To identify motivational factors linked to child health status that affected the likelihood of parents’ allowing their child to participate in pediatric research.

Objectives To characterize recruitment approaches to research on the brain and mind that involves Indigenous peoples. Methods We conducted a secondary analysis of a Harding et al. (2021) scoping review. Reviewers screened studies (_n_ = 66) for sampling methods, recruitment and engagement, positionality statements, and details on ethics approvals. Synthesis We identified twenty-nine (29) English-language articles relevant to the analysis. Of these, 52% (_n_ = 15/29) reported a mix of sampling methods; 45% (_n_ = 13/29) contained statements or information about (...) author positionalities. While, overall, 24% (_n_ = 7/29) of the studies were missing information about ethics protocols, we observe an improvement over time in the reporting of approvals and use of community-engaged participant recruitment methods. Current brain research studies demonstrate ways of collaborating with Indigenous communities that meet existing ethics guidelines. To be wholly responsive to the needs of Indigenous peoples, however, researchers may need to exceed existing ethical benchmarks.. Positionality statements successfully detailed the relationships of the research teams with the communities with which they work, and contextualized recruitment methods. Conclusion Improved quality and meaningfulness of brain research with Indigenous peoples and trust in the research process and public health will be enhanced when remaining gaps in protecting and reporting of participant recruitment methods are closed. (shrink)

Background Ethical considerations play a prominent role in the protection of human subjects in clinical research. To date the disclosure of ethical protection in clinical research published in the international nursing journals has not been explored. Our research objective was to investigate the reporting of ethical approval and informed consent in clinical research published in leading international nursing journals. Methods This is a retrospective observational study. All clinical research published in the five leading international nursing journals from the SCI Journal (...) Citation Reports between 2015 and 2017 were retrieved to evaluate for evidence of ethical review. Results A total of 2041 citations have been identified from the contents of all the five leading nursing journals that were published between 2015 and 2017. Out of these, 1284 clinical studies have been included and text relating to ethical review has been extracted. From these, most of prospective clinical studies discussed informed consent. Only half of those reported that written informed consent had been obtained; few reported oral consent, and few used other methods such as online consent or completion and return of data collection to denote assent. Notably, 36.2% of those did not describe the method used to obtain informed consent and merely described that “consent was obtained from participants or participants agreed to join in the research”. Furthermore, whilst most of clinical studies mentioned ethical approval; 92.5% of those stated the name of ethical committee and interestingly, only 37.1% of those mentioned the ethical approval reference. The rates of reporting ethical approval were different between different study type, country, and whether financial support was received. Conclusion The reporting of ethics in leading international nursing journals demonstrates progress, but improvement of the transparency and the standard of ethical reporting in nursing clinical research is required. (shrink)

Background: The objective of this research was to review reporting of ethical concerns and community involvement in peer-reviewed systematic reviews or meta-analyses concerning American Indian, Alaska Native, or Native Hawaiian (AI/AN/NH) health. Methods: Text words and indexed vocabulary terms were used to query PubMed, Embase, Cochrane Library, and the Native Health Database for systematic reviews or meta-analyses concerning AI/AN/NH health published in peer-reviewed journals, followed by a search through reference lists. Each article was abstracted by two independent reviewers; results were (...) discussed until consensus was reached. Results: We identified 107 papers published from 1986 through 2012 that were primarily about AI/AN/NH health or presented findings separately for AI/AN/NH communities. Two reported seeking indigenous reviewer feedback; none reported seeking input from tribes and communities. Approximately 7% reported on institutional review board (IRB) approval of included studies, 5% reported on tribal approval, and 4% referenced the sovereignty of AI/AN tribes. Approximately 63% used evidence from more than one AI/AN/NH population study, and 28% discussed potential benefits to communities from the synthesis research. Conclusions: Reporting of ethics and community involvement are not prominent. Systematic reviews and meta-analyses making community-level inferences may pose risks to communities. Future systematic reviews and meta-analyses should consider ethical and participatory dimensions of research. (shrink)

