1

Introduction

THE U.S. RESEARCH ENTERPRISE

The Traditions of Science

Scientific research is grounded in values such as integrity, honesty, trust, curiosity, and respect for intellectual achievement.1 The expression of these values in the diverse styles and approaches of the various scientific disciplines has contributed directly to the discovery of knowledge and thus to the achievements of the U.S. scientific research enterprise. Basic to the honor system that binds the community of scientists is truthfulness, both as a moral imperative and as a fundamental operational principle in the scientific research process.2 Ideally, it is the challenge of gaining a measure of truth that motivates scientists to formulate, test, and revise their hypotheses in ways that minimize errors.

Scientific achievement as well as human welfare, which is affected increasingly by the work of scientists, depend on the integrity of the research process. By integrity of the research process, the panel means the adherence by scientists and their institutions to honest and verifiable methods in proposing, performing, evaluating, and reporting research activities. The research process includes the construction of hypotheses; the development of experimental and theoretical paradigms; the collection, analysis, and handling of data; the



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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process 1 Introduction THE U.S. RESEARCH ENTERPRISE The Traditions of Science Scientific research is grounded in values such as integrity, honesty, trust, curiosity, and respect for intellectual achievement.1 The expression of these values in the diverse styles and approaches of the various scientific disciplines has contributed directly to the discovery of knowledge and thus to the achievements of the U.S. scientific research enterprise. Basic to the honor system that binds the community of scientists is truthfulness, both as a moral imperative and as a fundamental operational principle in the scientific research process.2 Ideally, it is the challenge of gaining a measure of truth that motivates scientists to formulate, test, and revise their hypotheses in ways that minimize errors. Scientific achievement as well as human welfare, which is affected increasingly by the work of scientists, depend on the integrity of the research process. By integrity of the research process, the panel means the adherence by scientists and their institutions to honest and verifiable methods in proposing, performing, evaluating, and reporting research activities. The research process includes the construction of hypotheses; the development of experimental and theoretical paradigms; the collection, analysis, and handling of data; the

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process generation of new ideas, findings, and theories through experimentation and analysis; timely communication and publication; refinement of results through replication and extension of the original work; peer review; and the training and supervision of associates and students. The traditions of skepticism, openness, sharing, and disclosure that are associated with the research process not only provide a means of identifying theoretical or experimental errors that occur inevitably in science, but also imply an obligation to maintain the integrity of the research process. Errors are often, corrected by later research, stimulated by the skepticism of other scientists. Error, however, is distinct from actions that directly compromise the integrity, of the research process. Scientists have relied on each other and the traditions of their community for centuries to safeguard the integrity of the research process. This approach has been successful largely because of the widespread acknowledgement that science cannot work otherwise, and also because high standards and reputation are important to scientists. Dishonest or untrustworthy individuals become known to their colleagues through various mechanisms, including word of mouth and the inability of other scientists to confirm the work in question. Such irreproducible work is recognized and discredited through the processes of peer review and evaluation that are critical to making professional appointments, accepting work for publication, and awarding research support. Changing Circumstances and Expectations The U.S. scientific community has maintained a high degree of autonomy and self-governance during a period of remarkable successes. But the ability of research scientists and their institutions to safeguard the integrity of the research process is now being questioned as a result of several significant and comparatively recent developments. 3 Among these developments are the dramatic increases in the size of the U.S. research enterprise and in the amounts and patterns of funding. 4 These increases have come in response to the many notable contributions of scientists, engineers, and health professionals, emerging research opportunities, and public demands for solutions to such complex problems as protecting the environment and ensuring economic well-being. Also apparent are pressures related to the quickening pace and use of new developments in science—research results in some areas can rapidly influence public policy, health care services, and the commercial value of new products.

