer center. DESIGN/METHODS: We retrospectively identified ethics consultations performed for patients diagnosed with cancer at ≤21 years of age who were treated in the Department of Pediatrics from 2007 to 2017. Using an established coding schema, two independent reviewers analyzed the content of ethics consultation notes and identified core ethical issues and relevant contextual issues. Demographic, clinical, and consultation-specific data were also collected. RESULTS: Thirty-five consultations were performed for 32 unique patients. The most commonly identified ethical issues were obligation to provide nonbeneficial treatment (29%) and resuscitation preferences (26%). Communication conflicts were the most commonly identified contextual issue (40%). There were two themes that emerged repeatedly but were not a part of the original coding schema-four consultations (11%) that involved physicians questioning their obligation to provide potentially toxic treatment in the setting of poor patient/parent compliance, and two consultations (6%) related to complex risk-benefit analysis in the setting of an invasive procedure with uncertain benefit. CONCLUSIONS: Pediatric ethics consultations are infrequent at this specialty cancer hospital. Ethical issues focused on treatment and end-of-life care and included a diversity of communication conflicts.

Instrumento de Marcação de Abdominoplastia / Abdominoplasty Marking Instrument

Introdução: A abdominoplastia, um dos procedimentos de cirurgia plástica mais comuns no Brasil, ficou em quarto lugar no ranking mundial, segundo dados da International Society of Aesthetic Plastic Surgery. Diversas técnicas cirúrgicas visam restaurar o contorno abdominal. A indicação da técnica utilizada deve visar a melhoria da deformidade individual presente no abdome. A marcação da abdominoplastia se faz por meio de régua, transferidor, compasso, fio de náilon, palito, canetas e/ou azul de metileno, de acordo com a preferência do cirurgião. O objetivo é produzir um instrumento cirúrgico com a finalidade de otimizar o tempo de marcação no procedimento de abdominoplastia. Métodos: O estudo foi aprovado pelo Comitê de Ética em Pesquisa, foram desenvolvidos desenhos gráficos para identificar cada uma das partes do instrumento, foi realizada a busca de anterioridade e, posteriormente, realizado o pedido de patente. Resultados: Foi desenvolvido um instrumento para marcação da abdominoplastia, que configura uma régua horizontal que recepciona uma régua vertical no seu ponto médio e duas réguas pivotantes com transferidor basal, todas essas peças milimetradas e com vazado central, que permitem o risco nessa região com o azul de metileno ou caneta afim e, por conseguinte, a marcação do procedimento de abdominoplastia. Além disso, também funciona como compasso e de cujas laterais derivam réguas pivotantes com transferidor de grau basal. Conclusão: O instrumento desse estudo foi criado para minimizar a quantidade de material utilizado e otimizar o tempo da marcação da abdominoplastia.

Introduction: Data from the International Society of Aesthetic Plastic Surgery indicate that abdominoplasty is the fourth most common plastic surgery performed worldwide. Several surgical techniques aim to restore the abdominal contour. The indication for the technique used should aim to improve any individual deformity present in the abdomen. Abdominoplasty marking is done using a ruler, protractor, compass, nylon thread, toothpick, pen, and/or methylene blue, according to the surgeon's preference. Here we aimed to produce a surgical instrument that optimizes the abdominoplasty marking procedure. Methods: The study was approved by the ethics research committee. Graphic designs were developed to identify each part of the instrument, a precedence search was performed, and a patent application was requested. Results: We developed an abdominoplasty marking instrument consisting of a horizontal ruler that receives a vertical ruler at its midpoint, two pivotal rulers with a basal protractor, all marked in millimeters, and a central area that allows marking in this region with methylene blue or a pen. Moreover, it acts as a compass and features side pivotal rulers derived from a basal grade protractor. Conclusion: The instrument developed in this study was designed to minimize the amount of material used and optimize abdominoplasty marking time.

Ethical obligations in fertility treatment when intimate partners withhold information from each other: an Ethics Committee opinion.

Clinicians should encourage disclosure between intimate partners but must maintain confidentiality in cases where there is no prospect of harm to the partner and/or offspring. In cases where one member of a couple refuses to disclose relevant health information to the other partner and there exists a risk of harm to the unaware partner and/or offspring, clinicians may refuse to offer care and should decline to treat if full informed consent is not possible due to lack of disclosure.

Disclosure of sex when incidentally revealed as part of preimplantation genetic testing (PGT): an Ethics Committee opinion.

Clinics may develop a policy to disallow selecting which embryos to transfer based on sex and choose to use only embryo quality as selection criteria. Clinics may also develop a policy to use randomization to select those embryos for transfer if more embryos suitable for transfer are available than can be transferred.

Fertility preservation and reproduction in patients facing gonadotoxic therapies: an Ethics Committee opinion.