Objective Cluster randomised trial (CRT) investigators face challenges in seeking informed consent from individual patients (cluster members). This study examined associations between reporting of patient consent in healthcare CRTs and characteristics of these trials. Study design Consent practices and study characteristics were abstracted from a random sample of 160 CRTs performed in primary or hospital care settings that were published from 2000 to 2008. Multivariable logistic regression was used to examine associations between reporting of patient consent and methodological characteristics, as (...) well as publication features such as date and journal of publication. Results 82 (53.8%) of 160 studies reported obtaining informed consent from individual patients. Reporting of patient consent was independently and positively associated with: smaller cluster size, the evaluation of experimental interventions targeted at patients, data collection from individual patients, publication later than 2004 and publication in higher-impact journals. Conclusions Reporting of consent practices in published CRTs should be improved. Consent practices in published CRTs appear to be related to the type of interventions under study, as well as journal impact and trends in research ethics practices. These findings will inform best practices in trial conduct and ethics review, remediation of errors in consent practices and ethics review and the development of regulatory guidance for CRTs. (shrink)

Ethical research conduct is a cornerstone of research practice particularly when research participants include vulnerable populations. This study mapped the extent of reporting ethical research practices in studies conducted among refugees and war-affected populations in the Arab World, and assessed variations by time, country of study, and study characteristics. An electronic search of eight databases resulted in 5668 unique records published between 2000 and 2013. Scoping review yielded 164 eligible articles for analyses. Ethical research practices, including obtaining institutional approval, access (...) to the community/research site, and informed consent/assent from the research participants, were reported in 48.2, 54.9, and 53.7% of the publications, respectively. Institutional approval was significantly more likely to be reported when the research was biomedical in nature compared to public health and social, when the study employed quantitative compared to qualitative or mixed methodologies, and when the journal required a statement on ethical declarations. Institutional approval was least likely to be reported in papers that were sole-authored, when these did not mention a funding source, or when published in national journals. Similar results were obtained for access to the community site and for seeking informed consent/assent from study participants. The responsibility of inadequacies in adherence to ethical research conduct in crisis settings is born by a multitude of stakeholders including funding agencies, institutional research boards, researchers and international relief organizations involved in research, as well as journal editors, all of whom need to play a more proactive role for enhancing the practice of ethical research conduct in conflict settings. (shrink)

The expansion of ethics review, beyond its origins in medical research, is the subject of growing critical analysis internationally, especially from social science researchers. Our study builds on this analysis by considering ethics review specifically within tertiary-based educational research. As a foundation for a larger study, we explore the reporting of ethics review within articles from a snapshot of education journals. A cross-sectional review considered 125 articles from 24 journals spanning medical and nurse education, the Scholarship of Teaching and Learning, (...) and educational technology. Among similar types of research our findings highlight variation in institutional ethical review processes and outcomes. Despite most journals providing guidelines for reporting ethics review, adherence to these guidelines by authors or editors was not always evident, but more likely in health-related education journals. We argue that identified areas of variation may reflect the differing influence and proximity of biomedical values. This influence has been under examined in tertiary-based educational research but may contribute to inequitable learning, researching and publishing experiences, potentially adding to negative sentiment about ethics review. (shrink)

BackgroundPrevious studies have indicated that failure to report ethical approval is common in health science articles. In social sciences, the occurrence is unknown. The Swedish Ethics Review Act requests that sensitive personal data, in accordance with the EU General Data Protection Regulation (GDPR), should undergo independent ethical review, irrespective of academic discipline. We have explored the adherence to this regulation. MethodsUsing the Web of Science databases, we reviewed 600 consecutive articles from three domains (health sciences with and without somatic focus (...) and social sciences) based on identifiable personal data published in 2020. ResultsInformation on ethical review was lacking in 12 of 200 health science articles with somatic focus (6%), 21 of 200 health science articles with non-somatic focus (11%), and in 54 of 200 social science articles (27%; p < 0.001 vs. both groups of health science articles). Failure to report on ethical approval was more common in (a) observational than in interventional studies (p < 0.01), (b) articles with only 1–2 authors (p < 0.001) and (c) health science articles from universities without a medical school (p < 0.001). There was no significant association between journal impact factor and failure to report ethical approval.ConclusionsWe conclude that reporting of research ethics approval is reasonably good, but not strict, in health science articles. Failure to report ethical approval is about three times more frequent in social sciences compared to health sciences. Improved adherence seems needed particularly in observational studies, in articles with few authors and in social science research. (shrink)

