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 Responsibility and the Conduct of Research completed its report. The Office of Scientific Integrity (OSI), whose creation in 1989 by then National Institutes of Health (NIH) Director James Wyngaarden was instigated by Representative John Dingell's inquiries, was assaulted by charges of incompetence and illegitimacy. OSI suffered a “scientific backlash” (Hamilton, 1991, p. 1084) that criticized it as too “zealous” (Davis, 1991, p. 12) and staffed by investigators reminiscent of the “Keystone Cops” (Wheeler, 1991, p. A5).

While testifying before Dingell's Oversight Subcommittee the subsequent NIH director, Bernadine Healy, expressed her doubts about “due process, confidentiality, fairness and objectivity” at OSI. Dingell countered that Healy had “made a mockery of the OSI's alleged independence in dealing with misconduct allegations” (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 Administrative 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 procedures. The district judge decided in Abbs's favor, invalidating OSI's internal policies and procedures in the Western District of Wisconsin. The judge decided the due process claim, however, in favor of the government, 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 court's ruling, validating OSI's 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 court's 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 Secretary of Health and Human Services (HHS) Louis Sullivan a plan to reorganize DHHS's 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 incorporated in ORI.

Still responding to criticism of ORI's procedures, the U.S. Public Health Service (PHS) in November 1992 issued notice of an interim procedure under which individuals found to have committed misconduct could request an administrative hearing before the Research Integrity Adjudications Panel (RIAP) of the Departmental Appeals Board (DAB) (PHS, 1992). During such hearings, respondents could be represented by counsel, question 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 federal 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 researcher's involvement with DHHS programs (OASH, 1994, p. 6).

One difficulty, however, has been DAB's interpretation of the burden and standard of proof, standards of conduct, and intent in research misconduct cases. DAB's ruling on the burden and standard of proof required 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 standard as well (ORI, 1999).

With respect to standards of conduct, however, DAB has held that ORI must demonstrate that the respondent's actions violated standards in effect at the time of the conduct—standards derived either from the relevant scientific community or from federal requirements of conduct. Finally, ORI must also demonstrate that the violation of standards was intentional, that is, that any reasonable researcher in the respondent's 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 OSI's 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 recommended 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, lawyers, and ethicists. The commission solicited input from the research community and reported its findings in November 1995 (DHHS, 1995). It placed an emphasis on whistle-blowing and promoted “responsible whistle-blowing” and a “whistle-blower's bill of rights” (DHHS, 1995, pp. 21–24). Implementing the commission's perspective, ORI developed Guidelines for Institutions and Whistleblowers: Responding to Possible Retaliation 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 misconduct, which had been controversial despite PHS's 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 community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgments of data (DHHS, 1995, p. 1).

At issue was the phrase “other practices…” and the lack of further definition of fabrication, falsification, or plagiarism. After significant deliberation, the commission recommended the following language:

Research misconduct is significant misbehavior that improperly appropriates the intellectual property or contribution 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 (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 government's 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 research misconduct policy implementation group; clarification or elaboration of some specific wording in the new definition; and greater specification 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. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. . . . Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit. Research misconduct does not include honest error or differences of opinion (OSTP, 2000, p. 76262). A finding of research misconduct requires that: There be a significant departure from accepted practices of the relevant research community; and the misconduct 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 misconduct:

[t]he fabrication, falsification, plagiarism or deception in proposing, carrying 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 environment (Koenig, 2001, p. 1411).

This definition, with its inclusion of “negligent deviations” and attention to risks to research subjects, is broader than the U.S. definition. In light of this development, some observers have noted the possible benefits 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 department's misconduct procedures and the commission's recommendations. This group's review ended ORI's role in investigations of research 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. ORI's 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 requiring a plan for education in research ethics as part of the application for NIH research training grants. NIH did not establish particular curricula 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 institutions to provide educational programs in the responsible conduct of research for all research staff associated with PHS funds. Several groups representing institutions of higher education issued a “community comment” in response to the proposal (Hasselmo et al., 2000). The comment “state[d] unequivocally” the support of these groups for the “core value” of “integrity of research and teaching” and a “strong belief in promoting the responsible conduct of research and preventing research misconduct through education and awareness” (Hasselmo et al., 2000, p.1). Nevertheless, the group thought that the proposal had an “overly prescriptive tone…which resembles rulemaking more than policy” (p.2). It took issue with the “heavy-handed prescription” (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 consideration by providing institutions with “considerable flexibility in designing an educational program for their research staff and extends the implementation period to October 1, 2003” (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 suggested that the department did not adhere to APA requirements in promulgating them. The Energy and Commerce Committee did not, however, explicitly question the substance of the rules (Brainard, 2001).

Although there have been meetings among interested parties about the requirements for the responsible conduct of research, a final resolution 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 regarding 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 policies and procedures in place for handling allegations of misconduct, protecting whistle-blowers, and providing training in research ethics in training 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 government, particularly through the DHHS DAB, has articulated clear standards 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 narrower and more expansive in different areas. Its precision, however, seems to buttress the greater emphasis on due process, particularly the emphasis on notice, that has been evolving as well. ORI is pursuing its charge to prevent misconduct and promote research integrity by maintaining oversight over institutional research misconduct investigations, providing technical assistance to institutions handling allegations, defending research 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.

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