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process By many measures, the U.S. research system has remained notably creative and productive in this changing environment. In addition to advances in knowledge about the fundamental processes of biological, physical, and social systems, a major achievement has been the creation of a generation of well-trained research investigators. The very success of these and other scientific achievements has contributed to an expanding research enterprise. But the new dimensions of the scientific enterprise do not come without stress (Hackett, 1990; OTA, 1991). The growth in the size and specialization of research teams in some fields has strained the capacity of individual scientists to maintain the degree of personal involvement and familiarity with their colleagues' and subordinates' efforts that characterized earlier work. In the words of one scientist: “It is increasingly difficult for a scientist to master, let alone know in detail, the reliability of every phase of a large, multiple-author work. Thus, the individual scientist depends upon the integrity and competence of colleagues” (Hoshiko, 1991, p. 11). Individual and institutional efforts to manage and resolve internal stresses in the research enterprise are increasingly apparent (Hackett, 1990; OTA, 1991). Disputes have arisen among scientists over allocation of credit and recognition of intellectual property rights. Schisms have increased between scientific investigators and research administrators, sponsors, and funders over issues such as research budgets, cost accounting for research activities, the appropriate allocation of time between teaching and research responsibilities, and the level of oversight for research activities. As a result, scientists are calling attention to factors in the research environment itself that have been identified as negative.5 But questions about how to safeguard the integrity of an enterprise that is central to contemporary American life are of concern to more than scientists alone. The self-regulatory system in science, which has evolved over the centuries to foster creativity and scientific achievement, may need to evolve further to meet the demands for public accountability that accompany government, foundation, and industrial support of scientific research.6 The Problem of Misconduct in Science In the 1980s, newspaper and magazine accounts brought to the attention of the scientific community, the public at large, and the federal government several instances of scientists who reported measurements they never made, altered research results, or plagiarized the work of others.7 In many cases, the responses of the institutions

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process where these actions had occurred seemed slow, inadequate, and confused. 8 Some research institutions and government agencies set up investigations that appeared to be biased or failed to disclose incidents of misconduct. Such events raised additional questions about the integrity of the research process and about the traditional self-governance of the scientific research community. Continuing concern has been fueled by anecdotal evidence emerging from press reports, congressional hearings, or institutional actions taken in specific cases. During the period from March 1989 to March 1991, more than 200 allegations of misconduct in science were recorded by U.S. government offices (NSF, 1990b; Wheeler, 1991).9 From this number, about 30 cases have resulted so far in confirmed findings of misconduct in science (NSF, 1990b; DHHS, 1991b). Although the possibility of underreporting needs to be considered, these statistics indicate that the reported incidence of misconduct in science is low—compared, for example, to the 26,000 research awards supported annually by the National Institutes of Health (NIH, 1991). But any misconduct comes at a high price both for scientists and for the public, and the possibility of underreporting needs to be considered. Cases of misconduct in science involving fabrication, falsification, and plagiarism breach the trust that allows scientists to build on others' work, as well as eroding the trust that allows policymakers and others to make decisions based on scientific and objective evidence. The inability or refusal of research institutions to address such cases can undermine both the integrity of the research process and self-governance by the research community. ENSURING INTEGRITY IN THE RESEARCH PROCESS Acknowledging the Range of Concerns Scientists are deeply troubled by reports of misconduct in science. At the same time, they are concerned that institutional and government bureaucracies designed to uncover or respond to allegations of misconduct in science may damage the vitality and productivity of U.S. scientific research. The creative processes of scientific judgment, experimentation, and error-correction that are intrinsic to the development of new scientific knowledge require a flexible and adaptable environment. In a time of expanding research opportunities and competitive funding pressures, many scientists also fear that significant time, and possibly resources, could be diverted from research endeavors and used instead to satisfy administrative controls derived from political imperatives.

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process In 1985, the U.S. Congress passed legislation that requires each institution receiving funds from the Public Health Service to develop an “administrative process to review reports of scientific fraud in connection with biomedical or behavioral research” sponsored by the institution.10 Later, the Public Health Service and the National Science Foundation each adopted regulations designed to address allegations of misconduct in science (DHHS, 1989a; NSF, 1987, 1991b). Such legislative and regulatory decisions concerned with the integrity of the research, process and misconduct in science mark the beginning of a new set of relationships between the scientific community and the federal government. In contrast to an earlier period characterized by unwritten agreements and personal trust, current policy discussions about integrity and misconduct in science raise difficult questions about the roles of individual scientists, their laboratories, research institutions, and government in providing oversight of the research enterprise to ensure that science is conducted in an honest and responsible manner. One observer has aptly summarized some of the basic concerns (Menninger, 1990): The appearance of federal policy [in an area] once mainly confined to academic and scientific circles must be taken as a significant matter reflecting a heightened public perception of scientific research as a determinant of the national future. This results not just from scientific research's role as producer of new knowledge, but from its expanding need for sizeable sums of money, its impact on the country's economic prospects and quality of life, and its generation of painfully complex ethical dilemmas. These factors have unequivocally moved the research enterprise out of the isolation of the laboratory and onto the public stage where a context of motives and expectations prevails that scientists may find incongruous with their vocation, but which they ignore at their peril. Taking Constructive Action Expectations within and outside of research institutions have generated desires for more visible, explicit mechanisms to handle allegations of misconduct in science and to assure integrity in the research process. One challenge is to develop vigorous approaches to protect and enhance scientific traditions and sound research practices and to penalize those who engage in misconduct. A second challenge is to foster responsible research conduct in a period of increasing diversification of funding sources, growing demands on limited research resources, and greater incentives for financial gain in the research

