COVID-19 Pandemic in Thailand: Implementing Containment Measures and Their Ethical Challenges

Containment measures have been implemented in Thailand after the country was hit by the Covid-19 pandemic. The top priority is to save people’s lives. Unavoidably, serious consequences that affected the people’s income, privacy, needs, equality, and equity emerged, presenting new challenges. In order to begin to investigate these complex ethical questions, the Office of Research Integrity of National Science and Technology Development Agency organized a meeting in order to bring together key experts in various fields related to the Covid-19 pandemic to discuss what was going on in Thailand and how to manage it properly. Three key ethical settings, each of which caused significant effects, were discussed in the meeting, namely public health, medical services, and research and clinical trial settings. Many key ethical issues were revealed during the meeting, as well as how best to address and manage them properly.

The Violation Imperative Part 1: Allegations and Fraud

In recent decades, a number of high-profile cases involving fraud as research misconduct have been in the media and resulted in severe consequences for those convicted. According to the increased cases of allegations and coverage in the media, this reflects a heightened awareness that fraudulent actions exist.  Nonetheless, the Office of Research Integrity data suggests that despite the growth in the number of the cases of allegation there has not been a commensurate increase in findings of misconduct. The purpose of this paper is to explore misconduct to better understand what it entails. An analysis of misconduct from the perspective of the definitions of allegations and fraud of is conducted and potential frameworks for understanding both are considered. The paper considers serial-positioning effects of primacy and recency on allegation phenomena, as well as supervenience theory and contextualism as a lens for understanding fraud. Discussion of the relational semantics of the core aspects of fraud and de facto grouping of forms of misconduct.  It is concluded that the interrogative pronouns of “what” and “when” could be used to categorize forms of misconduct laying the foundation for the next paper that deconstructs the definition of falsification according to the Public Health Service.

Status of retraction notices for biomedical publications associated with research misconduct

In order to assess the status of retraction notices for publications involving research misconduct, we collected and analyzed information from the Office of Research Integrity website. This site lists confirmed instances of misconduct in research supported by the National Institutes of Health. Over a 10-year period, 200 publications derived from misconduct were identified. For 20.5% of those papers, no retraction notice was published. We found that the majority of these cases were from investigations concluded at least two years before our analysis, and thus are unlikely to be explainable by timing considerations. These findings demonstrate that retraction notices for papers associated with misconduct are often not published and suggest that clear, adherent policies are needed in this circumstance to correct the scientific record.

Peer Review system: A Systematic Review

Peer review process helps in evaluating and validating of research that is published in the journals. U.S. Office of Research Integrity reported that data fraudulence was found to be involved in 94% cases of misconduct from 228 identified articles between 1994–2012. If fraud in published article are significantly as high as reported, the question arise in mind, were these articles peer reviewed? Another report said that the reviewers failed to detect 16 cases of fabricated article of Jan Hendrick Schon. Superficial peer reviewing process does not reveals suspicion of misconduct. Lack of knowledge of systemic review process not only demolish the academic integrity in publication but also loss the trust of the people of the institution, the nation, and the world. The aim of this review article is to aware stakeholders specially novice reviewers about the peer review system. Beginners will understand how to review an article and they can justify better action choices in dealing with reviewing an article.

Life After Research Misconduct

Research misconduct is a serious violation of a scientific community’s ethical standards. Scientists who commit research misconduct typically face corrective actions from employers and funding agencies, as well as significant professional stigma. Unfortunately, there is little systematic data about the post-misconduct career of these guilty parties. Through a review of Office of Research Integrity (ORI) case summaries, I identified a pool of 284 researchers who engaged in research misconduct and were subject to ORI corrective actions. To assess the prevalence of post-misconduct research activities for these scientists, I searched publicly available databases and online resources for evidence of post-misconduct research activities (such as publications and federal research support). The data demonstrate that researchers often receive second chances as researchers, with indicators of post-misconduct research activities identified for 134 (47.18%) of the offending researchers. In addition, those researchers have received more than US$123 million in federal support for their post-misconduct research efforts.

