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Executive Summary The pursuit and diffusion of knowledge enjoy a place of distinction in American culture, and the public expects to reap considerable benefit from the creative and innovative contributions of scientists. Most Ameri- cans have a positive attitude toward science and technology and are will- ing to demonstrate their support through public investments in science and research institutions. Public funding is based on the principle that the public good is advanced by science conducted in the interest of humanity. Such support is qualified, however. The public will support science only if it can trust the scientists and the institutions that conduct research. Major social institutions, including research institutions, are expected to be accountable to the public. Fostering an environment that promotes integrity in the conduct of research is an important part of that account- ability. As a consequence, it is more important than ever that individual scientists and their institutions periodically assess the values and profes- sional practices that guide their research as well as their efforts to perform their work with integrity. Considerable effort has been devoted to the task of defining research misconduct and elaborating methods for investigating allegations of mis- conduct. Much less attention has been devoted, however, to the task of fostering a research environment that promotes integrity. This report fo- cuses on the research environment and attempts to define and describe those elements that enable and encourage unique individuals, regardless of their role in the research organization or their backgrounds on entry, to act with integrity. Although integrity and misconduct are related, the 1
2 INTEGRITY IN SCIENTIFIC RESEARCH focus of this report is on integrity. The Institute of Medicine (IOM) Com- mittee on Assessing Integrity in Research Environments, which prepared this report, does not discuss or draw conclusions about current or pro- posed regulations or definitions relating to misconduct. The committeeâs goal was to define the desired outcomes and set forth a set of initiatives that it believes will enhance integrity in the research environment. The committee considered approaches that can be used to promote integrity and methods that can be used to assess the effectiveness of those efforts. The majority of these approaches and methods can and should be initi- ated as soon as feasible and administered by research institutions them- selves so that government regulation will not be required. CHARGE TO THE COMMITTEE In January 2001, IOM, in collaboration with the National Research Councilâs Division on Earth and Life Studies, formed the Committee on Assessing Integrity in Research Environments, in response to a request from the Office of Research Integrity (ORI) of the U.S. Department of Health and Human Service (DHHS). In general, the committee was charged with addressing the need of DHHS to track the state of integrity in the research environment. More specifically, the committee was asked to do the following: 1. define the concept âresearch integrityâ; 2. describe and define the concept âresearch environmentâ; 3. identify elements of the research environment that promote re- search integrity; 4. indicate how the elements may be measured; 5. suggest appropriate methodology for collecting the data; 6. cite appropriate outcome measures; 7. make recommendations regarding the adoption and implementa- tion by research institutions, government agencies, scientific societies, and others (as appropriate) of those elements of the research environment identified to promote integrity in research; and 8. convene a public meeting to discuss the IOM report, its recommen- dations, and potential strategies for their implementation. To respond to the charge, the committee explored various data sources in its effort to provide ORI with a means for tracking the state of integrity in the research environment. In addition to reviewing the pro- fessional literature, the committee also reviewed numerous reports, regu- lations, and guidelines of the federal government and articles and editori-
EXECUTIVE SUMMARY 3 als in the popular press. The committee invited experts to make public presentations, commissioned background papers, and sought additional technical assistance from knowledgeable individuals. OVERARCHING CONCLUSIONS Several overarching conclusions emerged as the committee addressed DHHSâs need to develop means for assessing and tracking the state of integrity in the research environment: â¢ Attention to issues of integrity in scientific research is very impor- tant to the public, scientists, the institutions in which they work, and the scientific enterprise itself. â¢ No established measures for assessing integrity in the research environment exist. â¢ Promulgation of and adherence to policies and procedures are nec- essary, but they are not sufficient means to ensure the responsible con- duct of research. â¢ There is a lack of evidence to definitively support any one way to approach the problem of promoting and evaluating research integrity. â¢ Education in the responsible conduct of research is critical, but if not done appropriately and in a creative way, then education is likely to be of only modest help and may be ineffective. â¢ Institutional self-assessment is one promising approach to assess- ing and continually improving integrity in research. The committee found that existing data are insufficient to enable it to draw definitive conclusions as to which elements of the research environ- ment promote integrity. The elements discussed in the report appear to be associated with integrity in research, but the specific contribution of each element remains poorly defined. Empirical studies evaluating the ethical climate before and after implementation of specific policies or practices are lacking. Because of the limited empirical data on factors influencing respon- sible conduct in the scientific environment, the committee drew on more general theory (e.g., theories of organizational behavior, ethical decision making, and adult learning) to formulate the suggestions presented in the report. The findings and conclusions are based on the committeeâs collec- tive knowledge and experience after its review of the literature in the science and business arenas as well as its discussions with experts who presented talks at the committeeâs open meetings.
