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Scientific Principles and Research Practices

Until the past decade, scientists, research institutions, and government agencies relied solely on a system of self-regulation based on shared ethical principles and generally accepted research practices to ensure integrity in the research process. Among the very basic principles that guide scientists, as well as many other scholars, are those expressed as respect for the integrity of knowledge, collegiality, honesty, objectivity, and openness. These principles are at work in the fundamental elements of the scientific method, such as formulating a hypothesis, designing an experiment to test the hypothesis, and collecting and interpreting data. In addition, more particular principles characteristic of specific scientific disciplines influence the methods of observation; the acquisition, storage, management, and sharing of data; the communication of scientific knowledge and information; and the training of younger scientists.1 How these principles are applied varies considerably among the several scientific disciplines, different research organizations, and individual investigators.

The basic and particular principles that guide scientific research practices exist primarily in an unwritten code of ethics. Although some have proposed that these principles should be written down and formalized,2 the principles and traditions of science are, for the most part, conveyed to successive generations of scientists through example, discussion, and informal education. As was pointed out in an early Academy report on responsible conduct of research in the



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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process 2 Scientific Principles and Research Practices Until the past decade, scientists, research institutions, and government agencies relied solely on a system of self-regulation based on shared ethical principles and generally accepted research practices to ensure integrity in the research process. Among the very basic principles that guide scientists, as well as many other scholars, are those expressed as respect for the integrity of knowledge, collegiality, honesty, objectivity, and openness. These principles are at work in the fundamental elements of the scientific method, such as formulating a hypothesis, designing an experiment to test the hypothesis, and collecting and interpreting data. In addition, more particular principles characteristic of specific scientific disciplines influence the methods of observation; the acquisition, storage, management, and sharing of data; the communication of scientific knowledge and information; and the training of younger scientists.1 How these principles are applied varies considerably among the several scientific disciplines, different research organizations, and individual investigators. The basic and particular principles that guide scientific research practices exist primarily in an unwritten code of ethics. Although some have proposed that these principles should be written down and formalized,2 the principles and traditions of science are, for the most part, conveyed to successive generations of scientists through example, discussion, and informal education. As was pointed out in an early Academy report on responsible conduct of research in the

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process health sciences, “a variety of informal and formal practices and procedures currently exist in the academic research environment to assure and maintain the high quality of research conduct” (IOM, 1989a, p. 18). Physicist Richard Feynman invoked the informal approach to communicating the basic principles of science in his 1974 commencement address at the California Institute of Technology (Feynman, 1985): [There is an] idea that we all hope you have learned in studying science in school—we never explicitly say what this is, but just hope that you catch on by all the examples of scientific investigation. It's a kind of scientific integrity, a principle of scientific thought that corresponds to a kind of utter honesty—a kind of leaning over backwards. For example, if you're doing an experiment, you should report everything that you think might make it invalid—not only what you think is right about it; other causes that could possibly explain your results; and things you thought of that you've eliminated by some other experiment, and how they worked—to make sure the other fellow can tell they have been eliminated. Details that could throw doubt on your interpretation must be given, if you know them. You must do the best you can—if you know anything at all wrong, or possibly wrong—to explain it. If you make a theory, for example, and advertise it, or put it out, then you must also put down all the facts that disagree with it, as well as those that agree with it. In summary, the idea is to try to give all the information to help others to judge the value of your contribution, not just the information that leads to judgment in one particular direction or another. (pp. 311-312) Many scholars have noted the implicit nature and informal character of the processes that often guide scientific research practices and inference.3 Research in well-established fields of scientific knowledge, guided by commonly accepted theoretical paradigms and experimental methods, involves few disagreements about what is recognized as sound scientific evidence. Even in a revolutionary scientific field like molecular biology, students and trainees have learned the basic principles governing judgments made in such standardized procedures as cloning a new gene and determining its sequence. In evaluating practices that guide research endeavors, it is important to consider the individual character of scientific fields. Research fields that yield highly replicable results, such as ordinary organic chemical structures, are quite different from fields such as cellular immunology, which are in a much earlier stage of development and accumulate much erroneous or uninterpretable material before the pieces fit together coherently. When a research field is too new or too fragmented to support consensual paradigms or established methods, different scientific practices can emerge.

