On "intent" in research misconduct.

Research misconduct, broadly defined as acts of fabrication, falsification and/or plagiarism, violate the value system of science, cost significant wastage of public resources, and in more extreme cases endanger research participants or members of the society at large. Determination of culpability in research misconduct requires establishment of intent on the part of the respondent or perpetrator. However, "intent" is a state of mind, and its perception is subjective, unequivocal evidence for which would not be as readily established compared to the objective evidence available for the acts themselves. Here, we explore the concept of "intent" in research misconduct, how it is framed in criminological/legal terms, and narrated from a psychological perspective. Based on these, we propose a framework whereby lines of questioning and investigation, as defined by legislative terms and informed by the models and tools of psychology, could help in establishing a preponderance of evidence for culpable intent. Such a framework could be useful in research misconduct adjudications and in delivering sanctions.

Post-publication Peer Review with an Intention to Uncover Data/Result Irregularities and Potential Research Misconduct in Scientific Research: Vigilantism or Volunteerism?

Irregularities in data/results of scientific research might be spotted pre-publication by co-workers and reviewers, or post-publication by readers typically with vested interest. The latter might consist of fellow researchers in the same subject area who would naturally pay closer attention to a published paper. However, it is increasingly apparent that there are readers who interrogate papers in detail with a primary intention to identify potential problems with the work. Here, we consider post-publication peer review (PPPR) by individuals, or groups of individuals, who perform PPPRs with a perceptible intention to actively identify irregularities in published data/results and to expose potential research fraud or misconduct, or intentional misconduct exposing (IME)-PPPR. On one hand, such activities, when done anonymously or pseudonymously with no formal discourse, have been deemed as lacking in accountability, or perceived to incur some degree of maleficence, and have been labelled as vigilantism. On the other, these voluntary works have unravelled many instances of research misconduct and have helped to correct the literature. We explore the tangible benefits of IME-PPPR in detecting errors in published papers and from the perspectives of moral permissibility, research ethics, and the sociological perspective of science. We posit that the benefits of IME-PPPR activities that uncover clear evidence of misconduct, even when performed anonymously or pseudonymously, outweigh their perceived deficiencies. These activities contribute to a vigilant research culture that manifests the self-correcting nature of science, and are in line with the Mertonian norms of scientific ethos.

Letter to editor: NLP systems such as ChatGPT cannot be listed as an author because these cannot fulfill widely adopted authorship criteria.

This letter to the editor suggests adding a technical point to the new editorial policy expounded by Hosseini et al. on the mandatory disclosure of any use of natural language processing (NLP) systems, or generative AI, in writing scholarly publications. Such AI systems should naturally also be forbidden from being named as authors, because they would not have fulfilled prevailing authorship guidelines (such as the widely adopted ICMJE authorship criteria).

A Review of Scientific Ethics Issues Associated with the Recently Approved Drugs for Alzheimer's Disease.

Alzheimer's disease (AD), the devastating and most prevailing underlying cause for age-associated dementia, has no effective disease-modifying treatment. The last approved drug for the relief of AD symptoms was in 2003. The recent approval of sodium oligomannate (GV-971, 2019) in China and the human antibody aducanumab in the USA (ADUHELM, 2021) therefore represent significant breakthroughs, albeit ones that are fraught with controversy. Here, we explore potential scientific ethics issues associated with GV-971 and aducanumab's development and approval. While these issues may be belied by socioeconomic and political complexities in the heady business of commercial drug development, they are of fundamental importance to scientific integrity and ultimately, welfare of patients. We posit that the push for approval of both AD drugs based on incomplete research and unconvincing marginal effectiveness is ethically unsound. Regardless of how both these drugs shall perform in the market for the years to come, the scientific ethics issues and potentially questionable research practices should therefore be duly noted and lessons learned.

Research data mismanagement - from questionable research practice to research misconduct.

Good record keeping practice and research data management underlie responsible research conduct and promote reproducibility of research findings in the sciences. In many cases of research misconduct, inadequate research data management frequently appear as an accompanying finding. Findings of disorganized or otherwise poor data archival or loss of research data are, on their own, not usually considered as indicative of research misconduct. Focusing on the availability of raw/primary data and the replicability of research based on these, we posit that most, if not all, instances of research data mismanagement (RDMM) could be considered a questionable research practice (QRP). Furthermore, instances of RDMM at their worst could indeed be viewed as acts of research misconduct. Here, we analyze with postulated scenarios the contexts and circumstances under which RDMM could be viewed as a significant misrepresentation of research (ie. falsification), or data fabrication. We further explore how RDMM might potentially be adjudicated as research misconduct based on intent and consequences. Defining how RDMM could constitute QRP or research misconduct would aid the formulation of relevant institutional research integrity policies to mitigate undesirable events stemming from RDMM.

