Suchergebnisse

On 9 August 1994 the German legislature revised the German Drug Law (AMG). Included in the revision is a passage requiring, for the first time, that the sponsors and investigators of clinical studies involving human subjects first obtain the approval of an ethics committee before carrying out such studies. According to the legislation, which takes effect on 17 August 1995, approval is to come from 'an independent ethics committee, set up and administered according to state law [emphasis added]' (1). Although it is clear according to the text that the 16 federal states have been empowered to establish ethics committees within their jurisdictions, this does not mean that the state governments are free to transfer exclusive authority in the matter to their respective medical associations, a step that would effectively abolish Germany's private ethics committees. First, the legislation does not rule out the authorization of private ethics committees. Second, as legal scholars attest, the exclusive control of ethics committees by the medical associations would constitute an illegal monopoly. Third, it is arguable that medical-association ethics committees fail to meet the one prior federal requirement, that of independence. There is a great deal of confusion in Germany today about which kinds of ethics committees (public and/or private) the states will sanction before 17 August 1995. In an attempt to sort things out we present a brief explanation of how ther came to be two kinds of ethics committees in Germany, review the legal battle between the two over the issue of authorization, point out how the German legislature, in passing the recent bill, has missed an opportunity to clarify the issue and, finally suggest why the administration of ethics committees by the medical associations may be incompatible with the requirement that ethics committees be independent.

For the first 25 years of their existence in the United Kingdom research ethics committees were left more or less in peace by the Department of Health. Since the publication of the "red book" in 1991, 1 however, they have undergone a continual process of radical change, from the introduction of multicentre research ethics committees in 1997, through research governance, to various legislative reforms of research practice including the clinical trials regulations of 2004. 2–4 Ethical review has been extended to more and more kinds and locations of research. At the same time, ethics committees have been subject to continuous criticism from researchers and public and private sector sponsors of research. Criticism from patients and the public has been less audible. Some of the criticism of research ethics committees has focused on issues for which they can bear no responsibility, such as the interpretation of the Data Protection Act 1998 or the operation of trusts' research governance procedures. Ethics committees have been the lightning rod for the frustration researchers have felt about the bureaucratisation of research. Yet much of this frustration is reasonably directed at ethics committees. They can be slow, idiosyncratic, and poorly informed about research methods or guidelines on the ethics of research. And researchers can reasonably feel that many of the reforms since 1991, while intended to simplify ethics review of research, have actually made matters worse. This criticism appears to be common across Europe, with wide variations in approval times and required amendments being reported by many researchers. 56 Late last year Lord Warner, then a junior health minister, commissioned an ad hoc advisory group to review the operation of NHS research ethics committees in the health and social care sector. The group's findings were published in June. 7 The group's principal conclusions are that independent ethical review of research is important but that it needs to be efficient and timely and to concentrate on ...

In this paper the authors argue that research ethics committees (RECs) should not be paternalistic by rejecting research that poses risk to people competent to decide for themselves. However it is important they help to ensure valid consent is sought from potential recruits and protect vulnerable people who cannot look after their own best interests. The authors first describe the tragic deaths of Jesse Gelsinger and Ellen Roche. They then discuss the following claims to support their case: (1) competent individuals are epistemologically and ethically in the best position to say which risks are reasonable for them, so RECs should be no more restrictive than the "normal" constraints on people taking risks with themselves; (2) RECs do not judge individual competence (that is for researchers and psychiatrists); (3) individual liberty is mostly limited by what serves the public interest, and RECs do not determine public interest; (4) RECs may have a paternalistic role in preventing exploitation of competent people vulnerable to the use of incentives, and in protecting the interests of incompetent people; however, (5) the moral and political authority of RECs has not been established in this respect.

The Law of 3 January 2018 established in Italy the "National Centre for the Coordination of Regional Ethics Committees for Clinical Trials of Medicines and Medical Devices for Human Use" and reduced the number of ethics committees in the country to 40. This Act should, amongst other things, facilitate Italy's compliance with the provisions set forth in European Regulation (EU) 536/2014. Hopefully, in addition to the provisions set forth in the Law, the National Centre will strive to foster the harmonisation of ethics committee procedures, in order to reform Italian legislation on the evaluation of clinical trials and, more generally, biomedical studies. Unfortunately, certain organizational and structural conditions do not bode well for the success of the National Centre.

Progress through the application of science cannot be achieved if the results of scientific studies are not communicated appropriately. This is particularly relevant in medical research, where experiments are often conducted on human volunteers. Expensive new innovations cannot be produced without returns for investigators, but the distortion of the evidence base by long term withholding of data, either for financial gain or simply through negligence, can do real harm to patients. To tackle this problem the World Medical Association has set standards for the conduct and dissemination of research, but the sheer number of funders and researchers make it difficult even to identify trials that have been conducted, let alone to discover whether the results have been reported accurately. This problem, called reporting bias, has become increasingly prominent both in the public's consciousness and politically. Efforts to tackle the problem include trial registration, consensus based statements on how to report research, and audit attempts by funders, companies, and research organisations. However, these solutions lack coordination and examine only limited populations of researchers. What is needed is a larger and more systematic method for detecting this substantial ethical problem. The Declaration of Helsinki states that "any experiment involving human beings must be submitted to an independent committee for review, comment, and guidance," and these research ethics committees could hold the answer. For example, in England the Health Research Authority coordinates 66 committees that review the ethical aspects of all research on human participants conducted in the NHS (or subject to certain regulations). Researchers submit an application form and protocol for review, including a clear statement of the intended outcomes and how they will report the study. This process results in a substantial and comprehensive database of trials with human participants. Such databases represent an untapped resource, both for making the objectives and methods of planned trials in human participants available, and for determining whether the research has been reported.

