1
Introduction

“Rather fail with honor than succeed by fraud.”

Sophocles

“Most people say that it is the intellect which makes a great scientist. They are wrong: it is character.”

Albert Einstein

Most Americans have a positive attitude toward science and technology (NSF, 2000b), and public confidence in consumer products is boosted by claims that they are “scientifically tested” or “scientifically proven.” Such support is qualified, however. The public will support science only if it can trust the people and the institutions that conduct research. Major social institutions, including research institutions, are expected to be accountable to the public (Grinnell, 1999a; IOM, 2001; Yarborough and Sharp, 2002). Fostering an environment that promotes integrity in the conduct of research is an important part of that accountability.

Because of the complexity, variability, and nature of scientific inquiry, the concept of integrity in research can be elusive, and its value cannot be easily assessed or measured. From the outside looking in, science is a quest for truth about the natural world. In reality, scientific “truth” is always tentative; and the means for testing it involve repetition, disclosure, sharing of information, and competition. Scientists understand that “truth” and “fact” are based on the weight of scientific evidence. “Facts” hold only until they are successfully challenged by additional evidence, after which they may be modified or interpreted differently. Research usually proceeds from a mélange of hypotheses and results based on previous experiments and knowledge. New results may support the proposed hypothesis, but they can never prove a general hypothesis or theory.

In this progression toward the truth, researchers strive to be objective; but prior knowledge, opinion, and personal biases can influence the selec-



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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct 1 Introduction “Rather fail with honor than succeed by fraud.” Sophocles “Most people say that it is the intellect which makes a great scientist. They are wrong: it is character.” Albert Einstein Most Americans have a positive attitude toward science and technology (NSF, 2000b), and public confidence in consumer products is boosted by claims that they are “scientifically tested” or “scientifically proven.” Such support is qualified, however. The public will support science only if it can trust the people and the institutions that conduct research. Major social institutions, including research institutions, are expected to be accountable to the public (Grinnell, 1999a; IOM, 2001; Yarborough and Sharp, 2002). Fostering an environment that promotes integrity in the conduct of research is an important part of that accountability. Because of the complexity, variability, and nature of scientific inquiry, the concept of integrity in research can be elusive, and its value cannot be easily assessed or measured. From the outside looking in, science is a quest for truth about the natural world. In reality, scientific “truth” is always tentative; and the means for testing it involve repetition, disclosure, sharing of information, and competition. Scientists understand that “truth” and “fact” are based on the weight of scientific evidence. “Facts” hold only until they are successfully challenged by additional evidence, after which they may be modified or interpreted differently. Research usually proceeds from a mélange of hypotheses and results based on previous experiments and knowledge. New results may support the proposed hypothesis, but they can never prove a general hypothesis or theory. In this progression toward the truth, researchers strive to be objective; but prior knowledge, opinion, and personal biases can influence the selec-

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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct tion of hypotheses and study design, the conduct of the research, and interpretation of the results (Grinnell, 1992; Macrina, 2000). These preconceptions can inform and improve research, but the existence of such preconceptions can also cause investigators to stretch, and sometimes exceed, the limits of acceptable behavior. Thus, recognition of preconceptions, biases, and the need for integrity in the research process is essential for maintaining scientific excellence and the public’s trust. Integrity in research embodies above all an individual’s commitment to intellectual honesty and personal responsibility and an institution’s commitment to creating an environment that promotes responsible conduct (see Chapter 2). Nevertheless, even the best scientific intentions may produce unverifiable results because of flawed hypotheses, inadequate technology, the faulty execution of research, or the incorrect interpretation of results. In fact, errors, responses to errors, and validation of errors are important elements of the scientific process. In testifying to the Institute of Medicine (IOM) Committee on Assessing Integrity in Research Environments, which prepared this report, former National Institutes of Health (NIH) Director Harold Varmus said, “The notion of truth in science is difficult…. We don’t know what the truth is. We are working our way toward the truth; and we are dependent on data, and data can be misleading.” Consequently, even the most promising of experiments, conducted by seasoned researchers, will frequently fail. An important aspect of integrity in research is how one deals with error and with studies conducted erroneously. How mistakes are dealt with may have an important impact on the ethical climate of a research environment. Biomedical research is often the focus of scrutiny because its findings can have important implications for health, it is highly regulated, and it receives substantial public funding. Moreover, serious errors or misconduct in biomedical research can lead to dire or even lethal consequences for research subjects. Media coverage of integrity in research usually focuses on clinical research catastrophes, egregious conflicts of interest, and overt research misconduct (e.g., the falsification or fabrication of data and plagiarism). Even though issues related to the conduct of research in the areas of health and disease are foremost in the minds of many people, responsible conduct is vital for all areas of science. For example, research in the physical, chemical, and environmental sciences leads to the innovative and more effective use of natural resources; the identification of new energy sources; the structural and mechanical safety of bridges, buildings, and various modes of transportation; and methods for managing and reducing the waste generated from the actions of humans and the machines that they create. Technology and communications are also important in

