The American experience: Lessons learned

This paper discusses ten lessons learned since 1989 about handling allegations of scientific misconduct involving biomedical and behavioral research supported by the U. S. Public Health Service. An earlier version of this paper was presented at a symposium, Scientific Misconduct: An International Perspective, organised by The Medical University of Warsaw, 16 November, 1998. The opinions expressed herein are those of the author and do not necessarily represent the views of the Office of Research Integrity, the U.S. Department of Health and Human Services, or any other federal agency.     

The poehlman case: running away from the truth

Eric T. Poehlman, Ph.D., was an internationally recognized, tenured professor at the University of Vermont (UVM) in Burlington when, in October 2000, a junior member of Poehlman’s laboratory became convinced that he had altered data from a study on aging volunteers from the Burlington area. This suspicion developed into one of the most significant cases of scientific misconduct in the history of the US Department of Health and Human Services’ (HHS) Office of Research Integrity (ORI), launching a US Department of Justice (DOJ) civil and criminal fraud investigation and, eventually, to a much publicized guilty plea and felony conviction. In the end, Dr. Poehlman admitted to 54 findings of scientific misconduct made by the UVM and ORI, agreed to retract or correct ten of his publications and to exclude himself from federal procurement and nonprocurement transactions for life. The United States Government’s handling of this case was distinguished by a highly cooperative approach that integrated the resources of the US Attorney’s Office for the District of Vermont (USAO) and both ORI and the Office of the Inspector General (OIG) in HHS in the common goal of prosecuting research fraud. The content of this article represents the personal views of the authors and does not express the opinion or policy of DHHS or its components. A paper on this topic was presented at the 6th International Bioethics Conference on the subject of ‘The Responsible Conduct of Basic and Clinical Research’, held in Warsaw, Poland, 3–4 June 2005.     

Scientific Forensics: How the Office of Research Integrity can Assist Institutional Investigations of Research Misconduct During Oversight Review

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.     

Scientific misconduct: Present problems and future trends

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. An earlier version of this paper was presented at the symposium entitled “Misconduct in Science: A Decade of Progress or Merely Years of Controversy” held during the Annual Meeting of the American Association for the Advancement of Science, Philadelphia, Pennsylvania, 13 February, 1998.     

Research misconduct among clinical trial staff

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.     

Evolving research misconduct policies and their significance for physical scientists

Scientific misconduct includes the fabrication, falsification, and plagiarism (FFP) of concepts, data or ideas; some institutions in the United States have expanded this concept to include “other serious deviations (OSD) from accepted research practice.” It is the absence of this OSD clause that distinguishes scientific misconduct policies of the past from the “research misconduct” policies that should be the basis of future federal policy in this area. This paper introduces a standard for judging whether an action should be considered research misconduct as distinguished from scientific misconduct: by this standard, research misconduct must involve activities unique to the practice of science and must have the potential to negatively affect the scientific record. Although the number of cases of scientific misconduct is uncertain (only the NIH and the NSF keep formal records), the costs are high in terms of the integrity of the scientific record, diversions from research to investigate allegations, ruined careers of those eventually exonerated, and erosion of public confidence in science. Existing scientific misconduct policies vary from institution to institution and from government agency to government agency; some have highly developed guidelines that include OSD, others have no guidelines at all. One result has been that the federal False Claims Act has been used to pursue allegations of scientific misconduct. As a consequence, such allegations have been adjudicated in federal courts, rather than judged by scientific peers. The federal government is now establishing a first-ever research misconduct policy that would apply to all research funded by the federal government regardless of which agency funded the research or whether the research was carried out in a government, industrial or university laboratory. Physical scientists, who up to now have only infrequently been the subject of scientific misconduct allegations, must nonetheless become active in the debate over research misconduct policies and how they are implemented since they will now be explicitly covered by this new federal wide policy. Disclaimer: The authors are grateful for the support for conduct of this research provided by the United States Department of Energy (DOE). The views expressed in this paper are solely those of the authors and were formed and expressed without reference to positions taken by DOE or the Pacific Northwest National Laboratory (PNNL). The views of the authors are not intended either to reflect or imply positions of DOE or PNNL.     