Chemotherapy and radiation therapy often result in reduced fertility. Patients receiving gonadotoxic treatment should be informed of options for fertility preservation and future reproduction prior to such treatment. Reproduction in the context of cancer also raises a number of ethical issues related to the welfare of both patients and offspring. This document replaces the document titled, "Fertility preservation and reproduction in patients facing goandotoxic therapies," last published in 2013.

Child-rearing ability and the provision of fertility services: an Ethics Committee opinion.

Fertility programs may withhold services from prospective patients on the basis of well-grounded reasons that those patients will be unable to provide minimally adequate or safe care for offspring. This document was reviewed and updated; this version replaces the previous version of this document, last published July 2013 (Fertil Steril 2013;100:50-53).

EsPRit: ethics committee proposals for Long Term Medical Data Registries in rapidly evolving research fields - a future-proof best practice approach.

BACKGROUND: Long-term data collection is a challenging task in the domain of medical research. Many effects in medicine require long periods of time to become traceable e.g. the development of secondary malignancies based on a given radiotherapeutic treatment of the primary disease. Nevertheless, long-term studies often suffer from an initial lack of available information, thus disallowing a standardized approach for their approval by the ethics committee. This is due to several factors, such as the lack of existing case report forms or an explorative research approach in which data elements may change over time. In connection with current medical research and the ongoing digitalization in medicine, Long Term Medical Data Registries (MDR-LT) have become an important means of collecting and analyzing study data. As with any clinical study, ethical aspects must be taken into account when setting up such registries. This work addresses the problem of creating a valid, high-quality ethics committee proposal for medical registries by suggesting groups of tasks (building blocks), information sources and appropriate methods for collecting and analyzing the information, as well as a process model to compile an ethics committee proposal (EsPRit). METHODS: To derive the building blocks and associated methods software and requirements engineering approaches were utilized. Furthermore, a process-oriented approach was chosen, as information required in the creating process of ethics committee proposals remain unknown in the beginning of planning an MDR-LT. Here, we derived the needed steps from medical product certification. This was done as the medical product certification itself also communicates a process-oriented approach rather than merely focusing on content. A proposal was created for validation and inspection of applicability by using the proposed building blocks. The proposed best practice was tested and refined within SEMPER (Secondary Malignoma - Prospective Evaluation of the Radiotherapeutics dose distribution as the cause for induction) as a case study. RESULTS: The proposed building blocks cover the topics of "Context Analysis", "Requirements Analysis", "Requirements Validation", "Electronic Case Report (eCRF) Design" and "Overall Concept Creation". Additional methods are attached with regards to each topic. The goals of each block can be met by applying those methods. The proposed methods are proven methods as applied in e.g. existing Medical Data Registry projects, as well as in software or requirements engineering. CONCLUSION: Several building blocks and attached methods could be identified in the creation of a generic ethics committee proposal. Hence, an Ethics Committee can make informed decisions on the suggested study via said blocks, using the suggested methods such as "Defining Clinical Questions" within the Context Analysis. The study creators have to confirm that they adhere to the proposed procedure within the ethic proposal statement. Additional existing Medical Data Registry projects can be compared to EsPRit for conformity to the proposed procedure. This allows for the identification of gaps, which can lead to amendments requested by the ethics committee.

La enfermera en los comités de ética / Nurse's role in ethics committees

Objetivo. El presente artículo pretende identificar cuál es el rol atribuido a la enfermera en los comités de ética y reflexionar sobre el desempeño de su labor en estos. Método. Búsqueda y revisión bibliográfica de la literatura científica tomando como base los descriptores o palabras claves: «enfermería», «comités de ética», «ética enfermera». Las bases de datos utilizadas fueron: Medline vía PubMed, Cochrane Library, CINAHL y Cuiden Plus, incluidas en la base de datos de la Biblioteca Virtual del Sistema Sanitario Público de Andalucía (BV-SSPA). La búsqueda se realizó en idioma español e inglés. Resultados. Se recogieron los artículos más destacados relacionados con los descriptores y se identificaron aquellos que relacionan el papel de la enfermera en los comités y su aportación desde el punto de vista bioético. Conclusiones. Resulta imprescindible, para las enfermeras de los comités de ética, el que asuman el desarrollo de los conocimientos (función educativa), habilidades y actitudes que les permitan profundizar en los dilemas éticos para dar una respuesta adecuada a cada caso clínico. Las enfermeras realizan ese papel de consultores (función consultiva) de casos de difícil resolución para ayudar y apoyar la toma de decisiones, por lo que su formación en estos temas resulta necesaria. Los miembros de los comités de ética deben realizar una labor asistencial basada en la calidad y en el respeto por los principios de la bioética. Su futuro va unido al de las enfermeras como pilares básicos de la ética de los cuidados (AU)

