Research misconduct and the scientific process: continuing quality improvement

The response to research misconduct involves the attempt to regulate behavior through (a) creating and enforcing a rule and (b) ethics education. The roles of each must be shaped by considerations of the nature of scientific practice. Given the nature of science, the role of (a) must be limited in scope: both in the types of behavior it covers and in the level of intent that must be present for an allegation of misconduct to be proven. Since one important role of ethics education is to fill the gaps that regulatory rules leave open, it is this limitation in scope and its source in theoretical concerns that better reveals the type and kind of education needed. It is argued that much of the current ethics education falls short. Since the gaps left by the rule are largely due to theoretical concerns about the very nature of the scientific process and the nature of that process is constantly evolving, ethics education must focus more heavily on theory and must reach a wider audience. It is argued that ethics education can be more effective if it aims, in part, in creating a discipline-specific, constantly evolving standard of care.     

Associations between attitudes towards scientific misconduct and self-reported behavior

We investigate the relationship between doctoral students’ attitudes towards scientific misconduct and their self-reported behavior. 203 questionnaires were distributed to doctoral candidates at the Faculty of Medicine, University of Oslo 2016/2017. The response rate was 74%. The results show a correlation between attitudes towards misconduct and self-reported problematic behaviors among doctoral students in biomedicine. The four most common reported misbehaviors are adding author(s) who did not qualify for authorship (17.9%), collecting more data after seeing that the results were almost statistically significant (11.8%), turning a blind eye to colleagues’ use of flawed data or questionable interpretation of data (11.2%), and reporting an unexpected finding as having been hypothesized from the start (10.5%). We find correlations between scientific misbehavior and the location of undergraduate studies and whether the respondents have had science ethics lectures previously. The study provides evidence for the concurrent validity of the two instruments used to measure attitudes and behavior, i.e. the Kalichman scale and the Research Misbehavior Severity Score (RMSS). Although the direction of causality between attitudes and misbehavior cannot be determined in this study the correlation between the two indicates that it can be important to engender the right attitudes in early career researchers.     

Evaluating research misconduct policies at major research universities: a pilot study

This pilot study evaluates the accessibility and usefulness of the research misconduct (RM) policies at the top-25 universities as ranked by NIH and NSF grant awards. Measuring accessibility demonstrates how readily-available policies are to the people they affect. Evaluating the range of policy content indicates whether policies and procedures on research misconduct are "useful" as opposed to merely "minimal" (Rhoades, 2003). On average, it took five clicks to get from a university's home page to its RM policies. Only nine policies were accessed within three or fewer clicks. Policy information was coded into categories comprising a total of 20 topic areas, which were then grouped into five content domains. The policies reveal a broad range of usefulness. Some provide relevant details on almost every topic area, while others leave most questions unanswered. Three of the 20 topic areas are almost universally covered in the policies analyzed. In contrast, five other topic areas average less than half of the information which could have been included. These policies, from elite U.S. research universities, may serve as role models; as such they should perhaps be held to the highest standards. If the message sent by a policy lacks clarity and precision, it should be revised to include an appropriate level of detail.     

Evaluating research misconduct policies at major research universities: A pilot study

This pilot study evaluates the accessibility and usefulness of the research misconduct (RM) policies at the top-25 universities as ranked by NIH and NSF grant awards. Measuring accessibility demonstrates how readily-available policies are to the people they affect. Evaluating the range of policy content indicates whether policies and procedures on research misconduct are “useful” as opposed to merely “minimal” (Rhoades, 2003 Rhoades, L. J. Policies and Procedures: Minimal or Useful. Presentation to the introductory workshop for institutional research integrity officers. University of Connecticut Health Center.  [Google Scholar]). On average, it took five clicks to get from a university's home page to its RM policies. Only nine policies were accessed within three or fewer clicks. Policy information was coded into categories comprising a total of 20 topic areas, which were then grouped into five content domains. The policies reveal a broad range of usefulness. Some provide relevant details on almost every topic area, while others leave most questions unanswered. Three of the 20 topic areas are almost universally covered in the policies analyzed. In contrast, five other topic areas average less than half of the information which could have been included. These policies, from elite U.S. research universities, may serve as role models; as such they should perhaps be held to the highest standards. If the message sent by a policy lacks clarity and precision, it should be revised to include an appropriate level of detail.     

From Baltimore to Bell Labs: reflections on two decades of debate about scientific misconduct

This essay proposes a new definition of scientific "misconduct," which is broader than the definition recently adopted by the U.S. government. According to the proposed definition, misconduct is a serious and intentional violation of accepted scientific practices, commonsense ethical norms, or research regulations in proposing, designing, conducting, reviewing, or reporting research. Punishable misconduct includes fabrication of data or experiments, falsification of data, plagiarism, or interference with a misconduct investigation. Misconduct does not include honest errors, differences of opinion, or ethically questionable research practices.     

Research misconduct and crime lessons from criminal science on preventing misconduct and promoting integrity

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).     

