The US Governmentwide Regulations of December 2000 Figure 233

During the ensuing five years, cases occurred and were reported in the media, and were summarised in regular reports from the ORI and the

Federal Policy on Research Misconducta

I. Researchb Misconduct Defined

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

• Fabrication is making up data or results and recording or reporting them.

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

• Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit.

Research misconduct does not include honest error or differences of opinion.

II. Findings of Research Misconduct

A finding of research misconduct requires that:

• There be a significant departure from accepted practices of the relevant research community; and

• The misconduct be committed intentionally, or knowingly, or recklessly; and

• The allegation be proven by a preponderance of evidence.

a No rights, privileges, benefits or obligations are created or abridged by issuance of this policy alone. The creation or abridgment of rights, privileges, benefits, or obligations, if any, shall occur only upon implementation of this policy by the Federal agencies.

b Research, as used herein, includes all basic, applied, and demonstration research in all fields of science, engineering, and mathematics.This includes, but is not limited to, research in economics, education, linguistics, medicine, psychology, social sciences, statistics, and research involving human subjects or animals.

c The research record is the record of data or results that embody the facts resulting from scientific inquiry, and includes, but is not limited to, research proposals, laboratory records, both physical and electronic, progress reports, abstracts, theses, oral presentations, internal reports, and journal articles.

The term "research institutions" is defined to include all organizations using Federal funds for research, including, for example, colleges and universities, intramural Federal research laboratories, Federally funded research and development centers, national user facilities, industrial laboratories, or other research institutes. Independent researchers and small research institutions are covered by this policy.

Figure 2.3 Federal policy on research misconduct.3

NSF. Gradually, as the media, the public and the profession realised that the system was working in a routine and reasonably efficient manner, the heat died down, meanwhile, the administration embarked on the lengthy process of making common regulations that would govern all types of research, and not just those in biomedicine.

On 6 December 2000, after a two-month public comment period, the Clinton administration issued the new, government-wide regulations defining research misconduct and laying down the rules for investigation and adjudication of allegations of misconduct concerning research done with US federal funds.3 Since all important universities and research institutions receive such funds, these regulations will become institutional rules, although institutions are allowed to have their own additional rules if they wish to impose a higher internal standard.

We strongly believe they should, and we say this because the new definition, confining itself to "fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results," leaves out many actions that we find destructive of good science, and which are not covered by other laws. We were both involved in assessing one case in which a junior investigator had sequestered data and materials from her colleagues - an action that would not be judged to be scientific or research misconduct by the new regulations, though commonsense would tell us that the investigator's conduct in the performance of research was wrong. We are troubled, then, that by making the definition too narrow, other egregious behaviours might seem to be condoned. It would send the worst possible signal if the academic community were to think such behaviour - by default - to be acceptable.

This new definition is again appropriately silent on prolonged non-compliance with other research regulations, such as the unethical treatment of human research subjects or mistreatment of laboratory animals used in research, because there are already regulations governing these problems. Again, the new regulations do not supersede criminal or other civil laws that have nothing to do with the faithful reporting of good science (for example, laws on sexual harassment).

Like the Ryan Commission Report, from which the new rules drew extensively, from the incorporation of interior definitions of critical terms and of states of mind for offences, to articulation of necessary procedural safeguards, the new rules provide the rationale for all the proposals. We strongly recommend that anyone interested in the formulation of adequate institutional responses to allegations of research misconduct, read both the Ryan Commission Report and these new US Government Regulations of December 2000.

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