HHS Panel Issues Proposals For Implementing Misconduct Report

SIDEBARS Implementation Group on Research Integrity and Misconduct Definitions of Misconduct in Science Scientific misconduct is front-page news again. Late last month, Tufts University immunologist Thereza Imanishi-Kari was cleared of misconduct by an appeals panel of the Department of Health and Human Services (HHS). In October 1994, she had been found guilty by the department's Office of Research Integrity (ORI) of fabrication and falsification related to a 1986 paper entitled "Altered repertoire of endogenous immunoglobulin gene expression in transgenic mice containing a rearranged mu heavy chain gene" (D. Weaver et al., Cell, 45:247-59, 1986). The decade-long saga involved Nobelist David Baltimore of the Massachusetts Institute of Technology, a coauthor of the disputed article and defender of Imanishi-Kari. Less visible to most scientists, but with potentially greater impact on their professional lives, is the report of an HHS working group charged with advising Secretary Donna Shalala on how to implement the recommendations of the Commission on Research Integrity (CRI). The congressionally mandated CRI issued a report last November to Shalala on ways to improve the Public Health Service's response to scientific misconduct. The recommendations were met with scattered support from individual researchers and a chorus of boos from the scientific establishment (B. Goodman, The Scientist, Jan. 22, 1996, page 1). CHAIRMAN: HHS's William Raub headed the implementation group. Last month, the implementation group transmitted its proposals to the secretary in a report called "Implementation Proposals on Recommendations by the Commission on Research Integrity." The panel, called the Implementation Group on Research Integrity and Misconduct (IGRIM), is chaired by former acting National Institutes of Health director William Raub-now Shalala's science adviser. IGRIM drew its 18 members from various HHS offices and agencies; they included the retired director and the acting director of ORI, an NIH laboratory chief, and several departmental attorneys (see list of members). After meeting nine times, the group endorsed-sometimes with caveats-23 of CRI's 33 recommendations. It said two called for policies or procedures already in place and seconded the one CRI recommendation directed at scientific societies. Among the seven recommendations that the implementation group rejected or deferred are several that have sparked the most outcry in the scientific community. The panel refrained from making specific proposals regarding the implementation of a new misconduct definition or the treatment of some "authorship disputes" as research misconduct. It rejected CRI's recommendation to separate misconduct investigations and adjudications, saying that ORI should retain authority to investigate and judge cases of alleged misconduct. The panel also said that HHS should rely on existing mechanisms for oversight of ORI rather than create new ones, as suggested by CRI. DEFINITIONS OF MISCONDUCT IN SCIENCE National Science Foundation: [adopted 1991; applies to activities outside agency]: "'Misconduct' means (1) fabrication, falsification, plagiarism, or other serious deviation from accepted practices in proposing, carrying out, or reporting results from activities funded by NSF; or (2) retaliation of any kind against a person who reported or provided information about suspected or alleged misconduct and who has not acted in bad faith." Public Health Service: [adopted 1989; applies to activities outside agency]: "'Misconduct' or 'misconduct in science' means 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 of data." Commission on Research Integrity : [proposed 1995]: "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. "Examples of research misconduct include, but are not limited to, the following: "Misappropriation: An investigator or reviewer shall not intentionally or recklessly a. plagiarize . . .; or b. make use of any information in breach of any duty of confidentiality associated with the review of any manuscript or grant application. "Interference: An investigator or reviewer shall not intentionally and without authorization take or sequester or materially damage any research-related property of another . . . . "Misrepresentation: An investigator or reviewer shall not with intent to deceive, or in reckless disregard for the truth, (a) state or present a material or significant falsehood; or (b) omit a fact so that what is stated or presented as a whole states or presents a material or significant falsehood." NO SHOCKER: CRI Kenneth Ryan isn't suprised by the scientific community's reaction to his group's report. CRI chairman Kenneth Ryan, Distinguished Kate Macy Ladd Professor, Emeritus, in the department of obstetrics, gynecology, and reproductive biology at Harvard Medical School, maintains that he is pleased with the implementation group's proposals. While Ryan notes there is a need to address the problem of scientific misconduct, he is not surprised by the vocal opposition to many CRI recommendations. "The average scientist doesn't want any restrictions or regulations [on research practice]," he notes. "They would draw a fine line between misconduct and anything they do. But," he adds, "the commission was impressed that you can't draw