Assessing the Preparedness of Research Integrity Officers (RIOs) to Appropriately Handle Possible Research Misconduct Cases

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.     

Incarceration, Restitution, and Lifetime Debarment: Legal Consequences of Scientific Misconduct in the Eric Poehlman Case

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.     

Scientific misconduct and findings against graduate and medical students

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.     

Mentoring and Research Misconduct: An Analysis of Research Mentoring in Closed ORI Cases

We are reporting on how involved the mentor was in promoting responsible research in cases of research misconduct. We reviewed the USPHS misconduct files of the Office of Research Integrity. These files are created by Institutions who prosecute a case of possible research misconduct; ORI has oversight review of these investigations. We explored the role of the mentor in the cases of trainee research misconduct on three specific behaviors that we believe mentors should perform with their trainee: (1) review source data, (2) teach specific research standards and (3) minimize stressful work situations. We found that almost three quarters of the mentors had not reviewed the source data and two thirds had not set standards. These two behaviors are positively correlated. We did not see convincing evidence in the records that mentors were causing stress, but it was apparent in the convicted trainees' confessions that over 50% experienced some kind of stress. Secondary data, while not created for this research purpose, allows us to look at concrete research behaviors that are otherwise not very researchable. We believe it is important for mentors and institutions to devote more attention to teaching mentors about the process of education and their responsibilities in educating the next generation of scientists. This becomes a critical issue for large research groups who need to determine who is in charge educating, supervising and assuring data integrity.     

Beyond conflict of interest: the responsible conduct of research

This paper reports data and scholarly opinion that support the perception of systemic flaws in the management of scientific professions and the research enterprise; explores the responsibility that professional status places on the scientific professions, and elaborates the concept of the responsible conduct of research (RCR). Data are presented on research misconduct, availability of research guidelines, and perceived research quality. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland, 5–6 April, 2002. The opinions expressed herein are those of the author and do not necessarily represent the views of the Office of Research Integrity, the U.S. Department of Health and Human Services, or any other federal agency.     

The fallout: What happens to whistleblowers and those accused but exonerated of scientific misconduct?

Current DHHS regulations require that policies and procedures developed by institutions to handle allegations of scientific misconduct include provisions for “undertaking diligent efforts to protect the positions and reputations of those persons who, in good faith, make allegations.” Analogously, institutions receiving PHS funds are required to protect the confidentiality of those accused of such misconduct or, failing that, to restore their reputations if the allegations are not confirmed. Based on two surveys, one of whistleblowers and one of individuals accused but exonerated of scientific misconduct, this paper examines how well the system works to protect both sets of participants in cases of alleged misconduct. Contrary to popular impressions created by notorious cases, substantial minorities of both whistleblowers and exonerated scientists experience no adverse outcomes at the time the allegations are made and pursued. During this period, however, whistleblowers report more negative outcomes and more severe negative outcomes than their accused but exonerated counterparts. In the longer run, majorities of both groups report little impact on different aspects of their careers or professional activities, though those who report any impacts generally report negative ones. The accused but exonerated, however, appear to fare worse than whistleblowers in impacts on several aspects of their personal lives; their mental health, physical health, self-esteem, and self-identity.     

The Case of Vipul Bhrigu and the Federal Definition of Research Misconduct

The Office of Research Integrity found in 2011 that Vipul Bhrigu, a postdoctoral researcher who sabotaged a colleague’s research materials, was guilty of misconduct. However, I argue that this judgment is ill-considered and sets a problematic precedent for future cases. I first discuss the current federal definition of research misconduct and representative cases of research misconduct. Then, because this case recalls a debate from the 1990s over what the definition of “research misconduct” ought to be, I briefly recapitulate that history and reconsider the Bhrigu case in light of that history and in comparison to other cases involving tampering. Finally, I consider what the aim of a definition of research misconduct ought to be, and argue that the precedent set by the reasoning in this case is problematic.     

