by Alan N. Schechter, NIDDK, and Joan P. Schwartz, NINDS
If adopted as federal policy, the recent recommendations of the Commission on Research Integrity would change significantly the way science is done at NIH and throughout the United States, especially with regard to resolution of disputes. Therefore, we feel it is imperative that as many scientists as possible read the commission's report and comment on its recommendations.
Health and Human Services (HHS) Secretary Donna Shalala established the Commission on Research Integrity (CRI) in 1993 after Congress directed her to form a panel to examine "issues of research, conduct and integrity." Congress specifically requested guidance in developing a new definition of research misconduct, an assurance process for institutional compliance with HHS regulations, processes by which to respond to and monitor related administrative processes and investigations, and a regulation to protect whistleblowers. The 12-member CRI, which was chaired by Kenneth Ryan of Harvard Medical School in Boston, spent two years holding hearings around the country and issued its final report last November. The report, entitled "Integrity and Misconduct in Research," covers three general areas: the definition of research misconduct, responsible whistleblowing, and administrative processes and investigations. Here is a brief summary of the recommendations and what we see as their implications for biomedical research.
Defining Research Misconduct
The current definition of research misconduct, adopted in 1989, was developed in response to a directive from Congress after several well-publicized cases of scientific misconduct. This definition-"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"-applies to all research funded by the Public Health Service, but not to that supported by the National Science Foundation or other federal agencies. Since its adoption, much concern has been raised about the vagueness of the "other practices" phrase.
One of CRI's main charges was to re-examine this hotly debated definition. To nearly everyone's surprise, instead of fine-tuning the currently accepted definition, the commission proposed a totally new definition, which it placed in the context of a broader category of professional misconduct. The definition states, "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 others."
These phrases are followed by examples of misappropriation, interference, and misrepresentation. In the commission's judgment, these acts represent misconduct, but we believe the CRI's definition overextends the boundaries of misconduct to matters that would best be left alone or resolved by the individuals or institutions involved. For example, it appears that omission of relevant references in a scientific paper could be construed as misappropriation, and an editor's actions in declining a paper could be defined as interference. Although CRI's approach of applying the general principle that "scientists be truthful and fair in the conduct of research and the dissemination of its results" has attractive features, many scientists and professional societies have reacted with alarm to the commission's proposed definition because it appears to broaden unnecessarily the scope of misconduct.
Furthermore, CRI specifically notes that some authorship disputes might fall under the purview of misconduct. Thus, the new definition could result in a flood of authorship-dispute cases that are not deemed scientific misconduct under current definitions.
The need to prevent retaliation against whistleblowers-people who report fraud, waste, and mismanagement-has been a concern of the federal government for the past decade. More recently, this concept has been extended to those making allegations of scientific misconduct-an uncharted area in which Congress asked CRI to propose some guidelines.
In its report, CRI strongly supported draft guidelines issued last November by the Office of Research Integrity (ORI). However, the commission added its own touch by drawing up "A Whistleblower's Bill of Rights," which it suggests be appended to the ORI's document.
Many concerns have been raised about the imbalance between the rights of the whistleblower and those of the accused, whether it be a scientist or an institution. The CRI "bill of rights" would provide significant protection to the whistleblower, but there is no comparable protection-or even acknowledgment-of the rights of the accused. Destroying a scientist's reputation through an unsubstantiated allegation that has been made public could be construed as a form of professional misconduct, and we believe measures that guard against this should be adopted. For example, standards for maintenance of confidentiality by all parties, with sanctions against those who break that confidentiality, are essential components of any dispute resolution, but they are not fully addressed in CRI's "bill of rights."
These sections of the CRI report cover many important issues, starting with how NIH intramural scientific misconduct cases will be reviewed. Other issues include 1) whether the results of all misconduct investigations-even those with no finding of misconduct-should be made public, 2) the increased potential for misconduct cases to overlap with civil and criminal procedures, 3) the suggestion that a law enforcement official be involved in all investigations, and 4) the proposal to assign retaliation cases to ORI, rather than allowing them to be handled through regular personnel channels.
Seeking Scientists' Responses
After receiving CRI's report, HHS Secretary Shalala appointed William Raub, who was formerly NIH's deputy director and is now Shalala's science policy adviser, to head a group that will recommend to her whether and how the CRI report should be implemented. This group is currently seeking input from scientists, and the NIH Committee on Scientific Conduct and Ethics would like to obtain as many comments from intramural researchers as possible. We will collate the comments and submit an unofficial response from the NIH community to the implementation group. Send your comments or suggested modifications to Alan Schechter (mail: Bldg. 10, Rm. 9N307: fax: 402-0101; e-mail:email@example.com). Copies of the CRI report can be obtained through HHS's Office of Research Integrity (phone: 301 443-3400; World Wide Web site: http://www.os.dhhs.gov/phs/ori).
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