Challenging misconceptions about clinical ethics support during COVID-19 and beyond: a legal update and future considerations.

The pace of change and, indeed, the sheer number of clinical ethics committees (not to be confused with research ethics committees) has accelerated during the COVID-19 pandemic. Committees were formed to support healthcare professionals and to operationalise, interpret and compensate for gaps in national and professional guidance. But as the role of clinical ethics support becomes more prominent and visible, it becomes ever more important to address gaps in the support structure and misconceptions as to role and remit. The recent case of Great Ormond Street Hospital for Children NHS Foundation Trust v MX, FX and X ([2020] EWHC 1958 (Fam), [21]-[23] and [58]) has highlighted the importance of patient/family representation at clinical ethics committee meetings. The court viewed these meetings as making decisions about such treatment. We argue that this misunderstands the role of ethics support, with treatment decisions remaining with the clinical team and those providing their consent. The considered review by clinical ethics committees of the moral issues surrounding complex treatment decisions is not a matter of determining a single ethical course of action. In this article, we consider current legal understandings of clinical ethics committees, explore current concepts of ethics support and suggest how they may evolve, considering the various mechanisms of the inclusion of patients and their representatives in ethics meetings which is not standard in the UK.

Implementation of Japan's First Clinical Research Regulatory Law: Background, Overview, and Challenges.

In April 2018, Japan's first law regulating clinical research went into effect. The law aimed to strengthen regulations on research integrity and conflicts of interest, which had been limited under existing administrative guidelines; the law also provided stipulations for legal penalties. The scope of the new regulations, however, is limited entirely to studies that evaluate unapproved drugs or the off-label use of approved drugs, and those that receive funding from companies. On the other hand, the law's application brings numerous complications, including the establishment of new review committees, troublesome procedures for transitioning studies that are currently underway, and ambiguities about the scope of what constitutes best efforts. Thus, the change has led to substantial strain and confusion in the field. This paper offers an overview of the law and its background, and discusses its future prospects from the practical standpoint of managing ethics committees and providing research ethics support in the field.

Who Makes Decisions for Incapacitated Patients Who Have No Surrogate or Advance Directive?

Unrepresented patients are those who have no surrogate or advance directive to guide medical decision making for them when they become incapacitated. While there is no perfect solution to the problem of making medical decisions for such vulnerable patients, 3 different approaches are noted in the literature: a physician approach, an ethics committee approach, and a guardianship approach. Recent policies and laws have required an approach that is "tiered" with respect to both who is involved and the gravity of the medical treatment questions at issue. In a general sense, some variant of a tiered approach is likely the best possible solution for jurisdictions and health institutions-both those already with and those without a tiered approach-to the challenging puzzle of treating unrepresented patients.

It is never lawful or ethical to withdraw life-sustaining treatment from patients with prolonged disorders of consciousness.

In English law there is a strong (though rebuttable) presumption that life should be maintained. This article contends that this presumption means that it is always unlawful to withdraw life-sustaining treatment from patients in permanent vegetative state (PVS) and minimally conscious state (MCS), and that the reasons for this being the correct legal analysis mean also that such withdrawal will always be ethically unacceptable. There are two reasons for this conclusion. First, the medical uncertainties inherent in the definition and diagnosis of PVS/MCS are such that, as a matter of medical fact, it can never be established, with the degree of certainty necessary to rebut the presumption, that it is not in the patient's best interest to remain alive. And second (and more controversially and repercussively), that even if permanent unconsciousness can be unequivocally demonstrated, the presumption is not rebutted. This is because there is plainly more to human existence than consciousness (or consciousness the markers of which can ever be demonstrated by medical investigations). It can never be said that the identity of the patient whose best interests are at stake evaporates (so eliminating the legal or ethical subject) when that person ceases to be conscious. Nor can it be said that the best interests of an unconscious person do not mandate continued biological existence. We simply cannot know. That uncertainty is legally conclusive, and (subject to resource allocation questions and views about the relevance of family wishes and the previously expressed wishes of the patient) should be ethically conclusive.

Las múltiples caras de la maternidad subrogada: ¿aceptamos el caos jurídico actual o buscamos una solución? / The multiple faces of surrogacy: do we accept the current legal chaos or do we look for a solution?

