Office Of Research Integrity Research Articles

Sodium channels in astrocytes of rat optic nerve in situ: immuno-electron microscopic studies.

This paper presents immunocytochemical studies using Antibody 7493. We interpreted immunostaining with Antibody 7493 as providing information about sodium channel localization, based on an immunological characterization of Antibody 7493 carried out in the laboratory of K.J. Angelides, a co-author of this paper. As reported in the Federal Register on March 12, 1999, based on an investigation by the Baylor College of Medicine into allegations of scientific misconduct by Dr. Angelides, the NIH Office of Research Integrity, on March 10, 1997, found that Dr. Angelides falsified the description of the data in the text and in the legend of Figure 1 of this paper and that his conduct constituted scientific misconduct. The Appeals Board of the Department of Health and Human Services issued a decision on February 5, 1999, in which it affirmed the findings of the Office of Research Integrity. More recent immunocytochemical studies, carried out in our laboratory using additional antibodies generated in other laboratories against conserved polypeptide sequences of sodium channels, have confirmed the presence of sodium channel immunoreactivity in astrocytes in vivo and in vitro, but we have not been able to determine whether perinodal astrocyte processes exhibit sodium channel immunoreactivity. Given the allegations of irregularity in the immunological characterization of Antibody 7493 and the findings that ORI and the DAB have made, we do not feel that we can stand behind the interpretation of results using this antibody. We therefore retract this paper.

Reporting unethical research behavior.

Scientists, as professionals, have a responsibility to self-regulate. However, whistleblowing is rare. We investigated scientists' infrequent disclosure of unethical behavior by studying their responses to scenarios describing unethical research acts and compared their responses to those of research administrators. A cross-sectional survey was administered to National Science Foundation-funded principal investigators and their institutions' representatives (IRs) to the Office of Research Integrity. Both scientists and IRs proposed to respond to nearly all research behaviors that they rated as unethical. Scientists more often proposed responses limited to the research team (58% vs. 25% of cases, p < .001) whereas IRs more often proposed to inform an administrator or dean, journal editor, funding agency, professional society, or reporter. The prior behavior and academic rank of the scenario protagonist were associated with responses, but consequences of the unethical behavior were not. Scientists appear to perceive that they uphold their responsibility to respond to unethical behavior by disclosures within the research team, whereas administrators propose to report to externally accountable individuals, raising the question of whether scientists' behavior constitutes professional self-regulation or cover up.

The history and future of the Office of Research Integrity: Scientific Misconduct and Beyond.

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.

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.

Scientific misconduct: the lessons of time. Commentary on "The history and future of the Office of Research Integrity: scientific misconduct and beyond" (C. Pascal)

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.

Commentary on “The history and future of the office of research integrity: Scientific misconduct and beyond” (C. Pascal)

Commentary on “The history and future of the office of research integrity: Scientific misconduct and beyond” (C. Pascal)

Punishment for unethical behavior in the conduct of research.

To investigate the perceptions of scientists and institutional representatives (IRs) to the National Institutes of Health's Office of Research Integrity concerning appropriate punishment for unethical research behavior. In 1994-95, 606 scientists and 91 IRs rated the ethical behaviors of and suggested appropriate punishments for protagonists in randomly generated scenarios describing scientific research behaviors. The authors evaluated the relationships of the suggested punishments to the protagonists' behaviors and characteristics, and compared recommendations of the scientists and IRs. The respondents suggested punishments for 80% of the scenarios that were rated unethical. Punishments were more often prescribed for behaviors rated more unethical and for repeat offenders. The type of punishment was related to the protagonist's academic status and the nature of the unethical behavior. IRs proposed more and different punishments than did scientists. Scientists and IRs proposed that most unethical research behaviors be punished. The decision to punish depended on the unethical level of the behavior. The type of punishment depended on the aims: correcting the wrong, rehabilitation, or sanction. Variation in the respondents' selections of punishments and the IRs' greater propensity to punish suggest that scientists committing similar ethical violations may receive different punishments. Explicit consideration of which punishment is merited under what circumstances should be undertaken by the scientific community.

