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.     

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 role of federal regulations in assuring research integrity

The federal government has a proper interest in research integrity. Regulations have had effects on scientists and institutions; some appear to have been beneficial, such as recent educational efforts; others have augmented bureaucracy and sowed divisiveness. The federal oversight bureaucracy should be subject to the sunset provision.

Participation by the community is essential to the development of effective regulations, but ethical issues should be dealt with by professional standards, not laws. It is argued that the scientific community had begun to respond to public concerns when change was accelerated by regulation, and that change from within is most effective.     

A Theoretical Comparison of the Models of Prevention of Research Misconduct

The current methods of dealing with research misconduct involve detection and rectification after the incident has already occurred. This method of monitoring scientific integrity exerts considerable negative effects on the concerned persons and is also wasteful of time and resources. Time has arrived for research administrators to focus seriously on prevention of misconduct. In this article, preventive models suggested earlier by Weed and Reason have been combined to arrive at six models of prevention. This is an effort to streamline the thinking regarding misconduct prevention, so that the advantages and disadvantages of each can be weighed and the method most appropriate for the institute chosen.     

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.     

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.     

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.     

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.     

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.     

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).     

Statistics,ethics, and research: An agenda for education and reform

This essay argues that the research community needs to pay more attention to the appropriate use of statistical methods in discussions of research ethics, and proposes some strategies for enhancing discussions of the ethical uses of statistics within investigational, educational, and organizational settings. The essay supports its position by 1) explaining why statistics plays such a key role in research integrity, 2) describing how some common misuses of statistics in research violate ethical standards pertaining to honesty and error avoidance, and 3) reviewing evidence which suggests that the misuse of statistics is more prevalent (and perhaps more significant) than research misconduct (narrowly defined as “fabrication, falsification, or plagiarism").     

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.     

Person-oriented research ethics: integrating relational and everyday ethics in research

Research ethics is often understood by researchers primarily through the regulatory framework reflected in the research ethics review process. This regulatory understanding does not encompass the range of ethical considerations in research, notably those associated with the relational and everyday aspects of human subject research. In order to support researchers in their effort to adopt a broader lens, this article presents a “person-oriented research ethics” approach. Five practical guideposts of person-oriented research ethics are identified, as follows: (1) respect for holistic personhood; (2) acknowledgement of lived world; (3) individualization; (4) focus on researcher-participant relationships; and (5) empowerment in decision-making. These guideposts are defined and illustrated with respect to different aspects of the research process (e.g., research design, recruitment, data collection). The person-oriented research ethics approach provides a toolkit to individual researchers, research groups, and research institutions in both biomedical and social science research wishing to expand their commitment to ethics in research.     

Effect of impact factor and discipline on journal data sharing policies

Data sharing is crucial to the advancement of science because it facilitates collaboration, transparency, reproducibility, criticism, and re-analysis. Publishers are well-positioned to promote sharing of research data by implementing data sharing policies. While there is an increasing trend toward requiring data sharing, not all journals mandate that data be shared at the time of publication. In this study, we extended previous work to analyze the data sharing policies of 447 journals across several scientific disciplines, including biology, clinical sciences, mathematics, physics, and social sciences. Our results showed that only a small percentage of journals require data sharing as a condition of publication, and that this varies across disciplines and Impact Factors. Both Impact Factors and discipline are associated with the presence of a data sharing policy. Our results suggest that journals with higher Impact Factors are more likely to have data sharing policies; use shared data in peer review; require deposit of specific data types into publicly available data banks; and refer to reproducibility as a rationale for sharing data. Biological science journals are more likely than social science and mathematics journals to require data sharing.     

Institutional Pathology and the Death of Dan Markingson

In the spring of 2015, 11 years after a mentally ill young man named Dan Markingson stabbed himself to death in an industry-sponsored drug study, officials at the University of Minnesota suspended recruitment of subjects into drug trials in its Department of Psychiatry. University officials agreed to act only after a scathing investigation by Minnesota Office of the Legislative Auditor found damning evidence of coerced recruitment, inadequate clinical care, superficial research oversight, a web of serious, disturbing conflicts of interest, and a pattern of misleading public statements by university officials aimed at deflecting scrutiny. In this article, I examine the larger institutional factors leading up to Markingson’s suicide and prevented corrective action for so long.     

Maori and the New Zealand values survey: The importance of research relationships

Abstract

Requirements for non‐Maori researchers to consult with Maori compete with “by Maori for Maori” research agendas. Nevertheless, Maori provide varying forms of consultation, with Maori perspectives rarely being entered into the literature. Following an invitation from the Centre for Social Health Outcomes Research and Evaluation (SHORE), members of the Whariki Research Group agreed to take a consultative role, providing Maori input into the New Zealand Values Survey 2004. After initial examination of the survey instrument and follow‐up on previous consultation with Maori, Whariki's main role focused on questions relevant to the Treaty of Waitangi (signed in 1840 between the United Kingdom and Maori) and to Maori. The questions and related findings were of particular salience in the context of ongoing controversy and challenges to the status of the Treaty in New Zealand and to the position of Maori. Here we describe research processes and relationships and present the findings with reference to their social and political implications.     

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.     

Physician duties in the conduct of human subject research

In this article, I examine a skeptical argument against the possibility of ethically justifying risky human subject research (rHSR). That argument asserts that such research is unethical because it holds the possibility of wronging subjects who are harmed and whose consent to participate was less than fully voluntary. I conclude that the skeptical argument is not in the end sufficient to undermine the ethical foundation of rHSR because it fails to take account of the special positive duty researchers owe their clients and future patients. Although the skeptical argument is defeated, it exacts certain novel concessions from the pro‐research position. Of particular importance are the admissions (a) that researchers presumptively owe a fiduciary duty to research subjects, (b) that because the most important risks of rHSR are unknown and unquantifiable that duty must be explicitly waived by all subjects before they participate in any protocol, and (c) that such waivers must be made by individuals who satisfy objective criteria of competence for giving fully voluntary consent. The implementation of procedures responsive to these concerns might have a dampening effect on the conduct of research. However, the article concludes with a consideration of the likely benefits to researchers and society of a more cautious ethical regime.     

The nature and quality of engineering research

Engineering is the application oí science to design and development of products intended for useful social purposes. Engineering research consists of a wide variety of activities ranging from study of material properties for possible future application to the testing necessary to establish design parameters or to verify the adequacy of new design concepts. Professors of engineering are generally expected to conduct research, preferably in the “engineering sciences”; (e.g. thermodynamics, metallurgy), to publish their results, and find their own sources of funding. Many private corporations maintain departments of research and development, the findings of which are often proprietary and not subject to peer review. Managers of engineering research projects attempt to assure the quality of their results by “instrumental”; or “organizational”; methods. Instrumental methods assure accuracy in data collection and processing, while organization methods maintain a work environment conducive to creativity and integrity among researchers. Organizational conditions can affect research quality adversely, by giving rise to ethical problems associated with conflicts between corporate interests and those of individuals.