En el presente artículo el Profesor Carlos María Romeo Casabona aborda la situación legal en torno a la maternidad subrogada en nuestro país, exponiendo las posiciones encontradas que esta problemática genera en órganos administrativos y judiciales, el desconcierto que ello ha suscitado y su efecto más nocivo, a saber: los ciudadanos/as españoles acuden al extranjero para conseguir descendencia por este medio, inscribiendo a los hijos como propios, en contra y en fraude de ley. En el trabajo se abordan varias de las posiciones sobre este asunto en nuestro país: Sociedad Española de Fertilidad, proposición de ley del Grupo Parlamentario Ciudadanos y el Comité de Bioética de España, del que incluye el autor su propio voto particular en cuanto vocal de este Comité. Para finalizar nos propone como solución dos vías. En primer lugar, asegurar que el marco legal actual sea respetado y en segundo orden, que se reforme nuestra legislación con el fin de admitir el recurso a la maternidad subrogada en algunos casos, pues representa valores también positivos, como la solidaridad y el altruismo

In this paper Professor Carlos María Romeo Casabona addresses the legal situation regarding surrogacy in our country, exposing the conflicting positions that this problem generates in administrative and judicial bodies, the confusion that this has caused and its most harmful effect, namely: Spanish citizens go abroad to obtain offspring by this means, inscribing the children as their own, against and in fraud of law. The work addresses several of the positions on this issue in our country: Spanish Fertility Society, proposed law of the Citizens Parliamentary Group and the Bioethics Committee of Spain, which includes the author his own particular vote as a member of this Committee. Finally, he proposes two ways as a solution. First, to ensure that the current legal framework is respected and secondly, that our legislation be reformed in order to admit the use of surrogate motherhood in some cases, since it also represents positive values, such as solidarity and altruism

Direitos Humanos, patrimônio genético e dados genéticos humanos: crítica à doutrina dos dados genéticos como interesse difuso / Human Rights, genetic heritage and human genetic data: a critical analysis to the doctrine of genetic data as diffuse interest

A proteção jurídica dos dados genéticos é tema fundamental para a reconstrução da teoria dos direitos humanos e dos direitos de personalidade no Estado Democrático de Direito. Os dados genéticos são expressões biológicas da personalidade humana. Logo, não é difícil relacioná-los aos direitos humanos. Mas quem são seus titulares? A tutela destes se dá em razão do «interesse difuso»? Metodologicamente, utilizou-se do modo teórico documental perfazendo uma revisão da literatura concernente ao tema e uma análise investigativa e reflexiva de caráter hermenêutico. Partindo da tensão já demonstrada por Habermas entre faticidade e validade, o discurso dos interesses difusos é esvaziado de validade, porquanto são vinculados a meros fatos, isto é, sua proteção jurídica decorreria da relevância social. O interesse fático, desvinculado da validade normativa do sistema jurídico, preocupa e os direitos humanos, revisitados como direitos subjetivos em uma concepção mais consentânea com a democracia, poderiam lançar o novo caminho para a validade pretendida. As normas jurídicas que contêm interesses aparentemente públicos não podem negligenciar o sistema de direitos humanos. Da mesma forma, normas que contêm interesses aparentemente privados não podem descuidar do entorno social em que se faz contextualizado. Há interdependência entre interesse público e interesse privado, posto que aquele nada mais é do que o resultado dos vários interesses privados. No campo da Moral e do discurso de justificação, a axiologia não pode conceber uma valorização «a priori» do interesse público sobre o interesse privado. No entanto, no discurso de aplicação tal consideração não se faz presente. Não são os dados genéticos interesses difusos. Em verdade, não há espaço para esse discurso na aplicação jurídica. A consideração da juridicidade dos interesses pressupõe a generalização de valores a um número indeterminado de pessoas (universalidade) somada a um aspecto de eficácia, que somente os direitos humanos podem garantir

