Nearly 90 % of allegations of biomedical research misconduct in the United States are dismissed by responsible institutions without any faculty assessment or auditable record. Recently, members of the U.S. Congress have complained that the penalties for those against whom findings of research misconduct are made are too light and that too few grant funds associated with research misconduct have been recovered for use by other researchers and taxpayers. Here we discuss the laws that empower federal agencies (...) that can oversee investigations of biomedical research misconduct: the Office of Research Integrity and the Office of the Inspector General, both located within the Department of Health and Human Services. Research misconduct investigations pertaining to U.S. physical sciences funded through the National Science Foundation are overseen by the NSF’s OIG. While OIGs may provide some improvement over the ORI in the handling of research misconduct, we have found that a much more serious flaw exists which undermines an ability to conduct performance audits of the effectiveness by which allegations of research misconduct are handled in the United States. Specifically, sufficient data do not need to be retained by U.S. research institutions funded by HHS or NSF to allow effective audit of why allegations of research misconduct are dismissed before being seen by faculty inquiry or investigative committees. U.S. federal Generally Accepted Government Auditing Standards, if applied to the research misconduct oversight process, would allow a determination of whether the handling of allegations of biomedical research misconduct actually functions adequately, and if not, how it might be improved. In particular, we propose that independent, external peer review under GAGAS audit standards should be instituted without delay in assessing the performance of ORI, or any other similarly tasked federal agency, in handling allegations of research misconduct. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Office of Scientific IntegrityDavid P. Hamilton (bio)For most of the 1980s, the specter of scientific fraud popped into public view every few years, usually only to submerge again. Faced with several well-publicized cases of scientists who blatantly faked their data—among the best-known being Harvard cardiologist John Darsee (whose colleagues watched him forge data) (Broad and Wade 1982, p. 14) and Sloan-Kettering Institute immunologist William Summerlin (who painted black (...) spots on white mice to simulate tissue grafts) (Broad and Wade 1982, p. 155)—the scientific community as a whole tended to dismiss the phenomenon as the work of a few deviants. Called in 1981 to testify before then-Representative Albert Gore Jr.'s subcommittee on investigations and oversight, Philip Handler, then-president of the National Academy of Sciences, told the panel that science was perfectly capable of regulating itself, and that the problem of scientific fraud had been "grossly exaggerated" by the press (Broad and Wade 1982). The message was clear: Congress should stick to its knitting, and science would take care of itself.Now, however, scientists are faced with a very different situation: a permanent federal bureaucracy, known as the Office of Scientific Integrity (OSI), devoted to the investigation of alleged scientific wrongdoing. The transition from the days of laissez-faire, when universities were entrusted with all investigations unless they were handled so badly that the federal government was forced to take notice, has been an uncomfortable one for many researchers. Lately, this discomfort has taken shape as a vocal protest against OSI. Largely as a result of this protest, federal officials recently promoted a plan to restructure OSI and change some of its operating procedures, a move with unpredictable consequences for universities and researchers alike.OSI was born largely because of investigations by two influential congressmen: Representatives John Dingell of Michigan and Ted Weiss of New York. While both claimed they acted mainly to make sure taxpayer dollars were not spent on fraudulent research, both also maintained a strong interest in protecting "whistleblowers," the often vulnerable, and usually junior, scientists who first raise questions about bad research. And Dingell seemed to take special pleasure in pointing up the deficiencies of investigations run by universities and by the National Institutes of Health (NIH) itself. (For reasons that are not well understood, [End Page 171] biomedical research seems far more prone to fraud than any other field of science. As a result, NIH, which funds most biomedical research in the United States, has held ultimate responsibility for most prominent cases of fraud.) Plagued as they often were by conflicts of interest, shoddy methodologies, and, in some cases, a willingness to believe any excuse by the accused, no matter how far-fetched, these investigations made easy targets. And the notion that science could "govern itself" grew harder to sustain.In late 1988, Dingell and other congressmen began circulating draft bills that would have created a new office for investigating scientific fraud. Dingell would have placed such an office under the aegis of the Inspector General of the Department of Health and Human Services, raising the possibility that scientific fraud might be probed by the same criminal investigators who unravel Medicare fraud. Unsettled by this vision of the "science police," NIH officials moved quickly to pre-empt Congress. On March 16, 1989, they published a notice in the Federal Register announcing the creation of OSI, an office with responsibility for ensuring thorough university investigations of misconduct and the authority to conduct its own investigations when necessary.From the beginning, OSI took an unusual approach to its work. For one thing, the office had a broad mandate: Although located within NIH, it was responsible for research funded throughout the entire Public Health Service, including the Food and Drug Administration, the Alcohol, Drug, and Mental Health Administration, and the Centers for Disease Control. Furthermore, it was not restricted to scientific fraud. Departmental lawyers, wishing to avoid the legal connotations of the term "fraud"—in particular, a requirement that fraudulent actions not only mislead others but also cause them noticeable harm—decided instead to adopt the term "scientific misconduct," defined as "fabrication, falsification, plagiarism, or other practices that deviate... (shrink)

The Division of Investigative Oversight within the U.S. Office of Research Integrity (ORI) is responsible for conducting oversight review of institutional inquiries and investigations of possible research misconduct. It is also responsible for determining whether Public Health Service findings of research misconduct are warranted. Although ORI findings rely primarily on the scope and quality of the institution’s analyses and determinations, ORI often has been able to strengthen the original findings by employing a variety of (...) analytical methods, often computer based. Although ORI does not conduct inquiries or investigations, it has broad authority to provide assistance to institutions at all stages of their reviews of allegations. This assistance can range from providing advice on best practices, to legal assistance, to suggestions for how best to investigate specific allegations. When asked, ORI can also conduct certain forensic analyses, such as a statistical examination of questioned digits or a simple examination of a questioned figure in Photoshop. ORI will not provide opinions or render judgment on such analyses while the institution is still conducting its investigation. Such analyses can be done without knowing much else about the case. (shrink)