Objective. This article aims to identify the role attributed to nurses in Ethics Committees and reflect on the performance discharging their duties within them. Method. Scientific literature search and review based on the following descriptors or keywords: nursing, ethics committees, and nursing ethics. Databases searched were: Medline via PubMed, Cochrane Library, CINAHL and Cuiden Plus, included in the Virtual Library of Andalusia’s Public Health System (BV-SSPA) database. The search was conducted in Spanish and English. Results. The most important items related to the descriptors were collected, identifying those related to the role of nurses in ethics committees and their contribution from a bioethical perspective. Conclusions. It is essential for nurses in ethics committees to undertake the development of knowledge (educational function), skills and attitudes that enable them to deepen in ethical dilemmas and provide adequate responses in every clinical case. In cases which are difficult to resolve, nurses act as consultants (advisory role), helping and supporting decision making. Therefore, their training on these issues is essential. Members of Ethics Committees should provide welfare-promoting healthcare, based on quality and respect for the principles of bioethics. Their success is linked to the future role of nurses as basic pillars in the ethics of care (AU)

[The impact of the EU Regulation 536/2014 on the tasks and functioning of ethics committees in Germany]. / Die EU-Verordnung 536/2014 und ihr Einfluss auf die Aufgaben und Arbeitsweisen der Ethikkommissionen in Deutschland.

The EU Clinical Trial Regulation 536/2014 (CTR) and its implementation in Germany led to substantial changes of the established, well-accepted and effective system of reviewing clinical trial applications by ethics committees (ECs), which impair their independence. For the first time, the German federal legislator specified in detail the composition, functioning, tasks and responsibilities of ECs. ECs have to be registered with the federal drug authority BfArM and if an EC does not perform properly the registration can be withdrawn. In addition, the drug authorities may override the negative opinion expressed by an EC. The ECs will also lose their financial autonomy as the fees will be fixed by the federal government. The tasks and responsibilities of the ECs remain almost entirely unchanged, however. The ECs remain involved in the assessment of both parts of the application dossier. Part I is assessed together with the drug authorities, the drug authorities having the lead. The assessment of part II remains the sole responsibility of the EC. As the deadlines for the assessment became rather short, in particular for multinational trials, and the communication with the sponsor will be in writing only, the established procedures of ECs have to be modified. Up to now it was common to verbally discuss problematic issues with the sponsor. The CTR is focused on written communication with the sponsor via the EU portal. ECs, their office staff and chairpersons will need considerable professionalism and respective training. The future workflow requires substantial IT support. The ECs and the Association of Medical Ethics Committees in Germany will do their utmost to protect efficiently the research subjects and to promote Germany as a major destination for clinical research.

Ethical Principles, Process, and the Work of Bioethics Commissions.

Shortly after the Presidential Commission for the Study of Bioethical Issues was constituted in 2010 and days before the commission members were to join a conference call to discuss possible topics for their deliberation, Craig Venter held a press conference announcing that his lab had created a synthetic chromosome for a species of mycoplasma and had inserted this genetic material into organisms of another species of mycoplasma (the genes of which had been deactivated), transforming the host species into the donor species. While not overtly claiming to have "created life in the test tube," Venter's publicity seemed cleverly designed to provoke the media into reporting his discovery in just that way. The resulting uproar caused President Obama to give his new bioethics commission the assignment of investigating the ethics of the emerging field of synthetic biology. The commission went right to work. It formed working groups to deliberate about parts of the report, feeding ideas and language to the staff members who would do the actual writing, and then present the working group suggestions to the commission as a whole for public deliberation at open meetings. One of those working groups was charged with coming up with ethical principles that would guide the analysis. Having served as a member of that working group, I report here on the process by which these principles emerged and reflect upon the suitability of that process for the work of public bioethics commissions.

Avances y retos de las Comisiones Estatales de Bioética en México / State Bioethics Commissions in Mexico, Achievements and Challenges

Se han realizado estudios comparativos sobre comisiones nacionales de bioética, comités hospitalarios de bioética y de ética en investigación de diversos países; sin embargo existen pocos datos sobre la aplicación de la bioética a nivel subnacional. Este trabajo ofrece una aproximación a la evolución de las Comisiones Estatales de Bioética en México, se identifican como actividades de su quehacer acciones de capacitación, difusión, asesoría y promoción de la bioética en la atención médica y la vinculación con la Comisión Nacional de Bioética y otras instituciones de salud y educativas. Las Comisiones Estatales ayudan a fomentar la bioética a nivel subnacional y a extender la atención integral en situaciones complejas en el ámbito médico e investigativo (AU)

Comparative studies have been developed on the infrastructure on bioethics of different countries, comprised mainly by national commissions, hospital bioethics and research ethics committees; however, there are few data on the application of bioethics at the subnational level. This work offers an approximation to the evolution of the State Commissions of Bioethics in Mexico and accounts for their work in outreach, education, and counseling, as well as entrenching a culture of bioethics in medical care and networking with the National Bioethics Commission and other health and educational institutions. State Commissions help to promote bioethics at the subnational level and to foster comprehensive care in complex medical and research settings (AU)