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process environment. A third challenge is to ensure fairness and balance in efforts to establish individual and institutional accountability in publicly supported research activities, so that frivolous or malicious charges as well as counterproductive regulations are avoided. PURPOSE AND SCOPE OF THIS STUDY Charge to the Panel The Committee on Science, Engineering, and Public Policy (COSEPUP) of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine sought to address these issues by convening the 22-member Panel on Scientific Responsibility and the Conduct of Research. The panel was asked to examine the following issues: What is the state of current knowledge about modern research practices for a range of disciplines, including trends and practices that could affect the integrity of research? What are the advantages and disadvantages of enhanced educational efforts and explicit guidelines for researchers and research institutions? Can the research community itself define and strengthen basic standards for scientists and their institutions? What roles are appropriate for public and private institutions in promoting responsible research practices? What can be learned from institutional experiences with current procedures for handling allegations of misconduct in science? In addition to outlining approaches to encourage the responsible conduct of scientific research, the panel was also asked to determine whether existing unwritten practices should be expressed as principles to guide the responsible conduct of research. If the panel members judged it advisable, they were encouraged to prepare model guidelines and other materials. Approach, Audience, Content In responding to its charge, the panel chose a two-part approach intended to produce a report that would speak to all members of the U.S. scientific research community. First, the panel examined factors fundamental to the integrity of the research process, including scientific principles and research practices; changes within the contemporary research environment; and the roles of individuals, educational programs, and research guidelines in fostering responsible research

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process practices. Second, the panel considered the incidence and significance of misconduct in science and also examined institutional approaches to handling allegations of misconduct, analyzing in addition the complex problems associated with responding to such allegations. The panel chose this approach to emphasize positive steps that might be taken to assure the integrity of the research process in the current environment. Although many organizations are absorbed with responding to the problem of misconduct in science, institutional experience with recently adopted regulatory requirements is very new, and there is not yet a clear consensus about procedural approaches that may be necessary to address allegations of misconduct.11 The panel did not attempt to resolve all of these matters in this report. At the same time, its selected approach is not intended to diminish the importance of related problems such as conflict of interest, the allocation of indirect costs, or federal support for scientific research, but rather to reflect the panel's judgment that integrity in the research process itself and issues arising from misconduct in science deserve critical examination and consideration on their own merits. Although this report addresses concerns that affect the entire U.S. scientific community, the members of the panel were obliged to generalize from their own particular specialized expertise and experience. Unfortunately, it was not possible to develop a detailed description of the diverse styles and approaches of the various scientific disciplines, a description that might have conveyed the richness, spirit, and disciplinary differences that characterize U.S. science. The panel recognizes this limitation but believes that a general approach will guide specific interpretations and applications. This report should therefore be viewed as part of a comprehensive dialogue on and examination of integrity in the research process. Finally, the panel emphasizes that this report speaks to all members of the scientific community, regardless of their institutional affiliation, whose research results become part of the scientific process. Although this report is addressed principally to an academic audience, the panel believes that the discussions, findings, and recommendations also have relevance for nonacademic research groups, including those in industry, and particularly those engaged in clinical trials and drug toxicology studies, as well as others whose members report research results at scientific meetings and publish in journals. Officials at research institutions also are responsible for taking educational, preventive, and remedial approaches to dealing with scientific conduct issues. All who participate in the research enterprise share responsibility for the integrity of the research process.

