Addressing researcher fraud: retrospective, real-time, and preventive strategies-including legal points and data management that prevents fraud.

Researcher fraud is often easy and enticing in academic research, with little risk of detection. Cases of extensive fraud continue to occur. The amount of fraud that goes undetected is unknown and may be substantial. Three strategies for addressing researcher fraud are (a) retrospective investigations after allegations of fraud have been made, (b) sting operations that provide conclusive evidence of fraud as it occurs, and (c) data management practices that prevent the occurrence of fraud. Institutional and regulatory efforts to address researcher fraud have focused almost exclusively on the retrospective strategy. The retrospective approach is subject to controversy due to the limitations of post-hoc evidence in science, the difficulty in establishing who actually committed the fraud in some cases, the application of a legal standard of evidence that is much lower than the usual standards of evidence in science, and the lack of legal expertise by scientists investigating fraud. The retrospective strategy may be reliably effective primarily in cases of extensive, careless fraud. Sting operations can overcome these limitations and controversies, but are not feasible in many situations. Data management practices that are effective at preventing researcher fraud and unintentional errors are well-established in clinical trials regulated by government agencies, but appear to be largely unknown or unimplemented in most academic research. Established data management practices include: archiving secure copies of the raw data, audit trails, restricted access to the data and data collection processes, software validation, quality control checks, blinding, preregistration of data processing and analysis programs, and research audits that directly address fraud. Current discussions about data management in academic research focus on sharing data with little attention to practices that prevent intentional and unintentional errors. A designation or badge such as error-controlled data management could be established to indicate research that was conducted with data management practices that effectively address intentional and unintentional errors.

Factors related to the severity of research misconduct administrative actions: An analysis of office of research integrity case summaries from 1993 to 2023.

We extracted, coded, and analyzed data from 343 Office of Research Integrity (ORI) case summaries published in the Federal Register and other venues from May 1993 to July 2023 to test hypotheses concerning the relationship between the severity of ORI administrative actions and various demographic and institutional factors. We found that factors indicative of the severity of the respondent's misconduct or a pattern of misbehavior were associated with the severity of ORI administrative actions. Being required by ORI to retract or correct publications and aggravating factors, such as interfering with an investigation, were both positively associated with receiving a funding debarment and with receiving an administrative action longer than three years. Admitting one's guilt and being found to have committed plagiarism (only) were negatively associated with receiving a funding debarment but were neither positively nor negatively associated with receiving an administrative action longer than three years. Other factors, such as the respondent's race/ethnicity, gender, academic position, administrative position, or their institution's NIH funding level or extramural vs. intramural or foreign vs. US status, were neither positively nor negatively associated with the severity of administrative actions. Overall, our findings suggest that ORI has acted fairly when imposing administrative actions on respondents and has followed DHHS guidelines.

La Oficina de Integridad Científica en España. Una tarea pendiente / The Research Integrity Office in Spain. A pending issue

En los últimos años han salido a la luz muchos casos de mala conducta científica, algunos con importantes consecuencias, que han evidenciado las brechas que globalmente existen en cuanto a integridad científica. En España también se han dado casos notables de mala conducta científica en el ámbito de la investigación biomédica. Sin embargo, hasta el momento no se ha creado un organismo encargado de supervisar las fases de ejecución, análisis y publicación de las investigaciones biomédicas desde un punto de vista ético. Por lo tanto, en este contexto, consideramos que es necesaria la creación de una oficina que supervise la integridad científica en España y que actúe en caso de sospecha de mala conducta científica, llevando a cabo una investigación independiente y con capacidad sancionadora. La existencia de dicho organismo sería de especial importancia en el caso de las investigaciones financiadas con fondos públicos, ya que en ese caso el fraude en investigación supondría la malversación de dinero público. La creación de una oficina que realmente actúe frente a los casos detectados podría tener un efecto disuasorio sobre una potencial mala conducta de algunos investigadores, previniendo así situaciones de mala conducta científica. (AU)

In recent years, many cases of scientific misconduct have come to light, some with considerable consequences, highlighting the existing breaches in the scientific integrity globally. In Spain, there have also been high-profile cases of scientific misconduct. However, so far, no organism or agency has been created to monitor the execution, analysis and publication phases of biomedical research from an ethical point of view. Therefore, in this context, we consider that there is a need for the creation of an office which supervises research integrity in Spain which would act in cases of suspected scientific misconduct, carrying out an independent investigation and proposing public sanctions. The existence of such an organism would be of particular importance in the case of publicly funded research, since in that case research fraud would involve the misappropriation of public funds. The creation of an office that would act on detected cases could have a deterrent effect on potential misconduct by some researchers, thus preventing cases of scientific misconduct. (AU)

[The Research Integrity Office in Spain. A pending issue]. / La Oficina de Integridad Científica en España. Una tarea pendiente.