a fine line." The most contentious issue has been a proposed new definition of research misconduct. Many scientists prefer a definition limited to fabrication, falsification, and plagiarism, known as FFP. Such a definition was proposed in 1992 by a panel convened by the Committee on Science, Engineering, and Public Policy (COSEPUP), which consists of members of the National Academy of Sciences (NAS), the National Academy of Engineering, and the Institute of Medicine. However, the definition used by the Public Health Service since 1989 (see definitions on page 6) includes an additional clause: "other practices that seriously deviate from those that are commonly accepted within the scientific community." As the commission noted, this definition has been widely criticized for being at once too broad and too narrow. On the other hand, the National Science Foundation uses a similar definition without problems. Donald Buzzelli, deputy assistant inspector general for oversight, says NSF's success comes from "applying the standards of the scientific community to every case." The definition that CRI came up with has been a lightning rod for prolonged condemnation of the entire report. CRI replaced FFP with "misappropriation, interference, and misrepresentation." In a March 15 letter to Raub, the NAS council-the academy's governing body-wrote, "[We] are convinced that many of the specific definitions and recommendations in the CRI report are counterproductive, and we urge that they not be implemented." Besides the definition, the council objected to a greater federal role in the oversight of scientific conduct. It also disapproved of what it views as a slighting by CRI of the rights of accused scientists in favor of whistleblowers. CONCERNED: NAS president Bruce Alberts fears CRI's definition of misconduct is too broad. NAS president Bruce Alberts tells The Scientist that of all CRI's recommendations, the one he most fears being implemented is the research misconduct definition. He feels the proposed definition is too broad. "We risk confusing not-so-terrible things with the terrible things," he says. If the definition were implemented, he believes, "the whole atmosphere of doing science would be so oppressive, burdened by accusations and formal hearings. People doing science will find it not enjoyable; young people will think about not doing science." IMPLEMENTATION GROUP ON RESEARCH INTEGRITY AND MISCONDUCT William Raub, science policy adviser to secretary, Department of Health and Human Services, and to assistant secretary for planning and evaluation, chairman Henrietta Hyatt-Knorr, assistant to director, Office of Research Integrity (ORI), executive secretary Lyle Bivens, director, ORI (retired March 31, 1996) Philip Chen, associate director for intramural affairs, National Institutes of Health Lily Engstrom, science policy analyst, office of assistant secretary for planning and evaluation Joel Goldstein, acting associate administrator for extramural programs, Substance Abuse and Mental Health Services Administration Terry Hoffeld, agency referral officer and agency research integrity liaison officer, Agency for Health Care Policy and Research Robert Knouss, special assistant to principal deputy assistant secretary for health, Office of Public Health and Science Robert Lanman, legal adviser, NIH Kurt Maurer, deputy director, Division of Health Examination Statistics, National Center for Health Statistics Chris Pascal, director, division of research investigations and acting director, ORI (since April 1, 1996) Richard Riseberg, associate general counsel, public health division, Office of the General Counsel Alan Schechter, chief, laboratory of chemistry and biology, National Institute of Diabetes and Digestive and Kidney Diseases Joan Schwartz, special assistant to deputy director for intramural research, NIH Andrea Selzer, senior attorney, Departmental Appeals Board Susan Sherman, senior attorney, Office of the General Counsel, NIH Stan Woollen, bioresearch monitoring program coordinator, Food and Drug Administration Frank Zuraf, audit director, public health area, Office of the Inspector General Alberts's worst fear is unlikely to come to pass. First, the Raub panel recommended that HHS solicit more comment on the definition from the scientific community and the public. Second, as Raub acknowledges, this go-slow strategy essentially hands the decision to an ad-hoc committee of the President's National Science and Technology Council, which is working to prepare a common federal definition of misconduct (as CRI proposed and IGRIM strongly endorsed). Raub says that HHS "should not step out front in soliciting comment about the CRI definition until it has the interagency definition." The Bethesda, Md.