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process METHODS, DEFINITIONS, AND BASIC ASSUMPTIONS Evaluating Available Data The panel sought to develop a report that would address conflicting perspectives and priorities basic to enhancing integrity in the research process. An examination of empirical studies on research behaviors yielded few significant insights.12 The panel also concluded that existing social studies of the U.S. scientific research enterprise are not adequate to support conclusions about the relative effectiveness of various alternatives for fostering the integrity of the research process. For example, the value of formal and informal educational approaches in fostering responsible research practices has, to the panel's knowledge, not been systematically addressed. And although some research institutions in recent years have adopted formal guidelines designed to foster responsible practices, the experience with research guidelines is limited.13 The panel also found barriers to obtaining data on specific incidents of misconduct. Confidential institutional reports are not available if misconduct cases are under appeal or are subject to litigation, if the institutions have negotiated private settlements with the subjects of misconduct complaints, if there are findings of no misconduct, or if the misconduct has been judged to be not significant enough to warrant penalties. Those involved in handling or evaluating misconduct cases are usually not at liberty to discuss their findings. Those who have been parties at interest in misconduct cases may have a biased view of specific actions. An increasing amount of litigation in misconduct cases has further complicated the collection and analysis of primary data. Thus many of the panel's findings and recommendations are derived from informed judgments based on discussions with persons knowledgeable about the research process and about factors that affect the contemporary research environment. The panel also met with individuals who have both knowledge of and a broad range of perspectives on the significance of the reported cases of misconduct in science. The panel's overall outlook and opinions are based on general ethical principles that are well accepted by scientists and by society. Defining Terms—Articulating a Framework for Fostering Responsible Research Conduct In the opening paragraphs of this chapter, the panel defined the term “integrity of the research process” as the adherence by scientists

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process and their institutions to honest and verifiable methods in proposing, performing, evaluating, and reporting research activities. This term is sometimes thought to be synonymous with “integrity of science, ” but the terms of reference are different.14 Science is not only a body of information, composed of current knowledge, theories, and observations, but also the process by which this body of knowledge is developed. Furthermore, the scientific process is a social enterprise that involves individuals and institutions engaged in developing, certifying, and communicating research results. Throughout this report the panel focuses on the integrity of the research process as defined above. Misconduct in science is commonly referred to as fraud.15 But most legal interpretations of the term “fraud” require evidence not only of intentional deception but also of injury or damage to victims. Proof of fraud in common law requires documentation of damage incurred by victims who relied on fabricated or falsified research results. Because this evidentiary standard seemed poorly suited to the methods of scientific research, “misconduct in science ” has become the common term of reference in both institutional and regulatory policy definitions. However, “misconduct in science” as commonly used is an amorphous term, often covering a spectrum of both significant and trivial forms of misbehavior by scientists. The absence of a clear, explicit definition that focuses on actions highly detrimental to the integrity of the research process has impeded the development of effective institutional oversight and government policies and procedures designed to respond to such actions. Varying definitions of misconduct in science have also impeded comparison of the results of survey studies. If, for example, survey respondents apply the term “misconduct in science” to a broad range of behaviors that extend beyond legal or institutional definitions, their responses weaken the significance of reported survey results. In order to provide policy guidance for scientists, research institutions, and government research agencies concerned about ensuring the integrity of the research process as well as addressing misconduct in science, the panel developed a framework that delineates three categories of behaviors in the research environment that require attention. These categories are (1) misconduct in science, (2) questionable research practices, and (3) other misconduct. The panel seeks to accomplish several goals by proposing these three categories. Foremost is a precise definition of misconduct in science aimed at identifying behaviors that scientists agree seriously damage the integrity of the research process. For example, although

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process using inadequate training methods or refusing to share research data or reagents are not desirable, such actions generally are regarded as behaviors that are not comparable to the fabrication of research data. In the same manner, sexual harassment and financial mismanagement are illegal behaviors regardless of whether scientists are involved, but these actions are different from misconduct in science because they do not compromise, in a direct manner, the integrity of the research process. Unethical actions of all types are intolerable, and appropriate actions by the research community to address such problems are essential. But the panel believes that there are risks inherent in developing institutional policies, procedures, and programs that treat all of these behaviors without distinction. Inappropriate actions by government and institutional officials can create an atmosphere that disturbs effective methods of self-regulation and harms pioneering research activities. In particular, many scientists are concerned that the term “misconduct in science,” which has been construed as including “serious deviations from accepted practices” (as currently defined in government regulations), could be defined in such a way that it could be applied inappropriately to the activities of honest scientists engaged in creative research efforts. The panel recognizes that this framework may not satisfy all scientists, lawyers, or policymakers. Its primary purpose is to advance the quality of policy and educational discussions about distinctions between different kinds of troubling behavior within the research environment, and to allow scientists, institutional officers, and public officials to focus their attention and their efforts toward prevention on substantive issues rather than discrepancies in terminology. Thus the framework of definitions proposed in this report should be viewed as a tool for use in a sustained effort by the research community to strengthen the integrity of the research process, to promote responsible research conduct, and to clarify appropriate methods to address instances of misconduct in science. The three categories will need to be refined through continued dialogue, criticism, and experience. In developing its framework of definitions, the panel adopted an approach that evaluates how seriously the various behaviors compromise the integrity of the research process. The panel also considered other criteria, such as intent to deceive. The panel concluded that while intention is important, especially in the adjudication of allegations of misconduct in science, intention is often hard to establish and does not provide, by itself, an adequate basis for separating actions that seriously damage the integrity of the research process from questionable research practices or other misconduct.16 17