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process THE NATURE OF SCIENCE In broadest terms, scientists seek a systematic organization of knowledge about the universe and its parts. This knowledge is based on explanatory principles whose verifiable consequences can be tested by independent observers. Science encompasses a large body of evidence collected by repeated observations and experiments. Although its goal is to approach true explanations as closely as possible, its investigators claim no final or permanent explanatory truths. Science changes. It evolves. Verifiable facts always take precedence. Scientists operate within a system designed for continuous testing, where corrections and new findings are announced in refereed scientific publications. The task of systematizing and extending the understanding of the universe is advanced by eliminating disproved ideas and by formulating new tests of others until one emerges as the most probable explanation for any given observed phenomenon. This is called the scientific method. An idea that has not yet been sufficiently tested is called a hypothesis. Different hypotheses are sometimes advanced to explain the same factual evidence. Rigor in the testing of hypotheses is the heart of science, if no verifiable tests can be formulated, the idea is called an ad hoc hypothesis—one that is not fruitful; such hypotheses fail to stimulate research and are unlikely to advance scientific knowledge. A fruitful hypothesis may develop into a theory after substantial observational or experimental support has accumulated. When a hypothesis has survived repeated opportunities for disproof and when competing hypotheses have been eliminated as a result of failure to produce the predicted consequences, that hypothesis may become the accepted theory explaining the original facts. Scientific theories are also predictive. They allow us to anticipate yet unknown phenomena and thus to focus research on more narrowly defined areas. If the results of testing agree with predictions from a theory, the theory is provisionally corroborated. If not, it is proved false and must be either abandoned or modified to account for the inconsistency. Scientific theories, therefore, are accepted only provisionally. It is always possible that a theory that has withstood previous testing may eventually be disproved. But as theories survive more tests, they are regarded with higher levels of confidence. In science, then, facts are determined by observation or measurement of natural or experimental phenomena. A hypothesis is a proposed explanation of those facts. A theory is a hypothesis that has gained wide acceptance because it has survived rigorous investigation of its predictions.

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process . science accommodates, indeed welcomes, new discoveries: its theories change and its activities broaden as new facts come to light or new potentials are recognized. Examples of events changing scientific thought are legion. Truly scientific understanding cannot be attained or even pursued effectively when explanations not derived from or tested by the scientific method are accepted. SOURCE: National Academy of Sciences and National Research Council(1984), pp. 8-11. A well-established discipline can also experience profound changes during periods of new conceptual insights. In these moments, when scientists must cope with shifting concepts, the matter of what counts as scientific evidence can be subject to dispute. Historian Jan Sapp has described the complex interplay between theory and observation that characterizes the operation of scientific judgment in the selection of research data during revolutionary periods of paradigmatic shift (Sapp, 1990, p. 113): What “liberties” scientists are allowed in selecting positive data and omitting conflicting or “messy” data from their reports is not defined by any timeless method. It is a matter of negotiation. It is learned, acquired socially; scientists make judgments about what fellow scientists might expect in order to be convincing. What counts as good evidence may be more or less well-defined after a new discipline or specialty is formed; however, at revolutionary stages in science, when new theories and techniques are being put forward, when standards have yet to be negotiated, scientists are less certain as to what others may require of them to be deemed competent and convincing. Explicit statements of the values and traditions that guide research practice have evolved through the disciplines and have been given in textbooks on scientific methodologies.4 In the past few decades, many scientific and engineering societies representing individual disciplines have also adopted codes of ethics (see Volume II of this report for examples),5 and more recently, a few research institutions have developed guidelines for the conduct of research (see Chapter 6). But the responsibilities of the research community and research institutions in assuring individual compliance with scientific principles, traditions, and codes of ethics are not well defined. In recent

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process years, the absence of formal statements by research institutions of the principles that should guide research conducted by their members has prompted criticism that scientists and their institutions lack a clearly identifiable means to ensure the integrity of the research process. FACTORS AFFECTING THE DEVELOPMENT OF RESEARCH PRACTICES In all of science, but with unequal emphasis in the several disciplines, inquiry proceeds based on observation and experimentation, the exercising of informed judgment, and the development of theory. Research practices are influenced by a variety of factors, including: The general norms of science; The nature of particular scientific disciplines and the traditions of organizing a specific body of scientific knowledge; The example of individual scientists, particularly those who hold positions of authority or respect based on scientific achievements; The policies and procedures of research institutions and funding agencies; and Socially determined expectations. The first three factors have been important in the evolution of modern science. The latter two have acquired more importance in recent times. Norms of Science As members of a professional group, scientists share a set of common values, aspirations, training, and work experiences.6 Scientists are distinguished from other groups by their beliefs about the kinds of relationships that should exist among them, about the obligations incurred by members of their profession, and about their role in society. A set of general norms are imbedded in the methods and the disciplines of science that guide individual, scientists in the organization and performance of their research efforts and that also provide a basis for nonscientists to understand and evaluate the performance of scientists. But there is uncertainty about the extent to which individual scientists adhere to such norms. Most social scientists conclude that all behavior is influenced to some degree by norms that reflect socially or morally supported patterns of preference when alternative courses of action are possible. However, perfect conformity with any rele-