Tough Job: Managing Research Labs

Over the past two decades, the academic research enterprise has undergone a rapid metamorphosis and in the process made the task of managing that enterprise much more difficult. To address these problems, the University of Arizona, Tucson, and the Office of Research Integrity (OBI) of the Public Health Service held a conference in early October on the management of biomedical research labs. Although the meeting focused on biomedicine, the problems and solutions discussed would apply to almost any science, including basic chemical research. One of the issues discussed at the meeting was difficulties posed by multidisciplinary collaborations. For example, although they have opened up unprecedented opportunities for advancing scientific knowledge and developing new products, multidisciplinary collaborations have presented lab managers with a new set of challenges. Among them are the sheer physical task of collecting and retaining vast quantities of data generated by interdisciplinary and interinstitutional t...

Anonymity and pseudonymity in whistleblowing to the U.S. Office of Research Integrity.

Given the concerns expressed by members of the academic and legal community about whether (and how) to handle anonymous and pseudonymous allegations of scientific misconduct, this paper summaries the experiences of the Office of Research Integrity and its predecessor from 1989 through 1997. Although the record shows that research institutions and the ORI have treated such allegations seriously, the fraction of complainants to the ORI who remain anonymous is small (8% of 986 allegations); few anonymous complaints are sufficiently substantive to be pursued (4% of the 357 formal cases opened in the ORI); and only 1 of these 13 cases resulted in an ORI finding of scientific misconduct.

Dr Bernard Fisher exonerated by office of research integrity

Dr Bernard Fisher exonerated by office of research integrity

At Law: Giving Scientists Their Due The Imanishi-Kari Decision

After ten years of investigation and controversy, the case against Dr. Thereza Imanishi-Kari has finally been resolved. Imanishi-Kari, an immunologist, was accused of scientific misconduct in 1986. After the fifth inquiry into the case, a Department of Health and Human Services (DHHS) appeals panel concluded in June 1996 that the evidence against Imanishi-Kari was insufficient prove that she had intentionally and deliberately fabricated and falsified experimental data and results support a published paper whose scientific accuracy had been questioned. Though the case had previously been reviewed by two institutional and two federal committees, the DHHS appeals panel took a fresh look at the facts. The panel of two lawyers and one scientist heard testimony for twenty-eight days and studied the massive written record prior inquiries had generated. For the first time, Imanishi-Kari was given the opportunity confront and cross-examine the government's witnesses. Current federal policy requires the DHHS Office of Research Integrity (ORI) establish misconduct by a preponderance of the evidence. Thus, prove its charges, ORI had furnish testimony and documents showing it was more likely than not that Imanishi-Kari had knowingly made up or altered experimental data. In a meticulous and lengthy opinion, the panel described the government's evidence against Imanishi-Kari and explained why it fell short.[1] In essence, the ORI and the appeals panel disagreed on the plausible inferences be drawn from Imanishi-Kari's research-related conduct and record keeping. The ORI contended that Imanishi-Kari's disorganized laboratory notebooks and her subsequent difficulty in accounting for various data entries indicated she had probably committed intentional data fabrication and falsification. But in the panel's judgment, the state of the notebooks and her problems in explaining them could just as plausibly be attributed a degree of sloppiness in recording and maintaining data, the anomalies and errors ordinarily found in real life scientific research, and ordinary forgetfulness about events that had occurred years earlier. The opinion analyzes an extensive array of evidence. Two points of disagreement between ORI and the appeals panel concerned the proper inferences be drawn from certain characteristics of Imanishi-Kari's reported data. The ORI contended that Imanishi-Kari had made up or changed data after the fact support the challenged paper. But the appeals panel noted that her notebook data contained many anomalies undermining the paper's conclusions. Why, the panel members wrote, would Imanishi-Kari make up or alter data in a way that would cast doubt on her published conclusions? Similarly, the panel noted that much of the challenged data addressed relatively trivial dimensions of the research. Why, they asked, would Imanishi-Kari report the central data truthfully, with all their flaws, but make up or change data on points of little importance the paper? The appeals panel also was extremely critical of the evidence ORI assembled support its claim of probable misconduct. The panel questioned the quality of forensic evidence offered show the notebook data were inauthentic; moreover, suggestions that the notebook materials were prepared and arranged at different times were not inconsistent with Imanishi-Kari's description of her usual data collection and record-keeping practices. Overall, the panel saw ORI as holding Imanishi-Kari a standard of excellence not found among scientists generally. The panel also faulted ORI for characterizing what was at most careless or negligent conduct as persuasive evidence of deliberate, intentional data manipulation. ORI charged Imanishi-Kari with misconduct because its staff was unconvinced by her explanation for the state of her laboratory materials. In turn, the panel was unconvinced by ORI's own explanation: to sustain the charges against Dr. …

