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Identification of ethics committees based on authors' disclosures: cross-sectional study of articles published in the European Journal of Anaesthesiology and a survey of ethics committees.

ABSTRACT: BACKGROUND:Since 2010, the European Journal of Anaesthesiology has required the reporting of five items concerning ethical approval in articles describing human research: ethics committee's name and address, chairperson's name, study's protocol number and approval date. We aimed to assess whether this requirement has helped to identify and to contact the referenced ethics committees. METHODS:In this cross-sectional study, we analysed articles requiring ethical approval, according to the Swiss federal law for human research and published in the European Journal of Anaesthesiology in 2011. Ethics committees were searched through our institutional Internet access based on information provided in the articles. The last search was performed in November 2015. Numbers (%) of items reported, of ethics committees identified, and of those that confirmed having provided ethical approval are reported. RESULTS:Of 76 articles requiring ethical approval, 74 (97%) declared it. Ethics committees' names and addresses were mentioned in 63/74 (85%), protocol numbers in 51/74 (69%), approval dates in 48/74 (65%), and chairpersons' names in 45/74 (61%). We could identify 44/74 (59%) committees; 36/74 (49%) answered our inquiry and 24/74 (32%) confirmed their role. Thirty-four of 74 articles (46%) reported all five items; in 25/34 (74%), we were able to identify an ethics committee, 18/34 (53%) answered our inquiry, and 15/34 (44%) confirmed their role. Forty of 74 articles (54%) reported ?4 items; in 19/40 (48%), we were able to identify an ethics committee, 18/40 (45%) answered our inquiry, and 9/40 (23%) confirmed their role. Reporting five items significantly increased identification of ethics committees (p?=?0.023) and their confirmation of ethical approval (p?=?0.048). Twelve of 74 ethics committees (16%) were unable to confirm their role in approving the study. CONCLUSIONS:Even when details concerning ethical approval were reported in these studies of human research, we were unable to identify almost half of the ethics committees concerned. The reporting of five items, compared with reporting ?4, was associated with facilitated identification of ethics committees, and increased the likelihood that they would be able to confirm the study's approval. Future research should identify which information facilitates identification of, and contact with, ethics committees.

SUBMITTER: Zoccatelli D

PROVIDER: S-EPMC5994111 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Identification of ethics committees based on authors' disclosures: cross-sectional study of articles published in the European Journal of Anaesthesiology and a survey of ethics committees.

Zoccatelli Davide D Tramèr Martin R MR Elia Nadia N

BMC medical ethics 20180608 1

<h4>Background</h4>Since 2010, the European Journal of Anaesthesiology has required the reporting of five items concerning ethical approval in articles describing human research: ethics committee's name and address, chairperson's name, study's protocol number and approval date. We aimed to assess whether this requirement has helped to identify and to contact the referenced ethics committees.<h4>Methods</h4>In this cross-sectional study, we analysed articles requiring ethical approval, according ...[more]

PMID: 29884170

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Project description:OBJECTIVES:To analyse the completeness of reporting of blinding in randomised controlled trials (RCTs) of interventions in anaesthesiology, the actual blinding status of various persons associated with an RCT and trial authors' interpretation of blinding terminology related to RCTs. METHODS:This was a methodological study and a cross-sectional survey. We analysed reporting related to blinding in published RCTs of interventions published in seven highly cited anaesthesiology journals from 2014 to 2016 and registered protocols in ClinicalTrials.gov. We surveyed corresponding authors of included RCTs about their definitions of blinding. The primary outcome was the number of RCTs that explicitly described who was blinded in a trial. Secondary outcomes were definitions of blinding terminology in the trials; trial authors' interpretation of blinding terminology; discrepancies in the blinding description within registered protocols and between registered protocols and publications. RESULTS:Out of 622 analysed RCTs, 38% were not explicitly described as either open label or blinded studies and 10% did not report any information about blinding or lack of blinding. Only one manuscript fully reported the status of blinding for various individuals that may be involved with a trial. The most common descriptor was that a trial was double-blind. We found discrepant information regarding blinding in the majority of registered protocols. Even when there were no discrepancies in the registration, we found discrepancies in the reporting of blinding between the majority of registered protocols and published manuscripts. The survey of authors (40 responses from 231 eligible authors; 17% response rate) of analysed RCTs showed that they differed in how they defined different levels of blinding in trials. CONCLUSIONS:Reporting of the blinding status of key individuals involved in analysed anaesthesiology RCTs was insufficient. For reporting guidelines, peer reviewers and editors should insist on clear information on who was blinded in a trial instead of using the term 'double-blind' for different blinding practices.