In recent years, many cases of scientific misconduct have come to light, some with considerable consequences, highlighting the existing breaches in the scientific integrity globally. In Spain, there have also been high-profile cases of scientific misconduct. However, so far, no organism or agency has been created to monitor the execution, analysis and publication phases of biomedical research from an ethical point of view. Therefore, in this context, we consider that there is a need for the creation of an office which supervises research integrity in Spain which would act in cases of suspected scientific misconduct, carrying out an independent investigation and proposing public sanctions. The existence of such an organism would be of particular importance in the case of publicly funded research, since in that case research fraud would involve the misappropriation of public funds. The creation of an office that would act on detected cases could have a deterrent effect on potential misconduct by some researchers, thus preventing cases of scientific misconduct.

Should the Regulation of Research Misconduct Be Integrated with the Ethics Framework Promulgated in The Belmont Report?

The federal research misconduct regulations finalized in 2005 did not incorporate important principles regarding human subjects protections articulated in The Belmont Report, yet research misconduct can involve harms to research subjects and to subsequent patients whose treatments are based on false research findings. Consistency with the Belmont principles would require assuring regular monitoring to detect research misconduct, tracing effects of research misconduct on trial participants and informing them of these effects, and assuring timely correction of published reports of research findings if research misconduct related to the study was subsequently discovered. Research misconduct has historically been viewed as a matter for the scientific community to manage; it is actually a threat to the welfare of human subjects and ethically ought to be treated as such.

Institutional Responsibility and the Flawed Genomic Biomarkers at Duke University: A Missed Opportunity for Transparency and Accountability.

When there have been substantial failures by institutional leadership in their oversight responsibility to protect research integrity, the public should demand that these be recognized and addressed by the institution itself, or the funding bodies. This commentary discusses a case of research failures in developing genomic predictors for cancer risk assessment and treatment at a leading university. In its review of this case, the Office of Research Integrity, an agency within the US Department of Health and Human Services, focused their report entirely on one individual faculty member and made no comment on the institution's responsibility and its failure to provide adequate oversight and investigation. These actions missed an important opportunity to emphasize the institution's critical responsibilities in oversight of research integrity and the importance of institutional transparency and accountability.

Historical model for editor and Office of Research Integrity cooperation in handling allegations, investigation, and retraction in a contentious (Abbs) case of research misconduct.

Cooperation between a journal editor and the federal Office of Research Integrity (ORI) in addressing investigations of research misconduct, each performing their own responsibilities while keeping each other informed of events and evidence, can be critical to the professional and regulatory resolution of a case. This paper describes the history of one of ORI's most contentious investigations that involved falsification of research on Parkinson's disease patients by James Abbs, Professor of Neurology, University of Wisconsin, published in the journal Neurology, which was handled cooperatively by the authors, who were the chief ORI investigator and the Editor-in-Chief of Neurology, respectively.

Financial costs and personal consequences of research misconduct resulting in retracted publications.

The number of retracted scientific articles has been increasing. Most retractions are associated with research misconduct, entailing financial costs to funding sources and damage to the careers of those committing misconduct. We sought to calculate the magnitude of these effects. Data relating to retracted manuscripts and authors found by the Office of Research Integrity (ORI) to have committed misconduct were reviewed from public databases. Attributable costs of retracted manuscripts, and publication output and funding of researchers found to have committed misconduct were determined. We found that papers retracted due to misconduct accounted for approximately $58 million in direct funding by the NIH between 1992 and 2012, less than 1% of the NIH budget over this period. Each of these articles accounted for a mean of $392,582 in direct costs (SD $423,256). Researchers experienced a median 91.8% decrease in publication output and large declines in funding after censure by the ORI.

Fraud and deceit in medical research.

Publication of medical research is the cornerstone for the propagation and dissemination of medical knowledge, culminating in significant effects on the health of the world's population. However, instances of individuals and institutions subverting the ethos of honesty and integrity on which medical research is built in order to advance personal ambitions have been well documented. Many definitions to describe this unethical behavior have been postulated, although the most descriptive is the "FFP" (fabrication, falsification, and plagiarism) model put forward by the United States' Office of Research Integrity. Research misconduct has many ramifications of which the world's media are all too keen to demonstrate. Many high-profile cases the world over have demonstrated this lack of ethics when performing medical research. Many esteemed professionals and highly regarded world institutions have succumbed to the ambitions of a few, who for personal gains, have behaved unethically in pursuit of their own ideals. Although institutions have been set up to directly confront these issues, it would appear that a lot more is still required on the part of journals and their editors to combat this behavioral pattern. Individuals starting out at very junior positions in medical research ought to be taught the basics of medical research ethics so that populations are not failed by the very people they are turning to for assistance at times of need. This article provides a review of many of the issues of research misconduct and allows the reader to reflect and think through their own experiences of research. This hopefully will allow individuals to start asking questions on, what is an often, a poorly discussed topic in medical research.

The American experience: lessons learned.

This paper discusses ten lessons learned since 1989 about handling allegations of scientific misconduct involving biomedical and behavioral research supported by the U.S. Public Health Service.