Background:It is acknowledged that publishers now require all primary research papers to demonstrate that they have obtained ethical approval for their research.Objectives:To assess the rate of reporting of ethical approval in clinical trials in core nursing journals in mainland China.Research design:A retrospective observational study.Participants:All clinical trials published in all of the 12 core nursing periodicals from 2016 edition China Science and Technology Journal Citation Report (core version) between 2013 and 2016 were retrieved by hand to explicate rate of reporting ethical (...) approval and informed consent.Ethical considerations:The study did not require approval from the research ethics committee as it did not involve human subjects or records.Results:In total, 40,278 papers were published in 12 nursing periodicals between 2013 and 2016. Out of these, 9488 (23.6%) focused on clinical trials. Informed consent obtained from patients or the legally authorized representative was reported in 51.8% of clinical trials. Notably, only 27.4% of clinical trials reported that they had obtained written consent. Furthermore, 25.9% of clinical trials described ethical approval; however, the rate of reporting informed consent and ethical approval in these 12 nursing journals in China during 4 years from 2013 to 2016 improved markedly, with 38.1%, 44.0%, 59.0% and 66.6%, respectively ( p < 0.001), and 17.6%, 21.9%, 28.6% and 35.8%, respectively ( p < 0.001). In addition, both reporting informed consent and reporting written informed consent had a positive significant correlation with the reporting ethical approval ( p < 0.05 or < 0.01).Conclusion:Chinese scientific nursing journals have improved the rate of reporting informed consent and ethical approval in clinical trials during the last 4 years. However, it should be noted that nearly half of clinical trials still did not report either ethical approval or whether informed consent was obtained. Efforts from editors, researchers, sponsors and authors are needed to ensure the transparency of ethical scrutiny and adherence to ethical guidelines in publishing clinical trials in Chinese nursing journals. (shrink)

Background Regulations on research ethics in France have evolved considerably over the past four years: the implementation of the Jardé law and of the General Data Protection Regulations have changed the landscape of research ethics for research involving or not involving human persons. In a context of creation of an Institutional Review Board at the University of Bordeaux, France, we sought to explore research ethics practices and perceptions in the medical community of our University Hospital. Methods A short questionnaire was (...) sent to all physicians of the University Hospital of Bordeaux. The questionnaire included closed questions and main topics were: physicians’ education in research ethics, ethics practices concerning researches non implying human persons, and physicians’ perceptions about current regulations. Results 86 questionnaires were sent back. If a majority of physicians have validated Good Clinical Practices trainings, there was a low rate of specific training on fundamental references in research ethics and a high proportion of responders do not consider themselves as educated in research ethics after completion of GCPs. Regulations on research ethics have many implications on medical research, especially by inducing changes in protocols in order to alleviate ethical requirements. Malpractices were acknowledged like false mention of positive opinion from an ethics committee. If If a majority of responders considers regulations as a positive answer to research ethics, a large majority considers it as a constraint and a complexification of research process. For 58%, regulations in research ethics are perceived as a hindrance for research initiatives. Conclusion Because of their impact on research process, regulations seem to constitute a scarecrow for physicians. Lack of training, bad representations and questionable practices highlight the need to improve education and to propose concrete guidance for medical researchers. (shrink)

Background Disclosure of obtaining informed consent from patients (ICP) and research ethics committee (REC) approval in published reports is sometimes omitted. To date, no disclosure data are available on surgical research. Objective Our aim was to assess whether REC approval and ICP were documented in surgical trials. Study design Overall, 657 randomised trials, published between 2005 and 2010 in 10 international journals, were included. We collected the report rate of REC approval and ICP and contacted the corresponding author when ethical (...) information was lacking. Results Among the 657 randomised controlled trials (RCT), 576 (87.7%) stated that an REC had approved the research, and 606 (92.2%) stated that ICP had been requested. Furthermore, 28 RCTs (4.3%) reported neither REC nor ICP. Conclusions The phase III randomised surgical trials that were analysed were shown to have respected fundamental ethical principles in approximately 90% of the cases examines. (shrink)

