5

Handling Allegations of Misconduct in Science—Institutional Responses and Experience

UNIVERSITY–GOVERNMENT APPROACHES

Growing Interaction in the 1980s

Public discussions of cases involving misconduct in science are common today in research seminars or professional meetings, but such discussions were rare until the past decade.1 Congressional hearings convened in 1980 by the House Science and Technology Committee's Subcommittee on Oversight and Investigations, chaired by then Rep. Albert Gore, were the first systematic public examination of reports of fraud in biomedical research (U.S. Congress, 1981a).

Prior to the mid-1980s, academic institutions sometimes examined allegations of misconduct in science through faculty conduct committees or other disciplinary procedures. But reports of formal investigations were rarely communicated to research sponsors, editors, or other research scientists; more commonly, misconduct-in-science cases were handled privately—if they were handled at all. Many universities adopted procedural reforms for addressing misconduct in science after a series of highly publicized cases in the early 1980s revealed the shortcomings of institutional processes for dealing with cases involving federal research funds (U.S. Congress, 1981b).

In 1985 Congress passed legislation (P.L. 100-504) requiring insti-



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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process 5 Handling Allegations of Misconduct in Science—Institutional Responses and Experience UNIVERSITY–GOVERNMENT APPROACHES Growing Interaction in the 1980s Public discussions of cases involving misconduct in science are common today in research seminars or professional meetings, but such discussions were rare until the past decade.1 Congressional hearings convened in 1980 by the House Science and Technology Committee's Subcommittee on Oversight and Investigations, chaired by then Rep. Albert Gore, were the first systematic public examination of reports of fraud in biomedical research (U.S. Congress, 1981a). Prior to the mid-1980s, academic institutions sometimes examined allegations of misconduct in science through faculty conduct committees or other disciplinary procedures. But reports of formal investigations were rarely communicated to research sponsors, editors, or other research scientists; more commonly, misconduct-in-science cases were handled privately—if they were handled at all. Many universities adopted procedural reforms for addressing misconduct in science after a series of highly publicized cases in the early 1980s revealed the shortcomings of institutional processes for dealing with cases involving federal research funds (U.S. Congress, 1981b). In 1985 Congress passed legislation (P.L. 100-504) requiring insti-

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process tutions that receive Public Health Service (PHS) research funds to adopt an administrative process for reviewing reports of scientific fraud. This legislation also authorized the secretary of the Department of Health and Human Services (DHHS) to adopt regulations to require assurances from PHS grantees that such an administrative process was in place (DHHS, 1986). In fulfilling its obligation under the legislation, the PHS issued interim guidelines in 1986 on policies and procedures for handling alleged misconduct. Educational and scientific societies such as the Association of American Universities, the Association of American Medical Colleges, and the American Association for the Advancement of Science provided forums to review progress by the research institutions in complying with the new regulatory requirements. In addition, educational, legal, and scientific organizations suggested approaches to addressing allegations of misconduct in science, assessing institutional experience in handling misconduct complaints, and providing national and regional forums for the exchange of information and experience in this area (AAU, 1983; AAMC, 1982; AAAS-ABA, 1989). In 1989 the DHHS's Office of Inspector General (OIG) reported that most of the research-intensive universities (institutions with 100 or more PHS awards) had adopted formal policies and procedures for addressing allegations of misconduct in science but that only 22 percent of all PHS institutional grantees had such policies and procedures (DHHS, 1989d). The OIG report suggested that many of the institutional policies and procedures were limited in scope and that most did not require notification to the National Institutes of Health (NIH) as the 1986 interim guidelines had suggested (DHHS, 1989d).2 The report found that some grantee institutions had been waiting for final PHS regulations to be promulgated before developing their own policies and procedures. Following congressional hearings that criticized university and agency responses to allegations of misconduct, the PHS, in 1989, published final regulations requiring all applicant and grantee institutions to adopt misconduct policies and procedures (42 C.F.R. 50).3 Although the regulations provide general direction about procedural elements (such as requirements for an inquiry, an investigation, disclosure, and notification), the specific content and scope of misconduct policies and procedures remain at the discretion of the research institutions. The procedural elements have been the subject of extensive debate and discussion over the past 3 years as more experience has been acquired by research institutions and federal agencies in the implementation of the regulations.

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process General Requirements All research institutions that receive PHS funds must now provide assurances that they have adopted policies and procedures to handle allegations of misconduct in science. NSF also requires that a grantee institution have such policies and procedures if that institution wishes NSF to defer to it for purposes of inquiry and investigation of misconduct cases. Because research institutions are able to design their own misconduct policies and procedures, institutional responses to federal regulatory requirements are very diverse. At present consensus is lacking about which procedural approaches are adequate responses to federal regulatory requirements, and institutional and governmental officials frequently disagree over fundamental matters of openness, completeness, or timeliness.4 Institutions that receive PHS research awards are required to submit to the DHHS's Office of Scientific Integrity Review (OSIR) an initial assurance and annual reports of compliance indicating that they have adopted policies and procedures for handling allegations of misconduct in science. PHS officials review research and training grant applications to determine whether the institutional assurance requirement has been met and may request copies of the institution's policies for addressing misconduct in science. However, they do not certify the acceptability of such institutional policies. PHS officials have judged some institutional investigative reports to be inadequate, even though the reports complied with local institutional policy and procedures for handling misconduct in science. More Specific Requirements Related to Misconduct Policies and Procedures Government regulations require that institutional policies and procedures include two separate stages: an inquiry and an investigation. An inquiry—a preliminary review of the complaint and other information to determine if there is sufficient basis for an investigation of alleged misconduct—does not yield a judgment on the question of guilt, although it can determine that an allegation lacks merit.5 An investigation is a formal examination and evaluation of relevant information to determine whether misconduct has occurred. Such an investigation, often using a standing committee or an ad hoc panel of experts, produces a report that includes findings, and possibly recommendations, that form the basis for an adjudicatory decision by a responsible institutional official. In cases where institutions find misconduct in science, government officials may recommend penalties