In little more than 30 years, China has recovered from the intellectual stagnation brought about by the Cultural Revolution to become a global leader in science and technology. Like other leading countries in science and technology, China has encountered some ethical problems related to the conduct of research. China 's leaders have taken some steps to respond to these problems, such as developing ethics policies and establishing oversight committees. To keep moving forward, China needs to continue to take (...) effective action to promote research integrity. Some of the challenges China faces include additional policy development, promoting education in responsible conduct of research, protecting whistle-blowers, and cultivating an ethical research environment. (shrink)

Following its determination of a finding of scientific misconduct the Office of Research Integrity (ORI) will seek redress for any injury sustained. Several remedies both administrative and statutory may be available depending on the strength of the evidentiary findings of the misconduct investigation. Pursuant to federal regulations administrative remedies are primarily remedial in nature and designed to protect the integrity of the affected research program, whereas statutory remedies including civil fines and criminal penalties are designed to (...) deter and punish wrongdoers. This commentary discusses the available administrative and statutory remedies in the context of a specific case, that of former University of Vermont nutrition researcher Eric Poehlman, and supplies a possible rationale for the legal result. (shrink)

BackgroundResearch on research integrity has tended to focus on frequency of research misconduct and factors that might induce someone to commit research misconduct. A definitive answer to the first question has been elusive, but it remains clear that any research misconduct is too much. Answers to the second question are so diverse, it might be productive to ask a different question: What about how research is done allows research misconduct to occur?MethodsWith that question (...) in mind, research integrity officers of the 62 members of the American Association of Universities were invited to complete a brief survey about their most recent instance of a finding of research misconduct. Respondents were asked whether one or more good practices of research were present in their case of research misconduct.ResultsTwenty-four of the respondents indicated they had dealt with at least one finding of research misconduct and answered the survey questions. Over half of these RIOs reported that their case of research misconduct had occurred in an environment in which at least nine of the ten listed good practices of research were deficient.ConclusionsThese results are not evidence for a causal effect of poor practices, but it is arguable that committing research misconduct would be more difficult if not impossible in research environments adhering to good practices of research. (shrink)

Over the past three decades, two separate federal regulatory structures have emerged, each seeking to assure separate aspects of the integrity and ethics of research conducted using federal funding. One set of regulations is described in the Public Health Service Policies on Research Misconduct and relates to research misconduct, defined as consisting of fabrication of data or results, falsification of data and results, or plagiarism, in accordance with the federal‐wide definition adopted by the Office of Science (...) and Technology Policy. The second set of regulations, set forth in the Department of Health and Human Services regulations on the protection of human subjects (known as the “Common Rule”), prescribes a set of ethical and procedural protections for research involving human subjects.These two sets of research regulations are distinguished from each other by having different foci of enforcement, priorities of protection, oversight officials, oversight procedures, seizure of evidence, standards of proof, expectations of privacy, and appeal procedures for researchers who are subject to adverse findings and penalties. These differences are significant and fundamental. They complicate the process of compliance for institutions and researchers, who are expected to adhere to both sets of standards for the same federally funded research activities in research with human subjects. Compliance is especially complicated when suspected violations of both sets of standards must be investigated and resolved concurrently. This document represents an effort to provide institutions and individuals with practical suggestions as they try to comply with both sets of regulations. (shrink)

A recent National Academy report on research integrity noted that policies are not evidence-based, with no formal entity responsible to attend to this deficit. Here we describe four areas of research misconduct regulations governing Public Health Service funded research that are empirically and/or ethically questionable. Policies for human subject protection, RM and conflict of interest are not harmonized, making it extremely difficult to deal with complex cases which often contain allegations in all of these areas. (...) Second, detection of RM has depended entirely on whistleblowers in spite of evidence of significant under-reporting. Third, the scientific record is far from cleansed of the effects of falsified/fabricated work through current mechanisms of retraction. Finally, lack of fairness in the regulations may reflect lack of a Belmont Report-like document to guide ethics of RM policy. These issues are likely common in other countries. RM regulations should be harmonized with related regulations and their effectiveness tracked, open access to data for independent replication and improved statistical tests are an essential supplement to whistleblowers, correction of the scientific record will require a major effort, and further ethical analysis and guidance are as important as is empirical study for the improvement of RM regulations. Further consideration should be given to assigning current regulations for human subjects protection, RM and conflict of interest to a single authority and to the further development of a Belmont-like report of essential principles, for RM. (shrink)

Institutions receiving federal funding for research from the U.S.Public Health Service need to have policies and procedures to both prevent research misconduct and to adjudicate it when it occurs. The person who is designated to handle research misconduct is typically referred to as the research integrity officer (RIO). In this interview study we report on 79 RIOs who describe how they would handle allegations of research misconduct. Their responses were compared to two expert RIOs. (...) The responses to the allegations in the scenarios demonstrated that RIOs are not uniformly well prepared to handle activities associated with reported allegations of research misconduct. We recommend greater preparation through directed training, use of check lists of possible behaviors necessary to consider when situations arise, being involved in a network of RIOs so one can discuss options, and the possible need to certify RIOs. (shrink)

Research misconduct is an alarming concern worldwide, and especially in Italy, where there is no formal training of young researchers in responsible research practices. The main aim of this study was to map the perceptions and attitudes about RM in a sample of young researchers attending a one-week intensive course on methodology, ethics and integrity in biomedical research, held at the University of Insubria. To this end, we administered the Scientific Misconduct Questionnaire to all attendees at (...) the beginning of the course. Thereafter, SMQ-R was re-administered at the end, to assess the impact of the course on the responsiveness of study participants, which is intended as the frequency of responses other than “don’t know”. Results show that respondents rate as high their own understanding about rules and procedures related to scientific misconduct, as well as the effectiveness of their institution’s measures for reducing it. Most of them perceive as low the chances of getting caught for RM. Some respondents believe that cases of misconduct occur in their workplace and that the integrity of a research is not solely the responsibility of the principal investigator. Among the main factors contributing to research misconduct, the need for publications, unclear definition of what constitutes misconduct and pressure for external funding do stand out. Respondents are concerned about the amount of misconduct and express a pressing need for training on research ethics. Remarkably, the responsiveness of participants tends to increase with course attendance. This finding may be useful to support education programmes devoted to research methodology, ethics and integrity among young researchers. (shrink)