A research misconduct severity matrix that could serve to harmonize adjudication of findings.

The procedures undertaken to investigate a research misconduct are usually dictated by research ethics and integrity policy, prescribed either by the institute or by the national agency overseeing research. This policy would typically contain information on how an investigation should be conducted, as well as a non-exhaustive list of what constitutes research misconduct. Typically lacking from these policies would be a precise prescription of how the degree of severity of research misconduct could be determined. Adjudication of severity may often be left to the discretion of individual research integrity officers, or a committee of enquiry. Owing to the subjectivity of this process, the conclusion reached could vary between investigating officers/committees, even when adjudicating based on similar evidence. This variation would likely have an impact on the sanctions delivered. We hereby propose a research misconduct severity matrix, which considers eight independent ethical elements with different weightage, each assigned a numerical score by factoring against five different shades of severity (from minor to major). The sum of the scores associated with these elements returns the research misconduct severity score, a numerical value which would aid investigating officers/committees in reaching a consensus on misconduct severity, and better standardize sanctions meted out.

Moral obligations in conducting stem cell-based therapy trials for autism spectrum disorder.

Unregulated patient treatments and approved clinical trials have been conducted with haematopoietic stem cells and mesenchymal stem cells for children with autism spectrum disorder (ASD). While the former direct-to-consumer practice is usually considered rogue and should be legally constrained, regulated clinical trials could also be ethically questionable. Here, we outline principal objections against these trials as they are currently conducted. Notably, these often lack a clear rationale for how transplanted cells may confer a therapeutic benefit in ASD, and thus, have ill-defined therapeutic outcomes. We posit that ambiguous and unsubstantiated descriptions of outcome from such clinical trials may nonetheless appeal to the lay public as being based on authentic scientific findings. These may further fuel caregivers of patients with ASD to pursue unregulated direct-to-consumer treatments, thus exposing them to unnecessary risks. There is, therefore, a moral obligation on the part of those regulating and conducting clinical trials of stem cell-based therapeutic for ASD minors to incorporate clear therapeutic targets, scientific rigour and reporting accuracy in their work. Any further stem cell-based trials for ASD unsupported by significant preclinical advances and particularly sound scientific hypothesis and aims would be ethically indefensible.

Wilfully submitting to and publishing in predatory journals - a covert form of research misconduct?

A predatory journal could be provisionally defined as one masquerading as a genuine academic publication but offer little, if any, rigorous peer review. Predatory journals or publishers place a focus on maximising financial profit, as opposed to regulated dissemination of scientific advancements. As a result, authors can often get their work published in such journals with little scrutiny on quality. Although generally warned against and discouraged, universally practiced sanctions against researchers' submission to and publication in predatory journals are not common. Predatory publishing thus remains prevalent, particularly in places where academic success is measured by the quantity rather than quality of publication output, which feeds the journal's business model that thrives upon significant market demand. However, such an undesirable enterprise has the potential to flood the scientific literature with unsound research that could be misleadingly perceived as authoritative. This may result in or add to the confusion of policy makers and the layperson, consequentially bringing disrepute to science and all parties involved. Here, we argue that wilfully submitting one's manuscript to a predatory journal may constitute an active act of avoidance of rigorous peer review of one's work. If such is the intention, it would be a questionable research practice and could be considered an, albeit covert, form of scientific misconduct. If labelled as such, and with institutional and funding rules erected to discourage the practice, predatory publishing could be effectively put out of business through diminishing the consumer demand.

An alarming retraction rate for scientific publications on Coronavirus Disease 2019 (COVID-19).

The ongoing Coronavirus Disease 2019 (COVID-19) global pandemic has triggered a flurry of associated research publications, numbering to ~137 papers a day since February 2020. This rate of publication appears to be exceptionally high, when compared to research papers published on other similar topics. Searches of COVID-19-associated publications on PubMed and Retraction Watch Database indicate that the retraction record appearance rate for COVID-19-related research is also exceptionally high compared to other related research topics in viral epidemics/pandemics and surpasses the basal level of about 4 in 10,000 papers. This finding serves as a reminder and caution against any lapses in the standard of work, peer review, and publication of COVID-19-related research.