scholarly journals The Missing Committees: Research Ethics in the Making in Switzerland

2021 ◽  
pp. 1-20
Author(s):  
Magaly Tornay
Keyword(s):  
Research Ethics ◽  
Ethics Committees ◽  
Ethics Committee ◽  
Early History ◽  
Human Experimentation ◽  
General Level ◽  
Medical Sciences ◽  
Local Practices ◽  
Long Time ◽  
Industrial Standards

Abstract This article analyzes the formation of research ethics and particularly of ethics committees in Switzerland by tracing their early history along distinct phases: (1) the first guidelines on human experimentation issued by the Swiss Academy of Medical Sciences in 1970; (2) conceptual struggles in establishing these norms; (3) the emergence of a central medical-ethical committee in 1979; and (4) the first local ethics committee established in the rural canton of Thurgau in 1987. It analyzes the interplay between local practices, industrial standards, and a neoliberal, low-key, soft regulation by negotiation among peers. Key actors are the Swiss Academy of Medical Sciences, the pharmaceutical industry, and the canton of Thurgau. In this context, ‘research’ and ‘experiments’ for a long time remained disputed, unclear and risky notions. rec s were encouraged mainly as a way of distributing responsibility, of managing a wide array of risks and, crucially, as part of a wider strategy to avoid juridical and political regulation. The article asks, on a more general level, how and why ‘ethics’ entered this field and what becomes visible or obscured when issues are transposed into an ethical language.

Research Ethics Committees in Europe — Living with Diversity

2007 ◽  
Vol 3 (3) ◽  
pp. 101-102
Author(s):  
Frank Wells
Keyword(s):  
Research Ethics ◽  
Working Party ◽  
Ethics Committees ◽  
Good Clinical Practice ◽  
Ethics Committee ◽  
Research Ethics Committees ◽  
European Forum ◽  
Working Groups ◽  
Vulnerable Subjects ◽  
The Eu

This paper presents a review, conducted by the ethics working party of the European Forum for Good Clinical Practice, of the structures and functions of research ethics committees across the member states of the EU. The findings demonstrate widespread differences, and further working groups have been established to develop thinking across Europe, in respect of the training of REC members, ethics committee quality assurance and the involvement of vulnerable subjects in research. In practical terms the differences do not matter, but they should be recognized. The review itself is considered a dynamic document and will be updated every six months.

scholarly journals Knowledge Awareness and Attitude about Research Ethics among Dental Faculties in India

2014 ◽  
Vol 15 (5) ◽  
pp. 608-613 ◽  
Author(s):  
Nithin Manchery Gopinath ◽  
Joseph John ◽  
E Senthilkumar ◽  
N Nagappan
Keyword(s):  
Research Ethics ◽  
Overall Response Rate ◽  
Response Rate ◽  
Ethics Committees ◽  
Ethics Committee ◽  
Chi Square ◽  
Cross Sectional ◽  
Level Of Knowledge ◽  
Self Administered Questionnaire ◽  
And Training

ABSTRACT Aim The aim of this study was to assess the level of knowledge, awareness and attitude about research ethics and research ethics committees (RECs) among dental faculties. Materials and methods This cross-sectional questionnaire study incorporated a self administered questionnaire. Descriptive, Chi-square and logistic regression analysis was used to analyze the data. Results The overall response rate to the study was 85%. More than half were familiar with research ethics, principles and functions of the research ethics committee. Though there were some faculties whose attitude regarding research ethics principle was not optimal. Conclusion The present study revealed a broad acceptance among the faculties acceptance toward RECs and training in research ethics, though there existed certain gap in knowledge about research among the faculties. Clinical significance This will help us to understand the knowledge, awareness and attitudes of dental faculties toward research ethics, which will help the institutional officials to develop better educational programs in the field of research ethics in order to help them conduct better research henceforth. How to cite this article MG Nithin, John J, Senthilkumar E, Nagappan N. Knowledge Awareness and Attitude about Research Ethics among Dental Faculties in India. J Contemp Dent Pract 2014;15(5):608-613.