In 1985, after nearly a decade of inconclusive professional response to public concern about misconduct in research, Congress passed legislation requiring action. Subsequent to this legislation, federal agencies and research universities adopted policies for responding to allegations of misconduct in research. Conferences, sessions at professional meetings, and special publications were organized. New educational initiatives were begun, many in response to a 1989 National Institutes of Health/ Alcohol, Drug Abuse, and Mental Health Administration requirement to include ethics instruction (...) in training grants. Notwithstanding a few key unresolved issues, such as the lack of a uniform federal definition of misconduct in research, the years since 1985 have witnessed a marked change in the professional response to misconduct in research. This paper evaluates the change since 1985 from the perspective of three key goals: 1) confronting misconduct, 2) promoting integrity and 3) ensuring integrity. While significant progress has been made in achieving the first two goals, the third remains largely unaddressed. The latter is due to the fact that researchers have not been interested in studying the integrity of their own profession. It is therefore suggested that studies are needed of routine or normal research practices and their impact on integrity for use in making decisions about research conduct policy. (shrink)

Issues related to research integrity receive increasing attention in policy discourse and beyond with most universities having introduced by now courses addressing issues of good scientific practice. While communicating expectations and regulations related to good scientific practice is essential, criticism has been raised that integrity courses do not sufficiently address discipline and career-stage specific dimensions, and often do not open up spaces for in-depth engagement. In this article, we present the card-based engagement method RESPONSE_ABILITY, which aims at (...) supporting researchers in developing their ability to respond to challenges of good scientific practice. The method acknowledges that what counts and what does not count as acceptable practice may not be as clear-cut as imagined and that research environments matter when it comes to integrity issues. Using four sets of cards as stimulus material, participants are invited to reflect individually and collectively about questions of research integrity from different perspectives. This approach is meant to train them to negotiate in which contexts certain practices can still be regarded as acceptable and where possible transgressions might begin. RESPONSE_ABILITY can be seen as fostering the creation of an integrity culture as it invites a more reflexive engagement with ideals and realities of good practice and opens a space to address underlying value conflicts researchers may be confronted with. Concluding the article, we call for caution that addressing issues of integrity meaningfully requires striking a delicate balance between raising researchers’ awareness of individual responsibilities and creating institutional environments that allow them to be response-able. (shrink)

Policing in South Africa reached notoriety for its extensive history of oppressive law enforcement. In 1994, as the country's apartheid system was replaced with a democratic order, the new government faced the significant challenge of transforming the South African police force into a democratic police agency-the South African Police Service (SAPS)-that would provide unbiased policing to all the country's people. More than two decades since the initiation of the reforms, it appears that the SAPS has rapidly developed a reputation as (...) a police agency beset by integrity challenges. This book offers a unique perspective by providing in-depth analyses of police integrity in South Africa. It is a case study that systematically and empirically explores the contours of police integrity in a young democracy. Using the organizational theory of police integrity, the book analyses the complex set of historical, legal, political, social, and economic circumstances shaping police integrity. A discussion of the theoretical framework is accompanied by the results of a nationwide survey of nearly 900 SAPS officers, probing their familiarity with official rules, expectations of discipline within the SAPS, and their willingness to report misconduct. The book also examines the influence of the respondents' race, gender, and supervisory status on police integrity. Written in a clear and direct style, this book will appeal to students and scholars of criminology, policing, sociology, political science, as well as to police administrators interested in expanding their knowledge about and enhancing police integrity. (shrink)

While empirical studies of research ethics and integrity are increasingly common, few have aimed at national scope, and even fewer at current results from Central and Eastern Europe. This article introduces the results of the first national research integrity survey in Estonia, which included all research-performing organisations in Estonia, was inclusive of all disciplines and all levels of experience. A web-based survey was developed and carried out in Estonia with a call sent to all accredited (...) Estonian research institutions. The results indicate that the vast majority (89%) of respondents consider research ethics and integrity issues important and view falsification, fabrication, and plagiarism (FFPs) as the most severe forms of misconduct. Self-reporting of FFPs is generally comparable to levels published in other studies (6.2%). Gift authorship (41%) and hampering the work of a colleague (32%) were problematic practices most noticed among colleagues. At the same time, two of the noticed questionable research practices (QRPs) – salami-slicing and misuse of research funding – were seen as less severe, hinting at the existence of counter-norms that career advancement rules and structural factors like funding policies may encourage. The availability of research ethics and integrity guidelines was considered good. Ethical aspects of studying potentially stigmatising data in a very small research community are discussed in the article and results are analysed through counter-norms and normative dissonance frames. (shrink)

Between 1993 and 2002, 39 clinical trial staff were investigated for scientific misconduct by the Office of Research Integrity (ORI). Analysis of ORI case records reveals practices regarding workload, training and supervision that enable misconduct. Considering the potential effects on human subjects protection, quality and reliability of data, and the trustworthiness of the clinical research enterprise, regulations or guidance on use of clinical trial staff ought to be available. Current ORI regulations do not hold investigators or institutions (...) responsible for supervision and training of clinical trial staff. Given the important issues at stake, the definition of research misconduct should encompass the intentional or negligent mismanagement of scientific projects. Individual institutions and professional associations not only can but should adopt stricter standards of conduct than those reflected in federal regulations. (shrink)

A growing number of research misconduct cases handled by the Office of Research Integrity involve image manipulations. Manipulations may include simple image enhancements, misrepresenting an image as something different from what it is, and altering specific features of an image. Through a study of specific cases, the misconduct findings associated with image manipulation, detection methods and those likely to identify such manipulations, are discussed. This article explores sanctions imposed against guilty researchers and the factors that resulted in (...) no misconduct finding although relevant images clearly were flawed. Although new detection tools are available for universities and journals to detect questionable images, this article explores why these tools have not been embraced. (shrink)