The legal protection of genetic data is a key area for the reconstruction of the human rights theory in a democratic state. Genetic data may be considered biological expressions of human personalities. Thus, it is not difficult to relate them with human rights. However, ownership of these data has been a polemic issue in past years. Is the protection of genetic data truly based on the «diffuse interest»? The aim of this study was to review the subject from a theoretic-documental perspective, as well as to present an investigative and reflective analysis of hermeneutical character. Based on the tension between facticity and validity, already debated by Habermas, the current discourse of diffuse interests lacks validation and relies on facts, thus, based on its social relevance. The detachment from a normative validation by the legal system is concerning. If we revise the human rights under a more democratic perspective, it would be possible to achieve an effective legal validation of genetic data. The legal parameters that include public interests must not neglect the human rights system. Similarly, rules that contain a seemingly private interest must not ignore the social environment in which it is contextualized. Public and private interests are interdependent. Under a moral perspective, axiology may not value «a priori» the public over the private interest. However, such consideration is challenging. Currently, the genetic data is not diffuse. In fact, currently, there is no room for debates on its legal implementation. The legality of interests presupposes a generalization of values to an undetermined number of people (universality). Only with the aid of human rights may we achieve this legal foundation in an efficient manner

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Impact of regulatory assessment on clinical studies in Brazil / Impacto da avaliação regulatória em estudos clínicos no Brasil

SUMMARY Introduction: Despite the recent expansion of clinical studies allocated to Brazil, the delay of local regulatory deadlines directly impacts their completion. Objective: This article examines the allocation process of clinical studies to Brazil in comparison with other countries, as well as the financial impact of studies not completed due to interruption caused by the delay in the regulatory process. Method: The allocation processes of studies were compared in nine countries with similar stages of economic development and countries in Latin America using the websites http://data.worldbank.org/data-catalog/GDP-rankings-table and http://worldpopulationreview.com and clinicaltrials.gov, comprising 185 countries. The 46 studies sponsored by the pharmaceutical industry underwent an analysis of the regulatory review process. Results: 46 studies sponsored by the industry and submitted in the country between June 2007 and June 2013 were analyzed; 18 (39%) were discontinued due to the delay in obtaining the necessary approvals. For the approved studies, patient recruitment began an average of 11 months after the other countries. It is estimated that 530 Brazilians patients did not have the opportunity to participate in these studies. Financial losses were to the order of 14.6 million dollars for the country, including patient, medication and supplies costs, and expenses. Conclusion: Brazil has enormous potential for the realization of clinical studies. Researchers, associations of disabled people and patients with chronic diseases, sponsors and the authorities must work together to develop an approval process that is efficient, predictable and, most of all, transparent. The current regulatory environment must and can be improved and optimized in order to result in tangible benefits for patients, society and the country’s scientific development.

RESUMO Introdução: apesar da recente expansão de estudos clínicos alocados para o Brasil, a demora dos prazos regulatórios locais impacta diretamente em sua realização. Objetivo: este artigo analisa o processo de alocação de estudos clínicos para o Brasil em comparação a outros países, bem como o impacto financeiro dos estudos não realizados em decorrência da interrupção pela demora no processo regulatório. Método: foram comparados os processos de alocação de estudos em nove países com estágios semelhantes de desenvolvimento econômico e países da América Latina através dos siteshttp://data.worldbank.org/data-catalog/GDP-ranking-table, http://worldpopulationreview.com e clinicaltrials.gov, que engloba 185 países. Os 46 estudos patrocinados pela indústria farmacêutica tiveram o processo de avaliação regulatória analisado. Resultados: foram analisados 46 estudos patrocinados pela indústria submetidos no país entre junho de 2007 e junho de 2013; 18 (39%) foram descontinuados pelo atraso na obtenção das aprovações necessárias. Para os estudos aprovados, o recrutamento de pacientes começou, em média, aos 11 meses após os demais países. Estima-se que 530 pacientes brasileiros não tiveram a oportunidade de participar desses estudos. As perdas financeiras foram da ordem de 14,6 milhões de dólares para o país, incluindo custos com paciente, medicação, suprimentos e despesas administrativas. Conclusão: o Brasil tem um enorme potencial para a realização de estudos clínicos. Investigadores, associações de deficientes e pacientes portadores de doenças crônicas, patrocinadores e autoridades devem trabalhar juntos para desenvolver um processo de aprovação eficiente, previsível e antes de tudo transparente. O atual ambiente regulatório deve e pode ser melhorado e aperfeiçoado, caso contrário não resultará em benefícios tangíveis para o paciente, para a sociedade e a evolução médico-científica do país.

Impact of regulatory assessment on clinical studies in Brazil.