scholarly journals Il dibattito sulla “Guide for Research Ethics Committee Members” del Consiglio d’Europa: il contributo dei Comitati di etica italiani al draft del documento

2012 ◽  
Vol 61 (2) ◽  
Author(s):  
Adriano Bompiani ◽  
Daniela Marrani
Keyword(s):  
Research Ethics ◽  
Ethics Committees ◽  
Legal Framework ◽  
Steering Committee ◽  
Ethics Committee ◽  
Research Ethics Committees ◽  
Council Of Europe ◽  
Research Ethics Committee ◽  
Strong Interest ◽  
Opinion Expression

Gli Autori hanno condotto una consultazione “aperta”, e cioè senza l’uso di precisi questionari, rivolta a 30 Comitati etici per la ricerca operanti in varie strutture universitarie, non universitarie, assistenziali in Italia, riguardante un Progetto “Guide for Research Ethics Committee Members” curato e diffuso dal Comitato Direttivo per la Bioetica (CDBI) del Consiglio d’Europa. Le risposte ottenute documentano un forte interesse dei Comitati interessati soprattutto alla prassi funzionale dei Comitati stessi, ritenendo ormai definito il quadro bioetico e giuridico di riferimento. L’interesse alla prassi esecutiva e all’espressione dei pareri sui vari protocolli di cui hanno esperienza i Comitati consultati, porta a ritenere che ulteriore lavoro di approfondimento possa essere dedicato allo sviluppo di questo obiettivo. Per quanto limitata nell’estensione, l’iniziativa di questa consultazione sottolinea l’interesse di procedure di consulenza degli stessi Comitati prima ancora che documenti più complessi di carattere nazionale europeo o internazionale vengano adottati. ---------- The authors conducted an “open” consultation, i.e. without the use of detailed questionnaires, with 30 research ethics committees operating in various universities, non-academic, healthcare institutes in Italy, on a “Draft Guide for Research Ethics Committee Members”, edited and published by the Steering Committee on Bioethics (CDBI) of the Council of Europe. The responses demonstrate a strong interest of the Committees on the functioning practice of the same committees, being defined yet the bioethical and legal framework of reference. The interest in practice and opinion expression of on the various protocols on which the consulted committees have experience, lead to believe that further work could be dedicated to the development of such goal. Even limited in extension, the initiative highlights the value of consulting committees before more complex national European or international documents are adopted.

Implementation of the EU clinical trial regulation transforms the ethics committee systems and endangers ethical standards

2020 ◽  
pp. medethics-2020-106757
Author(s):  
Vilma Lukaseviciene ◽  
Joerg Hasford ◽  
Dirk Lanzerath ◽  
Eugenijus Gefenas
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Research Ethics ◽  
Ethics Committees ◽  
Ethics Committee ◽  
Negative Consequences ◽  
Ethics Review ◽  
Clinical Trial Directive ◽  
Favourable Environment ◽  
The Eu

The upcoming Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use (Regulation), which will replace the current Clinical Trial Directive at the end of 2021, has triggered a significant reform of research ethics committee systems in Europe. Changes related to ethics review of clinical trials in the EU were considered to be essential to create a more favourable environment to conduct clinical trials in the EU. The concern is, however, that the role of the research ethics committees will weaken in at least some of the Member States because the new Regulation allows narrowing down the scope of ethics review as compared with the currently valid Clinical Trial Directive. Although the new Regulation may lead to faster approval procedures for clinical trials, which is especially relevant in the context of pandemics, high-quality ethics reviews integrating methodological aspects of a clinical trial should nevertheless be ensured. To maintain high research ethics standards as well as to foster measures to mitigate potential negative consequences of the reform, it is therefore of vital importance to start debating and sharing the reflections about the potential consequences of these transformations and trends as soon as possible.

scholarly journals Liability in the Law of Tort of Research Ethics Committees and Their Members

2005 ◽  
Vol 1 (2) ◽  
pp. 53-59 ◽  
Author(s):  
J.V. McHale
Keyword(s):  
Research Ethics ◽  
Ethics Committees ◽  
Ethics Committee ◽  
Research Subject ◽  
Research Subjects ◽  
Research Project ◽  
Malpractice Litigation ◽  
Primary Responsibility ◽  
Legal Costs ◽  
The Law

