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C Developments in Misconduct and Integrity Policies Since Publication of the 1992 COSEPUP Report1 In 1992, the Committee on Science, Engineering, and Public Policy (COSEPUP) of the National Academy complex2 published Responsible Sci- ence: Ensuring the Integrity of the Research Process (NAS, 1992). Its publica- tion followed years of broader political turmoil over integrity in research and misconduct. In the 10 years since publication of the COSEPUP report there have been significant changes in the science policy system that over- sees and promotes integrity in research, particularly in the Office of Re- search Integrity (ORI) of the U.S. Department of Health and Human Ser- vices (DHHS). The former âcrisisâ of integrity in research has been normalized over the last decade. A clear indicator of this normalization is the emergence of educational efforts in the responsible conduct of re- search and the study of integrity in research as a field unto itself. The reorganization of ORI as a less controversial body principally interested in education, oversight, assurance, and, now, research was important in this process. The transformation of the policy environment has, however, been slow. 1This chapter is based on a commissioned review prepared by David H. Guston, associate professor and director, Program in Public Policy, E. J. Bloustein School of Planning and Public Policy, Rutgers, the State University of New Jersey. 2The National Academy complex consists of the National Academy of Sciences, the Na- tional Academy of Engineering, and the Institute of Medicine. 167
168 APPENDIX C STATUS QUO IN 1991 In 1991 there was still a great deal of turmoil in policies regarding misconduct in research as the COSEPUP Panel on Scientific Responsibil- ity and the Conduct of Research completed its report. The Office of Scien- tific Integrity (OSI), whose creation in 1989 by then National Institutes of Health (NIH) Director James Wyngaarden was instigated by Representa- tive John Dingellâs inquiries, was assaulted by charges of incompetence and illegitimacy. OSI suffered a âscientific backlashâ (Hamilton, 1991, p. 1084) that criticized it as too âzealousâ (Davis, 1991, p. 12) and staffed by investigators reminiscent of the âKeystone Copsâ (Wheeler, 1991, p. A5). While testifying before Dingellâs Oversight Subcommittee the subse- quent NIH director, Bernadine Healy, expressed her doubts about âdue process, confidentiality, fairness and objectivityâ at OSI. Dingell coun- tered that Healy had âmade a mockery of the OSIâs alleged independence in dealing with misconduct allegationsâ (Greenberg, 1991, p. 5). A suit filed by James Abbs, a neurophysiologist at the University of Wisconsin and the subject of an investigation by OSI, asked the court to halt the investigation, charging that OSI failed to provide due process and to promulgate its procedures under the requirements of the Administra- tive Procedures Act (APA). Abbs argued that he had a property stake in his grant, his academic position, and his reputation and that OSI had deprived him of this property without due process of law under the Fifth and Fourteenth Amendments to the U.S. Constitution. The government argued that no such property rights exist and that, even if they did, OSI provided due process. The government also argued that OSI was not required to fulfill any requirements of public notice for its internal proce- dures. The district judge decided in Abbsâs favor, invalidating OSIâs inter- nal policies and procedures in the Western District of Wisconsin. The judge decided the due process claim, however, in favor of the govern- ment, declaring that the invalid procedures did, in fact, provide sufficient due process. Both parties appealed the split decision, and the Seventh Circuit Court vacated the district courtâs ruling, validating OSIâs claim under APA as well as its due process claim. Abbs and ORI ultimately accepted a settlement imposing special conditions on federal research funding. The case focused a great deal of scrutiny on OSI; however, many commentators misinterpreted the district courtâs opinion as substantively critical of OSI (Guston, 2000). ORI AND THE DEPARTMENTAL APPEALS BOARD Despite the validation of OSI by the circuit court, on February 1992, then Assistant Secretary of Health James Mason forwarded to then Secre-
