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)

Background: Authors are required to describe in their manuscripts ethical approval from an appropriate committee and how consent was obtained from participants when research involves human participants.Objective: To assess the reporting of these protections for several study designs in general medical journals.Design: A consecutive series of research papers published in the Annals of Internal Medicine, BMJ, JAMA, Lancet and The New England Journal of Medicine between February and May 2003 were reviewed for the reporting of ethical approval and patient consent. (...) Ethical approval, name of approving committee, type of consent, data source and whether the study used data collected as part of a study reported elsewhere were recorded. Differences in failure to report approval and consent by study design, journal and vulnerable study population were evaluated using multivariable logistic regression.Results: Ethical approval and consent were not mentioned in 31% and 47% of manuscripts, respectively. 88 papers failed to report both approval and consent. Failure to mention ethical approval or consent was significantly more likely in all study designs than in randomised controlled trials . Failure to mention approval was most common in the BMJ and was significantly more likely than in The New England Journal of Medicine. Failure to mention consent was most common in the BMJ and was significantly more likely than in all other journals. No significant differences in approval or consent were found when comparing studies of vulnerable and non-vulnerable participants.Conclusion: The reporting of ethical approval and consent in RCTs has improved, but journals are less good at reporting this information for other study designs. Journals should publish this information for all research on human participants. (shrink)

Background: Publication of ethically uncertain research occurs despite well-published guidelines set forth in documents such as the Declaration of Helsinki. Such guidelines exist to aide editorial staff in making decisions regarding ethical acceptability of manuscripts submitted for publication, yet examples of ethically suspect and uncertain publication exist. Our objective was to survey journal editors regarding practices and attitudes surrounding such dilemmas. Methods: The Editor-in-chief of each of the 103 English-language journals from the 2005 Abridged Index Medicus list publishing original research (...) were asked to complete a survey sent to them by email between September-December 2007. Results: A response rate of 33% (n = 34) was obtained from the survey. 18% (n = 6) of respondents had published ethically uncertain or suspect research within the last 10 years. 85% (n = 29) of respondents stated they would always reject ethically uncertain articles submitted for publication on ethical grounds alone. 12% (n = 4) of respondents stated they would approach each submission on a case-by-case basis. 3% (n = 1) stated they would be likely to publish such research, but only with accompanying editorial. Only 38% (n = 13) give reviewers explicit instruction to reject submissions on ethical grounds if found wanting. Conclusions: Editorial compliance with the Declaration of Helsinki in rejecting research that is conducted unethically was difficult to ascertain because of a poor response rate despite multiple attempts using different modalities. Of those who did respond, the majority do reject ethically suspect research but few explicitly advise reviewers to do so. In this study editors did not take advantage of the opportunity to describe their support for the rejection of the publication of unethical research. (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)

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:The right of children to have their voice heard has been accepted by researchers, and there are increasing numbers of qualitative health studies involving children. The ethical and methodological issues of including children in research have caused worldwide concerns, and many researchers have published articles sharing their own experiences.Objectives:To systematically review and synthesise experts’ opinions and experiences about ethical and methodological issues of including children in research, as well as related solution strategies.Research design:The research design was a systematic review of (...) opinion-based evidence, based on the guidelines by Joanna Briggs Institute.Methods:A search of five computerised databases has been conducted in April 2014 and 2271 articles were found. After screening the titles, abstracts, full texts and appraising the quality, 30 articles were finally included in the review. A meta-aggregative approach was applied in the data analysis and synthesis process.Ethical considerations:Ethical approval is not needed as it is a systematic review of published literature.Results:Six themes were identified, including evaluating potential risks and benefits, gaining access, obtaining informed consent/assent, protecting confidentiality and privacy, building rapport and collecting rich data. The similarities and differences between research involving children and that involving adults were indicated.Conclusion:All potential incentives should be justified when designing the study. Further studies need to research how to evaluate individual capacity of children and how to balance protecting children’s right to participate and their interests in the research. Cultural differences related to researching children in different regions should also be studied. (shrink)

Ethical dilemmas are part of medicine, but the type of challenges, the frequency of their occurrence and the nuances in the difficulties have not been systematically studied in low-income settings. The objective of this paper was to map out the ethical dilemmas from the perspective of Ethiopian physicians working in public hospitals. A national survey of physicians from 49 public hospitals using stratified, multi-stage sampling was conducted in six of the 11 regions in Ethiopia. Descriptive statistics were used and the (...) responses to the open-ended question “If you have experienced any ethical dilemma, can you please describe a dilemma you have encountered in your own words?” were analyzed using a template analysis process. A total of 587 physicians responded, and 565 met the inclusion criteria. Twelve of 24 specified ethically challenging situations were reported to be experienced often or sometimes by more than 50% of the physicians. The most frequently reported challenge concerned resource distribution: 93% agreed that they often or sometimes had to make difficult choices due to resource limitation, and 83% often or sometimes encountered difficulties because patients were unable to pay for the preferred course of treatment. Other frequently reported difficulties were doubts about doing good or harming the patient, relating to conflicting views, concern for family welfare, disclosure issues and caring for patients not able to consent. Few reported dilemmas related to end-of-life issues. The 200 responses to the open-ended question mirrored the quantitative results. Ethiopian physicians report ethical challenges related more to bedside rationing and fairness concerns than futility discussions and conflicts about autonomy as described in studies from high-income countries. In addition to the high report of experienced challenges, gravity of the dilemmas that are present in their narratives are striking. Recognition of the everyday experiences of physicians in low-income settings should prompt the development of ethics teaching and support mechanisms, discussion of ethical guidelines as well as increase our focus on how to improve the grave resource scarcity they describe. (shrink)

BackgroundInternational guidelines on research have focused on protecting research participants. Ethical Research Committee (ERC) approval and informed consent are the cornerstones. Externally sponsored research requires approval through ethical review in both the host and the sponsoring country. This study aimed to determine to what extent ERC approval and informed consent procedures are documented in locally and internationally published human subject research carried out in Sri Lanka.MethodsWe obtained ERC approval in Sri Lanka and the United Kingdom. Theses from 1985 to 2005 (...) available at the Postgraduate Institute of Medicine (PGIM) library affiliated to the University of Colombo were scrutinised using checklists agreed in consultation with senior research collaborators. A Medline search was carried out with MeSH major and minor heading 'Sri Lanka' as the search term for international publications originating in Sri Lanka during 1999 to 2004. All research publications from CMJ during 1999 to 2005 were also scrutinized.ResultsOf 291 theses, 34% documented ERC approvals and 61% documented obtaining consent. From the international journal survey, 250 publications originated from Sri Lanka of which only 79 full text original research publications could be accessed electronically. Of these 38% documented ERC approval and 39% documented obtaining consent. In the Ceylon Medical Journal 36% documented ERC approval and 37% documented obtaining consent.ConclusionOnly one third of the publications scrutinized recorded ERC approval and procurement of informed consent. However, there is a positive trend in documenting these ethical requirements in local postgraduate research and in the local medical journal. (shrink)