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.     

International Standards for Research Integrity: An Idea Whose Time has Come?

A movement to promulgate international ethics standards covering areas of conduct other than research with human subjects has now begun to gain momentum. This commentary explains why it is important to develop international research integrity standards and some of the problems that must be overcome to bring them to fruition.     

Inaction over retractions of identified fraudulent publications: ongoing weakness in the system of scientific self-correction

Published articles may be retracted when their findings are no longer considered reliable due to honest error, publication misconduct, or research misconduct. This article focuses on the case of a single serial violator of research and publication ethics in anesthesiology and critical care, which is widely publicized. A chain of events led to detection of misconduct that had substantial impact on the evidence base for the safety of hydroxyethyl starch, an intravenous artificial colloid solution, which is reflected in current guidelines on fluid management and volume resuscitation. As citations to retracted works continue to be a cause for concern, this article reviews the retraction status of this author’s published articles to determine whether sufficient action has been taken to retract his body of work. Results show that retraction practices are not uniform and that guidelines for retraction are still not being fully implemented, resulting in retractions of insufficient quantity and quality. As retractions continue to emerge for the author’s publications, with ten more since 2011, and as they are generally increasing, these data on retractions not only provide findings of misconduct, but also allow us to make inferences about ongoing weaknesses in the system of scientific literature.     

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.     

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.     

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.     

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 Its Federal Regulation: The Origin and History of the Office of Research Integrity—With Personal Views by ORI's Former Associate Director for Investigative Oversight

Misconduct in science and research became the subject of significant public attention and Congressional scrutiny beginning in the 1970s and 1980s, which led to public statements, policies, and finally formal federal regulations being promulgated by Government agency officials. The Office of Research Integrity (ORI) in the Department of Health and Human Services was a major and very visible component of this process. This article provides a detailed history of the first two decades of federal research misconduct regulations and of ORI's history (under extremely difficult and unfair challenges), including personal views by the former ORI chief investigator and associate director.     

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.     

The Scientific Misconduct Questionnaire—Revised (SMQ-R): Validation and Psychometric Testing

Purpose: The overall purposes of this article are to report the development of a survey instrument, Scientific Misconduct Questionnaire-Revised (SMQ-R) that elicits the perceptions of research coordinators managing clinical trials about the various aspects of scientific misconduct and to present the psychometric analyses for the SMQ-R.

Methods: A panel of five researchers and research coordinators reviewed the original SMQ (Rankin and Esteeves, 1997 Rankin, M. and Esteves, M. 1997. Perceptions of scientific misconduct in nursing. Nursing Research, 46(5): 270–276. [PUBMED][CSA][CROSSREF][Crossref] , [Google Scholar]) and suggested an additional 42 items based on the review of the literature and their own experiences in research. The SMQ-Revised (SMQ-R) consists of 68 closed-choice items in six sections and one section with 12 open-ended questions. The SMQ-R was sent to 5302 persons who were members of the Association for Clinical Research Professionals (ACRP) or subscribers to Research Practitioner, published by the Center for Clinical Research Practice (CCRP).

Findings: Internal consistency of subscales was assessed with Cronbach's alpha and ranged from .83 to .84. Confirmatory factor analysis was used to test construct validity of the instrument subscales. The factor structure was assessed with the principal factors method, using the squared multiple correlations as initial communality estimates followed by varimax (orthogonal) or biquartimax (oblique) rotations. Analyses revealed five distinct factors among three subscales. Construct validity for the SMQ-R was also assessed by testing hypothesized relationships using the known groups approach.

Conclusion: The current effort demonstrated the usefulness of the SMQ-R in obtaining information from a national sample of experienced research coordinators about their perceptions of the prevalence of different types of scientific misconduct and of factors that influence the occurrence of misconduct. The psychometric evaluation of the SMQ-R suggests good internal consistency for most subscales and suggests adequate construct validity of the instrument as a whole. The analyses also suggest that further refinement of the instrument for future studies is warranted.     

Researchers’ interpretations of research integrity: A qualitative study

Despite increasing interest in integrity issues, relatively few studies have examined researchers’ own interpretations of integrity. As part of the Perspectives on Research Integrity in Science and Medicine (PRISM) project, we sought to explore how researchers themselves define research integrity. We conducted 33 semi-structured interviews with clinical and laboratory-based researchers from across Switzerland. Data were transcribed and coded using thematic analysis and illustrative quotes were selected. Researchers defined integrity in terms of honesty, transparency, and objectivity, and generally stressed the importance of sticking to the research question and avoiding bias in data interpretation. Some saw research integrity as being synonymous with scientific integrity, but others regarded research integrity as being a subset of the wider domain of scientific integrity. A few participants equated research integrity with mere absence of misconduct, but the majority of participants regarded integrity as being more than this. Researchers regarded truth as the key aspect of integrity, though they expressed this in different ways and with various emphases on honesty, transparency, and objectivity. Integrity goes beyond avoiding misconduct, and scientific integrity has a wider domain than research integrity.     

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.     

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.     

Fostering Integrity in Postgraduate Research: An Evidence-Based Policy and Support Framework

Postgraduate research students have a unique position in the debate on integrity in research as students and novice researchers. To assess how far policies for integrity in postgraduate research meet the needs of students as “research trainees,” we reviewed online policies for integrity in postgraduate research at nine particular Australian universities against the Australian Code for Responsible Conduct of Research (the Code) and the five core elements of exemplary academic integrity policy identified by Bretag et al. (2011 Bretag, T., Mahmud, S., Wallace, M., Walker, R., Green, M., East, J., James, C., McGowan, U. and Partridge, L. 2011. Core elements of exemplary academic integrity policy in Australian higher education. International Journal for Educational Integrity, 7: 3–12.  [Google Scholar]), i.e., access, approach, responsibility, detail, and support. We found inconsistency with the Code in the definition of research misconduct and a lack of adequate detail and support. Based on our analysis, previous research, and the literature, we propose a framework for policy and support for postgraduate research that encompasses a consistent and educative approach to integrity maintained across the university at all levels of scholarship and for all stakeholders.     

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).     

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.     

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.     

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.     

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).