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process including institutional oversight, certification of future research applications, prohibition from service on government committees, or debarment. Government agencies may initiate separate proceedings to adjudicate cases involving serious offenses for which severe sanctions, such as a recommendation for debarment, are to be considered. Research institutions must inform the sponsoring agency in writing when the institution decides to move from an inquiry to an investigation of an allegation of misconduct in science (DHHS, 1989a). A final report of the misconduct investigation must be submitted to the sponsoring agency, and the report may be subject to disclosure in response to requests under the Freedom of Information Act. Both NSF and PHS rely on research institutions to conduct misconduct inquiries and investigations. But if government officials determine that the report of an institutional inquiry or investigation is not thorough, fair, objective, or responsive to government regulatory requirements, the agencies may intervene and investigate allegations of misconduct directly. The criteria for determining what constitutes an “adequate” inquiry or investigation remain somewhat vague, although PHS and NSF officials have made efforts to clarify the policies, procedures, and criteria that guide their evaluations of investigative reports. 6 7 Institutional Responses to Requirements Before government agencies adopted regulations for handling allegations of misconduct in science, most universities and other research centers addressed such complaints through a variety of informal and formal, often confidential processes. In the early 1980s, few academic institutions had formal policies or procedures to review allegations of misconduct in science. For example, a 1982 survey indicated that fewer than one-quarter of the respondent academic institutions and hospitals had written rules to deal with allegations of fraud but that just over one-half were reportedly engaged in formulating such rules. 8 The survey found “vast differences of opinion” (p. 214) about the desirability or necessity of rules or policies for responding to allegations of fraud in research as well as “major disagreements” (p. 207) about the issues to be addressed by such policies (Greene et al., 1985). Since that time, many academic institutions have adopted policies and procedures for handling allegations of misconduct in science, but substantial variation remains in definitions and methods for conducting inquiries and investigations. Although the DHHS's OSIR and the NSF's OIG have evaluated reports of some misconduct investigations,9 the experience of research

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process universities in conducting misconduct-in-science inquiries and investigations has not been comprehensively analyzed. Thus information about the broad range of experience of diverse institutions in handling allegations of misconduct in science is often derived from anecdotes and journalistic accounts describing the experiences of universities and individual participants in specific cases. Stage One: Misconduct Inquiry Research institutions have different methods for structuring an inquiry to determine whether an allegation of misconduct in science has substance. 10 Some institutions (such as Harvard Medical School) rely on existing faculty conduct committees to handle misconduct inquiries and investigations, if necessary. Others (such as The University of Chicago) have established a standing committee on academic fraud to oversee the university 's handling of misconduct cases. Some universities (such as the University of California, San Diego) rely on administrative officials to appoint an investigator or faculty panel to conduct a preliminary inquiry and subsequent investigation, if necessary. When an initial allegation of misconduct has been made, an administrative official or designated faculty member usually conducts a confidential inquiry in response to the allegation. The official may consult with selected faculty members or co-workers to determine the nature of the suspected offense, and, in some cases, the individual accused of misconduct may not be informed that an allegation has been made. The inquiry may be closed by the preparation of a brief file memorandum —which may be provided to the complainant for comment—that either states the reasons that no further investigation was judged to be necessary or recommends that an investigation be initiated. Stage Two: Misconduct Investigation If an investigation is recommended, the individual accused of misconduct and the appropriate government research sponsor are informed of the nature of the allegations. According to an OSIR analysis, research institutions generally establish a panel of scientific experts, usually numbering three to eight members, to conduct an investigation, review evidence, and interview witnesses and relevant parties (DHHS, 1991b). For the most part, such a panel is composed of persons from the institution, although they are usually not from the department or research center of the subject of the investigation. In a few cases, institutions have used panel members from other

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process organizations. The OSIR's report describes the investigative process as follows (DHHS, 1991b, p. 4): The typical investigation conducted by institutions involved interviews of the subject, the informant, and other relevant parties, review of publications, manuscripts, or other documents, review of data notebooks, and in a few cases, site visits to the laboratories involved. In 5 of the outside [i.e., non-PHS] investigations, the subject was accompanied by legal counsel during meetings with the panel, with counsel acting in an advisory capacity. Interviews were recorded or transcribed in 6 of the outside investigations and in 2 of the PHS investigations. One institution held a formal hearing before a five-member “Hearing Board.” Provision was made for full disclosure of evidence prior to the hearing, testimony from witnesses, cross examination of witnesses by the subject's attorney, and written and oral summary positions at the end of the hearing. The hearing transcript was made available within ten days and the record was kept open for about two weeks to allow for additional information or comment. The time required for outside institutions to complete investigations varied from one to 12 months. The majority of the outside investigations for which PHS accepted the conclusions were completed within 4 months (10 out of 16). One of the investigations conducted by PHS components took 12 months, one lasted 9 months, one 7 months, one 3 months, and one 2.5 months. There does not appear to be any systematic relationship between the nature of the alleged misconduct and the amount of time required to conduct an investigation. In misconduct cases reviewed by PHS and NSF, research institutions have sometimes imposed sanctions as a direct result of their investigations, in some cases prior to or in addition to governmental actions. Private settlements between a research institution and an individual accused of misconduct have also been reported, in which an individual accused of misconduct agrees to resign in lieu of the institution initiating a formal investigation, although such settlements may not be consistent with government regulations. Cases involving serious offenses that could result in dismissal or termination of funding usually have clear distinctions between the investigative and adjudicatory stages. Most academic institutions have specific procedures that must be followed before severe disciplinary sanctions can be applied to tenured faculty. These procedures typically are invoked after the misconduct investigation concludes that serious misconduct did occur and that disciplinary action is warranted. In some cases, the investigative panel may then refer the case to a faculty conduct committee or an academic senate for adjudication. But am-