DEVELOPMENTS SINCE PUBLICATION OF THE 1992 COSEPUP REPORT 169 tary of Health and Human Services (HHS) Louis Sullivan a plan to reor- ganize DHHSâs approach to scientific integrity. Under the new plan, ORI would replace both OSI and the Office of Scientific Integrity Review (OSIR). The new structure demonstrated greater attention to traditional legal concerns, as a branch of the Office of the General Counsel was incor- porated in ORI. Still responding to criticism of ORIâs procedures, the U.S. Public Health Service (PHS) in November 1992 issued notice of an interim proce- dure under which individuals found to have committed misconduct could request an administrative hearing before the Research Integrity Adjudica- tions Panel (RIAP) of the Departmental Appeals Board (DAB) (PHS, 1992). During such hearings, respondents could be represented by counsel, ques- tion evidence and cross-examine witnesses, and present rebuttal evidence and witnesses. Despite these enhanced procedural aspects, however, no formal rules of evidence apply to DAB hearings. The first such hearing occurred in June 1993. Generally, DAB has been a defender of PHS action on misconduct. In response to appeals made before it, DAB has confirmed that DHHS has had the authority to investigate allegations of misconduct involving fed- eral funds and take administrative action when misconduct has been found. DAB identifies this authority as emanating from the nature of the grants process that, as the court in the Abbs case held, is discretionary to the secretary of DHHS. DAB concluded that previous attempts to deal with misconduct, including the 1980 rules for debarment and the 1986 policies and procedures, were appropriate expressions of this authority. Under the same logic, DAB also ruled that DHHS might place conditions on the future awarding of grants and other aspects of a researcherâs in- volvement with DHHS programs (OASH, 1994, p. 6). One difficulty, however, has been DABâs interpretation of the burden and standard of proof, standards of conduct, and intent in research mis- conduct cases. DABâs ruling on the burden and standard of proof re- quired for a finding of misconduct is straightforward: the burden rests on ORI to demonstrate misconduct by a preponderance of the evidence, which is the normal standard in civil cases but lower than the standard in the 1980 debarment rule (see 45 CFR Part 76). More recently, the DHHS Review Group on Research Misconduct endorsed the preponderance stan- dard as well (ORI, 1999). With respect to standards of conduct, however, DAB has held that ORI must demonstrate that the respondentâs actions violated standards in effect at the time of the conductâstandards derived either from the rel- evant scientific community or from federal requirements of conduct. Fi- nally, ORI must also demonstrate that the violation of standards was intentional, that is, that any reasonable researcher in the respondentâs
170 APPENDIX C position would have understood the actions as constituting misconduct (OASH, 1994; ORI, 1993). The introduction of the intent standard by DAB led ORI to drop charges against Robert Gallo in November 1993. DAB also overturned findings of misconduct in high-profile cases against Ramesh Sharma (in 1993), Mikulas Popovic (in 1993), and Thereza Imanishi-Kari (in 1996). The original findings of misconduct in these cases were made under OSIâs policies and procedures. The ORI case record of scientific misconduct from its origin in June 1992 through the end of CY 2001 shows ORI made 125 findings of scientific misconduct. Since 1996, one case went to a full DAB hearing, which was won by ORI, leading to an HHS debarment of Dr. Kimon Angelides in 1999 from federal funding for five years (see http://ori.hss.gov/html/misconduct/ori_summary_angelides.asp). A second was settled by the respondent, in the middle of the DAB hearing; Dr. Evan Dreyer was debarred in 2000 by HHS for 10 years (see http:// ori.dhhs.gov/html/programs/fedregnotice.asp). In June 1994, the Office of the Secretary of DHHS issued notice that ORI had revised its guidelines for such hearings (DHHS, 1994). One of the revisions allowed for a scientist to be included at the request of either DHHS or the respondent (in the original procedure, a scientist would be included at the discretion of the panel chair), and in 1999 the DHHS Review Group on Research Misconduct and Research Integrity recom- mended that up to two scientists be allowed to serve on DAB panels (ORI, 1999). COMMISSION ON RESEARCH INTEGRITY In the NIH Revitalization Act of 1993 (PL 103-43), the U.S. Congress authorized ORI in law and delegated the formulation of a definition of misconduct, among other tasks, to a department-level commission of 12 members, including academic physicians, biomedical researchers, law- yers, and ethicists. The commission solicited input from the research com- munity and reported its findings in November 1995 (DHHS, 1995). It placed an emphasis on whistle-blowing and promoted âresponsible whistle-blowingâ and a âwhistle-blowerâs bill of rightsâ (DHHS, 1995, pp. 21â24). Implementing the commissionâs perspective, ORI developed Guidelines for Institutions and Whistleblowers: Responding to Possible Retalia- tion Against Whistleblowers in Extramural Research in November 1995. ORI issued a notice of proposed rulemaking in 2000 to apply due process protections to whistle-blowers at universities and is reviewing comments received (DHHS, 2000a). The commission also addressed the definition of research miscon-