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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct health and health care but they are just as important in commerce, services, and defense. CHARGE TO THE COMMITTEE In January 2001, in response to a request from the Office of Research Integrity (ORI) of the U.S. Department of Health and Human Services (DHHS), IOM, in collaboration with the National Research Council’s Division on Earth and Life Studies, formed the Committee on Assessing Integrity in Research Environments. 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: define the concept “integrity in research”; describe and define the concept “research environment”; identify elements of the research environment that promote integrity in research; indicate how the elements may be measured; suggest an appropriate methodology for collecting the data; cite appropriate outcome measures; make recommendations regarding the adoption and implementation 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 convene a public meeting to discuss the IOM report, its recommendations, and potential strategies for their implementation. The committee membership included research and university administrators; educators; and active researchers from academic, industry, association, and private research settings. These individuals brought expertise from a broad array of fields, including biology, biomedical research, chemistry, clinical research, evaluation research and methodology, medicine, medical education, physics, public policy, science education, science ethics, and sociology. ORIGINS OF THE STUDY Several specific cases of alleged fraud or other scientific misconduct have been widely covered by the press in the past decade; and the federal government, the National Academies, and numerous scientific societies have made a considerable effort to develop a definition of research misconduct and guidelines for handling allegations of research misconduct. Such allegations remain relatively rare, however, and investigations of

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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct misconduct are not likely to be sensitive indicators of the changes in the research environment that might discourage misconduct and promote integrity in science. In 1992, the National Academies’ Committee on Science, Engineering, and Public Policy (COSEPUP) published Responsible Science: Ensuring the Integrity of the Research Process (NAS, 1992). That report was published after years of debate about policy over integrity in research that included serious allegations, congressional hearings, and media coverage.1 That debate included controversy over the Office of Scientific Integrity (OSI), which DHHS created in 1989. OSI was immediately criticized for being overzealous in its investigations and inflexible in its process (Davis, 1991; Hamilton, 1991). A high-profile court case challenged the due process and legitimacy of OSI, and a later reorganization of the office consolidated activities into what is now the Office of Research Integrity (ORI) (Guston, 2000). As a result, new procedures provided a review and hearing process that gave accused individuals or institutions more opportunity to present their case (ORI, 1999). In 1999, Secretary Shalala accepted the recommendations of the HHS Review Group on Research Misconduct and Research Integrity, and the primary focus of ORI shifted away from active investigation to education, oversight, and assurance, and, more recently, to research. The federal government firmly asserted its authority and discretion in setting conditions on the awarding of research grants. It now requires research institutions to have in place policies and procedures for handling allegations of misconduct, protecting whistle-blowers, and providing education in the responsible conduct of research for recipients of training grants (DHHS, 1995, pp. 21–24; DHHS, 2000). At the same time that research institutions have augmented their ability to combat misconduct, the specific role of the federal government in investigating allegations has been legalized and limited. The federal government, particularly through the DHHS Departmental Appeals Board, has articulated clear standards for the adjudication of allegations of misconduct in research, with “misconduct” defined by the Office of Science and Technology Policy as “fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results” (OSTP, 2000, p. 76262). Institutions must conduct inquiries and investigations, and only when further fact finding is required by the federal government will the Office of the Inspector General at DHHS intervene. 1   The committee asked David Guston, Rutgers University, to survey related events over the 10 years since publication of the COSEPUP report. Portions of this section were drawn from his report, which is summarized in Appendix C.

