Will medically-assisted suicide mean the rebirth of (clinical) ethics committees in Italy?

The Italian Constitutional Court has held that, in certain specific circumstances, prosecution for assisted suicide, regulated by Article 580 of the Criminal Code, is not compatible with the Constitution. The circumstances in question relate to individuals who are being kept alive by life-sustaining treatments, who are fully capable of taking free, informed decisions and are suffering from irreversible conditions that are a source of intolerable physical or mental suffering. The Court has held that the Ethics Committees must assess a request for assisted suicide made by an individual meeting these conditions. The decision requires the identification of the Ethics Committee authorised to issue authorisation in such cases and a guarantee that these Ethics Committees are able to deal with this type of issue. The Court's decision is an important opportunity to establish and promote clinical Ethics Committees, which are not nationally regulated in Italy and exist in very small numbers in only a few parts of the country.

Investigación clínica a pie de cama. Sepsis / Clinical research at the bedside. Sepsis / Recerca clínica a peu de llit. Sèpsia

La investigación clínica en sepsis es una prioridad y una obligación cuyo objetivo primordial ha de ser tanto el conocimiento de su compleja fisiopatología como la búsqueda de herramientas diagnósticas precoces y eficaces para mejorar el tratamiento y disminuir la tasa de mortalidad. Los principios éticos de la investigación biomédica ayudan a determinar el equilibrio entre el avance de la ciencia y la protección de los derechos y bienestar de los sujetos de la investigación

Clinical research in sepsis is a priority and an obligation whose primary objective must be both knowledge of its complex pathophysiology and the search for early and effective diagnostic tools to improve treatment and reduce the mortality rate. The ethical principles of biomedical research help to determine the balance between the advancement of science and the protection of the rights and welfare of research subjects

La recerca clínica en la sèpsia és una prioritat I una obligació l'objectiu primordial de la qual ha de ser tant el coneixement de la seva complexa fisiopatología, com la cerca d'eines diagnòstiques precoces I eficaces per a millorar-ne el tractament I disminuir la taxa de mortalitat. Els principis ètics de la recerca biomèdica ajuden a determinar l'equilibri entre l'avanç de la ciència I la protecció dels drets I benestar dels subjectes de la recerca

Preserving Do No Harm: Supreme Court Tosses Challenge to Medical Ethics Committee Law.

Twenty years after it took effect, Texas' medical ethics committee review law has withstood challenge after challenge. The Texas Supreme Court is on the verge of ending the latest high-profile attack on the law that ensures physicians can uphold their professional obligation to "do no harm." In October 2019, the state's high court declined to take up Kelly v. Houston Methodist Hospital, in which the mother of a deceased patient attempted to overturn a provision of the Texas Advance Directives Act. Justices' action leaves intact an appeals court decision that preserves physicians' ability to use their medical judgment in end-of-life cases.

Ethics committee registration and re-registration with the regulatory authority in India.

Background: All ethics committees (ECs) that review and monitor clinical trials in India must be registered with the regulatory authority. We ascertained the status of registration and re-registration of ECs till December 2017. Methods: The ECs registered and re-registered with the Indian regulatory authority till December 2017 were extracted. The status of ECs was analysed according to the state, institute category and registration. Results: A total of 1260 ECs were registered, of which 14% were based in medical colleges, 2% in dental colleges, 61.2% in hospitals other than medical colleges and 8% as independent ECs. Of the recognized medical and dental colleges, only 37.3% and 10.9%, respectively, and 45.9% of ECs from teaching hospitals (other than medical and dental colleges) had registered with the regulatory authority. Of the 911 ECs eligible for re-registration, 516 (56.5%) had reregistered. Conclusion: A low proportion of registrations ofECs from eligible academic health institutions raises concern about adherence to regulatory guidelines and conduct of clinical trials in India. The lower re-registration of ECs helps in the identification of factors which should be addressed to facilitate clinical research in India.

Misconduct in third-party assisted reproduction: an Ethics Committee opinion.

Professionals who discover misconduct or other undisclosed information that would be material to the participation of another party (such as a donor, gestational carrier, intended parent, or lawyer) in an assisted reproductive technology arrangement should encourage disclosure to that party. In some instances, it is ethically permissible for the physician either to disclose material information to the affected party or to decline to provide care. In all cases involving the legal status or rights of the parties, referral to legal professionals is advised. This document replaces the document of the same name, last published in 2014 (Fertil Steril 2014;101:38-42).