INTRODUCTION: Despite the recent expansion of clinical studies allocated to Brazil, the delay of local regulatory deadlines directly impacts their completion. OBJECTIVE: This article examines the allocation process of clinical studies to Brazil in comparison with other countries, as well as the financial impact of studies not completed due to interruption caused by the delay in the regulatory process. METHOD: The allocation processes of studies were compared in nine countries with similar stages of economic development and countries in Latin America using the websites http://data.worldbank.org/data-catalog/GDP-rankings-table and http://worldpopulationreview.com and clinicaltrials.gov, comprising 185 countries. The 46 studies sponsored by the pharmaceutical industry underwent an analysis of the regulatory review process. RESULTS: 46 studies sponsored by the industry and submitted in the country between June 2007 and June 2013 were analyzed; 18 (39%) were discontinued due to the delay in obtaining the necessary approvals. For the approved studies, patient recruitment began an average of 11 months after the other countries. It is estimated that 530 Brazilians patients did not have the opportunity to participate in these studies. Financial losses were to the order of 14.6 million dollars for the country, including patient, medication and supplies costs, and expenses. CONCLUSION: Brazil has enormous potential for the realization of clinical studies. Researchers, associations of disabled people and patients with chronic diseases, sponsors and the authorities must work together to develop an approval process that is efficient, predictable and, most of all, transparent. The current regulatory environment must and can be improved and optimized in order to result in tangible benefits for patients, society and the country's scientific development.

Aspectos éticos y legales relativos al tratamiento de muestras biológicas humanas en ensayos clínicos con medicamentos. Propuesta de criterios de evaluación para los Comités Éticos de Investigación Clínica / Ethical and legal aspects related to the management of human biological samples in clinical trials. Proposal of evaluation criteria for clinical research ethics committees

La Ley 14/2007 de Investigación Biomédica incluyó algunas referencias a los ensayos clínicos que provocaron ciertas dudas en relación con su aplicación en este contexto. Estas dudas no han quedado resueltas de manera definitiva con la publicación del Real Decreto 1716/2011. No quedan determinados los procedimientos o condiciones específicas en este ámbito para la transferencia de muestras a otros países o para la recepción y utilización en centros españoles de muestras obtenidas en el extranjero. Tampoco se han establecido las condiciones para la solicitud de muestras biológicas para investigaciones futuras después de la finalización de un ensayo. Los comités éticos de investigación clínica se enfrentan con incertidumbre a situaciones complejas en su tarea de evaluación de los ensayos clínicos, que incluye la valoración de las condiciones de utilización de muestras biológicas. El objetivo de este trabajo es proponer una interpretación sistemática de la normativa aplicable a la utilización de muestras biológicas en el contexto de los ensayos clínicos con medicamentos (AU)

The Spanish biomedical research Law 14/2007 contains some references that raised some doubts with regard to its application in clinical trials. These doubts have not been definitely resolved with the publication of Royal Decree 1716/2011. There are no established procedures or specific conditions for the transfer of biological samples between Spain and other countries or the use of samples from other countries in clinical trials in Spanish centers. There are also no established conditions for the use of biological samples or for the request of biological samples for future investigations within clinical trials. Clinical research ethics committees face complex situations with uncertainty in their task of assessing clinical trials, including the evaluation of the conditions of use of biological samples. The aim of this paper is to propose a systematic interpretation of the applicable regulations for the use of biological samples in the execution of drug clinical trials (AU)

What is the role of ethics committees after Regulation (EU) 536/2014?

EU Regulation 536/2014 stipulates that when assessing applications for authorisation to conduct clinical trials, Member States should formulate a 'single decision'. This raises the problem of identifying: (1) the facility designated to express this 'single decision' and (2) the role of ethics committees in the decision-making process. The article addresses the consequences of the requirement that for each Member State the assessment of an application for approval to conduct a trial must take the form of a 'single decision' by the Member State concerned. Three possible approaches to the procedures for expressing that 'single decision' and to the role of ethics committees in the decision-making process are described, one of which is indicated as the preferred option.

The European "clinical trial" regulation; relationship with the Jardé Act: a Giens workshop.