The current rise in malpractice litigation has led to concern in the research community as to the prospect of litigation against researchers. Clearly as the responsibility for the day-to-day conduct of the research falls upon the researchers they will be potentially liable should there be negligence in the conduct of the research project itself. But to what extent can the research ethics committee and its members be held liable should harm result to the research subject? How far does the prospect of the threat of litigation equate with the reality of the prospect of liability? Although the NHS research governance framework suggests that primary responsibility for the conduct of the trial is with the researcher this does not mean that REC members will be immune from actions in tort where research subjects suffer harm in the conduct of a research project approved by their NHS REC. This paper focuses upon the prospect for liability in the law of tort of NHS RECs and their members. While in practice the vast majority of such claims are unlikely to be successful members of RECs may incur resultant legal costs as a consequence of involvement in proposed litigation. It is submitted that the scope of indemnity provision provided to RECs and their members should be precisely determined, otherwise there is a real prospect that the risk of malpractice litigation may deter individuals from serving on such committees.

Hospital Ethics Committees in Paris

2000 ◽  
Vol 9 (3) ◽  
pp. 424-428 ◽  
Author(s):  
Jean-Christophe Mino
Keyword(s):  
Research Ethics ◽  
National Level ◽  
Life Sciences ◽  
Ethics Committees ◽  
Ethics Committee ◽  
Institutional Form ◽  
Permanent Commission ◽  
Hospital Ethics Committees ◽  
The World ◽  
Hospital Ethics

Even if the term bioethics is used all over the world, its meanings are multiple and different, especially between American and European countries, depending on local cultural and medical contexts. These differences concern the issues discussed or the institutional form bioethics takes. In France, bioethics was used from the end of the 1970s and focused on research ethics and issues at the beginning of life. At the national level, a permanent commission, the “national consultative ethics committee on life sciences and health” (Comité Consultatif National d'Ethique, CCNE) was created by President François Mitterrand in 1983. Its recommendations dealt essentially with procreative medicine and biomedical research ethics.

scholarly journals Good intentions and dangerous assumptions: Research ethics committees and illicit drug use research

2012 ◽  
Vol 8 (4) ◽  
pp. 191-199 ◽  
Author(s):  
Kirsten Bell ◽  
Amy Salmon
Keyword(s):  
Drug Use ◽  
Research Ethics ◽  
Financial Incentives ◽  
Drug Users ◽  
Illicit Drug ◽  
Illicit Drug Use ◽  
Ethics Committees ◽  
Ethics Committee ◽  
Evidence Based ◽  
Special Protection

Illicit drug users are frequently identified as a ‘vulnerable population’ requiring ‘special protection’ and ‘additional safeguards’ in research. However, without specific guidance on how to enact these special protections and safeguards, research ethics committee (REC) members sometimes fall back on untested assumptions about the ethics of illicit drug use research. In light of growing calls for ‘evidence-based research ethics’, this commentary examines three common assumptions amongst REC members about what constitutes ethical research with drug users, and whether such assumptions are borne out by a growing body of empirical data. The assumptions that form the focus of this commentary are as follows: (i) drug users do not have the capacity to provide informed consent to research; (ii) it is ethically problematic to provide financial incentives to drug users to participate in research; and (iii) asking drug users about their experiences ‘re-traumatizes’ and ‘re-victimizes’ them.

scholarly journals How to approach a research ethics committee

2007 ◽  
Vol 13 (3) ◽  
pp. 220-227 ◽  
Author(s):  
George Masterton ◽  
Prem Shah
Keyword(s):  
Research Ethics ◽  
Ethics Committees ◽  
Ethics Committee ◽  
Successful Outcome ◽  
Research Ethics Committees ◽  
Research Projects ◽  
Research Ethics Committee ◽  
The Uk

This article describes research ethics and the UK research ethics system for psychiatrists who are engaged in research or in supporting trainees with research projects. The emphasis on practical aspects should ensure that submissions to research ethics committees are improved, and consequently the likelihood of a successful outcome is increased.

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