Scientific misconduct: Undue process

Numerous professional societies, universities, research funding sources, federal agencies, and Congressional committees have expressed concern about an apparent increasing incidence of scientific misconduct. Many of these organizations also have published standards for defining such misconduct and their procedures for investigating allegations of scientific misconduct. The futility of these procedures is illustrated by an example of blatant data falsification and fabrication in two different research projects conducted by a single researcher. The problem derives from administrative and judicial systems which have evolved to a stage where they are more concerned with process than outcome. An alternative to the resulting interminable “due process”; of the present system is tentatively suggested.     

NSF's approach to misconduct in science

At the National Science Foundation (NSF), the investigation of allegations of misconduct in science is the responsibility of the Office of Inspector General (OIG). NSF's procedures distinguish between the preliminary inquiry and the formal investigation. They also distinguish these stages from the adjudication stage, which is the responsibility of the Office of the Director of NSF rather than of OIG. If an investigation seems warranted, OIG usually asks the university that employs the accused person to perform it, after which OIG reviews the university's investigation report. NSF in effect is asking universities to move from an informal to a formal method of dealing with misconduct in science allegations. This transition is not yet complete. Universities encounter many difficulties in investigating misconduct allegations, in particular when they try to assess an individual's intent. About half of the allegations NSF receives have to do with intellectual property violations, and most of the findings of misconduct that NSF has made were in connection with plagiarism. One plagiarism case illustrates some aspects of the problem of intent.     

The role of culture in research misconduct

There seems to be a taboo against discussing the role culture or national origin might play in research misconduct. Still, some observers wonder why so many scientists representing foreign cultures are among those found guilty of misconduct. Even after examining the scant available data, whether foreign nationals are disproportionately represented among Office of Research Integrity (ORI) respondents remains unclear. The lack of data, however, does not negate culture as a possible explanatory variable in research misconduct. Applying theories from sociological criminology, the author posits that the culture some researchers bring may be at odds with the norms of academic science and may emphasize ends more than means. As such, culture simply may be one of several etiological factors in research misconduct and should be considered in the spirit of objective scientific inquiry. Acknowledging the role of culture in the adherence to research ethics underscores the importance of education and training of both researchers and administrators in the responsible conduct of research and cultural diversity.     

Research records and the resolution of misconduct allegations at research universities

Accurate record keeping is an important part of the responsible conduct of research. However, there is very little empirical research on scientific record keeping. No one knows the incidence of serious problems with research records, the types of problems that occur, nor their consequences. In this study, we examined the role of research records in the resolution of misconduct allegations as a useful barometer for the incidence and types of problems that occur with records. We interviewed Research Integrity Officers (RIOs) at 90 major research universities and conducted focus groups with active research faculty. RIOs reported problems with research records in 38% of the 553 investigations they conducted. Severe problems with research records often prevented completion of investigations while problems that are more typical lengthened them by 2 to 3 weeks. Five types of poor record keeping practices accounted for 75 % of the problems with incomplete/inadequate records being the most common (30%). The focus groups concurred with the findings from the interviews with RIOs, stressed the importance of the research group leader in setting and maintaining record practices, and offered additional insights. While university officials and faculty members have suspected for many years that there are serious problems with research record keeping, our study provides empirical evidence for this belief. By documenting some of the problems with record keeping in university-based research, the results of our study provide information that will be useful for policy development at academic institutions.     

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.     

Reforming the oversight of multi-site clinical research: a review of two possible solutions

The current system for the ethical oversight of clinical research suffers from structural, procedural, and performance assessment problems. Initially conceived primarily to handle local investigator-initiated single-site studies, the system of institutionally-based committee review has become progressively more inefficient given the increased prevalence of commercially or federally sponsored multi-center trials. To date, proposed solutions do not adequately address these problems. Beginning with a review of these structural, procedural, and performance assessment problems, this article will then consider two proposals for addressing these deficiencies: (a) regional ethics organizations; and (b) IRBNet, a newly developed web-based program for cooperative IRB review. The strengths and weaknesses of these two approaches will be evaluated in light of recent experience with centralized review. The proposal to establish a system of regional ethics organizations presents a comprehensive approach to many of the problems faced by the current system. However, IRBNet offers an immediate and feasible solution to many of the problems faced by the review of multi-site clinical studies.     

The Canadian agency for the oversight of research involving humans: a reform proposal

In this paper, I propose the creation of a Canadian agency for the oversight of research involving humans. I describe first a series of significant problems with Canada's current system of oversight. I then argue for the creation of a national-level agency, covering all research involving humans, with three branches (policy and standards, education, and compliance). Of particular note, the proposed compliance branch consists of a number of independent national and regional Research Ethics Boards (i.e., REBs no longer reside within institutions). There is also an Audit Committee and a Non-compliance Committee (with supporting staff of auditors and compliance officers) to ensure compliance with the policies and standards set by the Policy and Standards Branch. Finally, I answer a series of "frequently asked questions" about the proposed agency design such as "What about 'local context'?" and "Why not have a system of accreditation of institutional REBs instead?" In sum, radical reform is needed and, in this paper, I present a proposal for such reform.