Global Research Integrity in Relation to the United States' Research-Integrity Infrastructure

Recent global attention to research integrity has led to international meetings and the development of international policies and guidelines. The United States's infrastructure for fostering research integrity (policy, instruction, oversight) has usefully supported these international initiatives. The United States cannot and should not, however, expect other national and global systems to match exactly its approach to research integrity.     

Data-Intensive Science and Research Integrity

In this commentary, we consider questions related to research integrity in data-intensive science and argue that there is no need to create a distinct category of misconduct that applies to deception related to processing, analyzing, or interpreting data. The best way to promote integrity in data-intensive science is to maintain a firm commitment to epistemological and ethical values, such as honesty, openness, transparency, and objectivity, which apply to all types of research, and to promote education, policy development, and scholarly debate concerning appropriate uses of statistics.     

Dealing with Misconduct in Biomedical Research: A Review of the Problems and the Proposed Methods for Improvement

The increasing complexity of scientific research has been followed by increasing varieties of research misconduct. Dealing with misconduct involves the processes of detection, reporting, and investigation of misconduct. Each of these steps is associated with numerous problems which need to be addressed. Misconduct investigation should not stop with inquiries and disciplinary actions in specific episodes of misconduct. It is necessary to decrease the personal price paid by those who expose misconduct and to protect the personal and professional interests of honest researchers accused of misconduct unfairly or mistakenly. There is no dearth of suggestions to improve the objectivity and fairness of investigations. What is needed is the willingness to test the various options and implement the most suitable ones.     

Research Integrity and Conflicts of Interest: The Case of Unethical Research-Misconduct Charges Filed by Edward Calabrese

Special-interest polluters often file research-misconduct (RM) charges against scientists whose research suggests needed pollutant regulation. This article argues that U.S. RM regulations are flawed in requiring RM assessors/experts/accused, but not accusers, to reveal possible conflicts of interest (COI) that could affect RM allegations. It (1) summarizes U.S. RM regulatory history; (2) uses a case study about 2011 RM allegations, filed by chemical-industry-funded toxicologist Edward Calabrese, to illustrate problems with RM regulations; and (3) offers 4 arguments in favor of revising RM regulations so as to require RM-accuser revelation of possible COI and who funded preparation of the RM allegations.     

Prevalence of Industry Support and its Relationship to Research Integrity

Most U.S. clinical trials are funded by industry. Opportunities exist for sponsors to influence research in ways that jeopardize research objectivity. The purpose of this study was to survey U.S. medical school faculty to assess financial arrangements between investigators and industry to learn about investigators' first hand knowledge of the effects of industry sponsorship on research.

Here we show first-hand knowledge that compromises occurred in: research participants' well-being (9%), research initiatives (35%), publication of results (28%), interpretation of research data (25%), and scientific advancement (20%) because of industry support. Financial relationships with industry were prevalent and considered important to conducting respondents' research.     

Assessing the Seriousness of Research Misconduct: Considerations for Sanction Assignment

Federal and institutional policies recommend the criterion of “seriousness” as a guide for sanction assignment in cases where researchers have been found to have committed research misconduct. Discrepancies in assessments of seriousness for similar acts of misconduct suggest the need to clarify what might be meant by the seriousness of research misconduct and how the criterion can be used to assign sanctions. This essay demonstrates how determinations of seriousness can differ depending on the set of ethical appeals employed and argues that an expanded lexicon for talking about the seriousness of research misconduct would help to promote fairness and consistency in sanction assignment. It concludes with some policy recommendations for those charged with research misconduct sanction assignment and for those who oversee research integrity at institutional levels.     

Research Misconduct and Crime Lessons from Criminal Science on Preventing Misconduct and Promoting Integrity

Crime is naught but misdirected energy. So long as every institution of today, economic, political, social, and moral, conspires to misdirect human energy into wrong channels; so long as most people are out of place doing the things they hate to do, living a life they loathe to live, crime will be inevitable.

Emma Goldman, Anarchism and Other Essays

For 200 years, criminologists theorized that delinquent and criminal acts arise from deviant psychological states (such as irrationality or immorality) and/or social conditions that produce these psychological states. This theoretical perspective, which is being duplicated in most efforts to understand and control research misconduct, has not been productive. More recently, criminological perspectives have emerged, emphasizing situational factors that enhance or restrict the opportunity for illegal or imprudent behavior. These so-called “opportunity” theories have been shown to have practical value in reducing crime rates. We explore the promise of these newer theories for the responsible conduct of research (RCR).     

