Definitions and boundaries of research misconduct: perspectives from a federal government viewpoint.
Introduction The definitions and boundaries of misconduct in science and research are important public policy issues. They are particularly important to scientists who may become the subject of allegations, to their colleagues or to the officials of their employing institutions who may have to deal with such allegations, and to the federal agencies that have established regulations requiring the investigation and reporting to the government of such matters as they may relate to applications and awards for fellowships, grants, and contracts for research from federal funds. The purpose of this article is to review and to contrast between two major federal agencies the development of the definition of scientific misconduct. Background of Federal Definitions of Misconduct Early PHS/NIH Policy The United States Congress passed the Health Research Extension Act of 1985 (12), enacting Section 493 of the Public Health Service (PHS) Act, which required research institutions to review reports of "scientific fraud" and required the director of the National Institutes of Health (NIH) to establish an administrative process to respond to such information and to recommend sanctions where appropriate (20). The PHS agencies had previously handled cases and imposed administrative actions (sanctions) based on the inherent authority of the Department of Health and Human Services (HHS) to administer and protect effectively the integrity of PHS grant programs. This authority was publicly announced in 1982 when the HHS published a Privacy Act notice (3) that stated: "Individuals who are recipients of, or candidates for, awards may be subjects of investigations or determinations of misconduct. Such misconduct might consist of falsification of scientific data, misuse of public funds, or fraud. It might involve other violations or infractions of laws, regulations, or ethical standards, indicating that the individual does not fulfill the responsibilities and qualifications expected in the conduct of biomedical research or the expenditure of public funds." As a first step toward formal regulations, interim PHS policies and procedures were published in 1986 in the NIH Guide to Grants and Contracts (23), with an initial definition of "misconduct in science" as "(1) serious deviation, such as fabrication, falsification, or plagiarism, from accepted practices in carrying out research or in reporting the results of research; or (2) material failure to comply with Federal requirements affecting specific aspects of the conduct of research, for example, the protection of human subjects and the welfare of laboratory animals." NSF's First Regulations During this same period, the National Science Foundation (NSF), a separate federal agency, developed and published in 1987 (13) a Notice of Proposed Rulemaking (NPRM), which was followed by the establishment (14) of formal NSF regulations at 45 CFR Part 689. The NSF adopted a definition of "misconduct in science and engineering research" that was similar to that in the 1986 NIH Guide, but NSF included an additional section: "failure to meet other material legal requirements governing research." Under this definition, the NSF's Office of Inspector General (OIG) recommended in 1990, and the NSF deputy director proceeded with, a debarment for a case of misconduct involving sexual malfeasance/harassment by an investigator; this behavior was judged to be an integral part of his performance as the mentor of students involved in field research on an NSF grant (15). A number of scientists and their professional associations publicly criticized this application of the definition of "misconduct in science" to include sexual harassment-related activities (26). The NSF OIG staff has recently defended this position (1). PHS Regulations Following the NSF's process, the PHS (4) also published an Advance NPRM (a preliminary public announcement) and then a Proposed Rule (an NPRM) in 1988, seeking public comment on a PHS definition of misconduct in science including: "(1) fabrication, falsification, plagiarism, deception or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research; or (2) material failure to comply with other requirements that are uniquely related to the conduct of research. …