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.     

Promoting research on research integrity in Canada

Research on research integrity is an important element in building a strong national research integrity framework. There is a lack of empirical evidence and conceptual research on research integrity in Canada. To further strengthen and develop our system of research integrity, we believe that greater support is needed to promote research on research integrity. Research on research integrity is imperative in order to gain a richer understanding of the diversity of responsible conduct of research norms, practices, education and policies from a Canadian perspective. The knowledge gained would help in the development of an evidenced-based and responsive Canadian system of research integrity.     

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.     

The role of litigation in human research accountability

This essay examines and analyzes the recent and dramatic series of personal injury lawsuits instituted against those individuals and institutions that conduct and monitor human research. It discusses the social engineering functions of tort litigation, outlines the legal elements and viability of lawsuits against those who conduct and monitor human research, and evaluates and predicts what role tort litigation will play in fulfilling the goals of accountability in the context of human research and human research regulation. In general, tort law engenders two forms of accountability: retrospective and prospective. Retrospective accountability is backward looking, focusing on harms that have already occurred, their culprits, and the reimbursement of individuals for their injuries. Prospective accountability is forward looking in that it encourages actors and institutions to fulfill responsibilities toward individuals in order that harm does not occur, or at least that the risk of harm is decreased. This article argues that research litigation is not, and will probably never become, an effective means of ensuring retrospective accountability in regard to research injuries and ethical violations. Paradoxically though, the current wave of research litigation may serve an important and even key role in encouraging and ensuring prospective accountability.     

Ensuring scientific integrity in research: Aspects of fairness and justice

The procedures established by the Public Health Service and the National Science Foundation reflect an inclination to keep lawyers and legalistic procedures out of scientific misconduct cases. Although misconduct cases resolved at the agencies’ Washington headquarters probably reflect a greater degree of concern with due process, their published procedures require institutions to resolve misconduct cases with virtually no guidance as to the demands of procedural due process.

A number of deficiencies in the handling of misconduct cases under PHS rules at the institutional level are discussed anecdotally on the basis of the author's experience in representing both whistle blowers and accused scientists in misconduct cases.

It is inevitable that some misconduct cases will be heard by the federal courts, and that some of the legalistic trappings of due process will be imposed by the courts. Lawyers and scientists should work together to develop techniques for resolving cases in a way that meets due process requirements without smothering science in a legalistic straight‐jacket.     

The Research Environment Norm Inventory (RENI): a study of integrity in research administrative systems

University research administrators have been generally ignored in basic studies of research integrity. Hensley noted that research administrators are "essential... to the achievement of the specific missions of postsecondary institutions... and to science and the academic infrastructure". The following study sought to extend the scope of research on research integrity to research administrative structures with a new instrument called the Research Environment Norm Inventory or RENI. University research administrators and their professional association were targeted for data collection. Evidence suggested that research administration in the United States supports integrity in the research environment through: (1) respect for community; (2) respect for institutional boundaries; (3) professionalism; (4) respect for authority structures; (5) sensitivity to system conflicts. The study suggested that integrity structures are dictated largely by the institutional settings and environments.     

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.     

Perceptions concerning research integrity and the practice of data audit in the biotechnology industry

A survey was conducted in order to evaluate the responses of biotechnology executives concerning their perceptions of the frequency of questionable R & D studies performed in their companies and to assess the extent to which their companies voluntarily conducted data audits. Data audit was found to be commonly practiced on a voluntary basis by biotechnology companies, in contrast to its almost lack of practice by universities. However, public companies were more likely to practice data auditing than privately held companies. Moreover, the likelihood that managers suspected or detected questionable studies in their companies was significantly increased if the company practiced data auditing.     

Ethical challenges to the integrity of physicians: financial conflicts of interest in clinical research

Financial conflicts of interest arise when physician's judgment and decision making become compromised by financial gains or interests, and thus create risk of undo harm to research participants, to the integrity of research projects, and, ultimately to society at large. Such conflicts also violate the moral maxims of medicine, and thus damage the integrity of physicians and the medical profession. I submit that key remedies for this problem are the integrity (self-respect) of physicians and the respectful engagement of research participants (whether patients or nonpatient volunteers) as partners in research projects. Accordingly, I consider physicians the primary moral agents, research participants the secondary moral agents, and society the tertiary moral agent with responsibilities for protection against whatever undue harm in clinical research. The latter needs to address the powerful, cultural, commercial, political, and social factors that contribute to physicians' financial conflicts of interest.     

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.     

The office of scientific integrity investigations: The importance of data analysis

Certified Public Accountants serve as independent auditors of financial statements. They perform information‐integrity testing for the economy and society, adding creditability to financial statements prepared by organizations’ management. Investors, creditors, and others rely on these financial statements and the audit report to make business decisions. Auditing work involves gathering evidence (research) and forming an opinion (reporting results) about the “fairness”; of financial statements according to regulatory, legal, and professional rules. As researchers, auditors are subject to a complex network of mechanisms to promote accountability in their work. These mechanisms exist at environmental, professional, and audit‐firm levels. They combine to influence the judgments of individual auditors.     

中国传媒业的发展模式与规则再造

中国的传媒业正在面临巨大的转变 ,资本与媒体的重新组合 ,将导致传媒业发展道路、传媒集团模式和行业规则的改变。机遇与挑战并存