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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct The Public Health Service (PHS) has also addressed research integrity. PHS regulation on responding to allegations of scientific misconduct states that “institutions shall foster a research environment that discourages misconduct in all research and that deals forthrightly with possible misconduct associated with research for which PHS funds have been provided or requested” (45 C.F.R. § 50.105, 2001). PHS has devoted considerable effort to the task of defining research misconduct and elaborating methods for investigation of allegations of misconduct. It has devoted much less attention to the task of fostering a research environment that promotes integrity. In 1999, the DHHS Review Group on Research Misconduct and Research Integrity recommended that “the role, mission, and structure of ORI change to become one of preventing misconduct and promoting integrity in research principally through oversight, education, and review of institutional findings and recommendations” (DHHS, 2000, p. 30601). To provide an empirical basis for this new mission, ORI plans to develop a longitudinal database that tracks the state of integrity in research environments. ORI, PHS, and the extramural research community could use this database to guide development of education, prevention, and research programs related to the responsible conduct of research and to evaluate the effectiveness of those programs. In the absence of such data, the federal government and the scientific community will continue to manage issues related to integrity in research in a relative vacuum and will primarily rely on speculation and the infrequent individual case reports that receive notoriety. This regulation by crisis can lead to expensive and inefficient solutions when the scope of the actual problem is unknown. Other Efforts to Foster Integrity This report is not the first effort that IOM has made to address and assess the best means for fostering integrity in the research environment. In 1989, IOM published The Responsible Conduct of Research in the Health Sciences. Since then, the National Academies has published a number of reports, essays, and guides that have recommended actions to promote responsible research practices, including guides on education and training, mentoring, and careers in science. Key among these are volumes 1 and 2 of Responsible Science: Ensuring the Integrity of the Research Process (NAS, 1992, 1993) and On Being a Scientist (NAS, 1989a, 1995). The 1992 report Responsible Science: Ensuring the Integrity of the Research Process recommended “individual scientists in cooperation with officials of research institutions should accept formal responsibility for ensuring the integrity of the research process. They should foster an environment, a reward system, and a training process that encourage respon-

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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct sible research practices” (NAS, 1992, p. 13). The report went on to recommend that scientists and research institutions integrate into their curricula educational programs that foster integrity, and that institutions adopt formal guidelines on the conduct of responsible research. A variety of other efforts have been made to foster integrity in the conduct of research. Professional groups, agencies of the federal government, and foundations have addressed the importance of integrity in the conduct of research for some time. For example, in 1982 the Association of American Medical Colleges published a policy statement entitled “The Maintenance of High Ethical Standards in the Conduct of Research,” which emphasized the significance of integrity in the conduct of biomedical research. Scientific societies, led by the American Association for the Advancement of Science (AAAS) and Sigma Xi, The Scientific Research Society, educate their members about the ethical issues associated with research and develop materials to help foster integrity in research (e.g., AAAS videos entitled “Integrity in Scientific Research”; see http://www.aaas.org/spp/video). AAAS has also joined forces with other scientific societies in considering ways to enhance the role of the societies in promoting integrity in research (AAAS, 2000). At the federal level, the National Science Foundation (NSF) and NIH have begun to support education in ethics and the responsible conduct of research (for examples see http://www.nsf.gov/sbe/ses/sdest; http://www.nih.gov/sigs/bioethics/researchethics.html). In 2001, the Wellcome Trust, a private philanthropy in England, published draft guidelines for Good Practice in Biomedical Research (Wellcome Trust, 2001). Although these guidelines will apply only to those receiving funds from the Wellcome Trust, the guidelines have been looked upon as a positive development for research overall (Koenig, 2001). Other organizations, such as Public Responsibility in Medicine and Research (http://www.primr.org), endeavor to promote the responsible conduct of research through broad educational efforts, such as national conferences and published reports. Efficacies of Efforts to Foster Integrity Opinions differ, and research is inconclusive, on which efforts to foster integrity are the most effective, but education consistently ranks high. As Ruth Fischbach noted during her testimony to this committee, “The elements of a research environment that promote integrity are education, education, education—ethical behavior favors a prepared mind.” Both the 1989 and 1992 NAS reports stressed the importance of “educational programs that foster faculty and student awareness of concerns related to the integrity of the research process” (NAS, 1992, p. 13). ORI lists nine