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process biguity remains as to whether an individual accused of misconduct in science is entitled to a full disciplinary hearing for penalties or disciplinary sanctions that may be mild, such as a letter of reprimand or mandatory supervision. TABLE 5.1 Types of Local Institutional Actions Resulting from Misconduct Investigations, March 1989 to December 1990 Penalty or Action Number of Cases Issued letter of reprimand 1 Terminated research support (i.e., would not allow subject to continue as principal investigator) 2 Required review of future applications for research support 1 Informed future prospective employers of findings 1 Required correction of literature or withdrawal of manuscripts 3 Denied or revoked tenure 2 Dismissed subject or requested retirement 4a Accepted voluntary retirement 1 a Includes dismissal of an NIH intramural scientist. SOURCE: Department of Health and Human Services (1991b). The types of institutional actions taken in response to misconduct investigations reviewed by the DHHS's OSIR are given in Table 5.1. Findings, Discussion, and Conclusions Government agencies, congressional oversight committees, and academic institutions generally agree that the primary responsibility for handling complaints of misconduct in science rests with the research organization. However, the development and implementation of policies and procedures for handling misconduct in science have been problematic. Some universities, particularly small research institutions, are not prepared to accept responsibility for pursuing allegations of misconduct in science. 11 It is difficult for any institution to investigate members of its own community, especially individuals who hold positions of high esteem. In addition, some research institutions and government agencies have made mistakes in investigations of complex cases, such as appointing to investigatory panels members who have personal or professional ties to the individuals who have been

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process accused of misconduct in science. All these factors foster a perception that research institutions are not dealing effectively with misconduct in science,12 prompting criticism of the speed, rigor, honesty, fairness, and openness of the mechanisms now used by academic institutions to address misconduct in science. Public officials, journalists, and even some scientists themselves continue to question whether universities are willing to address the problem of misconduct in a vigorous and effective manner.13 However, the difficulties of maintaining informed awareness of existing policies and procedures in the academic research environment should not be underestimated. Scientists and students are highly mobile, and research centers are decentralized organizational units within the university. Informing individuals about appropriate methods for raising concerns about misconduct in the research environment requires sustained collaboration among research administrators, faculty, and laboratory directors. Many universities have now established policies and procedures for handling allegations of misconduct in science, and some research institutions have acquired valuable experience in implementing these procedures to deal with cases of misconduct. However, the legal and procedural issues associated with misconduct-in-science investigations are extraordinarily complex, and there is little case law in the public record to guide and inform analysis of these issues. The panel believes that, in general, the current and evolving system of government and institutional relationships requires more experience and adjustments before specific policy or procedural changes can be recommended. Research institutions and government agencies need to clarify their own approaches and judgments on these issues before any general consensus can be reached on procedural matters. The panel did not have a sufficient base of institutional experience or consensus about these matters within the academic community on which to develop recommendations about the nature of institutional procedures for handling allegations of misconduct in science. Part of the difficulty in developing vigorous and effective institutional responses to incidents or allegations of misconduct in science arises from variation in and disagreement about essential elements of fairness, completeness, and objectivity that should characterize investigations. Effective responses are impeded also by recurring patterns of denial by some institutional officials and faculty members who believe that misconduct in science is not a serious matter. The pressures of conducting an objective investigation of complaints involving respected or prestigious scientists cannot be underestimated.

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process Strong and informed leadership is needed to clarify procedural matters and to ensure that allegations or apparent incidents of misconduct in science are not ignored or covered up. Members of the research community and government officials agree that deliberate efforts to misrepresent research findings or to distort the research process should not be tolerated. Disagreement focuses on which acts of misconduct should be subject to institutional or governmental penalties and what methods are appropriate to respond to unprofessional behaviors that do not fit institutional or regulatory definitions of misconduct in science. Experience suggests that complainants, administrative officials, or investigative panels may be unable to determine, at the outset, whether the behavior in question constitutes misconduct in science, other misconduct, a questionable research practice, or none of these. Allegations of misconduct are sometimes based on uncertain or fragmentary information, and the nature of the suspected offense may change as additional evidence is obtained. Whatever procedures are adopted, the point of first contact and early judgment in handling allegations of misconduct in science are extremely important. Although it is necessary to preserve informality and flexibility in handling individual complaints, some of which may be unfounded or mistaken, it is also important to assure the credibility of the process by which these complaints are addressed. General Conclusions Institutional policies and procedures should include a common entry point for handling complaints from the outset; clear procedures are necessary for determining which types of alleged offenses will be reviewed by administrative staff or faculty. A sequence of steps to achieve resolution of significant disputes is required. All of these steps require clear separations between each of the following groups: the affected parties, those who are judging the seriousness of the complaint and formulating the evidentiary base to substantiate charges, and those who must adjudicate penalties based on charges of misconduct in science. Disputes or accusations involving questions of scientific judgment or questionable research practices are generally settled, whenever possible, by the research process itself. However, when disputes involve specific charges of misconduct in science or other misconduct, they cannot be resolved by scientists alone. Institutional procedures, based on sound legal principles, are necessary to determine whether such an allegation has substance and, if so, to implement appropriate responses and penalties, if warranted.