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process vant set of norms is always lacking for a variety of reasons: the existence of competing norms, constraints, and obstacles in organizational or group settings, and personality factors. The strength of these influences, and the circumstances that may affect them, are not well understood. In a classic statement of the importance of scientific norms, Robert Merton specified four norms as essential for the effective functioning of science: communism (by which Merton meant the communal sharing of ideas and findings), universalism, disinterestedness, and organized skepticism (Merton, 1973). Neither Merton nor other sociologists of science have provided solid empirical evidence for the degree of influence of these norms in a representative sample of scientists. In opposition to Merton, a British sociologist of science, Michael Mulkay, has argued that these norms are “ideological” covers for self-interested behavior that reflects status and politics (Mulkay, 1975). And the British physicist and sociologist of science John Ziman, in an article synthesizing critiques of Merton's formulation, has specified a set of structural factors in the bureaucratic and corporate research environment that impede the realization of that particular set of norms: the proprietary nature of research, the local importance and funding of research, the authoritarian role of the research manager, commissioned research, and the required expertise in understanding how to use modern instruments (Ziman, 1990). It is clear that the specific influence of norms on the development of scientific research practices is simply not known and that further study of key determinants is required, both theoretically and empirically. Commonsense views, ideologies, and anecdotes will not support a conclusive appraisal. Individual Scientific Disciplines Science comprises individual disciplines that reflect historical developments and the organization of natural and social phenomena for study. Social scientists may have methods for recording research data that differ from the methods of biologists, and scientists who depend on complex instrumentation may have authorship practices different from those of scientists who work in small groups or carry out field studies. Even within a discipline, experimentalists engage in research practices that differ from the procedures followed by theorists. Disciplines are the “building blocks of science,” and they “designate the theories, problems, procedures, and solutions that are prescribed, proscribed, permitted, and preferred” (Zuckerman, 1988a,

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process p. 520). The disciplines have traditionally provided the vital connections between scientific knowledge and its social organization. Scientific societies and scientific journals, some of which have tens of thousands of members and readers, and the peer review processes used by journals and research sponsors are visible forms of the social organization of the disciplines. The power of the disciplines to shape research practices and standards is derived from their ability to provide a common frame of reference in evaluating the significance of new discoveries and theories in science. It is the members of a discipline, for example, who determine what is “good biology” or “good physics” by examining the implications of new research results. The disciplines' abilities to influence research standards are affected by the subjective quality of peer review and the extent to which factors other than disciplinary quality may affect judgments about scientific achievements. Disciplinary departments rely primarily on informal social and professional controls to promote responsible behavior and to penalize deviant behavior. These controls, such as social ostracism, the denial of letters of support for future employment, and the withholding of research resources, can deter and penalize unprofessional behavior within research institutions.7 Many scientific societies representing individual disciplines have adopted explicit standards in the form of codes of ethics or guidelines governing, for example, the editorial practices of their journals and other publications.8 Many societies have also established procedures for enforcing their standards. In the past decade, the societies' codes of ethics—which historically have been exhortations to uphold high standards of professional behavior —have incorporated specific guidelines relevant to authorship practices, data management, training and mentoring, conflict of interest, reporting research findings, treatment of confidential or proprietary information, and addressing error or misconduct. The Role of Individual Scientists and Research Teams The methods by which individual scientists and students are socialized in the principles and traditions of science are poorly understood. The principles of science and the practices of the disciplines are transmitted by scientists in classroom settings and, perhaps more importantly, in research groups and teams. The social setting of the research group is a strong and valuable characteristic of American science and education. The dynamics of research groups can foster —or inhibit—innovation, creativity, education, and collaboration.

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process One author of a historical study of research groups in the chemical and biochemical sciences has observed that the laboratory director or group leader is the primary determinant of a group's practices (Fruton, 1990). Individuals in positions of authority are visible and are also influential in determining funding and other support for the career paths of their associates and students. Research directors and department chairs, by virtue of personal example, thus can reinforce, or weaken, the power of disciplinary standards and scientific norms to affect research practices. To the extent that the behavior of senior scientists conforms with general expectations for appropriate scientific and disciplinary practice, the research system is coherent and mutually reinforcing. When the behavior of research directors or department chairs diverges from expectations for good practice, however, the expected norms of science become ambiguous, and their effects are thus weakened. Thus personal example and the perceived behavior of role models and leaders in the research community can be powerful stimuli in shaping the research practices of colleagues, associates, and students. The role of individuals in influencing research practices can vary by research field, institution, or time. The standards and expectations for behavior exemplified by scientists who are highly regarded for their technical competence or creative insight may have greater influence than the standards of others. Individual and group behaviors may also be more influential in times of uncertainty and change in science, especially when new scientific theories, paradigms, or institutional relationships are being established. Institutional Policies Universities, independent institutes, and government and industrial research organizations create the environment in which research is done. As the recipients of federal funds and the institutional sponsors of research activities, administrative officers must comply with regulatory and legal requirements that accompany public support. They are required, for example, “to foster a research environment that discourages misconduct in all research and that deals forthrightly with possible misconduct” (DHHS, 1989a, p. 32451). Academic institutions traditionally have relied on their faculty to ensure that appropriate scientific and disciplinary standards are maintained. A few universities and other research institutions have also adopted policies or guidelines to clarify the principles that their members are expected to observe in the conduct of scientific research.9 In addition, as a result of several highly publicized incidents of miscon-