4 INTEGRITY IN SCIENTIFIC RESEARCH FINDINGS AND RECOMMENDATIONS Integrity in Research Integrity in research is essential for maintaining scientific excellence and for keeping the publicâs trust. Integrity characterizes both individual researchers and the institutions in which they work. The concept of integ- rity in research cannot, however, be reduced to a one-line definition. For a scientist, integrity embodies above all the individualâs commitment to intellectual honesty and personal responsibility. It is an aspect of moral character and experience. For an institution, it is a commitment to creat- ing an environment that promotes responsible conduct by embracing stan- dards of excellence, trustworthiness, and lawfulness and then assessing whether researchers and administrators perceive that an environment with high levels of integrity has been created. Many practices are likely to promote responsible conduct (see Box 1). Individuals and institutions should use these practices with the goal of fostering a culture in which high ethical standards are the norm, ongoing professional development is encouraged, and public confidence in the scientific enterprise is preserved. The Research Environment The research environment changes continually, and these changes influence the culture and conduct of research. As with any system being scientifically examined, the research environment itself contains variables and constants. The most unpredictable and influential variable is the indi- vidual scientist. The human contribution to the research environment is greatly shaped by each individualâs professional integrity, which in turn is influenced by that individualâs educational background and cultural and ethical upbringing and the resulting values and attitudes that con- tribute to identity formation, unique personality traits, and ethical deci- sion-making abilities. Since each individual researcher brings unique qualities to the re- search environment, the constants must come from the environment it- self. Research institutions should consistently and effectively provide training and education, policies and procedures, and tools and support systems. Institutional expectations should be unambiguous, and the con- sequences of oneâs conduct should be clear. Institutional leaders should set the tone for the institutions with their own actions. Those in leadership positions should explicitly and actively endorse, and participate in, activi- ties that foster responsible conduct of research. Anyone needing assis- tance should have ready access to knowledgeable leaders and should be able to seek help and advice without fear of retribution. Institutions re-
EXECUTIVE SUMMARY 5 BOX 1 Integrity in Research Individual Level For the individual scientist, integrity embodies above all a commitment to intel- lectual honesty and personal responsibility for oneâs actions and to a range of practices that characterize the responsible conduct of research, including â¢ intellectual honesty in proposing, performing, and reporting research; â¢ accuracy in representing contributions to research proposals and reports; â¢ fairness in peer review; â¢ collegiality in scientific interactions, including communications and sharing of resources; â¢ transparency in conflicts of interest or potential conflicts of interest; â¢ protection of human subjects in the conduct of research; â¢ humane care of animals in the conduct of research; and â¢ adherence to the mutual responsibilities between investigators and their research teams. Institutional Level Institutions seeking to create an environment that promotes responsible con- duct by individual scientists and that fosters integrity must establish and continu- ously monitor structures, processes, policies, and procedures that â¢ provide leadership in support of responsible conduct of research; â¢ encourage respect for everyone involved in the research enterprise; â¢ promote productive interactions between trainees and mentors; â¢ advocate adherence to the rules regarding all aspects of the conduct of research, especially research involving human participants and animals; â¢ anticipate, reveal, and manage individual and institutional conflicts of interest; â¢ arrange timely and thorough inquiries and investigations of allegations of scientific misconduct and apply appropriate administrative sanctions; â¢ offer educational opportunities pertaining to integrity in the conduct of re- search; and â¢ monitor and evaluate the institutional environment supporting integrity in the conduct of research and use this knowledge for continuous quality improvement. quire support mechanisms, such as ombudspersons, that research team members can turn to with concerns about integrity, including reporting suspected misconduct. The committee found no comprehensive body of research or writing that can guide the development of hypotheses regarding the relationships