DEVELOPMENTS SINCE PUBLICATION OF THE 1992 COSEPUP REPORT 171 duct, which had been controversial despite PHSâs publication in 1989 of the final rule, which defined it as: [f]abrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific com- munity for proposing, conducting, or reporting research. It does not in- clude honest error or honest differences in interpretations or judgments of data (DHHS, 1995, p. 1). At issue was the phrase âother practices. . . â and the lack of further definition of fabrication, falsification, or plagiarism. After significant de- liberation, the commission recommended the following language: Research misconduct is significant misbehavior that improperly appro- priates the intellectual property or contribution of others, that intention- ally impedes the progress of research, or that risks corrupting the scien- tific 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 (DHHS, 1995, p. 13). The commission further defined misappropriation, interference, and misrepresentation. It recommended that a federal interagency task force consider drafting a definition that would be common across all federal research. THE COMMON DEFINITION3 In April 1996 the move toward a common definition began. The need was threefold: some research-funding agencies still lacked definitions and policies; the definitions at PHS and the National Science Foundation were not the same, leading to the possibility that a researcher jointly funded by the two agencies could be judged by different standards; and courts could conceivably overturn rulings on due process grounds, as the absence of a clear federal statement could be seen as lack of appropriate notice. The National Science and Technology Council (NSTC), an operating arm of the White House Office of Science and Technology Policy responsible for coordinating policy among the governmentâs many agencies that perform research and development, created a panel to draft the definition. The panel reported its definition in December 1996, followed by a round of review and comments by the various federal agencies and a public comment period before publishing it in December 2000 (Francis, 1999; OSTP, 1999). The final policy included the formation of an NSTC 3Most of this section is drawn from Guston (1999); but see Francis (1999), OSTP (1999), and Porter and Dustira (1993).
172 APPENDIX C research misconduct policy implementation group; clarification or elabo- ration of some specific wording in the new definition; and greater specifi- cation of options and duties toward the scientific record, human research subjects, and others in response to findings of misconduct (OSTP, 2000). The final common policy defined research misconduct as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. . . . Fabrication is making up of data or results and recording or reporting them. Falsifica- tion is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accu- rately represented in the research record. . . . Plagiarism is the appropri- ation of another personâs ideas, processes, results, or words without giv- ing appropriate credit. Research misconduct does not include honest error or differences of opinion (OSTP, 2000, p. 76262). A finding of re- search misconduct requires that: There be a significant departure from accepted practices of the relevant research community; and the miscon- duct be committed intentionally, or knowingly, or recklessly; and the allegation be proven by a preponderance of the evidence (65 Fed. Reg. 76260-76264). Although the definition and other content of the rule are final, they are not effective until agencies formally implement the rule, a process expected to be complete in 2003. In the meantime, the Wellcome Trust, the largest biomedical charity in the United Kingdom, offered its own definition of scientific miscon- duct: [t]he fabrication, falsification, plagiarism or deception in proposing, car- rying out or reporting results of research or deliberate, dangerous or negligent deviations from accepted practices in carrying out research. It includes failure to follow established protocols if this failure results in unreasonable risk or harm to humans, other vertebrates or the environ- ment (Koenig, 2001, p. 1411). This definition, with its inclusion of ânegligent deviationsâ and atten- tion to risks to research subjects, is broader than the U.S. definition. In light of this development, some observers have noted the possible ben- efits of international discussions and even international guidelines for research ethics (Kaiser, 1999; Mishkin, 1999). RESPONSIBLE CONDUCT OF RESEARCH In 1996, DHHS Secretary Donna Shalala charged Assistant Secretary of Health Philip Lee to lead a group of DHHS officials in reviewing the departmentâs misconduct procedures and the commissionâs recommen-