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process duct in science and the subsequent enactment of governmental regulations, most major research institutions have now adopted policies and procedures for handling allegations of misconduct in science. Institutional policies governing research practices can have a powerful effect on research practices if they are commensurate with the norms that apply to a wide spectrum of research investigators. In particular, the process of adopting and implementing strong institutional policies can sensitize the members of those institutions to the potential for ethical problems in their work. Institutional policies can establish explicit standards that institutional officers then have the power to enforce with sanctions and penalties. Institutional policies are limited, however, in their ability to specify the details of every problematic situation, and they can weaken or displace individual professional judgment in such situations. Currently, academic institutions have very few formal policies and programs in specific areas such as authorship, communication and publication, and training and supervision. Government Regulations and Policies Government agencies have developed specific rules and procedures that directly affect research practices in areas such as laboratory safety, the treatment of human and animal research subjects, and the use of toxic or potentially hazardous substances in research. But policies and procedures adopted by some government research agencies to address misconduct in science (see Chapter 5) represent a significant new regulatory development in the relationships between research institutions and government sponsors. The standards and criteria used to monitor institutional compliance with an increasing number of government regulations and policies affecting research practices have been a source of significant disagreement and tension within the research community. In recent years, some government research agencies have also adopted policies and procedures for the treatment of research data and materials in their extramural research programs. For example, the National Science Foundation (NSF) has implemented a data-sharing policy through program management actions, including proposal review and award negotiations and conditions. The NSF policy acknowledges that grantee institutions will “keep principal rights to intellectual property conceived under NSF sponsorship” to encourage appropriate commercialization of the results of research (NSF, 1989b, p. 1). However, the NSF policy emphasizes “that retention of such rights does not reduce the responsibility of researchers and in-

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process stitutions to make results and supporting materials openly accessible ” (p. 1). In seeking to foster data sharing under federal grant awards, the government relies extensively on the scientific traditions of openness and sharing. Research agency officials have observed candidly that if the vast majority of scientists were not so committed to openness and dissemination, government policy might require more aggressive action. But the principles that have traditionally characterized scientific inquiry can be difficult to maintain. For example, NSF staff have commented, “Unless we can arrange real returns or incentives for the original investigator, either in financial support or in professional recognition, another researcher's request for sharing is likely to present itself as ‘hassle'—an unwelcome nuisance and diversion. Therefore, we should hardly be surprised if researchers display some reluctance to share in practice, however much they may declare and genuinely feel devotion to the ideal of open scientific communication ” (NSF, 1989a, p. 4). Social Attitudes and Expectations Research scientists are part of a larger human society that has recently experienced profound changes in attitudes about ethics, morality, and accountability in business, the professions, and government. These attitudes have included greater skepticism of the authority of experts and broader expectations about the need for visible mechanisms to assure proper research practices, especially in areas that affect the public welfare. Social attitudes are also having a more direct influence on research practices as science achieves a more prominent and public role in society. In particular, concern about waste, fraud, and abuse involving government funds has emerged as a factor that now directly influences the practices of the research community. Varying historical and conceptual perspectives also can affect expectations about standards of research practice. For example, some journalists have criticized several prominent scientists, such as Mendel, Newton, and Millikan, because they “cut corners in order to make their theories prevail” (Broad and Wade, 1982, p. 35). The criticism suggests that all scientists at all times, in all phases of their work, should be bound by identical standards. Yet historical studies of the social context in which scientific knowledge has been attained suggest that modern criticism of early scientific work often imposes contemporary standards of objectivity and empiricism that have in fact been developed in an evolutionary manner.10 Holton has argued, for example, that in selecting data for

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process publication, Millikan exercised creative insight in excluding unreliable data resulting from experimental error. But such practices, by today 's standards, would not be acceptable without reporting the justification for omission of recorded data. In the early stages of pioneering studies, particularly when fundamental hypotheses are subject to change, scientists must be free to use creative judgment in deciding which data are truly significant. In such moments, the standards of proof may be quite different from those that apply at stages when confirmation and consensus are sought from peers. Scientists must consistently guard against self-deception, however, particularly when theoretical prejudices tend to overwhelm the skepticism and objectivity basic to experimental practices. In discussing “the theory-ladenness of observations,” Sapp (1990) observed the fundamental paradox that can exist in determining the “appropriateness” of data selection in certain experiments done in the past: scientists often craft their experiments so that the scientific problems and research subjects conform closely with the theory that they expect to verify or refute. Thus, in some cases, their observations may come closer to theoretical expectations than what might be statistically proper. This source of bias may be acceptable when it is influenced by scientific insight and judgment. But political, financial, or other sources of bias can corrupt the process of data selection. In situations where both kinds of influence exist, it is particularly important for scientists to be forthcoming about possible sources of bias in the interpretation of research results. The coupling of science to other social purposes in fostering economic growth and commercial technology requires renewed vigilance to maintain acceptable standards for disclosure and control of financial or competitive conflicts of interest and bias in the research environment. The failure to distinguish between appropriate and inappropriate sources of bias in research practices can lead to erosion of public trust in the autonomy of the research enterprise. RESEARCH PRACTICES In reviewing modern research practices for a range of disciplines, and analyzing factors that could affect the integrity of the research process, the panel focused on the following four areas: Data handling—acquisition, management, and storage; Communication and publication;

