December 2, 1999 - Proposed Federal Policy on Research Misconduct To Protect the Integrity of the Research Record

The American Society for Microbiology (ASM) wishes to submit the following formal comments in response to the Office of Science and Technology Policy's (OSTP) request for comments on the proposed federal policy on research misconduct. The ASM is the largest single life science society with over 40,000 members who are involved in basic, applied and clinical research.

The ASM has a long history of involvement with research integrity issues and has commented extensively in the past on federal policies and procedures related to issues of scientific misconduct. The ASM Publications Board is responsible for the publication of 10 journals that printed 6,378 scientific articles in 1998. In addition, the ASM holds two major scientific meetings each year. In one, over 2,200 papers are presented on new developments in the microbiological sciences and the other is the largest meeting on infectious diseases in the world. The Society has developed strong and well-enforced procedures for peer review of manuscripts published in its journals; its instructions to authors specify procedures, which the ASM believes contribute to ensuring the quality and integrity of the scientific literature.

The ASM has made a significant contribution to education in the area of ethical behavior in a research setting by publishing a textbook by Dr. Francis Macrina entitled "Scientific Integrity: An Introductory Text with Cases." This text is widely used by research institutions that have initiated formal courses dealing with this subject.

We are grateful for the opportunity to comment on the proposed policy on research misconduct published in the Federal Register on October 14, 1999. Dr. Julius Youngner, Chair of the ASM's Committee on Ethics and the only scientist who has served on two Research Integrity Adjudication Panels of the Department of Appeals Board of the Department of Health and Human Services, namely the panels for the Gallo and Imanishi-Kari appeals, presented the views of the ASM at the National Academy of Sciences Town Meeting on November 17, 1999, which was held to discuss the OSTP's proposed policy on research misconduct.

The OSTP is to be commended for crafting a policy that will serve as a workable guide for the federal agencies that fund research and for the research institutions responsible for the use of these funds. The ASM welcomes the revised definition of research misconduct: it is clearly stated and eliminates the ambiguity that many scientists took exception to in earlier versions. In addition, the Policy places strong emphasis on the primary role of research institutions in dealing with allegations of misconduct and provides administrative guidelines for evaluating such charges. We hope that the NAS town meeting discussion, as well as the public comments received on the OSTP notice, will be part of the process of evolving procedures and definitions for insuring the integrity of the scientific record. As a continuation of the dialogue with the scientific community, we hope that the discussion and comments will lead to amendment, if needed, of the policy that has been published in the Federal Register.

Although the definitions in Section I (Research Misconduct Defined) are generally clear and unambiguous, we suggest that the sections should be restructured to include the essential elements of research misconduct in the definition. We believe that the definition of misconduct should be amended to include the last statement after the definitions and the statement after the second bullet under section II (Findings of Research Misconduct). Adding the element of intent to the definition of misconduct in section I will make it clear that intent is an essential aspect of research misconduct. Also, we believe that the idea of "honest error or honest differences of opinion" should be part of this definition. The amended paragraph we propose would read:

"Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. The misconduct must be committed intentionally, knowingly, or in reckless disregard of accepted practices. Misconduct does not include honest error or honest differences of opinion."

Section II. (Findings of Research Misconduct) calls attention to a problem that many in the scientific community had with previous definitions. Strong exception was taken to the definition of research misconduct that included the phrase "...or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research." Inclusion of such a phrase in previous definitions suggested activities for which there is no clear consensus of accepted behavior. In commenting on the earlier definition, the ASM took the position that careful and complete attention to cases of true research misconduct was diluted by such an addition, and that such deviant behavior is best dealt with by mechanisms distinct from those proposed for research misconduct. Although similar wording does not occur in the definition of misconduct in the Policy being discussed, an equally ambiguous version of the unacceptable wording cited above appears in section II. (Findings of Research Misconduct). This section states that "A finding of research misconduct requires that: There be a significant departure from accepted practices of the scientific community for maintaining the integrity of the research record." Despite the subtle changes in wording and its inclusion in a section other than the one that defines research misconduct, this phrase carries the same burden of imprecision and vagueness as its earlier version. The fact that it is omitted from the section of definitions does not mitigate its reality when it is imbedded in a section of the policy that makes it a requirement for a finding of misconduct. It is our position that the definitions are sound and that they stand on their own without appending this terminology to the process. To paraphrase a statement in the 1992 NAS report "Responsible Science", the use of ambiguous terms in regulatory definitions invites overexpansive interpretation. We strongly recommend the sentence referred to be deleted from the Proposed Policy.

We suggest that Section II (Findings of Research Misconduct) consist simply of the statement, "Allegations of research misconduct must be proven by a preponderance of the evidence."

A noteworthy and desirable recommendation of the Proposed Policy is the separation of the investigation and adjudication phases of the misconduct process. This separation will eliminate an overlap that can be inconsistent with fairness and objectivity. In this connection, on October 22, 1999, Secretary Shalala announced that the Department of Health and Human Services will implement this separation. In the past, both investigation and adjudication functions were the responsibility of the Office of Research Integrity. In the future, fact-finding functions will be assigned to the HHS Office of Inspector General. The Office of Research Integrity will then use these findings to determine if misconduct occurred and recommend actions to the HHS Assistant Secretary of Health, who will make the final decision regarding misconduct, subject to appeal by the respondent to the Departmental Appeals Board.

Section IV (Guidelines for Fair and Timely Procedures) deals with safeguards for informants who make allegations of research misconduct. It is clear that protection of such informants from retribution is absolutely necessary when allegations are made in good faith. Research institutions and scientific societies must encourage scientists to come forward without fear of reprisal when they have knowledge of wrongdoing. On the other hand, the Policy does not provide for appropriate consequences for those who make false, malicious, or capricious allegations. Research institutions should adopt suitable mechanisms to deal with such conduct.

The policy spells out safeguards for the scientist who is accused of research misconduct but the safeguards fall short in a crucial way. Given the devastating impact that an allegation of research misconduct may have on a scientist's career, it is essential that the accused be afforded fundamental fairness at all levels of the investigative process. The accused should have the opportunity to confront and question any adverse witness and to present favorable evidence and witnesses. To state that the subjects of allegations should have "the opportunity to respond to allegations and to the evidence and findings upon which they are based" falls short. No guidance is provided to federal agencies or research institutions for providing appropriate procedures or insuring due process rights during the investigation phase of an inquiry. Should there be a formal finding of misconduct by the federal awarding agency and administrative actions are proposed, the accused must have the right to a due process hearing to contest the factual and legal basis for the finding. We urge all federal agencies to include such safeguards in their rules.