Last December, eleven years after the Public Health Service issued the first federal regulations addressing research misconduct, the Office of Science and Technology Policy published misconduct rules covering all research performed or sponsored by U.S. government agencies. Key to both policies was their definition of research misconduct. Although the latest government definition resembles the earlier PHS provision, the path from one to the other was far from direct. Between the first and the latest government regulations there was much debate over what research misbehavior warrants federal sanctions.
Controversy over the Federal Definition
During the 1980s, several high-profile cases of research misconduct captured media and congressional attention. In 1985, Congress directed the Department of Health and Human Services to develop regulations requiring institutions applying for PHS funds to review allegations of "scientific fraud." Four years later, the regulations were issued. Instead of fraud, however, they targeted "misconduct in science," defined as:
fabrication, falsification, plagiarism, or other practices that seriously
deviate from those that are commonly accepted within the scientific
community for proposing, conducting, or reporting research. It does not
include honest error or honest differences in interpretations or judgments
Soon after that, the National Science Foundation adopted a similar definition that added retaliation against good faith whistleblowers to the list of proscribed behaviors.(2)
These definitions did not sit well with some scientists. The primary objections were to the phrase "other practices that seriously deviate." Critics claimed the phrase was vague and could be applied to unorthodox but defensible research approaches. Besides chilling innovative science, they said, the provision opened the door to investigations against unpopular or low-ranking scientists pursuing legitimate research strategies. In 1995, a National Academy of Sciences panel strongly criticized the PHS and NSF definitions and presented a counterproposal. According to the panel, misconduct should cover only "fabrication, falsification, or plagiarism, in proposing, performing, or reporting research." The panel proposed a different label, "questionable research practices," to cover "actions that violate traditional values of the research enterprise and that may be detrimental to the research process."(3) In the panel's view, though such actions merited attention, scientific disagreement over their nature and seriousness meant they should not be considered misconduct.
Yet another proposal came in 1995 from the DHHS Commission on Research Integrity, a group charged with developing an agency-wide misconduct definition. Although the commission dropped the reference to other serious deviations from its recommended definition, it also rejected the National Academy panel's preferred approach. The commission concluded that the panel's definition failed to cover forms of conduct that should be proscribed, such as sabotage of another scientist's research.
The commission decided to try a different approach. Instead of describing specific offenses constituting research misconduct, it offered a general statement of the researcher's duty--to "be truthful and fair in the conduct of research and the dissemination of its results"--as well as a general definition of misconduct:
Research misconduct is significant misbehavior that improperly appropriates
the intellectual property or contributions of others, that intentionally
impedes the progress of research, or that risks corrupting the scientific
record or compromising the integrity of scientific practices. Such
behaviors are unethical and unacceptable in proposing, conducting, or
reporting research, or in reviewing the proposals or research reports of