Ethical evaluation of projects involving animal testing is mandatory within the EU and other countries. However, the evaluation process has been subject to criticism, e.g., that the committees are not balanced or democratic enough and that the utilitarian weighting of harm and benefit that is normally prescribed is difficult to carry out in practice. In this study, members of Swedish Animal Ethics Committees (AECs) completed a survey aiming to further investigate the decision-making process. We found that researchers and animal laypersons make significantly different ethical judgments, and hold disparate views on which ethical aspects are the most relevant. Researchers were significantly more content than laypersons with the functioning of the committees, indicating that the ethical model used suited their preferences better. We argue that in order to secure a democratic and proper ethical evaluation, the expectations of a scientific discourse must be acknowledged, while giving room for different viewpoints. Further, to fulfil the purpose of the project evaluations and meet public concern, the functions of the different AEC member categories need to be clarified. We suggest that one way of achieving a more thorough, balanced and inclusive ethical evaluation is to allow for more than one model of ethical reasoning.

Background Rationing and allocation decisions at the clinical level – bedside rationing – entail complex dilemmas that clinicians and managers often find difficult to handle. There is a lack of mechanisms and aids for promoting fair decisions, especially in hard cases. Reports indicate that clinical ethics committees (CECs) sometimes handle cases that involve bedside rationing dilemmas. Can CECs have a legitimate role to play in bedside rationing? Main text Aided by two frameworks for legitimate priority setting, we discuss how CECs can contribute to enhanced epistemic, procedural and political legitimacy in bedside rationing decisions. Drawing on previous work we present brief case vignettes and outline several potential roles that CECs may play, and then discuss whether these might contribute to rationing decisions becoming legitimate. In the process, key prerequisites for such legitimacy are identified. Legitimacy places demands on aspects such as the CEC's deliberation process, the involvement of stakeholders, transparency of process, the opportunity to appeal decisions, and the competence of CEC members. On these conditions, CECs can help strengthen the legitimacy of some of the rationing decisions clinicians and managers have to make. Conclusions On specified conditions, CECs can have a well-justified advisory role to play in order to enhance the legitimacy of bedside rationing decisions. ; publishedVersion

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.

With the recent Clinical Trials Directive, a degree of harmonisation into research ethics committees (RECs) across Europe, including the time taken to assess a trial proposal and the kinds of issues a committee should take into account, has been introduced by the European Union (EU). How four different member states—Hungary, Portugal, Sweden and the UK—have chosen to implement the directive is shown. Although this has resulted in four very different ways of structuring RECs, similar themes are present in all four cases, such as centralisation of control over RECs within member states, harmonisation of REC procedures across the EU and increased role of political decision making with regard to such committees.

Background Rationing and allocation decisions at the clinical level – bedside rationing – entail complex dilemmas that clinicians and managers often find difficult to handle. There is a lack of mechanisms and aids for promoting fair decisions, especially in hard cases. Reports indicate that clinical ethics committees (CECs) sometimes handle cases that involve bedside rationing dilemmas. Can CECs have a legitimate role to play in bedside rationing? Main text Aided by two frameworks for legitimate priority setting, we discuss how CECs can contribute to enhanced epistemic, procedural and political legitimacy in bedside rationing decisions. Drawing on previous work we present brief case vignettes and outline several potential roles that CECs may play, and then discuss whether these might contribute to rationing decisions becoming legitimate. In the process, key prerequisites for such legitimacy are identified. Legitimacy places demands on aspects such as the CEC's deliberation process, the involvement of stakeholders, transparency of process, the opportunity to appeal decisions, and the competence of CEC members. On these conditions, CECs can help strengthen the legitimacy of some of the rationing decisions clinicians and managers have to make. Conclusions On specified conditions, CECs can have a well-justified advisory role to play in order to enhance the legitimacy of bedside rationing decisions.