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process The appropriate treatment of misconduct allegations is time consuming and costly, and it diverts faculty and administrative attention from other matters. Questions about the integrity of an individual also create enormous emotional stress; at least two incidents of suicide have been associated with the investigation of misconduct allegations. The Issue of Adjudication Some authors have noted that confusion exists about the nature of the investigative stage in both university and governmental investigations of misconduct in science.14 Criminal and civil legal procedures traditionally distinguish between “investigations” and “adjudications” for purposes of due process analysis (Andersen, 1988). “Investigations” are commonly thought to be fact-gathering processes that precede formal charges. “Adjudications” are deliberations as to the guilt or innocence of the individual who has been charged. However, many institutional policies and procedures for addressing misconduct in science do not specify this distinction. Thus in some cases, findings of guilt or innocence, rather than charges of misconduct, may result from an investigative panel's deliberations, leading to criticism that appropriate due process concerns were not met in the investigation. As a result, the amount of confidentiality appropriate for the investigative stage has not been clearly resolved. Research institutions are required by NSF and PHS regulations to inform the research sponsor when investigations have been initiated, and some observers have suggested that moving from an inquiry to an investigation is thus comparable to an indictment by the courts. Many individuals in the scientific community have complained that the reputation of a subject of a misconduct investigation is damaged simply by the announcement that an investigation has been initiated—before the completion of the investigation and before the subject of the investigation has had an opportunity to confront witnesses or respond to evidence. Confusion is also compounded by the fact that many scientists and others view the imposition of formal charges of misconduct in science as a de facto adjudicatory decision. The panel believes that institutional procedures should define explicit and clear criteria that are to be used in determining when a misconduct inquiry should proceed to a more formal investigation. The panel concludes that administrative officials and faculty have a responsibility to inform all members of their institution, espe cially junior personnel, of existing channels for handling complaints about misconduct in science or other misconduct.

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process GOVERNMENT REGULATIONS AND PROCEDURES The Public Health Service and the National Science Foundation have promulgated procedures for the federal agencies themselves in addressing charges of misconduct in science. The federal procedures govern the handling of such charges by the agencies and also serve as a model for universities. Federal procedures are invoked if the university has not investigated alleged misconduct or if the funding agency concludes that the university investigation was inadequate. Federal procedures may also be invoked if the grantee institution lacks the resources and the impartial personnel needed to conduct an investigation. These procedures also apply if the funding agency seeks to impose additional sanctions (Andersen, 1988). During the period of the panel's study, various administrative and legislative proposals were introduced to organize the government's activities in handling allegations of misconduct in federally supported research programs. The panel was not able to review fully each of these proposals, since some were published late in the deliberative stages of the study.15 Recognizing the evolving character of the organizational programs designed to address misconduct in science, especially in the PHS, the panel did not attempt to define specific procedures for federal agencies or the relationship of individual offices but focused instead on issues pertinent to the roles and responsibilities of government in handling allegations of misconduct in science. The Health Research Extension Act of 1985 (P.L. 100-504) established legislative authority for PHS regulations and other policies for identifying incidents of misconduct in science involving the use of federal funds. Final regulations were promulgated by PHS in 1989 (DHHS, 1989a). In the intervening years, there was much confusion and uncertainty about the nature of the required policies, the definitions of misconduct that should be incorporated into these policies, and the relationship of institutional responsibilities to those of the oversight agencies. NSF regulations, adopted in July 1987 and revised in May 1991 (NSF, 1987, 1991b), differ from the PHS regulations in some significant matters. Department of Health and Human Services The responsibility for handling misconduct in science is divided between two offices in the Department of Health and Human Services (DHHS)—the Office of Scientific Integrity (OSI) and the Office of Scientific Integrity Review (OSIR). The DHHS's Office of Inspector