The essential need for research misconduct allegation audits

Nearly ninety percent of allegations of biomedical research misconduct in the United States are dismissed by responsible institutions without any faculty assessment or auditable record. Recently, members of the U.S. Congress have complained that the penalties for those against whom findings of research misconduct are made are too light and that too few grant funds associated with research misconduct have been recovered for use by other researchers and taxpayers. Here we describe the laws that empower federal agencies which can oversee investigations of biomedical research misconduct: the Office of Research Integrity (ORI) and Office of the Inspector General (OIG), both located within the Department of Health and Human Services (HHS). Research misconduct pertaining to U.S. physical sciences funded through the National Science Foundation (NSF) is overseen by the NSF's OIG. While OIGs may provide some improvement over ORI in the handling of research misconduct, we have found that a much more serious flaw exists which undermines an ability to conduct performance audits as to the effectiveness by which allegations of research misconduct are handled in the United States. Federal audit standards (GAGAS/Yellow Book), if applied to the handling of research misconduct, would allow a determination as to whether the handling of allegations of biomedical research misconduct actually functions adequately, and if not, how it might be improved. Specifically, we propose that independent, external peer review under GAGAS audit standards should be instituted without delay in assessing the performance of ORI, or any other similarly tasked federal agency, in handling allegations of research misconduct.

The essential need for research misconduct allegation audits

Nearly ninety percent of allegations of biomedical research misconduct in the United States are dismissed by responsible institutions without any faculty assessment or auditable record. Recently, members of the U.S. Congress have complained that the penalties for those against whom findings of research misconduct are made are too light and that too few grant funds associated with research misconduct have been recovered for use by other researchers and taxpayers. Here we describe the laws that empower federal agencies which can oversee investigations of biomedical research misconduct: the Office of Research Integrity (ORI) and Office of the Inspector General (OIG), both located within the Department of Health and Human Services (HHS). Research misconduct pertaining to U.S. physical sciences funded through the National Science Foundation (NSF) is overseen by the NSF's OIG. While OIGs may provide some improvement over ORI in the handling of research misconduct, we have found that a much more serious flaw exists which undermines an ability to conduct performance audits as to the effectiveness by which allegations of research misconduct are handled in the United States. Federal audit standards (GAGAS/Yellow Book), if applied to the handling of research misconduct, would allow a determination as to whether the handling of allegations of biomedical research misconduct actually functions adequately, and if not, how it might be improved. Specifically, we propose that independent, external peer review under GAGAS audit standards should be instituted without delay in assessing the performance of ORI, or any other similarly tasked federal agency, in handling allegations of research misconduct.

Fraud and misconduct

Fraud and misconduct are firstly introduced by clearly defining the meaning of the two words along with what constitutes good data quality and data integrity. Falsification, Fabrication and Plagiarism are discussed. The concept of how regulators view high quality data is described along with the consequences of falsification. The chapter then goes on to present multiple definitions of fraud and misconduct to show similarities and differences between regulatory authorities in the UK and US as compared to other organisations such as the Royal College of Physicians, the Medical Research Council Policy and UK Research Integrity office. Additionally, five landmark and historical cases are presented to demonstrate what constitutes fraud. The General Medical Counsel's role in protecting public safety by ensuring proper medical standards is described along with the UK Research Integrity Office (UKRIO) and the EU Competent Authority roles in conducting investigations of suspected fraud and misconduct cases. The important roles of whistleblowers are described as well as COPE's role in reviewing published medical journal's research. Practical examples are provided to be used for the detection of fraud as well as specific approaches used by the pharmaceutical industry to detect fraudulent data. In the US, databases are available to conduct searches for individuals who have committed fraud such as the Office of Research Integrity (ORI) and the PHS Administration Action Bulletin Board. Additionally, the process for how fraud and misconduct cases are handled in the UK are discussed along with the options available for regulators, such as the MHRA, on sharing information with the public.

The essential need for research misconduct allegation audits

The percentage of allegations of biomedical research misconduct in the United States that are dismissed by responsible institutions without any faculty assessment or auditable record is near 90%. Recently, members of the U.S. Congress have complained that the penalties for those against whom findings of research misconduct are made are too light and that too few grant funds associated with research misconduct have been recovered for use by other researchers and taxpayers. Here we describe the laws that empower federal agencies which can oversee investigations of biomedical research misconduct: the Office of Research Integrity (ORI) and Office of the Inspector General (OIG), both located within the Department of Health and Human Services (HHS). Research misconduct pertaining to U.S. physical sciences funded through the National Science Foundation (NSF) is overseen by the NSF's OIG. While OIGs may provide some improvement over ORI in the handling of research misconduct, we have found that a much more serious flaw exists which undermines an ability to conduct performance audits as to the effectiveness by which allegations of research misconduct are handled in the United States. Federal audit standards (GAGAS/Yellow Book), if applied to the handling of research misconduct, would allow a determination as to whether the handling of allegations of biomedical research misconduct actually functions adequately, and if not, how it might be improved. Specifically, we propose that independent, external peer review under GAGAS audit standards should be instituted without delay in assessing the performance of ORI, or any other similarly tasked federal agency, in handling allegations of research misconduct.