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

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e026840 ◽  
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.

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.

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.

New Zealand Research Ethics Committee Matters

2011 ◽  
Vol 7 (4) ◽  
pp. 132-135
Author(s):  
Andrew Moore
Keyword(s):  
Clinical Trials ◽  
New Zealand ◽  
Research Ethics ◽  
Review Process ◽  
Cervical Screening ◽  
Ethics Committees ◽  
Ethics Committee ◽  
Select Committee ◽  
Research Ethics Committee ◽  
Good Research

New Zealand's health (and disability) ethics committees are children of public inquiries: the ‘Cartwright’ ministerial inquiry of 1988, the ‘Gisborne’ cervical screening ministerial inquiry of 2001, and the Health Select Committee clinical trials inquiry of 2011. The Cartwright inquiry strengthened external scrutiny of research. The Gisborne Inquiry strengthened ethics committee accountability and expertise, and greatly streamlined review process. The Health Select Committee inquiry is further sharpening accountability and process. Under-discussed systemic issues also persist, including: how to keep the ethical primacy of the researcher-participant relationship and of researcher responsibility for good study conduct; whether the point of ethics committees is to facilitate good research as well as to protect participants; and whether ethics committees are just standard public bodies - to be given powers and limitations just like any other administrative tribunal or licensing board.

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

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.

scholarly journals The contribution and attitudes of research ethics committees to complete registration and non-selective reporting of clinical trials: A European survey

2016 ◽  
Vol 12 (3) ◽  
pp. 123-136 ◽  
Author(s):  
Daniel Strech ◽  
Jasper Littmann ◽  
Keyword(s):  
Clinical Trials ◽  
Research Ethics ◽  
Time Lag ◽  
Ethics Committees ◽  
Trial Registration ◽  
Selective Reporting ◽  
Positive Trial ◽  
Research Ethics Committees ◽  
Publication Rates ◽  
Study Results

Background: For many years, studies have shown that the results of clinical trials are often published or reported selectively with a statistically significant bias in favour of positive trial results. Trial registration as a precondition for publication had only limited effects on current practice. Results of trials which were approved by research ethics committees (RECs) are often published only partially, with a substantial time lag or not at all. This study examined existing procedures of RECs in the European Union to monitor and prevent incomplete registration of trials and selective reporting of trial results. It further investigated opinions of REC members about the need to update current legislation on this matter. Methods: Web-based survey on members of RECs in 22 European countries. Results: Over 90 percent of respondents agreed that the incomplete publication of trial results had a strong or somewhat negative impact on public health and on healthcare professionals’ trust in the validity of clinical research, yet only 30 percent reported that their REC had some (often unsystematic) mechanism in place to check that findings of approved studies are published in some form. Less than 10 percent stated that their REC has further specific procedures in place to prevent or minimize selective reporting of study results. Respondents stated variously that their REC did not have the resources to follow up on this matter. Conclusions: The existing legislation to regulate trial registration and encourage complete publication of trial results leaves room for improvement. REC members welcome guidelines to adequately address both problems. The new Regulation EU No. 536/2014 as well as the FDA Amendment Act from 2007 require the reporting of summary results within 1 year after study end. As recent reviews demonstrated, without any systematic approach to monitor the adherence to these regulations, publication rates remain rather low.

scholarly journals Patient and public involvement prior to trial initiation: lessons learnt for rapid partnership in the COVID-19 era

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Zahra Jamal ◽  
◽  
Alexander Perkins ◽  
Christopher Allen ◽  
Richard Evans ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Research Ethics ◽  
Public Involvement ◽  
Ethics Committees ◽  
Patient And Public Involvement ◽  
Research Ethics Committees ◽  
The Public ◽  
Clinical Trials Unit ◽  
The Uk

Plain English summary Patient and Public Involvement (PPI) describes the active involvement of patients and the public in the research process. Through PPI, patients and members of the public are increasingly involved in the design and conduct of clinical trials. PPI has been shown to improve the quality and relevance of research. During the COVID-19 pandemic, clinical trials have been playing a vital role in helping us find ways to prevent and treat the infection and improve our understanding of the virus. It is important that patients and the public are actively involved in deciding how COVID-19 research is carried out. Unfortunately, Research Ethics Committees in the UK have seen far less PPI for COVID-19 research studies compared with research before the pandemic. A key reason for this is that research is being designed much faster than normal and researchers may feel they do not have time to properly involve patients and the public. In this paper, we share our experiences of PPI for a COVID-19 clinical trial. We show that it is possible to rapidly involve patients and the public in COVID-19 clinical trials. We also explain how the design of the clinical trial was changed in response to feedback from public contributors. Lastly, we discuss the wider learning from this process which might be useful for researchers planning PPI activities for COVID-19 clinical trials in the future. Abstract Background: Clinical trials are playing a critical role in the global public health response to the COVID-19 pandemic. Despite the increasing recognition of the value of PPI in clinical trials, just 22% of the COVID-19 research proposals reviewed by Research Ethics Committees in the UK at the start of the pandemic reported PPI. There is a perception that PPI might result in delays in delivering research and therefore delays in obtaining important results. In this paper, we report our experience of rapid PPI for a COVID-19 clinical trial. Methods: RAPID-19 is a COVID-19 clinical trial which was planned to be submitted for fast-track ethics review in the United Kingdom. During the development of the trial protocol, the PPI Panel at the London School of Hygiene & Tropical Medicine Clinical Trials Unit was involved in the design of the study. The meeting with the PPI Panel lasted just over 1 h and was conducted by teleconference. Results: Although we only had a short period of time to explore the study with the PPI Panel, we were able to gain valuable insight into how the trial would be perceived by potential trial participants. Substantive changes were made to the trial to improve the acceptability of the research without compromising the study timelines. Having access to public contributors with relevant lived experience is an important resource for a Clinical Trials Unit and is critical for rapid PPI. The move to remote working due to lockdown required virtual discussions which helped to overcome some of the barriers to organising face-to-face meetings at short notice. Conclusions: PPI for clinical trials can be conducted in a time-efficient manner within the pressured environment of a pandemic. Involving PPI contributors at an early stage in protocol development maximised the opportunity to shape and influence the trial as well as limited potential delays which could occur if changes to the protocol had to be made at a later stage.

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