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process An individual may have a property interest in a research or faculty position, particularly when the expectation of continued employment is explicitly granted by tenure or contract.28 Moreover, a government debarment action or the suspension of research funds might be seen as deprivations of a property or liberty interest. If so, government investigations must follow stringent procedures to minimize erroneous findings and meet the requirements of due process. However, less severe penalties, such as a letter of reprimand or a requirement of prior approval for particular activities, are probably not deprivations of constitutionally protected interests. While these sanctions might injure a scientist's reputation, such injury, absent a change in job status, is not recognized by the Supreme Court as a deprivation of a constitutionally protected interest.29 The Supreme Court has developed a balancing test to determine specific procedures that must be employed before an individual may be deprived of a constitutionally protected property or liberty interest.30 On the side of the accused the Court weighs the importance of the liberty or property interest at stake and the extent to which the procedure at issue may reduce the possibility of erroneous decision making. On the other side, the Court considers the government's interest in not increasing its administrative and fiscal burdens. Constitutionally required procedures are defined by a balancing process, and detailed requirements emerge through case decisions. Although constitutional protections apply only to actions by the government (i.e., a funding agency or a state university), the need for a fair process applies to any resolution of a case alleging misconduct in science. In order to accord with the principles of fairness embodied in due process, procedures for resolving misconduct-in-science cases probably should contain the following elements:31 A clear specification of what constitutes misconduct, as well as the possible sanctions. Assurance that when misconduct in science is alleged or suspected, an initial inquiry will be made to determine if a hearing32 is warranted. This inquiry should remain confidential in order to protect the reputation of the accused from groundless or trivial charges. It is not necessary to notify the accused or the research sponsor of the inquiry. Stipulation that if the evidence gathered from the initial inquiry warrants a hearing, notice will be given to the accused and the research sponsor of the charge and of the conduct or transaction(s) on which it is based, as soon as possible, consistent with the protection of evidence, particularly in potential criminal cases.

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process Provision of a hearing conducted by impartial decision makers. Prompt completion of the initial inquiry and hearing. Assurance that, at a minimum, an individual found guilty of misconduct in science will be provided with the investigation report and given an opportunity to file a written objection—procedures that would generally be sufficient for mild sanctions such as a reprimand (without a change in job status), special monitoring of future work, or probation. In hearings that consider more severe sanctions (suspension, salary reduction, rank reduction, or termination of employment), a requirement for many if not all of the following additional procedures on behalf of the subject of the misconduct allegations: (a) the opportunity to make an oral presentation to the decision maker; (b) the opportunity to present evidence or witnesses to the decision maker; (c) the opportunity to confront the witnesses against the accused and/or to review the documentation that serves as evidence of the allegations; (d) the right to have an adviser to assist in presenting the accused's case to the decision maker;33 and (e) a decision based on the record with a statement of reasons. A statement of exoneration should be issued if misconduct is not established. Consequences of Misconduct Inquiries and Investigations An investigation can result in a finding of “misconduct” or “no misconduct.” Research institutions, government and other sponsors, editors, prospective employers, and others may take actions as a result of a finding of misconduct. But if an inquiry or investigation does not establish a finding of misconduct in science or identifies problems that do not meet the criteria for a finding of scientific misconduct, the research sponsor or research institution may still take remedial actions. Government Sanctions The results of a misconduct investigation must be reported to the government research sponsor, and the sponsor may then determine what, if any, sanctions should be imposed. In determining the appropriate sanction for a particular act of scientific misconduct, government agencies consider (1) the seriousness of the misconduct, (2) whether it was a deliberate or merely a careless action, (3) whether it

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process was an isolated event or part of a pattern, and (4) whether it is relevant only to certain funding requests or awards or to all requests and awards of the accused.34 The burden of proof is on the agency proposing the sanctions, and the agency must prove its case by a preponderance of the evidence. 35 The NSF groups its possible sanctions into three classes, ranging from the least restrictive (such as a letter of reprimand) to the most severe (including termination of a grant and recommendation for debarment).36 Individuals subject to less severe restrictions are entitled to fewer procedural safeguards, whereas procedures for imposing debarment are strictly defined. The PHS categories for sanctions for misconduct differ slightly from those adopted by NSF. OSIR has indicated taking a variety of actions in response to findings of misconduct in science in addition to the actions implemented by the research institutions (see Table 5.1). The OSIR's actions have included referral to the DHHS's OIG (when there have been findings of possibly criminal offenses), use of PHS sanctions (such as repayment of funds or debarment), and other institutional penalties (such as “letters of admonishment to subjects or institutions, a requirement that the employing institution send letters of reprimand to the subjects, and a requirement that the subjects of an investigation send letters of apology to the informant ” (DHHS, 1991b, p. 6). Remedial Actions Some misconduct investigations have revealed problems that fall short of the regulatory definitions of misconduct in science but are judged to warrant remedial actions. These problems include “scientific sloppiness, incompetence, poor laboratory management, and poor authorship practices ” (DHHS, 1991b, p. 4). Failure to implement the remedial action can result in a loss of future funding or other institutional penalties. Local institutions may also take remedial actions (such as withdrawing a research proposal), even if an inquiry results in a finding of no misconduct and no further investigation is conducted. Faculty Participation in Misconduct Investigations A particular problem arises when a government agency undertakes a review of an investigation that has been completed by a university. The university investigation is often undertaken by members of the research community who are requested by university officials

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process to examine a matter that is usually complex and contentious. They are expected to do so to the best of their abilities. When a government agency decides to review the university investigation, the agency makes clear that a potential for a conflict of interest exists between the university that commissioned the investigation and the individuals who undertook the investigation. Faculty members who participate in misconduct investigations can find, unexpectedly, that they themselves are subjects of the government agency review. If the risk and consequences to the university investigators from the subsequent agency review are significant, universities face the possibility that qualified university members will refuse to serve on committees that are formed to carry out an inquiry or investigation of alleged misconduct in science. This would be very unfortunate because it would serve to exclude those who may have the best understanding of the context in which the alleged misconduct took place. The Role of Whistle-blowers Individuals who bring soundly based allegations of misconduct in science to the attention of research institutions or government agencies perform an important function. The act of charging a colleague with inappropriate behavior requires both courage and the strong conviction that the observed behavior is wrong. Many research institutions are able to respond immediately to reports of suspected misconduct, and in these cases, the individual who originated the complaint is not required to take further action. On some occasions, however, individuals who initially disclosed misconduct have become the targets of investigation or retaliation, especially if the accused person holds a position of power or authority in the research institution. Many whistle-blowers have reported having experienced professional discrimination and economic loss as a result of their actions.37 These experiences can discourage others from reporting misconduct in science. Providing protections for whistle-blowers is difficult because the reprisals that may be taken against them can be subtle and indirect. A researcher's reputation, especially in the early stages of career development, depends greatly not only on scientific and technical achievement, but also on positive recommendations from collaborators and senior figures who can provide access to research resources. It is also difficult to assure job protections in a research enterprise that is often characterized by temporary and collaborative research assignments. Once the whistle-blower has made an allegation of misconduct to an appropriate official, he or she is usually not a direct party to the