Seven ways to plagiarize: handling real allegations of research misconduct

As the research integrity officer at my university for two years, I handled eight allegations of plagiarism. These eight cases show that initial appearances can be mistaken, that policies for handling allegations of research misconduct cannot cover every contingency, and that many cases can be resolved collegially without resort to formal procedures. A preliminary version of this paper was presented at the Eleventh Annual Meeting of the Association for Practical and Professional Ethics, February 28 – March 3, 2002, Cincinnati, Ohio. The views, opinions, and recommendations expressed in this paper are not necessarily those of the University of Illinois at Urbana-Champaign.     

No One Likes a Snitch

Whistleblowers remain essential as complainants in allegations of research misconduct. Frequently internal to the research team, they are poorly protected from acts of retribution, which may deter the reporting of misconduct. In order to perform their important role, whistleblowers must be treated fairly. Draft regulations for whistleblower protection were published for public comment almost a decade ago but never issued (Dahlberg 2013). In the face of the growing challenge of research fraud, we suggest vigorous steps, to include: organizational responsibility to certify the accuracy of research including audit, required whistleblower action in the face of imminent or grave harm to subjects, strengthened legal protections against retaliation including prompt enactment of Federal whistleblower protections and consideration of criminalizing the most egregious cases of research misconduct.     

Scientific misconduct: The lessons of time

Conclusions 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. The views expressed here are the author’s own and reflect neither those of NSF nor of the National Science Board.     

Effectiveness of research guidelines in prevention of scientific misconduct

In response to a series of allegations of scientific misconduct in the 1980’s, a number of scientific societies, national agencies, and academic institutions, including Harvard Medical School, devised guidelines to increase awareness of optimal scientific practices and to attempt to prevent as many episodes of misconduct as possible. The chief argument for adopting guidelines is to promote good science. There is no evidence that well-crafted guidelines have had any detrimental effect on creativity since they focus on design of research studies, documentation of research findings, assignment of credit through authorship, data management and supervision of trainees, not on the origin and evolution of ideas. This paper addresses a spectrum of causes of scientific misconduct or unacceptable scientific behavior and couples these with estimates of the potential for prevention if guidelines for scientific investigation are adopted. The conclusion is that clear and understandable guidelines should help to reduce the chance that flawed research will escape from our institutions. However, they cannot be relied upon alone to prevent all instances of scientific misconduct and should be regarded rather as one means of bolstering the integrity of the entire scientific enterprise.     

Confronting misconduct in science in the 1980s and 1990s: What has and has not been accomplished?

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. An earlier version of this paper was presented at the symposium entitled “Misconduct in Science: A Decade of Progress or Merely Years of Controversy” held during the Annual Meeting of the American Association for the Advancement of Science, Philadelphia, Pennsylvania, 13 February, 1998.     

How Frequently do Allegations of Scientific Misconduct Occur in Ecology and Evolution, and What Happens Afterwards?

Scientific misconduct obstructs the advance of knowledge in science. Its impact in some disciplines is still poorly known, as is the frequency in which it is detected. Here, I examine how frequently editors of ecology and evolution journals detect scientist misconduct. On average, editors managed 0.114 allegations of misconduct per year. Editors considered 6 of 14 allegations (42.9%) to be true, but only in 2 cases were the authors declared guilty, the remaining being dropped for lack of proof. The annual rate of allegations that were probably warranted was 0.053, although the rate of demonstrated misconduct was 0.018, while the rate of false or erroneous allegations was 0.024. Considering that several cases of misconduct are probably not reported, these findings suggest that editors detect less than one-third of all fraudulent papers.