-based Federation of American Societies for Experimental Biology (FASEB) has also weighed in on the implementation proposals. FASEB, like the NAS council, is concerned about proposals that expand the federal government's oversight of scientific conduct, leading to "costly, burdensome, and unwarranted intervention into the activities of local institutions," as stated in a July 2 letter to Shalala. One irritation for FASEB and its supporters has been a CRI recommendation that HHS use more site visits to institutions to check on compliance with misconduct regulations. The implementation group partially endorsed this recommendation, encouraging more frequent site visits "within available funds." Howard Schachman, NIH ombudsman and a member of the 1992 NAS panel, calls such visits "a waste of money. Why should they visit Schachman's lab, just because they have free time? It would be intrusive, expensive, and fruitless." The implementation group did not endorse CRI's suggestion that site visits feature confidential interviews with members of the institution's community. "This could do more to erode than strengthen the role of institutions as the firstline promoters of research integrity," the Raub panel wrote. Another heavily criticized feature of the CRI report is its emphasis on whistleblower protection and, by contrast, its lack of attention to the rights of accused scientists. "The rights of the accused were ignored and the whistleblower was made part of the machinery, which is most unfortunate," says Schachman, referring to what he perceives as encouragement for greater involvement in misconduct investigations by whistleblowers. Regarding a draft Whistleblower Protection Regulation prepared by ORI, the implementation group wrote that "because the ORI draft [Whistleblower Protection Regulation] is generally in keeping with the Commission's recommendations, the Implementation Group proposes that ORI revise it, as appropriate, to address any issues identified by the Commission that ORI had not already covered. The Group also proposes that the draft regulation on whistleblower protection and subsequent regulations on ORI and institutional procedures be refined as necessary to ensure adequate protections for respondents and institutions." The implementation group recognized the appearance of overemphasis on whistleblowers' rights in the CRI report and suggested that ORI revise its draft Whistleblower Protection Regulation to emphazise the rights of the accused party. Former whistleblower Robert Sprague, a psychologist with the University of Illinois' Institute for Research on Human Development, observes that the young and vulnerable potential whistleblowers who contact him are usually too afraid to do anything. CRI's "Whistleblower's Bill of Rights" is "useful," he says. NIH's Walter Stewart, who along with colleague Ned Feder has investigated misconduct and counseled whistleblowers, agrees that the CRI proposals are "a step in the right direction. But no matter how favorable the rules are, whistleblowers do poorly." Things will change, Stewart says, only when the scientific community takes research misconduct seriously, which he believes has not yet happened. CRI recommended that results of all misconduct cases be publicized widely, which infuriated many scientists who believe the innocent will be tarred with the guilty. NAS president Alberts contends that the genuinely guilty will be overlooked among the far more numerous allegations that aren't substantiated. The implementation group rejected this recommendation. It also rejected outright three other CRI recommendations: It found no need to separate investigation and adjudication of misconduct cases, as NSF does. It said this already happens most of the time, since institutions receiving PHS funds carry out the investigations and judgments are rendered by ORI. VOCAL OPPOSITION: Harvard Medical School's Marc Kirschner sharply criticized CRI's original recommendations. "I think [the Raub panel] is on thin ice there," comments Stewart. Indeed, the implementation group acknowledged that in the most complex cases, ORI investigates and adjudicates. NSF's Buzzelli, noting that he is speaking for himself and not the foundation, maintains that the separation is important to fair outcomes of misconduct cases. In NSF's case, he says, "it would be wrong for us to make the finding [of misconduct], since we also make the recommendation [to charge a researcher with misconduct]." The implementation group saw no need for establishing a specific mechanism for reviewing and auditing ORI's record in upholding misconduct laws. ORI, says Stewart, "wouldn't stand the scrutiny." The group did not agree with CRI that NIH intramural programs ought to provide the same assurances and annual reports required of outside institutions. Those programs, Raub's group wrote, already have in place more detailed misconduct policies and procedures than do most institutions. When Raub presented his group's implementation proposals to an advisory committee to NIH director Harold Varmus in mid-June, he met extensive skepticism. Committee member Marc Kirschner, chairman of cell biology at Harvard Medical School, was outspoken at the meeting in his criticisms of the original CRI recommendations. The commission had "few leading scientists," he states. "It was made up mostly of administrators and lawyers, and they came up with a mess." Kirschner was disappointed that Raub's group did not reject all the CRI recommendations outright. Now, the implementation proposals are under consideration by Shalala. She has no timetable for her deliberations, according to Raub Billy Goodman, a freelance science writer based in Montclair, N.J., is online at goodmanb@styx.ios.com.

SIDEBARS
Implementation Group on Research Integrity and Misconduct Definitions of Misconduct in Science

HHS Panel Issues Proposals For Implementing Misconduct Report

Interested in reading more?

Become a Member of