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process misconduct inquiry or investigation. The whistle-blower may or may not serve as a witness or provide documentation for the charges. A whistle-blower who is dissatisfied with the adequacy of an institutional investigation may risk his or her scientific career by presenting an accusation to governmental authorities or the press. Some whistle-blowers have suffered serious harm even when their claims were correct.38 Furthermore, the initiation of a formal complaint of misconduct in science may result from a lengthy sequence of informal discussions and disputes between the complainant, the subject of the allegation, and other colleagues. Thus, in the human, dimension, issues associated with the resolution of allegations of misconduct can be quite problematic. The stress and personal animosities of these cases can have a serious impact on the morale of an entire research group. The Problem of False Accusations When allegations of misconduct in science are misguided or malicious, the target of the claim also can suffer serious harm. The need to support those who report misconduct in science therefore must be balanced against the damage that can be done to honest scientists by false or malicious allegations. It cannot be assumed that all who bring allegations of misconduct in science are acting in good conscience. Professional rivalries, personal conflicts, or other complicating factors may stimulate false or malicious allegations, although the panel has not seen evidence of such allegations in the public record. Individuals need to be accountable for a complaint of misconduct in science, and appropriate documentation should be provided at the time of an initial allegation to justify the investment of institutional time and resources necessary to review the complaint. ADDITIONAL FINDINGS AND CONCLUSIONS Current Situation The panel recognizes that the complexities of misconduct-in-science cases and their disposition are only beginning to emerge. Several factors can inhibit vigorous pursuit of misconduct-in-science allegations: concerns about individual reputations and the potential loss of institutional prestige, the lack of explicit channels for raising concerns about misconduct in science, confusion about the distinction between inquiries and investigations in misconduct-in-science procedures, the legal liability of institutions or of participants in the

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process investigatory process, uncertainty about the legal standing of records of institutional investigations, ambiguity about the level of documentation that is sufficient to initiate or terminate inquiries or investigations, confusion about the level of evidence that is necessary to sustain findings of misconduct in science, and uncertainty about appropriate forms of disclosure of findings and sanctions. Consideration of such matters by each research institution prior to the treatment of an allegation or incident of misconduct in science would improve the process. The panel is aware of the inherent difficulty posed by asking research institutions to investigate allegations of misconduct in science that involve their own members, especially when those members hold prominent positions of prestige and respect. Internal investigations must demonstrate a fundamental commitment to independence and objectivity to ensure their credibility and success, and may be enhanced by the participation of members from outside the affected organization. The objectivity of misconduct-in-science investigations relies heavily on the credibility of the process used to arrive at findings and recommendations. To maintain the privilege of self-regulation, research institutions must exercise vigilance and diligence in examining the conduct of their own members. Current ad hoc efforts to foster dialogue about misconduct in science, other misconduct, and questionable research practices between research institutions and government agencies have raised many questions about appropriate roles, procedural flaws, and adequate resources in addressing these factors. There is a growing expectation that confirmed findings of misconduct in science should be reported to all individuals and institutions who might be affected. The panel believes that it is important at this time to preserve institutional flexibility and discretion in developing and applying policies and procedures to address misconduct in science, but it is also important to clarify the basic criteria that will be used by faculty, administrative and governmental officials, and society as a whole in evaluating institutional methods for handling allegations of misconduct in science. It is necessary to include essential ele ments of fairness, objectivity, openness, and confidentiality in the investigations of alleged misconduct, and to reconcile competing interests, not only in principle but also in practice. In considering protections for whistle-blowers in misconduct proceedings, the panel formulated three fundamental principles: Whistle-blowers should be assured that their claims will be taken seriously and will receive full and fair consideration by responsible officials.

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process In some cases, whistle-blowers may seek anonymity as a protection against reprisals and discrimination, especially while an inquiry or investigation is in the early stages of development. While such anonymity may be desirable, there may be practical constraints in assuring confidentiality in a highly specialized research area or in a small research team. When reprisals against whistle-blowers are discovered, the responsible individuals should be punished in accord with the severity of the reprisals. The standards for examining complaints about possible reprisals in the academic environment should be consistent with those developed for federal employees under the Whistleblower Protection Act of 1989.39 Balancing Accountability and the Need for Intellectual Freedom In the wake of procedural and policy reforms in response to incidents of misconduct in science, representatives from the academic and scientific community have raised concerns about the long-term or unintended effects that might result from institutional or governmental intrusions into the research environment.40 Aggressive efforts to control research practices, if carried to an extreme, can damage the research enterprise. Balance is required. Inflexible rules or requirements can increase the time and effort necessary to conduct research, can discourage creative individuals from pursuing research careers, can decrease innovation, and can in some instances make the research process impossible. Governmental or regulatory efforts to define “correct” research conduct or analytical practices can do fundamental harm to research activities if such efforts encourage orthodoxy and rigidity and inhibit novel or creative research practices. However, the panel concludes that allegations and incidents of misconduct in science require a vigorous institutional response and that the methods used by research institutions and government to address allegations of misconduct in science need improvement. Research institutions sometimes require advice or assistance in addressing allegations of misconduct in science because of the complexities of these cases or because their faculty or administrators are reluctant to address in a systematic manner complaints or suspicions about possible misconduct in science. Research institutions have not developed mechanisms for broad exchange of information and experience in resolving difficult cases and consequently lack opportunities for learning from each other. On several occasions, institutional officials have waited for direction from government agencies before