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process such persons to prepare review articles or editorial commentaries for publication. Editors can clarify and insist on the confidentiality of review and take appropriate actions against reviewers who violate it. Journals also may require or encourage their authors to deposit reagents and sequence and crystallographic data into appropriate databases or storage facilities.22 Peer Review Peer review is the process by which editors and journals seek to be advised by knowledgeable colleagues about the quality and suitability of a manuscript for publication in a journal. Peer review is also used by funding agencies to seek advice concerning the quality and promise of proposals for research support. The proliferation of research journals and the rewards associated with publication and with obtaining research grants have put substantial stress on the peer review system. Reviewers for journals or research agencies receive privileged information and must exert great care to avoid sharing such information with colleagues or allowing it to enter their own work prematurely. Although the system of peer review is generally effective, it has been suggested that the quality of refereeing has declined, that self-interest has crept into the review process, and that some journal editors and reviewers exert inappropriate influence on the type of work they deem publishable.23 Correction of Errors At some level, all scientific reports, even those that mark profound advances, contain errors of fact or interpretation. In part, such errors reflect uncertainties intrinsic to the research process itself —a hypothesis is formulated, an experimental test is devised, and based on the interpretation of the results, the hypothesis is refined, revised, or discarded. Each step in this cycle is subject to error. For any given report, “correctness” is limited by the following: The precision and accuracy of the measurements. These in turn depend on available technology, the use of proper statistical and analytical methods, and the skills of the investigator. Generality of the experimental system and approach. Studies must often be carried out using “model systems.” In biology, for example, a given phenomenon is examined in only one or a few among millions of organismal species.

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process Experimental design—a product of the background and expertise of the investigator. Interpretation and speculation regarding the significance of the findings—judgments that depend on expert knowledge, experience, and the insightfulness and boldness of the investigator. Viewed in this context, errors are an integral aspect of progress in attaining scientific knowledge. They are consequences of the fact that scientists seek fundamental truths about natural processes of vast complexity. In the best experimental systems, it is common that relatively few variables have been identified and that even fewer can be controlled experimentally. Even when important variables are accounted for, the interpretation of the experimental results may be incorrect and may lead to an erroneous conclusion. Such conclusions are sometimes overturned by the original investigator or by others when new insights from another study prompt a reexamination of older reported data. In addition, however, erroneous information can also reach the scientific literature as a consequence of misconduct in science. What becomes of these errors or incorrect interpretations? Much has been made of the concept that science is “self-correcting”—that errors, whether honest or products of misconduct, will be exposed in future experiments because scientific truth is founded on the principle that results must be verifiable and reproducible. This implies that errors will generally not long confound the direction of thinking or experimentation in actively pursued areas of research. Clearly, published experiments are not routinely replicated precisely by independent investigators. However, each experiment is based on conclusions from prior studies; repeated failure of the experiment eventually calls into question those conclusions and leads to reevaluation of the measurements, generality, design, and interpretation of the earlier work. Thus publication of a scientific report provides an opportunity for the community at large to critique and build on the substance of the report, and serves as one stage at which errors and misinterpretations can be detected and corrected. Each new finding is considered by the community in light of what is already known about the system investigated, and disagreements with established measurements and interpretations must be justified. For example, a particular interpretation of an electrical measurement of a material may implicitly predict the results of an optical experiment. If the reported optical results are in disagreement with the electrical interpretation, then the latter is unlikely to be correct—even though the measurements them-

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process selves were carefully and correctly performed. It is also possible, however, that the contradictory results are themselves incorrect, and this possibility will also be evaluated by the scientists working in the field. It is by this process of examination and reexamination that science advances. The research endeavor can therefore be viewed as a two-tiered process: first, hypotheses are formulated, tested, and modified; second, results and conclusions are reevaluated in the course of additional study. In fact, the two tiers are interrelated, and the goals and traditions of science mandate major responsibilities in both areas for individual investigators. Importantly, the principle of self-correction does not diminish the responsibilities of the investigator in either area. The investigator has a fundamental responsibility to ensure that the reported results can be replicated in his or her laboratory. The scientific community in general adheres strongly to this principle, but practical constraints exist as a result of the availability of specialized instrumentation, research materials, and expert personnel. Other forces, such as competition, commercial interest, funding trends and availability, or pressure to publish may also erode the role of replication as a mechanism for fostering integrity in the research process. The panel is unaware of any quantitative studies of this issue. The process of reevaluating prior findings is closely related to the formulation and testing of hypotheses.24 Indeed, within an individual laboratory, the formulation/testing phase and the reevaluation phase are ideally ongoing interactive processes. In that setting, the precise replication of a prior result commonly serves as a crucial control in attempts to extend the original findings. It is not unusual that experimental flaws or errors of interpretation are revealed as the scope of an investigation deepens and broadens. If new findings or significant questions emerge in the course of a reevaluation that affect the claims of a published report, the investigator is obliged to make public a correction of the erroneous result or to indicate the nature of the questions. Occasionally, this takes the form of a formal published retraction, especially in situations in which a central claim is found to be fundamentally incorrect or irreproducible. More commonly, a somewhat different version of the original experiment, or a revised interpretation of the original result, is published as part of a subsequent report that extends in other ways the initial work. Some concerns have been raised that such “revisions” can sometimes be so subtle and obscure as to be unrecognizable. Such behavior is, at best, a questionable research practice. Clearly, each scientist has a responsibility to foster an environment that en-