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process Misconduct in Science Misconduct in science is defined as fabrication, falsification, or plagiarism, in proposing, performing, or reporting research. Misconduct in science does not include errors of judgment; errors in the recording, selection, or analysis of data; differences in opinions involving the interpretation of data; or misconduct unrelated to the research process. Fabrication is making up data or results, falsification is changing data or results, and plagiarism is using the ideas or words of another person without giving appropriate credit. By proposing this precise definition of misconduct in science, the panel is in unanimous agreement that the core of the definition of misconduct in science should consist of fabrication, falsification, and plagiarism. The panel unanimously rejects ambiguous language such as the category “other serious deviations from accepted research practices” currently included in regulatory definitions adopted by the Public Health Service and the National Science Foundation (DHHS, 1989a; NSF, 1991b). Although government officials have often relied on scientific panels to define “other serious deviations,” the vagueness of this category has led to confusion about which actions constitute misconduct in science. In particular, the panel wishes to discourage the possibility that a misconduct complaint could be lodged against scientists based solely on their use of novel or unorthodox research methods. The use of ambiguous terms in regulatory definitions invites exactly such an overexpansive interpretation. In rejecting the “other serious deviations” category, the panel considered whether a different measure of flexibility should be included in its proposed definition of misconduct in science, so as to allow the imposition of sanctions for conduct similar in character to fabrication, falsification, and plagiarism. Some panel members believe that the definition should also encompass other actions that directly damage the integrity of the research process and that are undertaken with the intent to deceive. For example, misuse of the peer-review system to penalize competitors, deceptive selection of data or statistical analysis, or encouragement of trainees to practice misconduct in science might not always constitute a form of fabrication, falsification, or plagiarism. Yet such actions could, in some circumstances, damage the integrity of the research process sufficiently to constitute misconduct in science. All members of the panel support the basic definition of misconduct in science proposed above, but the panel did not reach final consensus on whether additional flexibility was needed to address as

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process misconduct in science other practices of an egregious character similar to fabrication, falsification, and plagiarism. These issues deserve further consideration by the scientific research community to determine whether the panel's definition of misconduct in science is flexible enough to include all or most actions that directly damage the integrity of the research process and that were undertaken with the intent to deceive. Questionable Research Practices Questionable research practices are actions that violate traditional values of the research enterprise and that may be detrimen tal to the research process. However, there is at present neither broad agreement as to the seriousness of these actions nor any con sensus on standards for behavior in such matters. Questionable research practices do not directly damage the integrity of the research process and thus do not meet the panel's criteria for inclusion in the definition of misconduct in science. However, they deserve attention because they can erode confidence in the integrity of the research process, violate traditions associated with science, affect scientific conclusions, waste time and resources, and weaken the education of new scientists. Questionable research practices include activities such as the following: Failing to retain significant research data for a reasonable period; Maintaining inadequate research records, especially for results that are published or are relied on by others; Conferring or requesting authorship on the basis of a specialized service or contribution that is not significantly related to the research reported in the paper;18 Refusing to give peers reasonable access to unique research materials or data that support published papers; Using inappropriate statistical or other methods of measurement to enhance the significance of research findings;19 Inadequately supervising research subordinates or exploiting them; and Misrepresenting speculations as fact or releasing preliminary research results, especially in the public media, without providing sufficient data to allow peers to judge the validity of the results or to reproduce the experiments. The panel wishes to make a clear demarcation between misconduct in science and questionable research practices—the two catego-