Perceptions of research integrity and the Chinese situation: In-depth interviews with Chinese biomedical researchers in Europe

ABSTRACT

Research misconduct has been a threat to Chinese biomedical research. Despite many publications dealing with research integrity in China, little empirical data is available concerning Chinese biomedical researchers’ perceptions of research integrity and misconduct. To learn more about this issue, we interviewed Chinese biomedical researchers in Europe to investigate their perceptions of this issue. Semi-structured interviews were conducted with 25 participants until data saturation was reached. The findings indicate that certain aspects of research integrity need elaboration among Chinese biomedical researchers. Participants had a vague understanding of general concepts related to research integrity. Data fabrication, data falsification and plagiarism were perceived as the most severe deviance. Inappropriate authorship (especially gift authorship) and ghost writing were regarded as the most prevalent types of research misconduct in Chinese biomedical research. The harms of certain practices, such as inappropriate authorship, salami publication and multiple submission, were not well recognized. Attitudes toward research misconduct were divided. The current scientific evaluation system, pressures of promotion, motives for fame and other factors were perceived as the main reasons for research misconduct. Participants suggested various measures in addition to existing safeguards to improve research integrity in Chinese biomedical research.     

Evaluating U.S. Medical Schools' Efforts to Educate Faculty Researchers on Research Integrity and Research Misconduct Policies and Procedures

This paper examines how well U.S. medical school institutions are doing to promote research integrity. It is an important question to ask in order to determine whether there are sufficient and adequate protections in place to protect the U.S. Public Health Service's (PHS) resources devoted to medical research. This paper focuses on 5,100 medical school researchers' knowledge of what constitutes research misconduct as well as their willingness to report it to the research integrity officer (RIO) and educate their Ph.D. trainees. We learned that 5.6% of researchers could correctly distinguish seven or more of the nine scenarios that depicted likely research misconduct, as defined by the PHS regulations, from scenarios describing other ethical issues. Instead, researchers had expansive definitions and often inappropriately identified infractions such as conflicts of interest, Institutional Review Board (IRB) violations, and other breaches in ethical standards to be research misconduct. In addition, researchers who correctly identified four instances of likely research misconduct in the test items were highly unlikely to report their observations to a RIO. Researchers also provided insight on the factors they believe influence their decision making process of whether to report research misconduct. In addition, this paper also reports on the guidance that faculty said they provided their trainees on research misconduct issues. We conclude with a discussion and recommendations on what institutional leaders might consider doing in order to enhance their research integrity efforts and protect their institution's reputation.     

Responsible Conduct of Research Measure: Initial Development and Pilot Study

Although much discussion has been focused on research misconduct (RM) and questionable research practices, to date no self-report measures exist to examine this phenomenon. To help fill this void, the authors developed the Responsible Conduct of Research Measure (RCRM) through multiple pilot study waves involving researchers in the social and behavioral sciences. Preliminary results reveal adequate validity and reliability. The authors discuss limitations of the study as well as some possible directions for future research on this topic.     

National Scientific Misconduct Policies in Argentina: Two Definitions of Research Misconduct

ABSTRACT

In “An International Study of Research Misconduct Policies”, Resnik et al. count Argentina in the list of countries without national research misconduct policies. In this paper, we clarify that Argentina has national policies of research misconduct and present the research misconduct definitions of two official science organisms: the National Scientific and Technical Research Council (CONICET) and the Ethics Committee of the Argentine Ministry of Science (MINCyT).     

Protecting the Public's Health in An Era of Bioterrorism: The Model State Emergency Health Powers Act

During the fall of 2001, public health law scholars at the Center for Law and the Public's Health at Georgetown and Johns Hopkins Universities were asked by the Centers for Disease Control and Prevention (CDC) and a series of national partners to develop the Model State Emergency Health Powers Act (MSEHPA). The MSEHPA provides a series of modern powers for states to consider in responding to catastrophic public health emergencies, including bioterrorism events. Since December 2001, provisions based on the MSEHPA have been introduced in nearly 40 states and passed in 20. Underlying the development of the act is a long-standing debate between legal and ethical scholars and law- and policymakers as to the appropriate ways to balance individual and communal rights. The drafting challenge was to create a comprehensive model law that provides adequate powers to protect the public's health while also respecting individual and group rights. The MSEHPA empowers public health agents with broad authority and simultaneously limits the exercise of power in time, duration, and scope to accomplish communal goals of abating serious public health threats. Coercive public health powers, particularly isolation and quarantine, are exercised on a temporary basis, only so long as are reasonably necessary and only among persons who justifiably may pose a risk to others because of their contagious conditions. Individual rights to contest the coercive use of public health powers, even during an emergency, are secured.     

Research Misconduct Definitions Adopted by U.S. Research Institutions

In 2000, the U.S. federal government adopted a uniform definition of research misconduct as fabrication, falsification, or plagiarism (FFP), which became effective in 2001. Institutions must apply this definition of misconduct to federally-funded research to receive funding. While institutions are free to adopt definitions of misconduct that go beyond the federal standard, it is not known how many do. We analyzed misconduct policies from 183 U.S. research institutions and coded them according to thirteen different types of behavior mentioned in the misconduct definition. We also obtained data on the institution’s total research funding and public vs. private status, and the year it adopted the definition. We found that more than half (59%) of the institutions in our sample had misconduct policies that went beyond the federal standard. Other than FFP, the most common behaviors included in definitions were “other serious deviations” (45.4%), “significant or material violations of regulations” (23.0%), “misuse of confidential information” (15.8%), “misconduct related to misconduct” (14.8%), “unethical authorship other than plagiarism” (14.2%), “other deception involving data manipulation” (13.1%), and “misappropriation of property/theft” (10.4%). Significantly more definitions adopted in 2001 or later went beyond the federal standard than those adopted before 2001 (73.2% vs. 26.8%), and significantly more definitions adopted by institutions in the lower quartile of total research funding went beyond the federal standard than those adopted by institutions in the upper quartiles. Public vs. private status was not significantly associated with going beyond the federal standard.     