Improving the Scientific Misconduct Hearing Process

The overturning and withdrawal of several of the Office of Research Integrity's (ORI's) findings of scientific misconduct have called its role into question. The contested findings of scientific misconduct that have been tried before the hearing body have been based on lengthy and expensive ORI investigations. How could ORI have failed to prove its findings of scientific misconduct after the commitment of substantial resources that far exceed those devoted during institutional investigations? One reason may be that the current hearing process makes it difficult or impossible for ORI, institutions, or individuals to prove scientific misconduct. The hearing process has been criticized by discouraged whistleblowers who believe that their allegations of scientific misconduct should have been upheld, and by the accused for the expensive and protracted nature of the proceedings. The following article examines problems in the scientific misconduct hearing process and suggests that the process could be improved by letting administrative law judges, patent attorneys, and a scientific majority decide these cases.

Breast Cancer Researchers Cleared of Charges

AFTER NEARLY 3 years of investigation, the US Department of Health and Human Services' Office of Research Integrity (ORI) has dismissed all scientific misconduct charges against Bernard Fisher, MD, former head of the National Surgical Adjuvant Breast and Bowel Project (NSABP), and 2 colleagues. <h3>Fisher Guided Study</h3> As chair of the project and principal investigator for nearly 3 decades, Fisher, who is Distinguished Service Professor of Surgery at the University of Pittsburgh School of Medicine, Pittsburgh, Pa, guided the international study that has helped shift the treatment of breast cancer for many women from mastectomy to lumpectomy combined with subsequent radiation therapy. In 1994, following pressure from Rep John Dingell (D, Mich), the National Cancer Institute (NCI)—the principal sponsor of the NSABP—charged Fisher, Lawrence Wickerham, MD, adjunct research associate professor of surgery at Pittsburgh, and Carol Redmond, ScD, currently on leave from her professorship of biostatistics at Pittsburgh's Graduate

NIH genome lab head reports data fabrication

Francis S. Collins, director of the Human Genome Project at the National Institutes of Health, is retracting five published research papers because, he says, some of the data in them were fabricated by one of his former students. Collins, who also heads research laboratory at NIH, sent letter to research colleagues last month to inform them of what he called a stunning series of data misrepresentations and outright fabrications, extending over period of at least two years. He did not name the student involved, whom he said had confessed to the falsifications. A full inquiry is under way, Collins added, involving NIH, the Department of Health & Human Services' Office of Research Integrity (ORI), and research university he did not name. The University of Michigan—where Collins has remained professor of internal medicine and human genetics since his move to NIH in 1993—has issued statement saying it is investigating admissions ...