Concern is growing as research continues to find evidence of academic misconduct among medical students. There is, however, paucity of information on this issue among medical students and medical graduates in Africa. We determined the perceptions and attitude of house officers on academic misconduct within Nigerian medical schools. We conducted 7 focus group discussions among pre-registration house-officers working in a Nigerian Teaching hospital between October and November 2013. A FGD guide containing 7 broad questions related to their perception and (...) attitude on academic misconduct was employed. Ethnographic content analysis and manual coding were adopted in identifying themes, issues and representative quotations. A total of 58 participants out of an eligible pool of 76 PRHOs were recruited. All the groups associated academic misconduct chiefly with cheating in examinations, and perceived it as a commonplace problem. “It is a part of school life”, admitted one PRHO. Copying during exam appeared to be the commonest form of cheating. Another respondent opined that “The lecturers should be more concerned with helping students understand better. They should not make passing an exam a do-or-die affair.” The perception and attitudes towards academic misconduct may be a reflection of the prevailing moral decline in the contemporary Nigerian society. Underlying the reasons adduced by the participants for getting involved in academic misconduct is the fear of failure in examinations. Apart from consolidating formal and informal medical ethics education, the medical schools should ensure that the opportunities and pressures to indulge in academic misconduct are minimized. (shrink)

Recent, well-publicized scandals, involving unethical conduct have rekindled interest in academic misconduct. Prior studies of academic misconduct have focussed exclusively on situational factors (e.g., integrity culture, honor codes), demographic variables or personality constructs. We contend that it is important to also examine how␣these classes of variables interact to influence perceptions of and intentions relating to academic misconduct. In a sample of 217 business students, we examined how integrity culture interacts with Prudence and Adjustment to explain variance in estimated (...) frequency of cheating, suspicions of cheating, considering cheating and reporting cheating. Age, integrity culture, and personality variables were significantly related to different criteria. Overall, personality variables explained the most unique variance in academic misconduct, and Adjustment interacted with integrity culture, such that integrity culture had more influence on intentions to cheat for less well-adjusted individuals. Implications for practice are discussed and future research directions are offered. (shrink)

This paper looks at the issues and controversies that led to creation of the Office of Research Integrity (ORI) and that dominated its agenda in the early years. The successes and failures of ORI are described and new problems identified. This paper then looks ahead to the future, considering what issues will dominate ORI’s agenda and affect the research institutions, individual scientists, and the scientific community in the next several years.

Publication pressure has been touted to promote questionable research practices (QRP) and scientific or research misconduct (RM). However, logically attractively as it is, there is no unequivocal evidence for this notion, and empirical studies have produced conflicting results. Other than difficulties in obtaining unbiased empirical data, a direct causal relationship between perceived publication pressure (PPP) and QRP/RM is inherently difficult to establish, because the former is a complex biopsychosocial construct that is variedly influenced by multiple personal and environmental (...) factors. To effectively address QRP/RM by tackling the sources of PPP would also be difficult because of the competitive nature of the reward and merit system of contemporary science. We might do better with efforts in enhancing knowledge in research ethics and integrity among the practitioners, as well as institutional infrastructures and mechanisms to fairly and efficiently adjudicate cases of QRP/RM. (shrink)

Pascal’s paper indicates how far we have come. Now as then, however, there is a need to reflect from outside the cocoon of our agencies, institutions, and disciplines to behold the enterprise that shapes both our behavior and our interpretations of it. For the boundary separating propriety from impropriety continues to move. Just as science, and the knowledge it begets, continues to evolve, so must our collective standards. The lessons of time include this: ORI or biomedical research is no (...) island; each is connected to a body of practitioners who are accountable to a society that is ever-more skeptical of expert knowledge and the institutions entrusted with its development. We are participants in a process of continuous improvement , not occupants of a state of grace. For the good of the enterprise we cherish, it is best that we all remember that. (shrink)

As stewards of public money, government funding agencies have the obligation and responsibility to uphold the integrity of funded research. Despite an increasing amount of empirical studies examining research-related misconduct, a majority of these studies focus on retracted publications. How agencies spot funding-relevant wrongdoing and what sanctions the offenders face remain largely unexplored. This is particularly true for public funding agencies in emerging science powers. To amend this oversight, we retrieved and analyzed all publicized investigation results (...) from China’s largest basic research funding agency over the period from 2005 to 2021. Our findings reveal that both the “police patrol” and “fire alarm” approaches are used to identify misconduct and deter funding-related fraud in China. The principal triggers for investigations are journal article retractions, whistleblowing, and plagiarism detection software. Among the six funding-related misconduct types publicized and punished, the top three are: (1) fraudulent papers, (2) information fabrication and/or falsification in the research proposal, and (3) proposal plagiarism. The most common administrative sanctions are debarment and reclamation of grants. This article argues that more systematic research and cooperation among stakeholders is needed to cultivate research integrity in emerging science powers like China. Specific training and education should be provided for young scientists to help them avoid the pitfall of academic misconduct. (shrink)

There is a limited understanding of the student perspective of integrity in postgraduate research. This is of concern given that ‘research trainees’ may have a vulnerable position in formal investigations of research misconduct. This paper analyses qualitative data drawn from an Australian online academic integrity survey in a mixed methods research study. This analysis complements the quantitative survey data analysed earlier and sought to explore factors contributing to postgraduate research students’ satisfaction with policy (...) and process, the ways institutions can support students’ understandings and practice, suggestions for improving breach processes, and students’ concerns. We found that integrity training and modelling of ethical behaviour by staff were key factors contributing to students’ satisfaction. Students would have liked more ‘hands-on’ integrity training, accompanied by consistent and transparent enforcement of policy. Respondents expressed concern about the credibility of research output and educational standards. We call for recommendations from the extensive literature on academic integrity policy and practice to be extended to the postgraduate research sphere. (shrink)

