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.

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.

Trials, Regulation and tribulations.

INTRODUCTION: Regulation EU 536/2014 EU introduces a separation between two parts (technical-scientific aspects and locally relevant ethical aspects) in the assessment of applications for approval of trials and provides for each 'Member State concerned' to arrive at 'one single decision' regarding the application for authorisation to conduct a trial. PROPOSALS: The Regulation should be implemented in such a way as to avoid a separation between scientific assessment and ethical assessment; guarantee the absence of conflicts of interest in the institutions responsible for decision-making; promote efficiency on the part of ethics committees. In particular, (i) it is not appropriate to assess Parts I and II of the application for approval to conduct a trial separately (scientific soundness is the principal requisite for ethical soundness); (ii) conflicts of interest should be avoided, especially as regards links with the national authority responsible for drugs regulation; (iii) decision-making in each state should be the responsibility of a single coordinating ethics committee divided into sections specialising in different therapeutic fields; (iv) local committees affiliated to institutions where trial participants are recruited should be able to interact with the coordinating committee, provide consultation services-including on issues of clinical ethics-and promote training in the field of biomedical ethics.

[External Ethics Committees of biobanks: distinction of related entities and management of a disperse legislation]. / Los Comités de Ética externos del biobanco: distinción de figuras afines y ordenación en una legislación dispersa.

The Laws which legislate the Ethical Committees in the Management of Biobank also rule other kind of Committees, sometimes with the same functions, and this situation (denomination, nature and functions) need to be understood. On the other hand, those Committees are legislated in different Laws, and this is another situation that must be put in order.

Establishing institutional ethics committees: challenges and solutions - a review of the literature.

This review of the literature was conducted to identify the challenges faced while establishing institutional ethics committees (IECs) as well as to suggest some solutions. The search of the literature was carried out with the help of the PubMed search engine, using "research ethics committees" (MeSH] and "India" (MeSH]) as the key words for articles published between 2004 and 2012. We found 31 articles related to the topic, and the most common challenge mentioned was inappropriate functioning of IECs (n=17), followed by inappropriate structure (n=14). The authors identified many challenges related to the lack of oversight by regulatory bodies (n=14) as well as issues pertaining to the ethical training of IEC members and investigators (n=13). It is evident from the multitude of papers on the issue that the challenges related to the constitution and functioning of IECs must be given the attention they deserve to ensure that research participants in India are better protected.

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.

[Informed consent to the insertion of a PEG tube in a 53-year-old male patient with highly advanced dementia]. / Aufklärung und Einwilligung zur Anlage einer PEG Sonde bei einem 53 jährigen Patienten mit fortgeschrittener Demenz.

In patients with advanced dementia and dysphagia, regular fluid- and food intake together with oral medication can be guaranteed by insertion of a PEG tube. Consent to a treatment in a patient without legal capacity requires nomination of a legal substitute by an Austrian court. The following case report describes the problems associated with this particular situation exposing additional psychosocial stress to closest relatives and to the palliative care team in charge for the patient. This case report describes the legal options together with the finally chosen path of medical treatment which in clinical praxis may not always match.

Development of guidelines for the conduct of HIV research monitoring by ethics committees in Nigeria.

Nigerian research ethics committees are charged with the responsibility to monitor ongoing research to ensure compliance with ethical standards. Recent evidence from qualitative studies on research conduct however, indicate that many research studies fail to implement their protocols as written, and that this is not reported due to a failure of comprehensive monitoring. As Nigeria is in many respects a highly suitable country in which to conduct HIV biomedical prevention research, we argue there is a need to reprioritise the strengthening of the monitoring capacity of ethics committees so that such vital and ethically complex research can be conducted with confidence. We identify the need for (i) improved resourcing and training of ethics committee members, and (ii) comprehensive planning of research monitoring as part of the ethics committee protocol review process. We also highlight the significance of community collaboration and the establishment of a central pool of national monitors, as essential components for reinvigorating monitoring capacity.