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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct core content areas that it considers significant and that warrant inclusion in educational programs: (1) data acquisition, management, sharing, and ownership; (2) mentor-trainees relationships; (3) publication practices and responsible authorship; (4) peer review; (5) collaborative science; (6) human subjects; (7) research involving animals; (8) research misconduct; and (9) conflict of interest and commitment. These elements appear repeatedly in program and guidance documents (ORI, 2000). Very little is known, however, about the efficacies of such educational programs as they are currently conducted. As noted earlier, the low incidence of allegations of misconduct means that these cases are not likely to be helpful in measuring changes in the research environment. Therefore, ORI is seeking guidance on what might be called “surrogate measures of the health of research environments.” Examples of the kinds of measures that might be used include (1) the more familiar indicators of institutional effectiveness, such as the research record itself or the number of graduates who go on to prestigious positions; (2) outcome measures that an institution could use to assess the value added by educational efforts to promote abilities (e.g., moral reasoning) that relate to the responsible conduct of research; and (3) moral climate indicators, such as those designed to measure the organizational climate for business or the academic integrity of institutions of higher education. (See Appendix B for an extensive discussion of the outcome measures used to assess integrity in the research environment.) To measure and monitor the climate of an institution, two kinds of indicators are used: the perceptions of members that the environment values and supports responsible conduct, discourages questionable practices, and censures misconduct (data can be collected by using surveys, interviews, or focus groups), and process indicators, such as the number and quality of improvements that an institution has made in the processes and procedures used to support research activities (including such things as the accreditation of an institution’s institutional review board or the systems used to monitor the use of funds). Outcome measures that assess individual capacities could be used to assess the effectiveness of institutional efforts to promote the responsible conduct of individuals. Current Research on Integrity in Research2 The 1992 COSEPUP report Responsible Science: Ensuring the Integrity of the Research Process (NAS, 1992) noted the lack of research-based knowledge about research misconduct. To a small but real extent, integrity in 2   This section is based on a commissioned paper that David Guston prepared for the committee.

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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct research has now become an object of research itself, and ORI has begun funding grants on “research on research integrity” (RRI). The first request for applications (RFA) in this area was issued in summer 2000. The National Institute of Neurological Disorders and Stroke (NINDS) and the National Institute of Nursing Research (NINR) joined ORI in the RRI grant program. In July 2001, ORI announced awards for seven 2-year grants, five funded by ORI and one funded by each of the collaborating institutes. Table 1-1 lists the topics of each of these grants. Although the topics are diverse, none of the currently funded projects specifically addresses ways to assess the effectiveness of interventions intended to foster integrity in research. ORI, again in collaboration with NINDS and NINR, issued a second request for applications in May 2001. The RFA sought proposals that would “provide generalizable empirical knowledge about the ways in which researchers and research institutions meet or fail to meet their professional responsibilities in the conduct, evaluation, and reporting of research” (ORI, 2001b, p. 2). ORI also conducts research studies on its own. Two current studies of interest, to be released in 2003, are surveys of research integrity measures (not the integrity of research measures as stated) used in biomedical research laboratories and the incidence of research misconduct in biomedical research. NSF, since 1989, has funded a small number of projects related to research misconduct. Tables 1-2 and 1-3 detail information about eight funded projects directly related to integrity in research and four funded projects indirectly related to integrity in research, respectively. During this period, NSF has spent just over $2 million on all of these projects together. Many of the funded grants relate to education and training rather than to empirical investigation into integrity or misconduct as phenomena in and of themselves. TABLE 1-1 Grants Funded by ORI in the First Round of Research on Integrity in Research Grant Title Research Integrity in Pharmacological Clinical Trials Perceived Organizational Justice in Scientific Dishonesty Quality Assurance and Data in Clinical Trials Data Sharing and Data Withholding Among Trainees in Science Organizational Influences on Scientific Integrity Work-Strain, Career Course, and Scientific Integrity Management Decisions in Financial Conflicts of Interest   SOURCES: ORI (2001a) and M. Scheetz, Office of Research Integrity, Personal communication, October 10, 2001, with D. Guston, author of commissioned paper.