To foster research integrity (RI), it is necessary to address the institutional and system-of-science factors that influence researchers’ behavior. Consequently, research performing and research funding organizations (RPOs and RFOs) could develop comprehensive RI policies outlining the concrete steps they will take to foster RI. So far, there is no consensus on which topics are important to address in RI policies. Therefore, we conducted a three round Delphi survey study to explore which RI topics to address in (...) institutional RI policies by seeking consensus from research policy experts and institutional leaders. A total of 68 RPO and 52 RFO experts, representing different disciplines, countries and genders, completed one, two or all rounds of the study. There was consensus among the experts on the importance of 12 RI topics for RPOs and 11 for RFOs. The topics that ranked highest for RPOs concerned education and training, supervision and mentoring, dealing with RI breaches, and supporting a responsible research process (e.g. through quality assurance). The highest ranked RFO topics concerned dealing with breaches of RI, conflicts of interest, and setting expectations on RPOs (e.g. about educating researchers about RI). Together with the research policy experts and institutional leaders, we developed a comprehensive overview of topics important for inclusion in the RI policies of RPOs and RFOs. The topics reflect preference for a preventative approach to RI, coupled with procedures for dealing with RI breaches. RPOs and RFOs should address each of these topics in order to support researchers in conducting responsible research. (shrink)

Recent studies from Western countries indicate significant levels of questionable research practices, but similar data from low and middle-income countries are limited. Our aims were to assess the prevalence of and attitudes regarding research misconduct among researchers in several universities in the Middle East and to identify factors that might account for our findings. We distributed an anonymous questionnaire to a convenience sample of investigators at several universities in Egypt, Lebanon, and Bahrain. Participants were asked to a) self-report (...) their extent of research misconducts, as well as their knowledge of colleagues engaging in similar research misconducts and b) provide their extent of agreement with certain attitudes about research misconduct. We used descriptive, bivariate, and multivariate logistic regression statistics to analyze the data. Data from 278 participants showed a high prevalence of misconduct, as 59.4% of our respondents self-reported to committing at least one misbehaviors and 74.5% reported having knowledge of any misbehaviors among any of their colleagues. The most common type of self-report misconduct was “circumventing research ethics regulations” followed by “fabrication and falsification”. A significant predictor of misconduct included a lack of “prior ethics training”. Scientific misconduct represents a significant issue in several universities in the Middle East. The demonstration that a lack of “prior ethics training” was a significant predictor of misconduct should lead to educational initiatives in research integrity. Further studies are needed to confirm whether our results can be generalized to other universities in the Middle East. (shrink)

Nearly two decades of debate have not settled the definition of research misconduct. The literature provides four explanatory frameworks for misconduct. The paper examines these frameworks and maps them onto efforts by the U.S. Public Health Service to define research misconduct and subsequent responses to these efforts by the scientific community. The changing frameworks suggest that closure will not be achieved without an authoritative effort, which may occur through the Research Integrity Panel’s recent attempt to create (...) a government-wide definition. (shrink)

Allegations of scientific misconduct against graduate students appear to have unique attributes in the detection, investigation, processes used and sanctions imposed vis-à-vis other populations against which misconduct is alleged and found. An examination of the cases closed by the Department of Health and Human Services’ Office of Research Integrity and the National Science Foundation reveals that most of the allegations made against graduate and medical students are for falsification and fabrication. Further, additional processes are used in these cases, (...) e.g., student judicial processes, more students are “set up” and more students admit misconduct. Finally, the sanctions imposed when a finding is made typically involve separation from the institution and the federal sanction ranges from none to debarment. Drawing upon the teachings and circumstances of cases involving graduate student peers is a good vehicle for illustrating the concepts and perils of misconduct to graduate students. (shrink)

Substantial progress in handling scientific misconduct cases has been made since the first cases were investigated by the NIH Office of Scientific Integrity in 1989. The successor Office of Research Integrity (ORI) has simultaneously reduced the backlog of cases and increased the professionalism with which they are handled. However, a spate of lawsuits against universities, particularly those brought under the federal False Claims Act, threatens to undermine the ORI by encouraging use of the courts as an alternate (...) route for resolving claims of research misconduct. Next steps should include establishing a government-wide definition of scientific misconduct, providing immunity from lawsuits for institutions that follow proper procedures in investigating charges of scientific misconduct, and participating in the development of international guidelines for maintaining scientific integrity. (shrink)

To be a functional alternative to government regulation, self-regulation of science must be credible to both scientists and the public, accountable, ethical, and effective. According to some, serious problems continue in research ethics in the United States despite a rich history of proposed self-regulatory standards and oversight devices. Successful efforts at self-regulation in stem cell research contrast with unsuccessful efforts in research ethics, particularly conflicts of interest. Part of the cause for a lack of success in (...) self-regulation is fragmented, disconnected oversight, and failure to embody genuine scientific and public consensus. To be accountable, credible and effective, self-regulation must be inclusive and multidisciplinary, publicly engaged, sufficiently disinterested, operationally integrated with institutional goals, and must implement a genuine consensus among scientists and the public. The mechanisms of self-regulation must be sufficiently broad in their oversight, and interconnected with other institutional forces and actors, that they do not create fragmented solutions. (shrink)

This article focuses on scientific integrity and the identification of predisposing factors to scientific misconduct in Brazil. Brazilian scientific production has increased in the last ten years, but the quality of the articles has decreased. Pressure on researchers and students for increasing scientific production may contribute to scientific misconduct. Cases of misconduct in science have been recently denounced in the country. Brazil has important institutions for controlling ethical and safety aspects of human research, but there is a lack (...) of specific offices to investigate suspected cases of misconduct and policies to deal with scientific dishonesty. (shrink)