6 INTEGRITY IN SCIENTIFIC RESEARCH between the research environment and the responsible conduct of re- search. Thus, the committee drew on more general theoretical and re- search literature to inform its discussion. Relevant literature was found in the areas of organizational behavior and processes, ethical cultures and climates, moral development, theories of adult learning and educational practices, and professional socialization. Viewing the research environment as an open-systems model,1 which is often used in general organizational and administrative theory, enables one to hypothesize how various components affect integrity in research (Figure 1). Inputs of funds and other resources can influence behavior both positively and negatively. The organizational structure and processes that typify the mission and activities of the organization can either pro- mote or detract from the responsible conduct of research. The culture and climate that are unique to an organization both promote and perpetuate certain behaviors. Finally, the external environment (Figure 2), over which individuals and often institutions have little control, can affect behavior and alter institutional integrity for better or for worse. Fostering Integrity Institutions should develop a multifaceted approach to promoting integrity in research appropriate to their research environments. At present, research organizations rely on a variety of methods. They estab- lish organizational components to comply with regulations imposed by an external environment; they offer educational programs to teach the elements of the responsible conduct of research; and they implement poli- cies and procedures that delineate the normative practices of responsible conduct of research and establish their criteria for rewards and recogni- tion. In addition, organizations engage in activities that help establish an internal climate and organizational culture that are either supportive of or ambivalent toward the responsible conduct of research. Of course, these various approaches are not mutually exclusive, nor should they be. A number of programs and activities, integrated across organizational lev- els, should be in place in order to maximize the impact on the research environment and support the responsible conduct of research. 1The open-systems model depicts the various elements of a social organization, including the external environment, the organizational divisions or departments, the individuals com- prising those divisions, and the reciprocal influences between the various organizational elements and the external environment (see Chapter 3).
External Environment Resear ch Or ganizat ion Or ganizat ional St r uct ur e -Policies, procedures, codes -Roles and responsibilities Out put s/ Out com es I nput s/ Resour ces -Decision-making practices -Missions and goals, objectives, strategies Funding -Technology Resear ch-Relat ed Act ivit ies -Level and source -Quality/quantity of activity Hum an Resour ces Or ganizat ional Pr ocesses -Leadership Resear ch I nt egr it y -Training and experience -Competition -Knowledge of and attitudes toward -Sociocultural and -Supervision ethical standards psychological background -Communication -Behavioral adherence to standards -Socialization -Organizational learning Et hical Cult ur e and Clim at e Feedback FIGURE 1 Open-systems model of the research organization. This model depicts the internal environmental elements of a research organization (white oval), showing the relationships among the inputs that provide resources for organizational func- tions, the structures and processes that define an organizationâs operation, and the outputs and outcomes of an organizationâs activities that are carried out by individual scientists, research groups or teams, and other research-related programs. All of these elements function within the context of an organizationâs culture and climate. The internal environment is affected by the external environment (shaded area; see Figure 2 for further detail). The system is dynamic, and, as indicated by the feedback arrow, outputs and outcomes affect future inputs and resources. 7
8 General Sociocultural, Political, and Economic Environment Funding Government for regulation scientific work Research Organizations Journal policies and Human practices resources/ job market Policies and practices of scientific societies FIGURE 2 Environmental influences on integrity in research that are external to research organizations. The external-task environment includes all of the organizations and conditions that are directly related to an organizationâs main operations and technologies. The double arrows depict the interrelatedness between the research organization and the various external influenc- es (unshaded circles) that are hypothesized to have an impact on integrity in research. The general environment has a more indirect impact on an organization. The systems and subsystems of the external-task environment are embedded within the larger, general sociocultural, political, and economic environment (shaded area). Although not specifically shown in this figure, it is important to recognize that relationships exist between and among the elements within the external environment.