Researchers should strictly consider the participants’ rights. They are required to document such protections as an ethical approval of the study proposal, the obtaining “informed consent”, the authors’ “conflict of interests”, and the source of “financial support” in the published articles. The purpose of this study was to assess the frequency of reporting ethical issues in human subject articles published in Iranian medical journals during 2009–2013. In this cross-sectional study, we randomly reviewed 1460 human subject articles published in Iranian medical (...) journals during 2009–2013 in two Persian and English language groups. Data collection was carried out by assessing articles, focusing on the documentation “ethics committee approval”, patients’ “informed consent”, “financial support”, “confidentiality”, and “conflict of interest”. Of 1460 evaluated articles, 443 reported “ethics committee approval”, 686 reported “informed consent”, 594 reported “financial support”, and 341 reported “conflict of interest”. 13% of the articles referred to patients’ confidentiality in their text. There was a significant association between these ethical documentations and the year of publication. Articles published in English language journals reported “ethics committee approval”, “financial support”, and “conflict of interest” significantly more than Persian language journals, but the frequency of “informed consent” was similar. Ethical documentation rate in Iranian medical journals is not up to the expected standards of reputable journals which might be related to a lack of awareness and the education of the authors and the journal’s editors. Precise reporting of ethical considerations in medical articles by authors are recommended. It is suggested journals and policymakers pay more attention to reporting this issue while providing standard guidelines in this regard. (shrink)

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. 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. Of 76 articles requiring ethical approval, 74 declared it. Ethics committees’ names and addresses were mentioned in 63/74, protocol numbers in 51/74, approval dates in 48/74, and chairpersons’ names in 45/74. We could identify 44/74 committees; 36/74 answered our inquiry and 24/74 confirmed their role. Thirty-four of 74 articles reported all five items; in 25/34, we were able to identify an ethics committee, 18/34 answered our inquiry, and 15/34 confirmed their role. Forty of 74 articles reported ≤4 items; in 19/40, we were able to identify an ethics committee, 18/40 answered our inquiry, and 9/40 confirmed their role. Reporting five items significantly increased identification of ethics committees and their confirmation of ethical approval. Twelve of 74 ethics committees were unable to confirm their role in approving the study. 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. (shrink)

ObjectivesTo describe reporting of informed consent in pragmatic trials, justifications for waivers of consent and reporting of alternative approaches to standard written consent. To identify factors associated with (1) not reporting and (2) not obtaining consent.MethodsSurvey of primary trial reports, published 2014–2019, identified using an electronic search filter for pragmatic trials implemented in MEDLINE, and registered in ClinicalTrials.gov.ResultsAmong 1988 trials, 132 (6.6%) did not include a statement about participant consent, 1691 (85.0%) reported consent had been obtained, 139 (7.0%) reported a (...) waiver and 26 (1.3%) reported consent for one aspect (eg, data collection) but a waiver for another (eg, intervention). Of the 165 trials reporting a waiver, 76 (46.1%) provided a justification. Few (53, 2.9%) explicitly reported use of alternative approaches to consent. In multivariable logistic regression analyses, lower journal impact factor (p=0.001) and cluster randomisation (p<0.0001) were significantly associated with not reporting on consent, while trial recency, cluster randomisation, higher-income country settings, health services research and explicit labelling as pragmatic were significantly associated with not obtaining consent (all p<0.0001).DiscussionNot obtaining consent seems to be increasing and is associated with the use of cluster randomisation and pragmatic aims, but neither cluster randomisation nor pragmatism are currently accepted justifications for waivers of consent. Rather than considering either standard written informed consent or waivers of consent, researchers and research ethics committees could consider alternative consent approaches that may facilitate the conduct of pragmatic trials while preserving patient autonomy and the public’s trust in research. (shrink)