Research integrity is a well-established term used to talk and write about ethical issues in research. Part of its success might be its broad applicability. In this paper, we suggest that this might also be its Achilles heel, since it has the potential to conceal important value conflicts. We identify three broad domains upon which research integrity is applied in the literature: (1) the researcher (or research group), (2) research, and (3) research-related (...) institutions and systems. Integrity in relation to researchers concerns character, although it remains to specify precisely what character traits are the desirable ones in this context and what values researchers should endorse. Integrity in relation to research concerns correct and sufficient description of the research process, data, results, and overall ‘research record’. Hence, it concerns the quality of research. However, whether or not this notion of research integrity covers all ethical aspects of research depends on whether one endorses a wider or a narrower interpretation of the ‘research process’. Integrity in relation to research-related institutions and systems leaves open whether they should be understood as agents in their own right or merely as means to research integrity. Besides the potential lack of clarity that our analysis reveals, we point to how this variety in uses might lead to concealment of value conflicts and propose an open discussion of central values. (shrink)

Concern for and interest in research integrity has increased significantly during recent decades, both in academic and in policy discourse. Both in terms of diagnostics and in terms of therapy, the tendency in integrity discourse has been to focus on strategies of individualisation. Other contributions to the integrity debate, however, focus more explicitly on environmental factors, e.g. on the quality and resilience of research ecosystems, on institutional rather than individual responsibilities, and on the quality of (...) the research culture. One example of this is the Bonn PRINTEGER Statement. This editorial to the LSSP thematic series entitled Addressing integrity challenges in research: the institutional dimension invites authors to contribute to the research integrity debate. Notably, we are interested in submissions addressing issues such as institutional responsibilities, changes in the research climate, duties of research managers and research performing or research funding organisations as well as new approaches to integrity education. (shrink)

Researchers sometimes engage in various forms of dishonesty and unethical behavior, which has led to regulatory efforts to ensure that they work according to acceptable standards. Such regulation is a difficult task, as research is a diverse and dynamic endeavor. Researchers can disagree about what counts as good and acceptable standards, and these standards are constantly developing. This paper presents and discusses recent changes in research integrity and ethics regulation in Norway, Denmark, and Sweden. Recognizing that (...) class='Hi'>research norms are developed through practice and are therefore unsuited for comprehensive national regulation, the Scandinavian countries focus on empowering the research community to regulate itself instead, except for the most severe cases of misconduct. This empowerment takes the form of giving research institutions tools and investigatory powers while also holding them responsible for ensuring that both the institution and individual researchers are up to date on relevant norms. In this way, the Scandinavian governments seek to avoid some of the challenges found in more legalistic approaches, which risk lagging behind the continuous development of research norms and can be insensitive to the fact that different disciplines have different norms. While the new approach in Scandinavian has several potential benefits, it also involves potential trade-offs and limitations. The new laws can create confusion about what researchers are allowed to do. Another issue is that it only addresses the fundamental drivers of misconduct to a limited extent. (shrink)

This document presents the Bonn PRINTEGER Consensus Statement: Working with Research Integrity—Guidance for research performing organisations. The aim of the statement is to complement existing instruments by focusing specifically on institutional responsibilities for strengthening integrity. It takes into account the daily challenges and organisational contexts of most researchers. The statement intends to make research integrity challenges recognisable from the work-floor perspective, providing concrete advice on organisational measures to strengthen integrity. The statement, which was (...) concluded February 7th 2018, provides guidance on the following key issues: § 1. Providing information about research integrity§ 2. Providing education, training and mentoring§ 3. Strengthening a research integrity culture§ 4. Facilitating open dialogue§ 5. Wise incentive management§ 6. Implementing quality assurance procedures§ 7. Improving the work environment and work satisfaction§ 8. Increasing transparency of misconduct cases§ 9. Opening up research§ 10. Implementing safe and effective whistle-blowing channels§ 11. Protecting the alleged perpetrators§ 12. Establishing a research integrity committee and appointing an ombudsperson§ 13. Making explicit the applicable standards for research integrity. (shrink)

A Scientific Integrity Consortium developed a set of recommended principles and best practices that can be used broadly across scientific disciplines as a mechanism for consensus on scientific integrity standards and to better equip scientists to operate in a rapidly changing research environment. The two principles that represent the umbrella under which scientific processes should operate are as follows: Foster a culture of integrity in the scientific process. Evidence-based policy interests may have legitimate roles to play (...) in influencing aspects of the research process, but those roles should not interfere with scientific integrity. The nine best practices for instilling scientific integrity in the implementation of these two overarching principles are Require universal training in robust scientific methods, in the use of appropriate experimental design and statistics, and in responsible research practices for scientists at all levels, with the training content regularly updated and presented by qualified scientists. Strengthen scientific integrity oversight and processes throughout the research continuum with a focus on training in ethics and conduct. Encourage reproducibility of research through transparency. Strive to establish open science as the standard operating procedure throughout the scientific enterprise. Develop and implement educational tools to teach communication skills that uphold scientific integrity. Strive to identify ways to further strengthen the peer review process. Encourage scientific journals to publish unanticipated findings that meet standards of quality and scientific integrity. Seek harmonization and implementation among journals of rapid, consistent, and transparent processes for correction and/or retraction of published papers. Design rigorous and comprehensive evaluation criteria that recognize and reward the highest standards of integrity in scientific research. (shrink)

Ethics and Business: An integrated approach for business and personal success equips students with business ethics concepts and pragmatic knowledge they need to identify and solve ethical dilemmas, understand their own and others' ethical behavior, promote ethical behavior in their organization, and begin the process of living a life rich in meaning and happiness. Ethics and Business: An integrated approach for business and personal success provides a systematic and logical framework for understanding ethical challenges and thinking about how to respond. (...) The chapters build on each other. Part 1 (chapters 2-4) lay a foundation for a holistic view of individual ethics. Part 2 (chapters 5-7) provide important knowledge and language about organizational realities and how they deal with issues of ethics and compliance. Part 3 (chapters 8-12) offer students the opportunity to apply what they've learned around four common ethical challenges in business: Conflict of Interest, Bribery, Honesty/ Integrity, the Use and Abuse of Power, and Corporate Social Responsibility. Part 4 takes up some larger issues of ethics: the role of ethics in a market-based or planned economy and the ethical challenges that come with technological innovation. (shrink)