Consideration of the gestational carrier: an Ethics Committee opinion.

Intended parents engage with gestational carriers in an attempt to achieve their personal reproductive goals. All gestational carriers have a right to be fully informed of the risks as well as the contractual and legal aspects of the gestational-carrier process. Gestational carriers have autonomy in making their own decisions regarding medical care and should be free from undue influences by the stakeholders involved. They should have free access to and receive psychological evaluation and counseling before, during, and after participating. Gestational carriers require independent legal counsel regarding the execution of contracts. This document replaces the document of the same name, last published in 2013 (Fertil Steril 2013;99:1838-1841).

Threats to bioethical principles in medical practice in Brazil: new medical ethics code period.

We aimed to outline the profile of medical professionals in Brazil who have violated the deontological norms set forth in the ethics code of the profession, and whose cases were judged by the higher tribunal for medical ethics between 2010 and 2016. This survey was conducted using a database formed from professional ethics cases extracted from the plenary of the medical ethics tribunal of the Federal Council of Medicine. These were disciplinary ethics cases that were judged at appeal level between 2010 and 2016. Most of these professionals were male (88.5%) and their mean age was 59.9 years (SD=11.62) on the date of judgment of their appeals, ranging from 28 to 95 years. Most of them were based in the southeastern region of Brazil (50.89%). Articles 1 and 18 of the medical ethics code were the rules most frequently violated. The sentence given most often was the cancellation of their professional license (37.6%) and the acts most often sentenced involved malpractice, imprudence, and negligence (18.49%). It is acknowledged that concern for the principles of bioethics was present in the appeal decisions made by the plenary of the medical ethics tribunal of the Federal Council of Medicine.

Threats to bioethical principles in medical practice in Brazil: new medical ethics code period

We aimed to outline the profile of medical professionals in Brazil who have violated the deontological norms set forth in the ethics code of the profession, and whose cases were judged by the higher tribunal for medical ethics between 2010 and 2016. This survey was conducted using a database formed from professional ethics cases extracted from the plenary of the medical ethics tribunal of the Federal Council of Medicine. These were disciplinary ethics cases that were judged at appeal level between 2010 and 2016. Most of these professionals were male (88.5%) and their mean age was 59.9 years (SD=11.62) on the date of judgment of their appeals, ranging from 28 to 95 years. Most of them were based in the southeastern region of Brazil (50.89%). Articles 1 and 18 of the medical ethics code were the rules most frequently violated. The sentence given most often was the cancellation of their professional license (37.6%) and the acts most often sentenced involved malpractice, imprudence, and negligence (18.49%). It is acknowledged that concern for the principles of bioethics was present in the appeal decisions made by the plenary of the medical ethics tribunal of the Federal Council of Medicine.

Manual de procedimientos del Comité de Ética de la Investigación en una institución hospitalaria: una propuesta indispensable / Procedures manual from the Ethics Committee of Investigation in a hospital institution: an indispensable proposal

Los comités de ética de la investigación son los encargados del proceso de revisión y evaluación de las investigaciones en general y de la vigilancia y control del cumplimiento de los principios éticos. A tales efectos, se diseñó un manual de procedimientos para el Comité de Ética de la Investigación del Hospital General Docente Dr Juan Bruno Zayas Alfonso de Santiago de Cuba, sobre la base de normativas nacionales e internacionales actualizadas, con vistas a establecer una metodología a seguir en los diferentes procesos que ejecuta dicho Comité. Para su elaboración se cumplieron 3 etapas que incluyeron: revisión documental, discusión grupal y consulta a expertos, en ese orden. Se estructuró teniendo en cuenta primeramente una serie de contenidos de orden general y luego se establecieron los diferentes procedimientos que rigen su funcionamiento. Su implementación contribuyó decisivamente a la recertificación del hospital en buenas prácticas clínicas

Ethics committees for investigation are those in charge of the review and evaluation processes of investigations in general and of the surveillance and control of ethical principles fulfillment. To such effects the procedures manual for the Ethics Committee of investigation from Dr Juan Bruno Zayas Alfonso Teaching General Hospital in Santiago de Cuba, was designed on the base of updated national and international regulations, aimed at establishing a follow up methodology in the different processes that this Committee carries out. For its elaboration 3 stages were accomplished such as: documental review, group discussion and experts consultations, in that order. It was structured taking into account first, a series of general contents and then, different procedures that lead its operation were established. Its implementation contributed decisively to the hospital recertification in good clinical practices.