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process courages and demands rigorous evaluation and reevaluation of every key finding. Much greater complexity is encountered when an investigator in one research group is unable to confirm the published findings of another. In such situations, precise replication of the original result is commonly not attempted because of the lack of identical reagents, differences in experimental protocols, diverse experimental goals, or differences in personnel. Under these circumstances, attempts to obtain the published result may simply be dropped if the central claim of the original study is not the major focus of the new study. Alternatively, the inability to obtain the original finding may be documented in a paper by the second investigator as part of a challenge to the original claim. In any case, such questions about a published finding usually provoke the initial investigator to attempt to reconfirm the original result, or to pursue additional studies that support and extend the original findings. In accordance with established principles of science, scientists have the responsibility to replicate and reconfirm their results as a normal part of the research process. The cycles of theoretical and methodological formulation, testing, and reevaluation, both within and between laboratories, produce an ongoing process of revision and refinement that corrects errors and strengthens the fabric of research. Research Training and Mentorship The panel defined a mentor as that person directly responsible for the professional development of a research trainee.25 Professional development includes both technical training, such as instruction in the methods of scientific research (e.g., research design, instrument use, and selection of research questions and data), and socialization in basic research practices (e.g., authorship practices and sharing of research data). Positive Aspects of Mentorship The relationship of the mentor and research trainee is usually characterized by extraordinary mutual commitment and personal involvement. A mentor, as a research advisor, is generally expected to supervise the work of the trainee and ensure that the trainee's research is completed in a sound, honest, and timely manner. The ideal mentor challenges the trainee, spurs the trainee to higher scientific achievement, and helps socialize the trainee into the community

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process of scientists by demonstrating and discussing methods and practices that are not well understood. Research mentors thus have complex and diverse roles. Many individuals excel in providing guidance and instruction as well as personal support, and some mentors are resourceful in providing funds and securing professional opportunities for their trainees. The mentoring relationship may also combine elements of other relationships, such as parenting, coaching, and guildmastering. One mentor has written that his “research group is like an extended family or small tribe, dependent on one another, but led by the mentor, who acts as their consultant, critic, judge, advisor, and scientific father” (Cram, 1989, p. 1). Another mentor described as “orphaned graduate students” trainees who had lost their mentors to death, job changes, or in other ways (Sindermann, 1987). Many students come to respect and admire their mentors, who act as role models for their younger colleagues. Difficulties Associated with Mentorship However, the mentoring relationship does not always function properly or even satisfactorily. Almost no literature exists that evaluates which problems are idiosyncratic and which are systemic. However, it is clear that traditional practices in the area of mentorship and training are under stress. In some research fields, for example, concerns are being raised about how the increasing size and diverse composition of research groups affect the quality of the relationship between trainee and mentor. As the size of research laboratories expands, the quality of the training environment is at risk (CGS, 1990a). Large laboratories may provide valuable instrumentation and access to unique research skills and resources as well as an opportunity to work in pioneering fields of science. But as only one contribution to the efforts of a large research team, a graduate student's work may become highly specialized, leading to a narrowing of experience and greater dependency on senior personnel; in a period when the availability of funding may limit research opportunities, laboratory heads may find it necessary to balance research decisions for the good of the team against the individual educational interests of each trainee. Moreover, the demands of obtaining sufficient resources to maintain a laboratory in the contemporary research environment often separate faculty from their trainees. When laboratory heads fail to participate in the everyday workings of the laboratory—even for the most beneficent of reasons, such as finding funds to support young investigators—their inattention may harm their trainees' education.

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process Although the size of a research group can influence the quality of mentorship, the more important issues are the level of supervision received by trainees, the degree of independence that is appropriate for the trainees' experience and interests, and the allocation of credit for achievements that are accomplished by groups composed of individuals with different status. Certain studies involving large groups of 40 to 100 or more are commonly carried out by collaborative or hierarchical arrangements under a single investigator. These factors may affect the ability of research mentors to transmit the methods and ethical principles according to which research should be conducted. Problems also arise when faculty members are not directly rewarded for their graduate teaching or training skills. Although faculty may receive indirect rewards from the contributions of well-trained graduate students to their own research as well as the satisfaction of seeing their students excelling elsewhere, these rewards may not be sufficiently significant in tenure or promotion decisions. When institutional policies fail to recognize and reward the value of good teaching and mentorship, the pressures to maintain stable funding for research teams in a competitive environment can overwhelm the time allocated to teaching and mentorship by a single investigator. The increasing duration of the training period in many research fields is another source of concern, particularly when it prolongs the dependent status of the junior investigator. The formal period of graduate and postdoctoral training varies considerably among fields of study. In 1988, the median time to the doctorate from the baccalaureate degree was 6.5 years (NRC, 1989). The disciplinary median varied: 5.5 years in chemistry; 5.9 years in engineering; 7.1 years in health sciences and in earth, atmospheric, and marine sciences; and 9.0 years in anthropology and sociology.26 Students, research associates, and faculty are currently raising various questions about the rights and obligations of trainees. Sexist behavior by some research directors and other senior scientists is a particular source of concern. Another significant concern is that research trainees may be subject to exploitation because of their subordinate status in the research laboratory, particularly when their income, access to research resources, and future recommendations are dependent on the goodwill of the mentor. Foreign students and postdoctoral fellows may be especially vulnerable, since their immigration status often depends on continuation of a research relationship with the selected mentor. Inequalities between mentor and trainee can exacerbate ordinary conflicts such as the distribution of credit or blame for research error (NAS, 1989). When conflicts arise, the expectations and assumptions