DEVELOPMENTS SINCE PUBLICATION OF THE 1992 COSEPUP REPORT 173 dations. This groupâs review ended ORIâs role in investigations of re- search misconduct (DHHS, 1999). Grantee institutions would continue to conduct investigations, and should federal investigations be needed, the Office of the Inspector General would conduct them (DHHS, 2000b). ORI would also no longer be responsible for conducting investigations for PHS intramural laboratories. ORIâs primary function would be to support grantee institutions through educating officials from such institutions, validating their policies for investigating misconduct, overseeing their findings in specific cases, and generally bolstering their legitimacy to maintain some degree of control over integrity in research (ORI, 2000a). The responsible conduct of research had to some extent already been a focus of important developments. As early as 1990, NIH began by re- quiring a plan for education in research ethics as part of the application for NIH research training grants. NIH did not establish particular cur- ricula or curricular requirements, and the quality of the curriculum did not contribute to the score for the grant application, but applications could not be funded until acceptable plans were articulated (Dustira, 1996). More recently, ORI proposed a policy to require all funded institu- tions to provide educational programs in the responsible conduct of re- search for all research staff associated with PHS funds. Several groups representing institutions of higher education issued a âcommunity com- mentâ in response to the proposal (Hasselmo et al., 2000). The comment âstate[d] unequivocallyâ the support of these groups for the âcore valueâ of âintegrity of research and teachingâ and a âstrong belief in promoting the responsible conduct of research and preventing research misconduct through education and awarenessâ (Hasselmo et al., 2000, p.1). Neverthe- less, the group thought that the proposal had an âoverly prescriptive toneâ¦which resembles rulemaking more than policyâ (p.2). It took issue with the âheavy-handed prescriptionâ (p.3) of the core instructional areas and made specific recommendations to allow institutions to have greater flexibility in specifying both the curriculum and the definition of research staff to whom the policy would apply. According to ORI, the final policy took these concerns into consider- ation by providing institutions with âconsiderable flexibility in designing an educational program for their research staff and extends the imple- mentation period to October 1, 2003â (ORI, 2000b, p. 1). In February 2001, however, DHHS suspended the implementation of these requirements at the behest of the House Energy and Commerce Committee, which sug- gested that the department did not adhere to APA requirements in pro- mulgating them. The Energy and Commerce Committee did not, how- ever, explicitly question the substance of the rules (Brainard, 2001). Although there have been meetings among interested parties about
174 APPENDIX C BOX C-1 Time Line of Some Significant Events in Research Integrity, 1991 to Present 1991 COSEPUP Panel on Scientific Responsibility and the Conduct of Research holds final meeting. PHS Advisory Committee on Scientific Integrity meets for the first time. Congressional hearings held on investigation of research misconduct. 1992 Office of Research Integrity (ORI) is created within the Office of the Assistant Secretary for health by merging the Office of Scientific Integrity (OSI) and Office of Scientific Integrity Review (OSIR). PHS announces interim procedures for hearings before the Departmental Appeals Board (DAB). NIH strengthens responsible conduct of research requirement in training grant applications. 1993 PHS Advisory Committee on Scientific Integrity holds last meeting. DAB holds first hearing. PHS ALERT system listings limited to misconduct findings; allegations no longer included. DAB confirms HHS authority to investigate scientific misconduct. NIH Revitalization Act codifies the establishment of ORI, creates the Commission on Research Integrity, and mandates the development of a regulation to protect whistle-blowers. ORI begins publishing information about closed cases of confirmed research misconduct. Commission on Research Integrity chartered. ORI drops pursuit of allegations against Robert Gallo. 1994 ORI revises guidelines for inclusion of scientists on DAB and other procedures for DAB hearings. Notification to journal editors about corrections or retractions resulting from confirmed research misconduct is initiated by ORI. Reviews of allegations of retaliation against whistle-blowers start. Model Policy and Procedures are developed for responding to research misconduct allegations. 1995 Commission on Research Integrity, under Kenneth Ryan, issues report. ORI publishes Guidelines for Institutions and Whistleblowers: Responding to Possible Retaliation Against Whistleblowers in Extramural Research. ORI reviews of institutional policies for responding to research misconduct allegations begin.