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process ries are not equivalent, and they require different types of responses by the research community and research institutions. However, the relationship between these two categories is not well understood. It may be difficult to tell, initially, whether alleged misconduct constitutes misconduct in science or a questionable research practice. In some cases, for example, scientists accused of plagiarism have testified about an absence of appropriate training methods for properly citing the work of others. The selective use of research data is another area where the boundary between fabrication and creative insight may not be obvious. The panel emphasizes that scientists, individually and collectively, need to take questionable research practices seriously because when tolerated, such practices can encourage an environment that fosters misconduct in science. But questionable practices are not equivalent to misconduct in science, and they are not appropriate subjects for investigations directed to misconduct. Other Misconduct Certain forms of unacceptable behavior are clearly not unique to the conduct of science, although they may occur in a laboratory or research environment. Such behaviors, which are subject to generally applicable legal and social penalties, include actions such as sexual and other forms of harassment of individuals; misuse of funds; gross negligence by persons in their professional activities; vandalism, including tampering with research experiments or instrumentation; 20 and violations of government research regulations, such as those dealing with radioactive materials, recombinant DNA research, and the use of human or animal subjects. Industry-university relationships, and the resultant possibility of conflicts of interest, also raise issues that require special attention. In these cases, recognized legal and institutional procedures should be in place to address complaints and to discourage behavior involving forms of misconduct that are not unique to the research process. Allegations of harassment, for example, should be handled by officials designated to implement personnel or equal opportunity regulations. Allegations of misuse of research funds should be addressed by those responsible for the financial integrity of the research institutions involved. The panel concluded that such behaviors require serious attention but lie outside the scope of the charge for this study. On some occasions, however, certain forms of “other misconduct” are directly associated with misconduct in science. Among these are cover-ups of misconduct in science, reprisals against whistle-blow-

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process ers, malicious allegations of misconduct in science, and violations of due process protections in handling complaints of misconduct in science. These forms of other misconduct may require action and special administrative procedures (see Chapter 5 for further discussion). Understanding Causes and Evaluating Cures The causes of misconduct in science are undoubtedly diverse and complex. Individual scientists, institutional officials, and scholars in the social studies of science over the past decade have suggested that various factors lead to or encourage misconduct in science, but the influence of any individual factor or combination of suggested factors has not been examined systematically. Two alternate, possibly complementary, hypotheses have been advanced for considering the causes of misconduct in science and formulating methods for prevention and treatment. Many observers have explained the problem of misconduct in science as one that results primarily from character or personality flaws, from environmental stimuli in the research system, or from some interaction of both:21 Misconduct in science is the result of individual pathology. Misconduct in science is commonly viewed as the action of a psychologically disturbed individual. An analysis by Bechtel and Pearson (1985) of 12 cases of deviant behavior reported in the 1970s and early 1980s supported the hypothesis that scientists who engage in deviant behavior are commonly individuals who operate alone and who conceal their misconduct.22 Factors in the modern research environment contribute to misconduct in science. But although the “bad person” approach to explaining deviant behavior in science has had strong support within the scientific community, Bechtel and Pearson and others have questioned whether this hypothesis alone adequately explains the phenomenon of misconduct in science. A broad range of factors in the research environment have been. suggested as possible causes of misconduct in science. Such factors include (a) funding and career pressures of the contemporary research environment (such as the pressure to publish; NSB, 1988); (b) inadequate institutional oversight; (c) inappropriate forms of collaborative arrangements between academic scientists and commercial firms; (d) inadequate training in the methods and traditions of science;23 (e) the increasing scale and complexity of the research environment, leading to the erosion of peer review, mentorship, and educational processes in science; and (f) the possibility that misconduct in science

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process is an expression of a broader social pattern of deviation from traditional norms. In addition, it has been noted that some areas of research, such as biological and clinical research, do not yet proceed from explicit scientific laws and also make extensive use of empirical observations not related to theory. Moreover, the characteristics of certain research materials in these fields inhibit the replication of research findings as a vehicle for self-correction. The panel has reviewed various suggestions about possible causes of misconduct in science but makes no judgment about the significance of any one factor. The panel believes that speculations about individual pathology or about environmental factors as the primary causes have not been verified; misconduct in science is probably the result of a complicated interaction of psychological and environmental factors. Moreover, although one or more such factors may contribute to specific cases of misconduct in science, the panel has not discerned a broad trend that would highlight any single factor as a clear generic cause. Regardless of the causes of deviant behavior, the panel is concerned that some “cures” for misconduct in science would damage the research process itself. The uncertainty of evidence about external factors as causes means that recommending policy solutions for treating and preventing the problem of misconduct in science is problematic. As a result, efforts to foster integrity in the research process and to reduce the occurrence of misconduct in science should be evaluated systematically to identify steps that prove to be effective. A range of possible steps is discussed in the following chapters. Starting from Logical Assumptions The integrity of the research process has sometimes been called into question by sensationalized reports about specific cases of misconduct in science.24 But because misconduct in science seems infrequent, many scientists have suggested that it does not present a serious problem. According to this view, when misconduct occurs in an important field of research, incorrect information will be corrected or eventually replaced by correct results through the work of others. The panel agrees that confirmed cases of misconduct in science are rare. Nevertheless, the panel believes that every case of misconduct in science is serious and requires action for the following reasons: Misconduct is wrong. One can object to misconduct in science simply on ethical grounds, since it often involves actions that betray personal and public trust and the search for truth. Misconduct in