EXECUTIVE SUMMARY 9 Promoting Integrity in Research through Education The provision of instruction in the responsible conduct of research need not be driven by federal mandates, for it derives from a premise fundamental to doing science: the responsible conduct of research is not distinct from research; on the contrary, competency in research encom- passes the responsible conduct of that research and the capacity for ethical decision making. For lasting change in ethical climate to occur, changes in curriculum content alone are not sufficient. Attention also needs to focus on how education in the responsible conduct of research is conducted. Indeed, integrity in research should be developed within the context of other aspects of an overall research education program. The committee believes that doing so will be the best way to accomplish the following five objectives for graduate students and postdoctoral fellows: 1. emphasize responsible conduct as central to conducting good science; 2. maximize the likelihood that education in the responsible conduct of research influences individuals and institutions rather than merely sat- isfies an item on a checkoff list necessary for that institution; 3. impart essential rules and guidelines regarding responsible con- duct of research in oneâs discipline and profession in context; 4. enable participants in the educational programs to develop abili- ties that will help them to effectively manage concerns related to respon- sible conduct of research that cannot be anticipated but that are certain to arise in the future; and 5. verify that the first four objectives have been met. Teaching of the responsible conduct of research presents a special challenge because it requires a synthesis of ethics and science. When sci- entists and ethicists collaborate in the design and implementation of learn- ing experiences, students come to appreciate the complexity of problems that arise in the practice of science. Furthermore, when instruction re- quires the application of norms (and the ethical theories that support them), values, and rules and regulations to the practical problems that arise in the day-to-day practice of science, learning is more likely to last and to transfer to new situations. It follows, then, that instruction in the responsible conduct of research by a team of facultyâor by a faculty member with expertise in both ethics and scienceâis optimal. When fac- ulty take time from their scholarly work to provide practical instruction that draws on expertise from related fields, they demonstrate the impor- tance of this educational task and its relevance to the practice of science. Research advisers play a central role in the education of their trainees in
10 INTEGRITY IN SCIENTIFIC RESEARCH the responsible conduct of research, not only by what they teach, but also by their own conduct. The impact of educational efforts may be weak- ened if what is taught is not actively practiced by supervisors and admin- istrators. It should be noted that this report emphasizes the education of stu- dents and postdoctoral fellows, not because the committee believes that this is where a problem exists but, rather, because this is where the future lies. Thus, the model for providing instruction in the responsible conduct of research is taken from traditional programs for teaching students what is necessary for their performance as researchers: (1) start as soon as the students arrive; (2) make the instruction in this area part of everything they do, placing the education in the context of the research instead of making it a separate entity; (3) move from the simple to the complex; and (4) assess student competency. In this way, there is no mistaking the message: communicating well, obtaining employment and research grants, excelling in teaching and mentoring, engaging in ethical decision making, and behaving responsibly are at the core of being a researcher, in addition to sophisticated use of knowledge to plan and execute research. Evaluation by Self-Assessment To optimize the institutional approach to fostering the responsible conduct of research, it is critical that organizations simultaneously imple- ment processes for evaluating their efforts, thereby establishing a basis for organizational learning and continuous quality improvement. Evalua- tion can be approached in a variety of ways. One way is to rely on exter- nal evaluators to determine compliance with regulatory controls. Another is to rely on a system of performance-based assessments that are initiated and implemented internally. Such assessments can also be used to meet the accountability requirements of outside funding and government sources. In addition, peer reviewers may be used in institutional self- assessment processes; assessments done by peer reviewers may or may not be associated with accreditation by external organizations. Although the regulatory approach has led to some successes, the com- mittee felt that a regulatory approach to fostering integrity in research has some important limitations. Such an approach increases the bureaucrati- zation of science and requires documentation that institutions may find burdensome. Regulations often emphasize the areas of common agree- ment and reduce important concerns to rules and procedures, rather than foster a deep understanding of the ethical issues involved and the variety of sophisticated approaches available to address those issues. The adop- tion of new regulations and the creation of institutional and governmen- tal oversight offices increase the cost of doing science and add to the
