T H E   N I H   C A T A L Y S T      J A N U A R Y   -   F E B R U A R Y   2000



by Joan P. Schwartz, Ph.D., NINDS, Assistant Director, OIR

Science is built on trust. Everyone expects that data published in the literature are real data, and we base new experiments on that assumption. But occasionally an instance of misconduct is uncovered in which an author of a scientific paper has falsified or fabricated the reported results. A proposed new definition of research misconduct—which will apply government-wide for the first time—was published for comment in the Federal Register [64 (198): 55722–55725, October 14, 1999]. The definition is:

Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research reports.

Fabrication is making up results and recording or reporting them.

Falsification is manipulating research materials, or changing or omitting data or results such that the research is not accurately represented in the research record.

Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit, including those obtained through confidential review of others’ research proposals and manuscripts.

Research misconduct does not include honest error or honest differences of opinion. Research is defined as all basic, applied, and demonstration research in all fields of science, engineering, and mathematics. The research record is defined as the record of data or results that embody the facts resulting from scientific inquiry, and includes, for example, laboratory records, both physical and electronic, research proposals, progress reports, abstracts, theses, oral presentations, internal reports, and journal articles.

How NIH handles allegations of scientific misconduct within the intramural program will also be modified. The largest change is that NIH will carry out its own investigations, rather than turning them over to the Office of Research Integrity (ORI). The NIH Committee on Scientific Conduct and Ethics is currently rewriting the Guidelines that describe NIH Policies and Procedures for Investigation of Scientific Misconduct—a subject for a future Catalyst column.

Over the past few months, instances of falsification have turned up at NIH involving radiation contamination survey data, animal weight records, and publications listed in the bibliography of a scientist’s CV. In pondering the ramifications of these events, the specific offices involved, as well as the NIH Committee on Scientific Conduct and Ethics, first considered whether the material in question constituted a part of the research record as defined above, in which case the falsification or fabrication would be deemed scientific misconduct. In each case, it was concluded that, technically, no scientific misconduct had been committed but the scientist involved had behaved unacceptably and deserved some type of sanction.

Radiation contamination surveys must be done monthly in any laboratory that uses radioisotopes. The Nuclear Regulatory Commission (NRC) requires them as a condition of the NIH’s license because they ensure that no staff are exposed to radiation of which they are unaware. Twice recently, NIH lab staff members fabricated surveys in response to notifications that survey results for certain months were missing. Because such records are not a part of the research record per se and are never published as research results, this fabrication does not reach the bar for scientific misconduct. Rather, surveys of this sort might fall into a category of administrative records. Nevertheless, such fabrication is a violation of NRC regulations and the individual(s) involved could be subject to criminal penalties. The "authorized user" responsible for the laboratory could be barred from using NRC-licensed radioactive materials for up to 3 years, and NIH could deliver an official reprimand that becomes a part of the individual’s personnel record. As all NIH staff were recently notified in a desk-to-desk memo, such falsification of radiation contamination surveys is unacceptable.

The second incident involved fabrication of weights for a research animal that had been placed on a restricted diet—instead of weighing the animal and recording the actual weight weekly. As a consequence, the animal lost significantly more weight than acceptable, thereby endangering its health. The weight data were used neither in a scientific publication nor in a specific research protocol and, again, could be considered an administrative record. However, these actions clearly violated the NIH Guidelines for Animal Care, and the scientist involved therefore received an official reprimand and was prohibited from participating in animal protocols for the duration of his appointment at NIH.

The third example involved the identification of a series of irregularities in five references included in the bibliography of a researcher’s CV. For two of them, actual references existed in the literature, but the first author’s name had been replaced with the name of the person accused of the falsification; the year had also been changed. Two other references cited papers that do not exist; the fifth had the correct authors and title but the wrong journal. A CV is also a type of administrative document, used for applications for jobs and grants. If this CV had been used to apply for a federal job, the falsification would have been a criminal act. If used in a grant application, it would have constituted research misconduct. In this case, the NIH appointment of the errant CV author was ending and was simply not renewed. A major issue, however, was what a supervisor should say if asked for a letter of recommendation for this individual. It is ultimately a decision each supervisor must make, but NIH has recommended that the fact be disclosed that a CV was received from the individual in which certain bibliographic citations proved to be erroneous. Such a statement advises the next employer of potential problems with the applicant.

Too often, when a supervisor encounters such behaviors, he or she is eager to get the offender out of the laboratory but avoids coming to grips directly with the issues of fabrication and falsification. But we cannot turn our backs on the integrity of either the research record or the administrative record that supports it. The public trust—reflected in our licenses to conduct research with radioisotopes, animals, and human subjects, as well as the tax dollars that support NIH—is contingent on our responsible behavior as a community.


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