[Changes in the German Medicinal Product Act imposed by the EU regulation on clinical trials]. / Änderungen des Arzneimittelgesetzes durch die EU-Verordnung zu klinischen Prüfungen.

The entry into force of Regulation (EU) No. 536/2014 of the European Parliament, the Council of 16 April 2014 for clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC necessitated amendments to the national legislation on medicinal products. These changes mainly concern the sixth chapter of the German Medicinal Products Act (Arzneimittelgesetz, AMG) and the elimination of the GCP (good clinical practice) ordinance for clinical trials that will be covered by the regulation in the future. Sections 41a, 41b and 41c, which came into force in December 2016, regulate the registration procedure, the procedural rules and the business distribution plan according to which the responsibilities of the registered ethics committees for the authorisation procedures will be determined and cooperation with the federal higher authorities will be handled. All other amendments in the sixth chapter will not enter into force until the date of application of the regulation - presumably in the fourth quarter of 2018. In the future, Section 40a will regulate the general prerequisites - in particular the basic procedures for cooperation between the federal higher authority and the ethics committees - in addition to the provisions of the regulation. Section 40b governs special prerequisites for clinical trials and contains, in particular provisions for the informed consent in clinical trials with minors and incapacitated adults. Further changes concern, among other things, the transfer of previous regulations of the GCP ordinance into the AMG and adjustments regarding reporting obligations in the context of clinical trials in the AMG.

[Joint pilot project of the German higher federal authorities and ethics committees on implementing the EU Regulation on clinical trials]. / Gemeinsames Pilotprojekt von Bundesoberbehörden und Ethikkommissionen zur Umsetzung der EU-Verordnung zu klinischen Prüfungen.

BACKGROUND: The European Clinical Trials Regulation 536/2014 and the corresponding national legal transitions will require close cooperation between the federal higher authorities and ethics committees in the assessment of clinical trial applications involving medicinal products in humans. In preparation for this, a pilot project was launched to simulate the future processes of the regulation in line with current legal requirements and in order to give applicants, authorities and ethics committees the opportunity to familiarise themselves with the new procedures. OBJECTIVES: The aim of this paper is to examine all pilot project procedures of the first year since starting the pilot project at the end of 2015. MATERIALS AND METHODS: All 20 pilot projects completed in the first year were analysed for adherence to deadlines and results of the assessments. RESULTS: Within the time limits specified in the EU regulation, 17 of 20 procedures were fully completed. In two cases, the sponsors slightly exceeded the additional delivery period. In one case, the sponsor withdrew the application within the pilot procedure. All 20 applications were processed jointly by the federal authorities and ethics committees, and in all cases a coordinated assessment report was successfully compiled on time. All 20 applications were approved, five of which were subject to suspensive conditions. CONCLUSIONS: Compliance with the deadlines set by federal authorities and ethics committee shows that the technical infrastructures and processes established in the pilot procedure are fully functional. The cooperation between the federal higher authorities and ethics committees was very successful from the perspective of the parties involved.

[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.

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)

Novedades introducidas por el nuevo Real Decreto legislativo 1090/2015 de ensayos clínicos con medicamentos en España / News introduced by the new Real Legislative Decree 1090/2015 of clinical trials with medicines in Spain