DEVELOPMENTS SINCE PUBLICATION OF THE 1992 COSEPUP REPORT 175 1996 Departmental reorganization places ORI in the Office of Public Health and Science. Office of Science and Technology Policy (OSTP) begins to develop common federal definition of research misconduct. DAB reverses misconduct finding in Imanishi-Kari case. DHHS Review Group on Research Misconduct and Research Integrity is created. 1998 ORI reports that 174 institutions reported 432 allegations of research misconduct from 1991-1996, and that investigations by ORI from 1993-1997 resulted in 76 misconduct findings and 74 no-misconduct findings. 1999 DAB upholds research misconduct finding in Angelides case. HHS Secretary Shalala implements more than a dozen recommendations from the HHS Review Group on Research Misconduct and Research Integrity. Investigation of research misconduct allegations transferred from ORI to institutions, PHS agencies, Office of the Inspector General and research institutions. ASH delegates responsibility for research misconduct in intramural laboratories to the heads of PHS agencies, with ORI providing oversight. ORI mission is refocused on oversight, education, and prevention. 2000 First ORI research conference on research integrity is held. Guidance for editors managing research misconduct allegations is published by ORI. Research program on research integrity is initiated by ORI in collaboration with National Institute of Neurological Disorders and Stroke. PHS Policy on Instruction in the Responsible Conduct of Research is published. Federal Research Misconduct Policy, including common definition of misconduct, is published by OSTP. Notice of proposed rule making on protection of whistleblowers published by HHS. 2001 First awards made in research on research integrity program. PHS Policy on Instruction in the Responsible Conduct of Research suspended. Institute of Medicine Committee on Assessing Integrity in Research Environments holds initial meeting.
176 APPENDIX C the requirements for the responsible conduct of research, a final resolu- tion has not occurred. In the interim, ORI has also established a listserv on which individuals wishing to discuss the responsible conduct of research can share information and experience. The decade since publication of the COSEPUP report has witnessed a great deal of activity in the development and evolution of policies regard- ing research misconduct. Since the early 1990s the federal government has asserted its authority and discretion in setting conditions on the awarding of research grants. It requires research institutions to have poli- cies and procedures in place for handling allegations of misconduct, pro- tecting whistle-blowers, and providing training in research ethics in train- ing grants. At the same time that research institutions have augmented their ability to combat misconduct, the specific role of the government in investigating allegations has been legalized and rarefied. The govern- ment, particularly through the DHHS DAB, has articulated clear stan- dards for the adjudication of allegations. ORI has proposed to DHHS a revised regulation, consistent with the 2000 OSTP policy, to replace the 1989 PHS rule. Thus, the new, government-wide definition of research misconduct and associated procedures should be implemented shortly. The definition is more precise than previous definitions and is both nar- rower and more expansive in different areas. Its precision, however, seems to buttress the greater emphasis on due process, particularly the empha- sis on notice, that has been evolving as well. ORI is pursuing its charge to prevent misconduct and promote research integrity by maintaining over- sight over institutional research misconduct investigations, providing technical assistance to institutions handling allegations, defending re- search misconduct findings before the DAB, facilitating the creation of RCR programs at institutions, developing a research program on research integrity, responding to retaliation complaints from whiste-blowers, and ensuring regulatory compliance. REFERENCES Brainard J. 2001, March 2. Ethics-training rule is suspended. The Chronicle of Higher Educa- tion. P. A27. Davis B. 1991, May 13. Is the Office of Scientific Integrity too zealous? The Scientist. 5(10):12. DHHS (U.S. Department of Health and Human Services). 1994. Hearing procedures for scientific misconduct. Federal Register 59:29808â29811. DHHS. 1995. Integrity and Misconduct in Research: Report of the Commission on Research Integ- rity. Rockville, MD: Office of Research Integrity, Office of the Secretary, DHHS. DHHS. 1999. Report of the Department of Health and Human Services Review Group on Research Misconduct and Research Integrity. [Online]. Available: http://ori.hhs.gov/html/publi- cations/dhhsreview2.asp#background [Accessed March 14, 2002]. DHHS. 2000a. Notice of proposed rulemaking: Public Health Service standards for the protection of research misconduct whistleblowers. Federal Register 64:70830â70841.
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