The upcoming Regulation No 536/2014 on clinical trials on medicinal products for human use, 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. (shrink)

Although empirical evidence may provide a much desired sense of certainty amidst a pandemic characterised by uncertainty, the vast gamut of available COVID-19 data, including misinformation, has instead increased confusion and distrust in authorities’ decisions. One key lesson we have been gradually learning from the COVID-19 pandemic is that the availability of empirical data and scientific evidence alone do not automatically lead to good decisions. Good decision-making in public health policy, this paper argues, does depend on the availability of reliable (...) data and rigorous analyses, but depends above all on sound ethical reasoning that ascribes value and normative judgement to empirical facts. (shrink)

BackgroundPatients with COVID-19 may feel under pressure to participate in research during the pandemic. Safeguards to protect research participants include ethical guidelines [e.g. Declaration of Helsinki and good clinical practice (GCP)], legislation to protect participants’ privacy, research ethics committees (RECs) and informed consent. The International Committee of Medical Journal Editors (ICMJE) advises researchers to document compliance with these safeguards. Adherence to publication guidelines has been suboptimal in other specialty fields. The aim of this rapid review was to determine whether COVID-19 (...) human research publications report compliance with these ethical safeguards.MethodsA rapid systematic literature review was conducted in MEDLINE using the search term ‘COVID-19’. The search was performed in April 2020 with no start date and repeated to include articles published in November 2020. Filters were ‘Full free text available’ and ‘English Language’. Two reviewers assessed article title, abstracts and full texts. Non-COVID-19 articles and non-clinical studies were excluded. Independent reviewers conducted a second assessment of a random 20% of articles. The outcomes included reporting of compliance with the Declaration of Helsinki and GCP, REC approval, informed consent and participant privacy.ResultsThe searches yielded 1275 and 1942 articles of which 247 and 717 were deemed eligible, from the April search and November respectively. The majority of journals had editorial policies which purported to comply with ICMJE ethical standards. Reporting of compliance with ethical guidelines was low across all study types but was higher in the November search for case series and observational studies. Reporting of informed consent for case studies and observational studies was higher in the November search, but similar for case series. Overall, participant confidentiality was maintained but some case studies included a combination of details which would have enabled participant identification. Reporting of REC approval was higher in the November search for observational studies.ConclusionsWhile the majority of journal’s editorial policies purported to support the ethical safeguards, many COVID-19 clinical research publications identified in this rapid review lacked documentation of these important safeguards for research participants. In order to promote public trust, ethical declarations should be included consistently. (shrink)

Academic integrity is an essential pillar of any educational system. It is defined as acting in a manner consistent with the values and accepted standards of ethical practices in teaching, learning, and scholarship (Fishman, 2015). Contract cheating, or ghostwriting, is currently one of the most severe violations of academic integrity. It involves students engaging a third party, usually an online essay writing service, to complete their academic works on their behalf (Draper et al., 2021). Some of these services offer pre-written (...) essays, whereas others offer bespoke custom-written essays. According to the academic literature, the advent of the internet and digital technologies underlay this rapid deterioration of academic integrity (Ison, 2020; Lancaster & Clarke, 2014). Different learning environments, such as face-to-face (i.e., a learning environment involving the physical presence of both instructor and students) and online web-based (i.e., teaching mode that takes place partially or entirely over the internet), have been shown to affect academic integrity in different ways (Eshet et al., 2021). While contract cheating is common in both conventional face-to-face (F2F) and online settings, it is more likely to take place in the latter (Lancaster & Clarke, 2014; Slade et al., 2018). There are several possible explanations for why online students engage in contract cheating more often than F2F students. In particular, this includes the problem issue of psychological distance, which adversely affects interpersonal relationships; and the problem issue of moral distancing, because the internet can obscure the line between academically honest and dishonest behavior (Sharma & Maleyeff, 2003). These issues were further exacerbated by the sudden shift from F2F to emergency remote teaching (ERT) in response to the COVID-19 pandemic (Ahsan et al., 2021; Bjelobaba, 2021). Indeed, contract cheating had become a significant COVID-19 side effect for higher education institutions. In contrast to the well-planned F2F or online learning courses, ERTbased courses are not originally designed to be delivered virtually (Fatonia et al., 2020). The chaos brought by the abrupt campus closure and related unexpected transition to ERT provided both the opportunity and the incentive for contract cheating (Hill et al., 2021). Through social media, students have very quickly become fully aware of the possibilities of a wide variety of options to carry out Plagiarism (Bautista et al., 2022). There has been an increase in ways to try to bypass text-matching or text-reuse (i.e., plagiarism) detection systems, for example using micro-spaces, white ink, punctuation, and typos (Abdelhamid et al., 2022). Even though ghostwriters, especially commercial ones, claim their essays are original and therefore cannot be detected using text-matching software, third-party assignments may still contain recycled text (Aitken et al., 2017; Newton & Lang, 2015). Text matching detection software could use these breaches to identify outsourced academic work (Lancaster & Clarke, 2016; Wang & Xu, 2021). This study compared about four thousand term papers written in languages other than Hebrew. (shrink)