Research misconduct,NSF v NIH: Its nature and prevalence and the impact of their respective methods of investigation and adjudication

ABSTRACT

The National Science Foundation (NSF) and the National Institutes of Health (NIH) have established separate administrative mechanisms for investigation and adjudication of alleged research misconduct.

This report compares research misconduct at NSF and NIH and the possible effects of their respective methods of investigation and adjudication.

Notable and paradoxical findings were identified: NIH supported four times the number of grants as NSF, yet NSF reviewed 2.5 times the number of research misconduct reports. NSF faculty were two-times more likely to be found guilty (88%) than faculty at NIH (42%). 83.6% of NSF offenders were guilty of plagiarism, vs. 4.8% at NIH. NSF trainees made up 6% of the guilty, vs. 42% at NIH. These findings are most likely related to the nature of their respective sciences, scientists, and the nature of their publications.

Investigative policies and procedures are quite similar at these two agencies with the exception of the subpoena power available to the NSF’s Office of the Inspector General (OIG) where it would be infrequently utilized in investigations of its predominant offense, plagiarism. However, it could prove useful if made available to the NIH Office of Research Integrity (ORI) for investigations of fabrication/falsification, its most common offense. Federal criteria for prosecution should be modified to increase the likelihood of prosecution of serious offenders referred by ORI.     

Whistle blowing and research integrity: Potential remedy for research misconduct in Malaysian institutions of higher education

This study found that less than half of the respondents are willing to blow the whistle. The results reveal that a lack of protection with regard to the whistleblower’s identity, the tedious investigative process, and the notion of avoiding confrontation, which is more apparent in Asian cultures as compared to the West, are among the reasons why individuals who witnessed misconduct chose to remain silent. Adhering to the Asian cultural upbringing where the young must respect the old, those of lower rank must obey those with higher authority, and subordinates do not question the actions of their superior, has become a norm even in the working environment. Therefore, emphasize the need for better protection for whistleblowers including using experienced individuals with a research ethics background to handle allegations from whistleblowers. In addition, established guidelines and procedures for whistleblowers with regard to voicing their allegations against colleagues engaged in research misconduct is still lacking or, to a certain extent, is still unknown to researchers. Thus, the concern indicates a need for institutions to create awareness among researchers regarding the existing platform for whistleblowers, or to develop a systematic and clear procedure which is reliable and independent to promote professionalism in academia.     

Both Whistleblowers and the Scientists They Accuse Are Vulnerable and Deserve Protection

Whistleblowers play an important role diagnosing research misconduct, but often experience severe negative consequences. That is also true for incorrectly accused scientists. Both categories are vulnerable and deserve protection. Whistleblowers must proceed carefully and cautiously. Anonymous whistleblowing should be discouraged but cannot be ignored when the allegations are specific, serious, and plausible. When accused of a breach of research integrity it is important to be as transparent as possible. Sometimes accusations are false in the sense that the accuser knows or should know that the allegations are untrue. A mala fide whistleblower typically does not act carefully and we postulate a typology that may help in detecting them. Striking the right balance between whistleblower protection and timely unmasking false and identifying incorrect accusations is a tough dilemma leaders of research institutions have to face.     

What is Recklessness in Scientific Research? The Frank Sauer Case

On May 22, 2017, administrative law Judge Leslie Rogall of the Department of Health and Human Services’ Departmental Appeals Board, Civil Remedies Division, ruled in favor of the Office of Research Integrity (ORI) concerning its decision to charge former University of California at Riverside biochemistry professor Frank Sauer with research misconduct for fabricating or falsifying digital image data included in three papers and seven grant applications submitted to the National Institutes of Health. More specifically, Sauer was deemed responsible for manipulating, reusing, and falsely labeling images of autoradiograms and gels in his research in epigenetics. One month after this decision, ORI announced its final ruling concerning Sauer, which barred him from serving in any advisory capacity to the Public Health Services and required him to retract affected papers. The case raises some interesting and important questions concerning research integrity because it focused on the legal issue of what constitutes recklessness in scientific research.     

Federal agencies can do more to ensure correction of the literature when research misconduct is found

Federal agencies can do more to ensure the integrity of the peer-reviewed literature including providing timely notice of misconduct findings or admissions regarding published articles, requiring the individual found guilty of misconduct to provide notice to affected journals, and to work with the journals and co-authors on making appropriate correction. The case of Andrew Cullinane underscores weakness in the current U.S. government administrative processes and the negative impact on journals.