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 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 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 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 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 Training Needs Of Research Ethics Committee Members In Cameroon Regarding Research Participant Protection

2021 ◽  
Author(s):  
Ingrid Marcelle Koutio Douanla ◽  
Paul Nyibio Ntsekendio ◽  
Frank Forex Kiadjieu Dieumo ◽  
Felicité Tabala Naah ◽  
Fernando Kemta Lekpa ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Research Ethics ◽  
Ethical Issues ◽  
Research Participant ◽  
Ethics Committee ◽  
Training Needs ◽  
Research Protocol ◽  
Ethical Evaluation ◽  
Research Ethics Committee ◽  
Research Protocols

Abstract Background The capacity of the Research Ethic Committee (REC) members to review research protocol is one of the frequently raised problems. The purpose of this study was to assess training needs of members of research ethics committee in Cameroon regarding research participant protection.Methods It was a cross-sectional descriptive study conducted in all the regions of Cameroon during the last quarter of the year 2020, assessing training needs of REC members’ ethical evaluation of health research protocols. Data were collected from all eligible REC members by trained and supervised surveyors using a well designed questionnaire integrated in smartphones via ODK-collect. The data were analyzed by estimating proportions with 95% Confidence Interval using the EpiInfo software version 7.2.2.6.Findings Out of the 79 ethics committee members reached, 64 (81.01%) accepted to participate including 28 (43.75) female. The result showed that,21 (32.81%) of ethics committee members were not trained in research ethics evaluation including 68.75% not exposed to training on research participants protection during clinical trials. A given fraction of respondent was not aware of the existence of key national regulations (25%) and international guidelines like the Helsinki Declaration (32.81%). Participants identified and ranked their priorities in terms of training needs in research participant’s protection, national text regulating research in Cameroon, evaluations’ procedures of research protocol, organization of research in Cameroon, and protection of participants in research involving the transfer of biological materials. The workshop and e-learning courses were seen to be the main accessible source of training.Conclusion Not all ethics committee members received training on ethical principles regarding research ethics review, review process and monitoring of research protocols, and on ethical issues associated to each study design including clinical trials. These gaps and the needs perceived by participants are to be taken into account when setting up a training program for RECs members on ethical evaluation in Cameroon.

scholarly journals The Spectrum of Clinical Research with Medications in A Spanish University Hospital. Review of 1.000 Clinical Trials Evaluated by the Research Ethics Committee

2009 ◽  
Vol 3 (1) ◽  
pp. 20-27
Author(s):  
Emma Fernandez de Uzquiano ◽  
A. Gil Aguado ◽  
P. Lavilla Uriol ◽  
J. Frias Iniesta ◽  
R. Madero Jarabo ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Research Ethics ◽  
Ethics Committee ◽  
University Hospital ◽  
Research Ethics Committee
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