The Role, Remit and Function of the Research Ethics Committee — 5. Collective Decision-Making and Research Ethics Committees

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.

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Responses of local research ethics committees to a study with approval from a multicentre research ethics committee

BMJ ◽

10.1136/bmj.320.7243.1182 ◽

2000 ◽

Vol 320 (7243) ◽

pp. 1182-1183 ◽

Cited By ~ 41

Author(s):

A. L Lux

Keyword(s):

Research Ethics ◽

Ethics Committees ◽

Ethics Committee ◽

Research Ethics Committees ◽

Research Ethics Committee ◽

Multicentre Research ◽

Local Research

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How to approach a research ethics committee

Advances in Psychiatric Treatment ◽

10.1192/apt.bp.106.002915 ◽

2007 ◽

Vol 13 (3) ◽

pp. 220-227 ◽

Cited By ~ 1

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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Challenges During Review of COVID-19 Research Proposals: Experience of Faculty of Medicine, Ain Shams University Research Ethics Committee, Egypt

Frontiers in Medicine ◽

10.3389/fmed.2021.715796 ◽

2021 ◽

Vol 8 ◽

Author(s):

Diaa Marzouk ◽

Iman Sharawy ◽

Isabelle Nakhla ◽

Mostafa El Hodhod ◽

Hoda Gadallah ◽

...

Keyword(s):

Informed Consent ◽

Research Ethics ◽

Ethics Committees ◽

Ethics Committee ◽

University Research ◽

Online Research ◽

Research Ethics Committees ◽

Ethical Challenges ◽

Research Ethics Committee ◽

Research Protocols

The COVID-19 pandemic resulted in an overwhelming increase in research studies submitted to research ethics committees (RECs) presenting many ethical challenges. This article aims to report the challenges encountered during review of COVID-19 research and the experience of the Faculty of Medicine, Ain Shams University Research Ethics Committee (FMASU REC). From April 10, 2020, until October 13, 2020, the FMASU REC reviewed 98 COVID-19 research protocols. This article addressed the question of how to face an overwhelming amount of research submitted to the REC while applying the required ethical principles. Ethical challenges included a new accelerated mode of review, online meetings, balance of risks vs. benefits, measures to mitigate risks, co-enrolment in different studies, protection of a vulnerable COVID-19 population, accelerated decisions, online research, how to handle informed consent during the pandemic, and justification of placebo arm.

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Registration audit of clinical trials given a favourable opinion by UK research ethics committees

BMJ Open ◽

10.1136/bmjopen-2018-026840 ◽

2019 ◽

Vol 9 (2) ◽

pp. e026840 ◽

Cited By ~ 2

Author(s):

Carla Denneny ◽

Sue Bourne ◽

Simon E Kolstoe

Keyword(s):

Clinical Trials ◽

Research Ethics ◽

Ethics Committees ◽

Ethics Committee ◽

Trial Registration ◽

Research Ethics Committees ◽

The European Union ◽

Clinical Trial Registration ◽

Research Ethics Committee ◽

The Uk

ObjectiveTo determine levels of public registration for a cohort of clinical trials reviewed and given a favourable opinion by research ethics committees in the United Kingdom.Study designAudit of records.SettingClinical trials receiving a favourable ethics opinion between 1 January 2016 and 30 June 2016.Main outcome measuresCorrelation between trials on the UK research ethics committee database and any primary registry entry on the WHO International Clinical Trials Registry Platform or clinicaltrials.gov as of 29 August 2017 (14 to 20 months after the favourable ethics committee opinion).ResultsOver the study period 1014 trials received a favourable ethics opinion, with 397 (39%) registered on the European Union Drug Regulating Authorities Clinical Trials database, and 18 with an agreed clinical trial registration deferral. Excluding these trials, the total number subsequently requiring registration was 599, and of these 405 (40% of total) were found to be registered. Follow-up with the 194 investigators or sponsors of trials not found to be registered produced 121 responses with a further 10 (1%) trials having already registered, 55 commitments to register and a variety of other responses. The overall registration rate was therefore 80%.ConclusionsDespite researchers and sponsors being reminded that registration of clinical trials is a condition of the research ethics committee (REC) favourable opinion, one-fifth of clinical trials either had not been registered, or their registration could not easily be found, 14 to 20 months after receiving the favourable opinion letter. The methodology trialled here proved effective, and although there are positive indications of a culture change towards greater registration, our results show that more still needs to be done to increase trial registration.

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Research Ethics Committees in Europe — Living with Diversity

Research Ethics ◽

10.1177/174701610700300311 ◽

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.

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