We examined all 208 closed cases involving official findings of research misconduct published by the US Office of Research Integrity from 1992 to 2011 to determine how often scientists mention in a retraction or correction notice that there was an ethical problem with an associated article. 75 of these cases cited at least one published article affected by misconduct for a total of 174 articles. For 127 of these 174, we found both the article and a retraction (...) or correction statement. Since eight of the 127 published statements consisted of simply the word ‘retracted,’ our analysis focused on the remaining 119 for which a more detailed retraction or correction was published. Of these 119 statements, only 41.2% mentioned ethics at all (and only 32.8% named a specific ethical problem such as fabrication, falsification or plagiarism), whereas the other 58.8% described the reason for retraction or correction as error, loss of data or replication failure when misconduct was actually at issue. Among the published statements in response to an official finding of misconduct (within the time frame studied), the proportion that mentioned ethics was significantly higher in recent years than in earlier years, as was the proportion that named a specific problem. To promote research integrity, scientific journals should consider adopting policies concerning retractions and corrections similar to the guidelines developed by the Committee on Publication Ethics. Funding agencies and institutions should take steps to ensure that articles affected by misconduct are retracted or corrected. (shrink)

This research focuses on how research ethics committee and integrity board members discuss and decide on solutions to case scenarios that involve a dimension of research ethics or integrity in collaborative settings. The cases involved issues around authorship, conflict of interest, disregard of good scientific practice and ethics review, and research with vulnerable populations (children and neonates). The cases were set in a university, a hospital, or a research institute. In the (...) class='Hi'>research, we used a deductive qualitative approach with thematic analysis. Twenty-seven research ethics committee and research integrity board members from 16 European countries and one country outside Europe participated. Participants represented natural and life sciences, social sciences, and humanities. They worked on cases involving ethical/integrity issues in six different constellations. Results show that experts apply key elements of ethical decision making, namely identification of ethical issues, stakeholders, guidelines, solutions, and own positionality, in dealing collaboratively with ethics/ integrity problems, and the nature of the application depends on the complexity of the case. Understanding how individuals knowledgeable in research ethics and integrity, in this case, individuals serving on research ethics committees and integrity boards, approach ethical/ moral issues can help to identify strategies that may be useful in the development of research ethics and integrity training for junior researchers who may benefit from learning professional strategies. (shrink)

Human genomics is a translational field spanning research, clinical care, public health, and direct-to-consumer testing. However, law differs across these domains on issues including liability, consent, promoting quality of analysis and interpretation, and safeguarding privacy. Genomic activities crossing domains can thus encounter confusion and conflicts among these approaches. This paper suggests how to resolve these conflicts while protecting the rights and interests of individuals sequenced. Translational genomics requires this more translational approach to law.

Scientific authorship serves to identify and acknowledge individuals who “contribute significantly” to published research. However, specific authorship norms and practices often differ within and across disciplines, labs, and cultures. As a consequence, authorship disagreements are commonplace in team research. This study aims to better understand the prevalence of authorship disagreements, those factors that may lead to disagreements, as well as the extent and nature of resulting misbehavior. Methods include an international online survey of researchers who had published from (...) 2011 to 2015. Of the 6673 who completed the main questions pertaining to authorship disagreement and misbehavior, nearly half reported disagreements regarding authorship naming; and discipline, rank, and gender had significant effects on disagreement rates. Paradoxically, researchers in multidisciplinary teams that typically reflect a range of norms and values, were less likely to have faced disagreements regarding authorship. Respondents reported having witnessed a wide range of misbehavior including: instances of hostility, undermining of a colleague’s work during meetings/talks, cutting corners on research, sabotaging a colleague’s research, or producing fraudulent work to be more competitive. These findings suggest that authorship disputes may contribute to an unhealthy competitive dynamic that can undermine researchers’ wellbeing, team cohesion, and scientific integrity. (shrink)

How can we enhance police integrity? The authors surveyed over 3000 police officers from 30 U.S. police departments on how they would respond to typical scenarios where integrity is challenged. They studied three police agencies which scored highly on the integrity scale: Charlotte-Mecklenburg, North Carolina; Charleston, South Carolina; and St. Petersburg, Florida. The authors conclude that enhancing police integrity goes well beyond culling out "bad apple" police officers. Police administrators should focus on four aspects: organizational rulemaking; (...) detecting, investigating and disciplining rule violations; circumscribing the informal "code of silence" that prohibits police from reporting the misconduct of their colleagues; and understanding the influence of public expectations and agency history. (shrink)

The clinical Bioresearch Monitoring (BIMO) oversight program of the US Food and Drug Administration (FDA) assesses the quality and integrity of data submitted to the FDA for new product approvals and human subjects protection during clinical studies. A comprehensive program of on-site inspections and data verification, the BIMO program routinely performs random inspections to verify studies submitted to the FDA to support a marketing application. On occasion the FDA will conduct a directed inspection of a specific site or (...) study to look for problems that may have previously been identified. The inspection of a clinical study sometimes uncovers evidence of research fraud or misconduct and it must be decided how to deal with the investigator and the suspect data. The prevention of [or] decreasing the incidence of fraud and misconduct through monitoring by the sponsor is one way to manage compliance issues and can help prevent misconduct. A training program is another way to manage compliance issues in clinical research. While training does not guarantee quality, it does help to ensure that all individuals involved understand the rules and the consequences of research misconduct. (shrink)

Concern for and interest in research integrity has increased significantly during recent decades, both in academic and in policy discourse. Both in terms of diagnostics and in terms of therapy, the tendency in integrity discourse has been to focus on strategies of individualisation (detecting and punishing individual deviance). Other contributions to the integrity debate, however, focus more explicitly on environmental factors, e.g. on the quality and resilience of research ecosystems, on institutional rather than individual responsibilities, (...) and on the quality of the research culture. One example of this is the Bonn PRINTEGER Statement. This editorial to the LSSP thematic series (article collection) entitled Addressing integrity challenges in research: the institutional dimension invites authors to contribute to the research integrity debate. Notably, we are interested in submissions addressing issues such as institutional responsibilities, changes in the research climate, duties of research managers and research performing or research funding organisations (RPOs and RFOs) as well as new approaches to integrity education. (shrink)