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process science, if not properly addressed, can undermine the reasons for doing and supporting science itself. Misconduct in science wastes time and resources. Misconduct can mislead scientists and waste the efforts of those who try to build on reported results. It requires substantial effort to correct false claims. Plagiarism can discourage scientists who see their contributions stolen or misrepresented by others and can damage honest reputations and the intellectual audit trail that affects the history of science. Misconduct can lead to injuries and harmful consequences. Significant harm can result if false claims influence public health or technical or political decisions. Although mechanisms of self-correction may expose false claims, they are not designed to detect or deter misconduct in science. False information relating to medical procedures, for example, may lead to mistreatment of patients. Falsehoods should be publicly corrected, as soon as possible, to prevent such damage. We should not wait for the slow corrective action of further research. Similar comments apply in other areas of science in which false reports may have adverse practical consequences. The time interval between the release and application of initial research reports in medical treatment, commercial products, services, and public policy decisions is diminishing. Resources for replicative research may not be available in some areas of research. Thus correction of research results, through replicative or related research efforts, is not a panacea; neither is it always timely. Misconduct by scientists, and weak institutional responses to these incidents, can lead to counter-productive regulation and control. The image of scientists cheating in their laboratories is deeply disturbing to scientists themselves and to members of the public who have generally held scientists in high esteem. Even a few well-publicized cases of misconduct in science, particularly when such cases involve prominent individuals at respected institutions, have stimulated legal and administrative demands for accountability that divert funds and attention from scholarly purposes, interfere with the traditional autonomy granted to science, and malign the status of reputable scientists and their institutions. Misconduct in science can undermine public support of science. Misconduct is one part of a larger public examination of scientific and educational institutions. Public confidence in the methods by which scientists maintain the integrity of the research process can be eroded when misconduct occurs in a social environment that is already disturbed by, for example, reports of misuse of the indirect costs associated with research funds, and other behaviors that violate public trust.

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process On the basis of these assumptions, the panel concluded that actions designed both to foster the integrity of the research process and to respond to misconduct in science are both timely and warranted. NOTES 1. The values that characterize science are discussed in National Academy of Sciences (1989). 2. See, for example, further discussion on the ethos of science as described in Chapter 12 in Holton (1988). See also Sigma Xi (1986). 3. For a review of the impact of the contemporary research environment on the ethos of science, see Hoshiko (1991). 4. Government funding for U.S. basic research increased in current dollars from $5.4 billion in FY 1982 to an estimated $12.5 billion in FY 1991. See p. 53 in American Association for the Advancement of Science (1991a). Academic research investigators are also increasingly supported by nonfederal funds provided by a diverse mix of industrial sponsors, state, and local funds, foundations, and intramural support. For example, the industrial share of academic R&D funding grew from 3.9 percent in 1980 to an estimated 6.6 percent in 1989. Some specialized academic research centers now receive over 20 percent of their funding from industry. See p. 106 in National Science Board (1989). 5. These factors include competitive pressures to publish, increasing competition for funds, secrecy in research performance, and inadequate interaction of young researchers with their peers and mentors. See Institute of Medicine (1989a). 6. See, for example, the following statement of Rep. John Dingell: “We are directing our efforts to seeing to it that NIH is able to function efficiently, well, honorably and competently in the public interest. We expect them to do that with full attention to their responsibilities to the taxpayers, as well as their duties towards the achievement of good science” (U.S. Congress, 1990c, p. 4). 7. As noted in On Being a Scientist (NAS, 1989), Alexander Kohn (1986) presents several case studies of fraud and self-deception from the history of science and medicine. A more popularly written and controversial history of misconduct in science is presented in Broad and Wade (1982). Individual case histories have been reported in various journals and in newspaper accounts. See, for example, a summary of the controversy surrounding William Summerlin in McBride (1974) and an account of the Long, Soman, Alsabti, Straus, and Burt cases in Broad (1981). 8. See, for example, the cases described by Mazur (1989). See also the discussions in congressional oversight hearings (including U.S. Congress, 1981a; 1988a,b,c). 9. The term “allegation” here refers to complaints of misconduct in science that have resulted in a government case file. An analysis of these allegations is provided in Chapter 4. As of December 1991, about half of these allegations had been resolved. 10. Health Research Extension Act of 1985, P.L. 100-504, 99 Stat. 820 (1985). 11. See, for example, the reports resulting from three workshops sponsored by the National Conference of Lawyers and Scientists, American Association for the Advancement of Science and the American Bar Association (AAAS-ABA, 1989). 12. Some good examples of studies of scientific practice and the social organization of science include Traweek (1988), Hull (1988), Latour (1987), Latour and Woolgar (1979), Hackett and Chubin (1990), and Hackett (1990). 13. It is the panel's hope that the base of knowledge will be augmented by additional