More pricks than kicks

The first intimation that we face a dispiriting two and a half hours at Stephen Poliakoff's new play comes in the programme notes. “Scientific fraud,” David Jones writes, “is impossible to get away with. Once your findings are published, others will…try to repeat them. If they fail, questions will be asked…. So fraud doesn't happen very often….When it does, there is always some surprising or desperate human story behind it.” Jones is in academic chemistry, where perhaps fraud is unusual and failure to replicate results has uncovered several cases. Elsewhere fraud is far from rare; in medicine there are well over 100 documented cases, with half a dozen new ones being recorded every quarter in the bulletin of the US Office of Research Integrity alone. These are probably the tip of an iceberg. Most cases come …

The Baltimore affair: Let's not forget what went wrong

The Office of Research Integrity should rename itself the Office of Reputational Restoration.

Appeals Board Exonerates Baltimore, Imanishi-Kari

IN A DECISION that will undoubtedly have repercussions for dealing with scientific misconduct in government-financed research, the Departmental Appeals Board of the Department of Health and Human Services (DHHS) exonerated Thereza Imanishi-Kari, PhD, an immunology researcher at Tufts University, Boston, Mass, of all charges made by the Office of Research Integrity that she had "intentionally and deliberately fabricated and falsifed experimental data and results." The board's decision, number 1582, was released in late June after 6 weeks of hearings last summer and lengthy examination and discussion of the record (70 original laboratory notebooks and 6500 pages of hearing transcript). The board concluded that "the Office of Research Integrity (ORI) did not prove its charges by a preponderance of the evidence," and noted in its decision that the ORI is required to "produce evidence that is more convincing than the opposing evidence and shows as a whole that misconduct was more

US Scientific Fraud Office found at fault

The United States Office of Research Integrity has been portrayed as a kangaroo court and found at fault over a case of scientific fraud involving one of America's most well known medical scientists, Dr David Baltimore. Dr David Baltimore, a Nobel laureate, resigned in 1992 …

IMANISHI-KARI CLEARED HHS panel rejects misconduct charges

One of the longest and most acrimonious investigations of scientific misconduct has ended. After a decade of charges and probes, an adjudications panel appointed by the Department of Health & Human Services (HHS) has found that none of the allegations against Tufts University immunologist Thereza Imanishi-Kari has been proven. This ruling reverses a 1994 decision by HHS's Office of Research Integrity (ORI) that Imanishi-Kari fabricated data in a 1986 paper in the journal Cell—which she coauthored with Nobel Laureate David Baltimore and four others—and that she tried to cover it up with further falsifications. ORI recommended she be barred from federal research grants for 10 years. The three-member panel sharply criticized ORTs decision, saying, Much of what ORI presented was irrelevant, had limited probative value, was internally inconsistent, lacked reliability or foundation, was not credible or not corroborated, or was based on unwarranted assumptions/ 7 The panel's report adds that much of the eviden...

Advice to individuals involved in misconduct accusations.

The author offers advice to faculty, students, and staff who become involved in issues of research misconduct, whether as the accuser or as the accused. After reviewing the different definitions of research misconduct used by various authorities and discussing other kinds and degrees of misconduct, he provides information to those who suspect research misconduct, to help them identify their responsibilities and the risks involved: he makes it clear that an accusation of research fraud or other misconduct has serious consequences for all parties. The author then discusses how to pursue concerns about improper research practices, emphasizing a nonconfrontational approach and the use of proper channels for reporting. He explains the process of a formal review, including characteristic institutional responses; the role of the Office of Research Integrity; and when to seek the advice of an attorney. He argues that education is clearly preferable to denunciation as a way to improve scientists' ethics and practices. The author then gives similarly detailed advice to the accused, including a caution not to take criticism of methods or results as an accusation of fraud. He discusses the significances of the two stages of review of an allegation of misconduct, with practical advice for cooperative participation in any review; use of legal counsel; the importance of avoiding retaliation; information about due process and material evidence; the impact of a formal investigation; peer standards for evaluating misconduct; and the unavoidable discomfort that the accused will experience during the lengthy process. He advises that practicing good science is the first step in avoiding this unpleasant experience.