At Law: Defining Research Misconduct: Will We Know It When We See It?

Abstract

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 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 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 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 fraud. Four years later, the regulations were issued. Instead of fraud, however, they targeted misconduct in defined as: falsification, plagiarism, or practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting It does not include honest error or honest differences in interpretations or judgments of data.(1) 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 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, should cover only fabrication, falsification, or plagiarism, in proposing, performing, or reporting research. The panel proposed a different label, questionable research practices, to cover that violate traditional values of the research enterprise and that may 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 considered misconduct. Yet another proposal came in 1995 from the DHHS Commission on Research Integrity, a group charged with developing an agency-wide definition. Although the commission dropped the reference to 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 proscribed, such as sabotage of another scientist's 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 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 others. …