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process data derived from systematic evaluation of experiences in fostering responsible research practices. See also in Volume II of this report the background paper on this topic prepared for the panel by Nicholas Steneck. 14. A discussion of the dimensions of integrity in science is included in chapters 1 and 12 in Holton (1988). 15. Discussions focused initially on “scientific fraud” but encountered difficulties with the legal definition of the word “fraud.” Government regulations and institutional policies have adopted terms such as “research misconduct,” “scientific misconduct,” and “misconduct in science,” but these terms are subject to a variety of interpretations. For early discussions about the relationship between fraud and misconduct in science, see Andersen (1988). See also the discussion on “fraud ” and “misconduct” on p. 32447 in Department of Health and Human Services (1989a). Some scientists object to the terms “scientific fraud” or “misconduct in science” because the fabrication and falsification of research results are deceptive acts that are not in themselves science. However, the social, political, and legal framework in which scientists must operate requires that we admit to the possibility of deliberate falsehoods that may masquerade as science. 16. Some institutional policies make intention or deception an explicit part of their definition of misconduct in science, whereas other policies assume, implicitly, that intention is part of the common understanding of actions, such as falsification, fabrication, and plagiarism, that constitute misconduct in science. See, for example, the definitions in the policies for addressing allegations of misconduct in science included in Volume II of this report. 17. Another approach considered by the panel in defining behaviors that violate the integrity of the research process was to deal only with misconduct in science and questionable research practices and to omit “other misconduct” as a category for a framework of definitions. Although the panel chose to focus on behaviors that directly compromise the integrity of the research process, it also wanted to recognize the public dimensions of discussions about misconduct in science. Thus the panel concluded that issues such as conflict of interest, mismanagement of funds, and the harassment of colleagues on the basis of race or gender must necessarily be recognized in a framework of definitions intended to categorize behavior that adversely affects the conduct of scientific research. These forms of “other misconduct” deserve serious and sustained analysis on their own merits, but such an examination was beyond the resources and scope of this particular study. 18. It is possible that some extreme cases of noncontributing authorship may be regarded as misconduct in science because they constitute a form of falsification. These would include only cases in which an individual who has made no identifiable contribution to a research paper is named, or seeks to be named, as a co-author. 19. See Bailar (1986). 20. The fourth report of the NSF inspector general (NSF, 1991a) describes a misconduct case involving tampering with other researchers' experiments. This type of case would not constitute misconduct in science under the panel's definition. An allegation of this type of incident should be addressed under regulations governing vandalism or destruction of property. 21. As noted in Bechtel and Pearson (1985), several leading figures in the scientific community have advocated the “disturbed individual ” theory. For discussions of the impact of reward systems and social controls on deviant behavior in science, see the analysis by Zuckerman (1977). For a historical perspective, see Gaston (1978).

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process 22. The authors concluded that the deviant behavior in these cases, usually faking scientific experiments and data, was displayed by single individuals who acted alone. They observed that many of these individuals held positions of high social status and respectability within their professions and that the scientists involved also made elaborate efforts to conceal their illegitimate behavior. 23. It has been suggested that research physicians whose sole degree is an M.D. have not been adequately exposed to the scientific methods and skills that are the foundation of a Ph.D. program. 24. See Broad and Wade (1982).