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process clarifying their own procedures for handling allegations of misconduct in science. Need for an Independent Body as an Additional Resource In considering responses by research universities, government, and the courts to incidents of misconduct in science, the panel concludes that additional resources are required to strengthen the processes and procedures used for handling and resolving allegations of misconduct in science. This conclusion is derived from the following findings: First, the panel believes that some research institutions have been slow to respond to and to pursue alleged cases of misconduct in science within their own communities. The panel concludes that an independent organization could be an effective resource to assist individual research institutions by sharing knowledge of “best practice” among the community. Second, the research community has not been effective in responding to criticism about its record in handling allegations of misconduct in science. As a result, firsthand experiences in resolving problems of fairness, responsiveness, and accuracy in misconduct proceedings are often not systematically analyzed or disseminated to improve the resources and methods used by research institutions in handling allegations of misconduct in science. The panel believes that a knowledgeable and credible voice is needed in the debate about the effectiveness of the scientific community in meeting the public interest. This perspective should not be tainted by the accusation that a voice is protecting the interest of a particular research institution or individual under scrutiny. Third, the panel notes that several government agencies, notably the NSF and the PHS, have established offices for dealing with allegations of misconduct in science by their grantees. The panel is concerned about the scope of current government definitions of misconduct in science, the ability of government offices to handle allegations of misconduct in science effectively, and the possibility that the system established to handle misconduct in science could stray into matters that lie more appropriately in the domain of the scientific community (such as the detection of scientific error, the development of scientific methodologies, or the rejection or confirmation of new theories of scientific phenomena). The panel concludes that the scientific community, Congress, federal authorities, and the public should have a single, independent body

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process available to comment with knowledge and credibility on how working scientists, research institutions, and government agencies are progressing at meeting the common objective of ensuring integrity in the research process and responding vigorously and fairly to alleged misconduct. An independent organization could perform this important function if constituted and operated in an appropriate way. Further discussion and pertinent details are given in Chapter 7 . NOTES 1. See, for example, the discussion regarding the allegations against Franz Moewus as presented in Sapp (1990). 2. The survey consisted of a stratified random sample of 30 institutions with 100 or more grants, 31 with 10 to 99 grants, inclusive, and 28 institutions with fewer than 10 grants. 3. See Department of Health and Human Services (1989a). See also National Science Foundation (1987, 1991b). 4. See, for example, the report of a conference on misconduct in science sponsored by the American Association for the Advancement of Science, the American Bar Association, the National Conference of Lawyers and Scientists and the DHHS's Office of Scientific Integrity Review (AAAS, 1991b). 5. The NSF has taken the position that although an inquiry can produce a finding of no misconduct, an investigation is necessary to establish misconduct. Personal communication, OIG, NSF, February 1, 1991. 6. See Department of Health and Human Services (1991a). 7. See, for example, the “Dear Colleague” letter issued by the NSF's OIG on August 16, 1991. 8. See Greene et al. (1985). The survey was sent to 747 institutions, and 493 (66 percent) responded. 9. See Department of Health and Human Services (1991b). Also, National Science Foundation (1990b, 1991a). 10. Examples of misconduct policies and procedures from the institutions discussed in this section are included in Volume II of this report. 11. See, for example, the discussion in the DHHS's OIG report (DHHS, 1989d), which notes that although all “large grantee institutions considered [misconduct] investigations their responsibility, only 54 percent of the small institutions shared this view, and most of these institutions would support a more active NIH role in investigating allegations” (p. 11). 12. For a full discussion of some procedural complexities involved in academic investigations of misconduct-in-science allegations, see the proceedings of a series of workshops sponsored by the National Conference of Lawyers and Scientists (AAAS-ABA, 1989). 13. See the statement by Rep. John Dingell in U.S. Congress (1989b): “The apparent unwillingness on the part of the scientific community to deal promptly and effectively with allegations of misconduct is unfair to both the accuser and to the accused” (p. 1). See also Weiss (1991b) and the commentary in Dong (1991). 14. For an informative discussion, see Andersen (1988). 15. See, for example, Department of Health and Human Services (1991a). 16. Public Law 100-504 (102 Stat. 2515 [1988]) established Offices of Inspector General in a number of departments and smaller agencies, including NSF. In compliance