EXECUTIVE SUMMARY 11 administrative costs of research centers without necessarily creating a commensurate benefit. In addition, once regulations are adopted, it is difficult to change them. Regulatory frameworks reduce the flexibility of institutions and individuals to respond to research opportunities. At this time, neither the executive nor legislative branches of govern- ment has established a regulatory framework to foster integrity in scien- tific research, and the committee does not believe such a framework would be desirable or comparable to the system that has been put into place to address misconduct in science or the use of institutional review boards. Rather, the committee endorses the principle of self-assessment as a com- ponent of formal performance appraisals of academic departments and of individual faculty members. The committee proposes that research institutions work with estab- lished accrediting bodies to develop mechanisms for incorporating insti- tutional self-study for integrity in research into the overall accreditation process. The processes of established accrediting bodies are expected to be more effective and more cost-efficient than those of a new entity, whose establishment would be seen as one more administrative burden, and thus would encourage cynicism. If institutional cultures are to be changed, then both the call for change and its implementation must come from research institutions. An impor- tant next step will be for universities and university associations, working together, to acknowledge the importance of conducting research and re- search education in an environment of high integrity and developing an evaluative process based on self-study. Methods and Measures Gaining the methodological expertise needed to carry out research on the relationship between the research environment and integrity in re- search will require the development and validation of measures, particu- larly indicators that are observable and quantifiable within the research environment. For example, existing means of conceptualizing and mea- suring the organizational climate will have to be adapted to this specific context of the assessment of the ethical climate within the research envi- ronment. Furthermore, to measure the effectiveness of efforts related to foster- ing integrity in the research environment, specific outcomes must be iden- tified and defined within this context. Next, either new instruments must be designed and validated, or existing outcome measures must be modi- fied and validated for the assessment of the ethical climate within the research environment. This development of reliable and valid measures will take considerable time and effort, but it is a necessary step in a re-
12 INTEGRITY IN SCIENTIFIC RESEARCH BOX 2 Recommendations Future Research RECOMMENDATION 1: Funding agencies should establish research grant programs to identify, measure, and assess those factors that influence in- tegrity in research. â¢ The Office of Research Integrity should broaden its current support for re- search to fund studies that explore new approaches to monitoring and evaluating the integrity of the research environment. â¢ Federal agencies and foundations that fund extramural research should in- clude in their funding portfolios support for research designed to assess the factors that promote integrity in research across different disciplines and institutions. â¢ Federal agencies and foundations should fund research designed to as- sess the relationship between various elements of the research environment and integrity in research, including similarities and differences across disciplines and institutions. Institutional Commitment to Integrity RECOMMENDATION 2: Each research institution should develop and imple- ment a comprehensive program designed to promote integrity in research, using multiple approaches adapted to the specific environments within each institution. â¢ It is incumbent upon institutions to take a more active role in the develop- ment and maintenance of climate and culture within their research environments that promote and support the responsible conduct of research. â¢ The factors within the research environment that institutions should consid- er in the development and maintenance of such a culture and climate include, but are not limited to, supportive leadership, appropriate policies and procedures, ef- fective educational programs, and evaluation of any efforts devoted to fostering integrity in research. â¢ Federal research agencies and private foundations should work with edu- cational institutions to develop funding mechanisms to provide support for pro- grams that promote the responsible conduct of research. Education RECOMMENDATION 3: Institutions should implement effective educational programs that enhance the responsible conduct of research. â¢ Educational programs should be built around the development of abilities that give rise to the responsible conduct of research. â¢ The design of programs should be guided by basic principles of adult learning. â¢ Integrity in research should be developed within the context of other rele- vant aspects of an overall research education program, and instruction in the re-
