How to approach a research ethics committee

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

Medicina e Morale ◽

10.4081/mem.2012.139 ◽

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.

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

Research Ethics ◽

10.1177/174701611100700105 ◽

2011 ◽

Vol 7 (1) ◽

pp. 19-23 ◽

Cited By ~ 1

Author(s):

Sarah JL Edwards

Keyword(s):

Decision Making ◽

Research Ethics ◽

Ethics Committees ◽

Ethics Committee ◽

Collective Decision ◽

Collective Decision Making ◽

Research Ethics Committees ◽

Research Ethics Committee ◽

And Function

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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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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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The UK Human Tissue Act and the Use of Tissue for Research, Issues for Research Ethics Committees

SSRN Electronic Journal ◽

10.2139/ssrn.1294379 ◽

2008 ◽

Author(s):

David Hunter

Keyword(s):

Research Ethics ◽

Human Tissue ◽

Ethics Committees ◽

Research Ethics Committees ◽

Research Issues ◽

Tissue Act ◽

Human Tissue Act ◽

The Uk

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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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Implementation of the StandingTall programme to prevent falls in older people: a process evaluation protocol

BMJ Open ◽

10.1136/bmjopen-2020-048395 ◽

2021 ◽

Vol 11 (7) ◽

pp. e048395

Author(s):

Morag E Taylor ◽

Chris Todd ◽

Sandra O'Rourke ◽

Lindy M Clemson ◽

Jacqueline CT Close ◽

...

Keyword(s):

Older People ◽

Research Ethics ◽

Process Evaluation ◽

Ethics Committee ◽

Community Dwelling ◽

Innovative Technology ◽

Local Health ◽

Research Ethics Committee ◽

Personal Impact ◽

The Uk

IntroductionOne in three people aged 65 years and over fall each year. The health, economic and personal impact of falls will grow substantially in the coming years due to population ageing. Developing and implementing cost-effective strategies to prevent falls and mobility problems among older people is therefore an urgent public health challenge. StandingTall is a low-cost, unsupervised, home-based balance exercise programme delivered through a computer or tablet. StandingTall has a simple user-interface that incorporates physical and behavioural elements designed to promote compliance. A large randomised controlled trial in 503 community-dwelling older people has shown that StandingTall is safe, has high adherence rates and is effective in improving balance and reducing falls. The current project targets a major need for older people and will address the final steps needed to scale this innovative technology for widespread use by older people across Australia and internationally.Methods and analysisThis project will endeavour to recruit 300 participants across three sites in Australia and 100 participants in the UK. The aim of the study is to evaluate the implementation of StandingTall into the community and health service settings in Australia and the UK. The nested process evaluation will use both quantitative and qualitative methods to explore uptake and acceptability of the StandingTall programme and associated resources. The primary outcome is participant adherence to the StandingTall programme over 6 months.Ethics and disseminationEthical approval has been obtained from the South East Sydney Local Health District Human Research Ethics Committee (HREC reference 18/288) in Australia and the North West- Greater Manchester South Research Ethics Committee (IRAS ID: 268954) in the UK. Dissemination will be via publications, conferences, newsletter articles, social media, talks to clinicians and consumers and meetings with health departments/managers.Trial registration numberACTRN12619001329156.

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Current provision of myelopathy education in medical schools in the UK: protocol for a national medical student survey

BMJ Open ◽

10.1136/bmjopen-2019-035563 ◽

2020 ◽

Vol 10 (8) ◽

pp. e035563

Author(s):

Oliver Mowforth ◽

Benjamin Davies ◽

Max Stewart ◽

Sam Smith ◽

Alice Willison ◽

...

Keyword(s):

Medical Student ◽

Research Ethics ◽

Medical Schools ◽

Ethics Committee ◽

Psychology Research ◽

Research Ethics Committee ◽

University Of Cambridge ◽

Ethical Approval ◽

The Uk ◽

The Impact

IntroductionDegenerative cervical myelopathy (DCM) is a common, disabling and progressive neurological condition triggered by chronic compression of the cervical spinal cord by surrounding degenerative changes. Early diagnosis and specialist management are essential to reduce disability, yet time to diagnosis is typically prolonged. Lack of sufficient representation of DCM in undergraduate and postgraduate medical curricula may contribute to the poor recognition of DCM by non-specialist doctors in clinical practice.In this study, our objective, therefore, is to assess DCM teaching provision in medical schools throughout the UK and to assess the impact of teaching on the DCM knowledge of UK medical students.Methods and analysisA 19-item questionnaire capturing data on medical student demographics, myelopathy teaching and myelopathy knowledge was designed. Ethical approval was granted by the Psychology Research Ethics Committee, University of Cambridge. An online survey was hosted on Myelopathy.org, an international myelopathy charity. Students studying at a UK medical school are eligible for inclusion. The survey is advertised nationally through university social media pages, university email bulletins and the national student network of Myelopathy.org. Advertisements are scheduled monthly over a 12-month recruitment period. Participation is incentivised by entering consenting participants of completed surveys to an Amazon voucher prize draw. Responses are anonymised using participant-chosen unique identifier codes. A participant information sheet followed by an explicit survey question captures participant informed consent. Regular updates on the progress of the study will be published on Myelopathy.org.Ethics and DisseminationEthical approval for the study was granted by the Psychology Research Ethics Committee, University of Cambridge (PRE.2018.099). The findings of the study described in this protocol, and all other related work, will be submitted for publication in a peer-reviewed journal and will be presented at scientific conferences.

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