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process with the legislation, the National Science Board established the NSF's Office of Inspector General on February 10, 1989. 17. See, for example, the minutes of the meetings of the OSIR Advisory Committee held July 15, 1991, and November 17, 1991 (DHHS, 1991d). 18. See, for example, Hallum and Hadley (1990). 19. See Hamilton (1991b) and Weiser, B. 1991. “NIH alleges misconduct by Georgetown scientist.” Washington Post (March 22):A1. 20. Personal communication, OSIR, June 19, 1991. 21. One particularly troubling issue in the investigation of allegations of misconduct in science concerns the nature of the review or hearing that should be provided. Several principles of fairness, confidentiality, and completeness may come into conflict during this stage. For example, should the accused be allowed to cross-examine witnesses, including the complainant who filed the initial allegation? Although a formal hearing may be appropriate when specific and serious penalties have been proposed, there is no consensus that a subject is entitled to review testimony or to cross-examine witnesses during the fact-gathering process designed to provide evidence to substantiate or dismiss charges of misconduct in science. In contrast, there is general agreement that the subject should be given access to the draft investigative report for rebuttals, modifications, or other amendments prior to the formulation of specific charges or a dismissal of the complaint. Some institutions have also provided access to the draft report to significant witnesses, including the initial complainant, although this is not customary. 22. See 18 U.S.C. Sections 287, 1001 (1988); United States v. Breuning, No. K88-0135 (D. Md., Nov. 10, 1988). 23. For example, after a guilty plea on two counts of making false statements to the government on grant applications (issued in exchange for dropping a charge of obstruction of the government's investigation of his conduct), Stephen E. Breuning was sentenced in 1988 to 5 years probation, 2 months in a half-way house, and 250 hours of community service. He was ordered to repay $11,352 of salary for the time covered by his fraudulent research and to conduct no psychological research during the period of his probation. See Frankel (1988). 24. Abbs v. Sullivan, 756 F. Supp. 1172 (W.D. Wis. 1990). 25. “Nor shall any person be deprived of life, liberty, or property, without due process of law.” U.S. Constitution, Fifth Amendment. State governmental action is similarly limited by the due process clause of the Fourteenth Amendment. 26. Fuentes v. Shevin, 407 U.S. 67, 97 (1972). 27. See pp. 666-67 in Tribe (1988). See also Joint Anti-Fascist Refugee Committee v. McGrath, 341 U.S. 123, 168 (1951) (Frankfurter, J., concurring; procedural safeguards give the accused “the right to be heard before being condemned to suffer grievous loss”). 28. See Perry v. Sinderman, 408 U.S. 593, 601-03 (1972) (plaintiff, an untenured instructor, could have liberty or property interest in continued employment); see also Ferguson v. Thomas, 430 F.2d 852, 856 (5th Cir. 1970) (“a college can create an obligation as between itself and an instructor where none might otherwise exist. if it adopts regulations or standards of practice governing non-tenured employees which create an expectation of reemployment”) and Board of Regents v. Roth, 408 U.S. 564, 578 (1972) (non-tenured instructor had no right to a hearing before the university decided not to renew his contract, absent custom or mutual agreement that his employment would be renewed). 29. Paul v. Davis, 424 U.S. 693, 701 (1976) (“reputation alone, apart from some more tangible interests such as employment, is [n]either ‘liberty' [n]or ‘property' by itself

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process sufficient to invoke the procedural protection of the Due Process Clause”). But see Wisconsin v. Constantineau, 400 U.S. 433, 437-39 (1971), and Jenkins v. McKeithen, 395 U.S. 411, 426-31 (1969). 30. See, for example, Matthews v. Eldridge, 424 U.S. 319, 335 (1976). 31. The elements of due process, any or all of which may be required before an individual can be deprived of a particular liberty or property interest, include (1) adequate notice of expected conduct; (2) adequate notice of the charges; (3) a timely hearing; (4) a neutral decision maker; (5) an opportunity to make an oral presentation to the decision maker; (6) an opportunity to present evidence or witnesses to the decision maker; (7) a chance to confront and cross-examine witnesses or evidence to be used against the accused; (8) the right to have an adviser involved to assist in the presentation of the individual 's case to the decision maker; and (9) a decision based on the record with a statement of reasons for the decision. Not all of these elements must be present in every hearing. To the contrary, only the more serious deprivations of liberty or property interests by the state require extensive procedural safeguards. See generally, pp. 706-18 in Tribe (1988) and pp. 555-56 in Nowak et al. (1983). See also Mishkin (1988). 32. In this discussion the panel uses the term “hearing” to refer to the mechanism used to investigate complaints of misconduct in science. The hearing may or may not involve sessions in which the subject of a misconduct investigation may hear testimony by or cross-examine witnesses. 33. The issue of the involvement of attorneys in the investigation of misconduct in science is a vexing problem. Some universities believe that attorneys should not participate in the university investigatory process because their involvement may lead to an adversarial spirit that is not consistent with the academic environment. Other universities allow those accused of misconduct to be represented by attorneys in the misconduct investigation. In such cases, the investigative panel may also request the university to supply its legal counsel for the panel's assistance. 34. 45 C.F.R. Section 689.2(b) (1991). 35. 45 C.F.R. Sections 620.314(c), 689.2(d) (1991). 36. 45 C.F.R. Section 689.2(a) (1991). 37. See, for example, the accounts published in Westin (1981) and in Glazer and Glazer (1990). 38. Swazey and Scher (1981) and Glazer and Glazer (1990). See also Hollis (1987), Jacobstein (1987), and Sprague (1987). 39. Public Law 101-12 (103 Stat. 16 [1989]). 40. See, for example, testimony by academic officials and scientists in hearings on maintaining the integrity of scientific research convened by the House Committee on Science, Space, and Technology (U.S. Congress, 1990b).