Introducción: La participación de España en ensayos clínicos es una prueba fehaciente de su desarrollo en I+D en el sector salud y de intentar seguir a la vanguardia en cuanto a investigación médica se refiere. El nuevo reglamento del Parlamento Europeo y del Consejo sobre ensayos clínicos de medicamentos de uso humano (Reglamento UE 536/2014, de 16 de abril) deroga la legislación hasta ahora vigente (Directiva 2001/20/CE, de 4 de abril) obligando a modificar el Real Decreto español (RD 223/2004, de 16 de febrero), desarrollando aquellos aspectos que se dejan en mano de la legislación nacional. Objetivo: Analizar las principales modificaciones introducidas por el nuevo RD en investigación clínica (RD 1090/2015, de 4 de diciembre) que regula los ensayos clínicos con medicamentos, los Comités de Ética de la Investigación con medicamentos (CEIm) y el Registro español de ensayos clínicos y compararlas respecto a la normativa anterior. Material y Métodos: Se revisaron los RD 1090/2015, de 4 de diciembre y 223/2004, de 16 de febrero y se compararon las diferencias más destacables entre ambas normativas. Resultados: El nuevo desarrollo normativo introduce novedades importantes. Se abre la opción para la unificación del análisis de las solicitudes, de manera que junto con la autorización del ensayo clínico emitida por la AEMPS, únicamente haga falta que un CEIm acreditado emita su dictamen positivo que será vinculante. Regula nuevas definiciones, como la de ensayo clínico de bajo nivel de intervención, sujeto a normas menos rigurosas. Diferencia entre Comité de ética de la investigación (CEI) y CEIm, estableciendo los requisitos adicionales para pasar de ser CEI a CEIm. Define investigación clínica sin ánimo comercial (en la que el promotor es una universidad, hospital, organización científica pública, organización sin ánimo de lucro, organización de pacientes o investigador individual sin participación de la industria farmacéutica). Abre la opción de contratar un ensayo clínico previamente a su autorización. Define las indemnizaciones por daños y cómo se lleva a cabo la evaluación de los ensayos clínicos. Incorpora la figura del representante legalmente designado para sujetos incapaces y menores. Estipula las condiciones en situaciones de urgencia, embarazadas y periodos de lactancia así como del consentimiento informado. La principal novedad es el expediente único del ensayo clínico con dos partes, una de documentación para la Unión Europea (parte I) y otra de documentación nacional (parte II). Todos los datos tienen que ser enviados a una base de datos y un portal web de la Unión Europea de acceso público. Conclusiones: La nueva normativa propone dar un importante impulso a la investigación clínica en España con medicamentos, simplificando las trabas administrativas y agilizando la realización de estudios multicéntricos simultáneos en toda Europa. Mejora la delimitación de responsabilidades de los agentes que participan, aumenta la seguridad de los sujetos del ensayo, y a la vez, incrementa la eficiencia en los procesos de evaluación y comunicación implicados

Introduction: The participation of Spain in clinical trials is a reliable proof of its development in I+D in the health sector and of trying to follow at the vanguard of medical research. The new Regulation of the European Parliament and of the Council on Clinical Trials on medicines for human use (EU Regulation 536/2014, 16th April) derogates the legislation currently in force (Directive 2001/20/EC, 4th April) and it obliges to modify the Spanish Royal Decree (RD 223/2004, 16th February) to develop those aspects that are left in the hands of national legislation. Objetives: To analyze the main changes introduced by the new RD in clinical research (RD 1090/2015, 4th December), which regulates clinical trials with medicines, the Committees on Ethics of Research with Medicines (CERm) and the Spanish Registry of Clinical Trials and to compare them with the previous legislation. Material and methods: RD 1090/2015, 4th December was analyzed against RD 223/2004, 16th February, and the most important differences between the two regulations were compared. Results: The new regulatory development introduces important innovations. It opens the option for the unification of the analysis of the applications, so that, together with the authorization of the clinical trial issued by the SAMHP, it is only necessary that an accredited CERm emits its positive opinion that it will be binding. It regulates new definitions, such as the low-level clinical trial, subject to less stringent standards. It differentiates between Research Ethics Committee (REC) and CERm, establishing additional requirements to move from being REC to CERm. It defines non-commercial clinical research (in which the sponsor is a university, hospital, public scientific organization, non-profit organization, patient organization or individual researcher without involvement of the pharmaceutical industry). It opens the option to contract a clinical trial prior to its authorization. It defines compensation for damages and how the evaluation of clinical trials is conducted. It incorporates the figure of the legally designated representative for incapable and minor subjects. It stipulates the conditions in situations of urgency, pregnant and periods of lactation as well as informed consent. The main novelty is the single dossier of the two-part clinical trial, one for European Union (Part I) and another one for National Documentation (Part II). All data must be sent to a database and a European public access web portal. Conclusions: The new regulation proposes to give an important impulse to the clinical research in Spain with medicines, simplifying the administrative obstacles and speeding up the realization of multicentric studies simultaneously in all Europe. It improves the delimitation of the responsibilities of the agents involved, it increases the safety of the test subjects, and at the same time, it increases the efficiency in the evaluation and communication processes involved

Investigación biomédica con muestras biológicas de origen humano: un nuevo reto para la Bioética y los Comités Éticos de Investigación Clínica / Biomedical research with human biological samples: A new challenge for Bioethics and for the Clinical Research Ethics Committees

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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)