Introduction and objectives. Coinciding with the recent implementation in Italy of the "Directive 2010/63/EU, regarding the protection of animals used for scientific pur-poses", the Authors would like to analyse the topic of the introduction of ethical com-mittees for animal experimentation in Italy. This paper furthermore aims to underline some critical aspects concerning the actions taken by Italian institutions to comply with the provisions of EU.Results and discussion. The implementation of the recent Italian law (Decreto Legisla-tivo n. 26 on 4 March 2014 Implementation of the Directive 2010/63/EU on the protec-tion of animals used for scientific purposes) leans towards a restrictive interpretation of the European provisions about composition and responsibilities of "Ethical Committee for Animal Experimentation". In the composition of the bodies mentioned, we note a tendency to restrict the composition to few professional figures contemplated by Ital-ian law, without guaranteeing the independence of each committee; also, an absence of hierarchical relationship between a research institution and his committee is apparent. Moreover, a critical aspect is the lack of decision-making powers of these new organisms in terms of ethical evaluation of protocols and research projects.Conclusions. What EU legislation imposes on the member states is to set up an animal-welfare body (art. 26). This represents a strong incentive for Italy to follow the steps of many other European Countries, where ad hoc ethical committees have been working for a long time. The proper functioning of these bodies may contribute to guarantee the safety and welfare of the animals inside the laboratories, and to balance the protection of animal life and the interests of research.

BACKGROUND: Despite the growth of biomedical research in South Africa, there are few insights into the operation of Research Ethics Committees (RECs) in this setting. We investigated the composition, operations and training needs of health RECs in South Africa against the backdrop of national and international guidelines. METHODS: The 12 major health RECs in South Africa were surveyed using semi-structured questionnaires that investigated the composition and functions of each REC as well as the operational issues facing committees. RESULTS: Health RECs in SA have an average of 16 members and REC members are predominantly male and white. Overall, there was a large discrepancy in findings between under-resourced RECs and well resourced RECs. The majority of members (56%) are scientists or clinicians who are typically affiliated to the same institution as the health REC. Community representatives account for only 8% of membership. Training needs for health REC members varied widely. CONCLUSION: Most major health RECs in South Africa are well organized given the resource constraints that exist in relation to research ethics in developing countries. However, the gender, racial and occupational diversity of most of these RECs is suboptimal, and most RECs are not constituted in accordance with South African guidelines. Variability in the operations and training needs of RECs is a reflection of apartheid-entrenched influences in tertiary education in SA. While legislation now exists to enforce standardization of research ethics review systems, no provision has been made for resources or capacity development, especially to support historically-disadvantaged institutions. Perpetuation of this legacy of apartheid represents a violation of the principles of justice and equity.

The recent increase in research in the Middle East has been associated with the establishment of research ethics committees (RECs). Our aim was to obtain perspectives of RECs regarding the challenges that impede their effective functioning. We conducted in-depth interviews using a semi-structured interview guide. We transcribed and analyzed the interviews to uncover major themes and subthemes. We identified the following themes: membership composition; training needs of members; availability of human and capital resources; role of the national government; concerns with the informed consent process; government scrutiny of research; investigator-related issues; and concerns with transfer of biological samples to other countries. Our interview study revealed several barriers that need to be considered by appropriate stakeholders to enhance adequate functioning of RECs.

Abstract Background Despite the growth of biomedical research in South Africa, there are few insights into the operation of Research Ethics Committees (RECs) in this setting. We investigated the composition, operations and training needs of health RECs in South Africa against the backdrop of national and international guidelines. Methods The 12 major health RECs in South Africa were surveyed using semi-structured questionnaires that investigated the composition and functions of each REC as well as the operational issues facing committees. Results Health RECs in SA have an average of 16 members and REC members are predominantly male and white. Overall, there was a large discrepancy in findings between under-resourced RECs and well resourced RECs. The majority of members (56%) are scientists or clinicians who are typically affiliated to the same institution as the health REC. Community representatives account for only 8% of membership. Training needs for health REC members varied widely. Conclusion Most major health RECs in South Africa are well organized given the resource constraints that exist in relation to research ethics in developing countries. However, the gender, racial and occupational diversity of most of these RECs is suboptimal, and most RECs are not constituted in accordance with South African guidelines. Variability in the operations and training needs of RECs is a reflection of apartheid-entrenched influences in tertiary education in SA. While legislation now exists to enforce standardization of research ethics review systems, no provision has been made for resources or capacity development, especially to support historically-disadvantaged institutions. Perpetuation of this legacy of apartheid represents a violation of the principles of justice and equity.

Abstract Human/animal relations are potentially controversial and biotechnologically produced animals and animal-like creatures – bio-objects such as transgenics, clones, cybrids and other hybrids – have often created lively political debate since they challenge established social and moral norms. Ethical issues regarding the human/animal relations in biotechnological developments have at times been widely debated in many European countries and beyond. However, the general trend is a move away from parliamentary and public debate towards institutionalized ethics and technified expert panels. We explore by using the conceptual lens of bio-objectification what effects such a move can be said to have. In the bio-objectification process, unstable bio-object becomes stabilized and receives a single "bio-identity" by closing the debate. However, we argue that there are other possible routes bio-objectification processes can take, routes that allow for more open-ended cases. By comparing our observations and analyses of deliberations in three different European countries we will explore how the bio-objectification process works in the context of animal ethics committees. From this comparison we found an interesting common feature: When animal biotechnology is discussed in the ethics committees, technical and pragmatic matters are often foregrounded. We noticed that there is a common silence around ethics and a striking consensus culture. The present paper, seeks to understand how the bio-objectification process works so as to silence complexity through consensus as well as to discuss how the ethical issues involved in animal biotechnology could become re-politicized, and thereby made more pluralistic, through an "ethos of controversies".