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process that govern authorship practices, ownership of intellectual property, and the giving of references and recommendations are exposed for professional—and even legal—scrutiny (Nelkin, 1984; Weil and Snapper, 1989). Making Mentorship Better Ideally, mentors and trainees should select each other with an eye toward scientific merit, intellectual and personal compatibility, and other relevant factors. But this situation operates only under conditions of freely available information and unconstrained choice —conditions that usually do not exist in academic research groups. The trainee may choose to work with a faculty member based solely on criteria of patronage, perceived influence, or ability to provide financial support. Good mentors may be well known and highly regarded within their research communities and institutions. Unfortunately, individuals who exploit the mentorship relationship may be less visible. Poor mentorship practices may be self-correcting over time, if students can detect and avoid research groups characterized by disturbing practices. However, individual trainees who experience abusive relationships with a mentor may discover only too late that the practices that constitute the abuse were well known but were not disclosed to new initiates. It is common practice for a graduate student to be supervised not only by an individual mentor but also by a committee that represents the graduate department or research field of the student. However, departmental oversight is rare for the postdoctoral research fellow. In order to foster good mentorship practices for all research trainees, many groups and institutions have taken steps to clarify the nature of individual and institutional responsibilities in the mentor–trainee relationship.27 FINDINGS AND CONCLUSIONS The self-regulatory system that characterizes the research process has evolved from a diverse set of principles, traditions, standards, and customs transmitted from senior scientists, research directors, and department chairs to younger scientists by example, discussion, and informal education. The principles of honesty, collegiality, respect for others, and commitment to dissemination, critical evaluation, and rigorous training are characteristic of all the sciences. Methods and techniques of experimentation, styles of communicating findings,

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process the relationship between theory and experimentation, and laboratory groupings for research and for training vary with the particular scientific disciplines. Within those disciplines, practices combine the general with the specific. Ideally, research practices reflect the values of the wider research community and also embody the practical skills needed to conduct scientific research. Practicing scientists are guided by the principles of science and the standard practices of their particular scientific discipline as well as their personal moral principles. But conflicts are inherent among these principles. For example, loyalty to one's group of colleagues can be in conflict with the need to correct or report an abuse of scientific practice on the part of a member of that group. Because scientists and the achievements of science have earned the respect of society at large, the behavior of scientists must accord not only with the expectations of scientific colleagues, but also with those of a larger community. As science becomes more closely linked to economic and political objectives, the processes by which scientists formulate and adhere to responsible research practices will be subject to increasing public scrutiny. This is one reason for scientists and research institutions to clarify and strengthen the methods by which they foster responsible research practices. Accordingly, the panel emphasizes the following conclusions: The panel believes that the existing self-regulatory system in science is sound. But modifications are necessary to foster integrity in a changing research environment, to handle cases of misconduct in science, and to discourage questionable research practices. Individual scientists have a fundamental responsibility to ensure that their results are reproducible, that their research is reported thoroughly enough so that results are reproducible, and that significant errors are corrected when they are recognized. Editors of scientific journals share these last two responsibilities. Research mentors, laboratory directors, department heads, and senior faculty are responsible for defining, explaining, exemplifying, and requiring adherence to the value systems of their institutions. The neglect of sound training in a mentor's laboratory will over time compromise the integrity of the research process. Administrative officials within the research institution also bear responsibility for ensuring that good scientific practices are observed in units of appropriate jurisdiction and that balanced reward systems appropriately recognize research quality, integrity, teaching, and mentorship. Adherence to scientific principles and disciplinary standards is at the root of a vital and productive research environment.