In May 2014, the European Union Parliament and Council published a new regulation on clinical trials on medicinal products for human use, which is designed to replace Directive 2001/20/EC. It will not come into effect until 2016. Nevertheless, it is essential to examine its relationship with national legislation, i.e. the Jardé Act, whose implementation has been delayed pending publication of the European regulation. The Giens workshop identified and examined the various issues that this relationship is bound to raise. In particular, it looked at trial methodology assessment procedures, the working relationship between the French National Agency of Drug Safety and Health Products (Agence Nationale de Sécurité du Médicament et des Produits de Santé, ANSM) and ethics committees during the authorization application evaluation phase, review of post-authorization/registration studies on medicinal products and medical devices, and data transparency.

Aspectos éticos en Investigación Clínica / Ethical Issues in Clinical Reearh

En este trabajo se tratan los aspectos éticos más importantes relacionados con la investigación en humanos. En primer lugar, se diferencia entre práctica clínica e investigación clínica. Se refieren los tres principios éticos aplicables a la investigación en humanos: autonomía, beneficencia y justicia; se presenta el papel del Comité ético de Investigación Clínica como salvaguarda en la investigación en humanos. En segundo lugar, se presentan las principales características de la Hoja de Información al Paciente y de la Hoja de Firma del Consentimiento Informado. Finalmente, se comenta brevemente la Declaración de Helsinki

In this article the most important ethical issues surrounding human research are discussed. First, the difference between clinical research and clinical practice. The three ethical principles governing research on human studies: autonomy, beneficence and justice; the role of the ethics committee for clinical research as a safeguard in human research is presented. Second, the main characteristics of the participant informed consent, and patient information sheet. Finally, we briefly discuss Helsinki declaration

[Implementation of clinical ethics consultation in German hospitals]. / Wird Klinische Ethikberatung in Krankenhäusern in Deutschland implementiert?

BACKGROUND: There have been different initiatives for the implementation of clinical ethics consultation during the past years. The present study surveys current data. METHODS: A structured questionnaire was used. Of the 1,858 contacted hospitals throughout Germany 550 answered to that questionnaire (return rate 29,6 %). The survey took place between September 2013 and January 2014. RESULTS: The clinical ethics committee is the mostly implemented structure of clinical ethics consultation. Recommendations to implement those structures (ZEKO 2006, AEM 2010) show less influence than the legally binding standard (HKHG 2011). Structures of clinical ethics consultation are respected as instrument to solving ethical conflicts in clinical routines. CONCLUSIONS: Establishing ethics consultation should be promoted. Preferably appropriate legal rules for the implementation of clinical ethics consultation should be developed further as well as their structural framing.

Some comments on the new regulations governing ethics committees in Italy.

Italy has recently introduced regulations that profoundly change the arrangement of ethics committees. Specifically, their numbers have been reduced from more than 200 to a few dozen.The decree defining the criteria for their composition and functioning includes regulations intended to improve efficiency and efficacy. The present article provides a brief overview of the new provisions and identifies some critical aspects.

Comités éticos: perfil de los miembros no sanitarios de los comités éticos de investigación clínica y comités de ética asistencial de Cataluña / Profile of lay members of ethics committees in Catalonia (Spain)

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European Medicines Agency, CAT Secretariat & US Food and Drug Administration.

The European Medicines Agency (EMA) and the Committee for Advanced Therapies (CAT) are responsible for reviewing applications for marketing authorization for Advanced Therapy Medicinal Products (ATMP), which include (stem) cell-based medicines, for the ATMP classification and certification procedure, and to provide scientific advice to developers of ATMPs. The CAT, an expert committee dedicated to ATMPs, was established by the Regulation (EC) No 1394/2007 on Advanced Therapies. The CAT came into operation in January 2009. ATMPs are defined in this Regulation as gene therapy and cell therapy medicinal products, and tissue-engineered products. The US FDA's Center for Biologics Evaluation and Research is responsible for ensuring the safety, purity, potency and effectiveness of many biologically derived products, including blood intended for transfusion, blood components and derivatives, vaccines and allergenic extracts, and cell, tissue and gene therapy products for the prevention, diagnosis and treatment of human diseases, conditions or injury. Human cells or tissue intended for implantation, transplantation, infusion or transfer into a human recipient are regulated as human cells, tissues, and cellular and tissue-based products (HCT/Ps).