Project description:ObjectiveThe extent to which biomedical authors have received training in publication ethics, and their attitudes and opinions about the ethical aspects of specific behaviours, have been understudied. We sought to characterise the knowledge and attitudes of biomedical authors about common issues in publication ethics.DesignCross-sectional online survey.Setting and participantsCorresponding authors of research submissions to 20 journals.Main outcome measuresPerceived level of unethical behaviour (rated 0 to 10) presented in five vignettes containing key variables that were experimentally manipulated on entry to the survey and perceived level of knowledge of seven ethical topics related to publishing (prior publication, author omission, self-plagiarism, honorary authorship, conflicts of interest, image manipulation and plagiarism).Results4043/10 582 (38%) researchers responded. Respondents worked in 100 countries and reported varying levels of publishing experience. 67% (n=2700) had received some publication ethics training from a mentor, 41% (n=1677) a partial course, 28% (n=1130) a full course and 55% (n=2206) an online course; only a small proportion rated training received as excellent. There was a full range (0 to 10 points) in ratings of the extent of unethical behaviour within each vignette, illustrating a broad range of opinion about the ethical acceptability of the behaviours evaluated, but these opinions were little altered by the context in which it occurred. Participants reported substantial variability in their perceived knowledge of seven publication ethics topics; one-third perceived their knowledge to be less than 'some knowledge' for the sum of the seven ethical topics and only 9% perceived 'substantial knowledge' of all topics.ConclusionsWe found a large degree of variability in espoused training and perceived knowledge, and variability in views about how ethical or unethical scenarios were. Ethical standards need to be better articulated and taught to improve consistency of training across institutions and countries.

Project description:OBJECTIVE:Many journals permit authors to submit supplementary material for publication alongside the article. We explore the value, use and role of this material in biomedical journal articles from the perspectives of authors, peer reviewers and readers. DESIGN AND SETTING:We conducted online surveys (November-December 2016) of corresponding authors and peer reviewers at 17 BMJ Publishing Group journals in a range of specialities. PARTICIPANTS:Participants were asked to respond to one of three surveys: as authors, peer reviewers or readers. RESULTS:We received 2872/20340 (14%) responses: authors 819/6892 (12%), peer reviewers 1142/6682 (17%) and readers 911/6766 (14%). Most authors submitted (711/819, 87%) and 80% (724/911) of readers reported reading supplementary material with their last article, while 95% (1086/1142) of reviewers reported seeing these materials sometimes. Additional data tables were the most common supplementary material reported (authors: 74%; reviewers: 89%; readers: 67%). A majority in each group indicated additional tables were most useful to readers (61%-77%); 20%-36%?and 3%-4% indicated they were most useful to peer reviewers and journal editors, respectively. Checklists and reporting guidelines showed the opposite: higher proportions of each group regarded these as most useful to journal editors. All three groups favoured the publication of additional tables and figures on the journal's website (80%-83%), with <4% of each group responding that these do not need to be available. Approximately one-fifth (16%-23%) responded that raw study data should be available on the journal's website, while 24%-33% said that these materials should not be made available anywhere. CONCLUSIONS:Authors, peer reviewers and readers agree that supplementary materials are useful. Supplementary tables and figures were favoured over reporting checklists or raw data for reading but not for study replication. Journals should consider the roles, resource costs and strategic placement of supplementary materials to ensure optimal usage and minimise waste. TRIAL REGISTRATION NUMBER:NCT02961036.

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Identification of ethics committees based on authors' disclosures: cross-sectional study of articles published in the European Journal of Anaesthesiology and a survey of ethics committees.

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Identification of ethics committees based on authors' disclosures: cross-sectional study of articles published in the European Journal of Anaesthesiology and a survey of ethics committees.

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