Training in scientific integrity continues to be an important topic in universities and other research institutions. Its main goal is to prevent scientific misconduct and promote good scientific practice. However, there is still no consensus on how scientific integrity should be taught. Moreover, the perspective of those who receive such training is often underrepresented. Yet it is precisely their interests and needs that must be considered when developing educational programs. Against this backdrop, we conducted a mixed-methods study (...) with the goal of capturing students’ perspectives on the teaching of scientific integrity. Using our online Scientific Integrity course, we explore what specific aspects of digital teaching on scientific integrity are valued, and explore other topics of interest from students’ perspectives on scientific integrity. The article presents (1) students’ self-assessment before (Q1) and after (Q2) taking the online Scientific Integrity course at the RWTH Aachen University in Germany (2) students’ feedback on the course format, video, exam, organization, and support (Q2) (3) a list of other topics of interest in the area of scientific integrity (Q2). The research outcomes demonstrate an improvement in the study participants’ self-assessment after following the online course and there is a general satisfaction among the students in regard to the course digital format and its components although a desire to have more exchange and discussion was expressed. Further topics of interest in the area of scientific integrity that study participants would like to learn about have a practical appeal and among others include research pressure, examples of applications, preventive measures, theory of science, citation rules, funding of university research. Although the results relate to our course, they provide insight into students’ perspectives on online teaching of scientific integrity. Thus, they may be helpful to higher education institutions developing online courses on scientific integrity that are tailored to university students. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 12.2 (2002) 215-224 [Access article in PDF] Bioethics Inside the Beltway Expanding Human Research Oversight Ellen Holt [Table]Overwhelmed by all the changes and proposed changes in the system to ensure human subject protection? It is an important subject and one in which everyone is interested. Being for human subject protection is like being for Mom. However, we all know that Mom sometimes (...) can be a handful! So I shall quickly review how we got to where we are, what is being done, and who is doing it. The table at the end of this article provides an additional summary of the current state of human subject protections. How We Got Here The current system of human subject protection was built 30 years ago with Institutional Review Boards (IRBs) as the cornerstone. Some well-publicized system failures in the last decade prompted evaluations that identified increasing volume and research complexity as primary threats to the system's effectiveness. In response, the Department of Health and Human Services (DHHS) Office of Inspector General (OIG 1998), and the National Bioethics Advisory Commission (NBAC 2001) issued recommendations calling for education and reform. Since then, initiatives in pursuit of these objectives have been rolling out non-stop. What Is Being Done The Office of Human Research Protections (OHRP) is leading the effort for DHHS, holding noncompliant research organizations accountable, while expanding the government's capacity for oversight, monitoring, and educating the research community. OHRP already has leveraged resources by: (1) implementing a unified federal registration system for all IRBs that identifies where IRBs are, how they are constituted, what kinds of research they are reviewing, and what volume of work they handle; (2) implementing a streamlined assurance process allowing all federal agencies to recognize a single, common assurance and avoid redundancy. The assurance is a commitment from any entity that receives federal funds for research to follow federal rules for protection of research subjects; and (3) redeploying resources from the process of negotiating assurances to supporting [End Page 215] quality improvement, including increasing the number site visits and providing IRBs with tools for self assessment and guidance for improvement.The goal is to prevent problems before they occur, and positive reinforcement and supportive training are the preferred themes. OHRP does wield a big stick and can shut down clinical studies in response to lax oversight, but it also has developed a big carrot by creating a national awards program to recognize excellence in protection of human research subjects—e.g., best practices, innovations in protecting research volunteers, and lifetime achievement for outstanding protection activities.Dr. Greg Koski, Director of OHRP, also is working with other government agencies to consolidate and build a comprehensive program. OHRP has four goals for a new oversight framework: Simplicity, Uniformity, Efficiency and Effectiveness. Selecting representatives from throughout the federal government, Dr. Koski has created the "SUEE" task force to identify and eliminate inefficiencies between the various agencies' human testing regulatory approaches. In addition, the SUEE task force will suggest improvements to current OHRP practices that can be achieved relatively quickly and easily.OHRP is working in concert with the Food and Drug Administration (FDA), which in October 2001, established the Office of Good Clinical Practice (OGCP) to improve the conduct and oversight of clinical research and to promote the protection of participants in FDA-regulated clinical research. Congressional Developments Although Dr. Koski is leading an aggressive charge to consolidate oversight across the federal government, many feel that reform will require legislation to succeed.Action on Capitol Hill is encouraging Bush administration efforts to reform oversight of clinical research. The House International Relations Committee has approved a measure that protects individuals in clinical trials overseas. A six-part Washington Post series (17-22 December 2000), "The Body Hunters," prompted an amendment to the Export Administration Act that, if finalized, will require drug companies to show that a U.S. ethics committee has approved the clinical trial as part of the application for authorization to export the investigational product.Members of Congress also are considering legislation to expand federal oversight of... (shrink)

This document presents the Bonn PRINTEGER Consensus Statement: Working with Research Integrity—Guidance for research performing organisations. The aim of the statement is to complement existing instruments by focusing specifically on institutional responsibilities for strengthening integrity. It takes into account the daily challenges and organisational contexts of most researchers. The statement intends to make research integrity challenges recognisable from the work-floor perspective, providing concrete advice on organisational measures to strengthen integrity. The statement, which was (...) concluded February 7th 2018, provides guidance on the following key issues: § 1.Providing information about research integrity § 2.Providing education, training and mentoring § 3.Strengthening a research integrity culture § 4.Facilitating open dialogue § 5.Wise incentive management § 6.Implementing quality assurance procedures § 7.Improving the work environment and work satisfaction § 8.Increasing transparency of misconduct cases § 9.Opening up research § 10.Implementing safe and effective whistle-blowing channels § 11.Protecting the alleged perpetrators § 12.Establishing a research integrity committee and appointing an ombudsperson § 13.Making explicit the applicable standards for research integrity. (shrink)