History has demonstrated the necessity of protecting research participants. Research ethics are based on a concept of asymmetry of power, viewing the researcher as powerful and potentially dangerous and establishing ethics committees as external agencies in the field of research. We argue in favour of expanding this perspective on relationships of power to encompass the ethics committees as one among several actors that exert power and that act in a relational interplay with researchers and participants. We employ Michel Foucault’s ideas (...) of power as an omnipresent force which is dynamic and unstable, as well as the notion that knowledge and power are inextricably intertwined. The article discusses how research ethics committees may affect academic freedom. In addition it is pointed out that research participants could be harmed — not only by unfortunate research practices, but also by being subjected to the protective efforts of ethics monitoring bodies. (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)

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)

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)

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)