EXECUTIVE SUMMARY 13 sponsible conduct of research should be provided by faculty who are actively en- gaged in research related to that of the trainees. Institutional Self-Assessment RECOMMENDATION 4: Research institutions should evaluate and enhance the integrity of their research environments using a process of self-assess- ment and external peer review in an ongoing process that provides input for continuous quality improvement. â¢ The importance of external peer review of the institution cannot be overem- phasized. Such a process will help to ensure the credibility of the review, provide suggestions for improvement of the process, and increase public confidence in the research enterprise. â¢ Effective self-assessment will require the development and validation of evaluation instruments and measures. â¢ Assessment of integrity and the factors associated with it (including educa- tional efforts) should occur at all levels within the institutionâfor example, at the institutional level, the research unit level, and the individual level. At the individual level, assessment of integrity should be an integral part of regular performance appraisals. â¢ As with any new program, a phase-in or pilot testing period is to be expect- ed, and the assessment and accreditation process should be continually modified as needed based on results of these early actions. RECOMMENDATION 5: Institutional self-assessment of integrity in research should be part of existing accreditation processes whenever possible. â¢ Accreditation provides established procedures, including external peer re- view, that can be modified to incorporate assessments of efforts related to integrity in research within an institution. â¢ Entities that currently accredit educational programs at institutions where research is conducted would be the bodies to also review the process and the outcome data from the institutionâs self-assessment of its climate for promotion of integrity in research. These include the six regional organizations that accredit institutions of higher education in the United States, as well as organizations that accredit professional schools or professional educational programs. â¢ Federal research agencies and private foundations should support efforts to integrate self-assessment of the research environment into existing accredita- tion processes, and they also should fund research into the effectiveness of such efforts. RECOMMENDATION 6: The Office of Research Integrity should establish and maintain a public database of institutions that are actively pursuing or em- ploying institutional self-assessment and external peer-review of integrity in research. â¢ This database should initially include institutions that receive funding for, or are actively engaged in, the development and validation of self-assessment instruments.
14 INTEGRITY IN SCIENTIFIC RESEARCH search process leading to a better understanding of the relationship be- tween the research environment and integrity in research. Note that two distinct types of measures should be considered: measures that assess the integrity of the institution with respect to the conduct of research and measures that assess aspects of the integrity of the individual. Existing methods and measures, examples of which are described in Appendix B, provide models that could be adapted to evaluate the factors of culture and climate that promote integrity in research. Appendix B also provides examples of measures that have been used successfully to assess learning outcomes in professional ethics programs and that could be adapted to the research environment. On the basis of the available infor- mation, the committee describes practices that promote the responsible conduct of research and presents a model that captures the key compo- nents of the research environment and their interactivity. This is rela- tively new territory, however, that needs to be examined systematically with greater precision. Focusing on the Future Research institutions bear the primary burden of promoting and monitoring the responsible conduct of research. They must consistently provide members of research teams with the resources they need to con- duct research responsibly. These resources include leadership and ex- ample, training and education, and policies and procedures, as well as tools and support systems. Institutional behavior should be exemplary. What is expected of individuals should be unambiguous, and the conse- quences of oneâs conduct should be clear. Anyone needing assistance should have ready access to knowledgeable leaders. Individuals should be able to seek assistance without fear of retribution. Research institu- tions, accrediting agencies, and public and private organizations that fund or otherwise support research should collaborate to establish and ensure the integrity of the scientific research enterprise. The collection of specific empirical data on integrity in scientific research is essential to help insti- tutions determine the effectiveness of their efforts to foster a research climate that promotes integrity. Such data will also aid institutions in the development of better programs and policies in the future. Government oversight of scientific research is important, but such oversight, often in the form of administrative rules, typically stipulates what cannot be done; it rarely prescribes optimal performance. In es- sence, government rules define the floor of expected behavior. More, how- ever, should be expected from scientists when it comes to the responsible conduct of research. By appealing to the consciences of individual scien- tists, the scientific community as a whole should seek to evoke the highest
EXECUTIVE SUMMARY 15 possible standards of research behavior. When institutions committed to promoting integrity in research support those standards, the likelihood of creating an environment that promotes the responsible conduct of re- search is greatly enhanced. It is essential that institutions foster a culture of integrity in which students and trainees, as well as senior researchers and administrators, have an understanding of and commitment to integ- rity in research.