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process At present, scientific principles are passed on to trainees primarily by example and discussion, including training in customary practices. Most research institutions do not have explicit programs of instruction and discussion to foster responsible research practices, but the communication of values and traditions is critical to fostering responsible research practices and detering misconduct in science. Efforts to foster responsible research practices in areas such as data handling, communication and publication, and research training and mentorship deserve encouragement by the entire research community. Problems have also developed in these areas that require explicit attention and correction by scientists and their institutions. If not properly resolved, these problems may weaken the integrity of the research process. NOTES 1. See, for example, Kuyper (1991). 2. See, for example, the proposal by Pigman and Carmichael (1950). 3. See, for example, Holton (1988) and Ravetz (1971). 4. Several excellent books on experimental design and statistical methods are available. See, for example, Wilson (1952) and Beveridge (1957). 5. For a somewhat dated review of codes of ethics adopted by the scientific and engineering societies, see Chalk et al. (1981). 6. The discussion in this section is derived from Mark Frankel's background paper, “Professional Societies and Responsible Research Conduct,” included in Volume II of this report. 7. For a broader discussion on this point, see Zuckerman (1977). 8. For a full discussion of the roles of scientific societies in fostering responsible research practices, see the background paper prepared by Mark Frankel, “Professional Societies and Responsible Research Conduct,” in Volume II of this report. 9. Selected examples of academic research conduct policies and guidelines are included in Volume II of this report. 10. See, for example, Holton's response to the criticisms of Millikan in Chapter 12 of Thematic Origins of Scientific Thought (Holton, 1988). See also Holton (1978). 11. See, for example, responses to the Proceedings of the National Academy of Sciences action against Friedman: Hamilton (1990) and Abelson et al. (1990). See also the discussion in Bailar et al. (1990). 12. Much of the discussion in this section is derived from a background paper, “Reflections on the Current State of Data and Reagent Exchange Among Biomedical Researchers,” prepared by Robert Weinberg and included in Volume II of this report. 13. See, for example, Culliton (1990) and Bradshaw et al. (1990). For the impact of the inability to provide corroborating data or witnesses, also see Ross et al. (1989). 14. See, for example, Rennie (1989) and Cassidy and Shamoo (1989). 15. See, for example, the discussion on random data audits in Institute of Medicine (1989a), pp. 26-27. 16. For a full discussion of the practices and policies that govern authorship in the biological sciences, see Bailar et al. (1990).

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process 17. Note that these general guidelines exclude the provision of reagents or facilities or the supervision of research as a criteria of authorship. 18. A full discussion of problematic practices in authorship is included in Bailar et al. (1990). A controversial review of the responsibilities of co-authors is presented by Stewart and Feder (1987). 19. In the past, scientific papers often included a special note by a named researcher, not a co-author of the paper, who described, for example, a particular substance or procedure in a footnote or appendix. This practice seems to.have been abandoned for reasons that are not well understood. 20. Martin et al. (1969), as cited in Sigma Xi (1986), p. 41. 21. Huth (1988) suggests a “notice of fraud or notice of suspected fraud” issued by the journal editor to call attention to the controversy (p. 38). Angell (1983) advocates closer coordination between institutions and editors when institutions have ascertained misconduct. 22. Such facilities include Cambridge Crystallographic Data Base, GenBank at Los Alamos National Laboratory, the American Type Culture Collection, and the Protein Data Bank at Brookhaven National Laboratory. Deposition is important for data that cannot be directly printed because of large volume. 23. For more complete discussions of peer review in the wider context, see, for example, Cole et al. (1977) and Chubin and Hackett (1990). 24. The strength of theories as sources of the formulation of scientific laws and predictive power varies among different fields of science. For example, theories derived from observations in the field of evolutionary biology lack a great deal of predictive power. The role of chance in mutation and natural selection is great, and the future directions that evolution may take are essentially impossible to predict. Theory has enormous power for clarifying understanding of how evolution has occurred and for making sense of detailed data, but its predictive power in this field is very limited. See, for example, Mayr (1982, 1988). 25. Much of the discussion on mentorship is derived from a background paper prepared for the panel by David Guston. A copy of the full paper, “Mentorship and the Research Training Experience,” is included in Volume II of this report. 26. Although the time to the doctorate is increasing, there is some evidence that the magnitude of the increase may be affected by the organization of the cohort chosen for study. In the humanities, the increased time to the doctorate is not as large if one chooses as an organizational base the year in which the baccalaureate was received by Ph.D. recipients, rather than the year in which the Ph.D. was completed; see Bowen et al. (1991). 27. Some universities have written guidelines for the supervision or mentorship of trainees as part of their institutional research policy guidelines (see, for example, the guidelines adopted by Harvard University and the University of Michigan that are included in Volume II of this report). Other groups or institutions have written “guidelines ” (IOM, 1989a; NIH, 1990), “checklists” (CGS, 1990a), and statements of “areas of concern” and suggested “devices” (CGS, 1990c). The guidelines often affirm the need for regular, personal interaction between the mentor and the trainee. They indicate that mentors may need to limit the size of their laboratories so that they are able to interact directly and frequently with all of their trainees. Although there are many ways to ensure responsible mentorship, methods that provide continuous feedback, whether through formal or informal mechanisms, are apt to be the most successful (CGS, 1990a). Departmental mentorship awards (comparable to teaching or research prizes) can recognize, encourage, and enhance the

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process mentoring relationship. For other discussions on mentorship, see the paper by David Guston in Volume II of this report. One group convened by the Institute of Medicine has suggested “that the university has a responsibility to ensure that the size of a research unit does not outstrip the mentor's ability to maintain adequate supervision” (IOM, 1989a, p. 85). Others have noted that although it may be desirable to limit the number of trainees assigned to a senior investigator, there is insufficient information at this time to suggest that numbers alone significantly affect the quality of research supervision (IOM, 1989a, p. 33).