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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct TABLE 1-2 NSF Awards Directly Related to Integrity in Research, 1989 to Present Year Amount ($) Title 1991 36,000 Openness, Secrecy, Authorship, and Intellectual Property 1992 25,499 Planning Grant on Preserving Scientific Integrity in the Behavioral Sciences 1993 84,998 Sharing Research Data: An Examination of Practices 1994 22,500 Dynamic Issues in Scientific Integrity: Collaborative Research 1995 164,090 Professional Norms of Researchers in Cellular and Molecular Biology 1996 10,000 Conference: Historical Perspectives on Scientific Authorship 1998 171,261 Graduate Research Ethics Program 2001 763,907 Continuing and Expanding the Graduate Research Ethics Program NOTE: Projects were identified on NSF’s online awards database by searching on the terms “scientific misconduct” (yielding 5 hits) and “scientific integrity” (yielding 12 hits), although not all of the hits were fully relevant. Searching on “research integrity” and “research misconduct” yielded zero hits. Searching on the term “scientific ethics” yielded 42 hits, but there was no overlap with the “misconduct” and “integrity” hits, and so these were ignored. ORI notes in the second RFA on research on research integrity that “no systematic effort has been made to evaluate different approaches to transmitting high standards for integrity in research, making it difficult to know which ones, if any, are effective” (ORI, 2001b, p. 1). The IOM committee’s evaluation of the available literature supports this statement and further emphasizes the need for research in this area (see Chapter 7). TABLE 1-3 NSF Awards Indirectly Related to Integrity in Research, 1989 to Present Year Amount ($) Title 1989 600,255 Revision of the CHEM Study Films 1993 51,250 Undergraduate Research Participation: Collaborative Cross-Disciplinary Research in Biology 1996 11,858 Professional Development for Emerging Neuroscientists 1998 154,800 Research Experience for Undergraduates: Experimental Biology NOTE: Projects were identified on NSF’s online awards database by searching on the terms “scientific misconduct” (yielding 5 hits) and “scientific integrity” (yielding 12 hits), although not all of the hits were fully relevant. Searching on “research integrity” and “research misconduct” yielded zero hits. Searching on the term “scientific ethics” yielded 42 hits, but there was no overlap with the “misconduct” and “integrity” hits, and so these were ignored.

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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct THE CHANGING RESEARCH ENVIRONMENT The research environment changes continuously, and these changes influence the culture and conduct of research. For example, the once clearcut lines between academic and for-profit research that existed during the growth in federal funding for medical and health-related research after World War II have become increasingly blurred. Industry expenditures for medical and health-related research conducted in the United States have been rising faster than federal-sector expenditures (NIH, 1996; NSF, 2000a). As a result, industry funding plays an important role in the conduct of medical and health-related research. Because science is a cumulative, interconnected, and competitive enterprise, with tensions among the various societies in which research is conducted, now more than ever researchers must balance collaboration and collegiality with competition and secrecy. Another result of these tensions is conflict-of-interest and intellectual property issues, which are increasingly important to administrators of research institutions. Careful management of an institution’s discoveries and developments can yield significant funding in the form of licensed patents, royalties, and investment by industries. Lack of careful control over intellectual property and potential conflicts of interest and commitment, however, can lead, at a minimum, to lost opportunities and, more seriously, to legal actions, loss of research funding, and other penalties. In addition, the institution’s reputation may be tarnished and the institution may lose public and stakeholder trust. However, the management of conflicts of interest, although certainly important and desirable, does not ensure integrity in the conduct of research. Because so much of modern life is based on advances in science and technology, these advances have generated large industries. Academic laboratories in the United States have become, in a sense, small businesses that are constantly seeking capital and the brightest minds to work in them (Grinnell, 1999b). In addition, information technologies contribute to all areas of research, while they simultaneously raise challenges in terms of data sharing, data protection, and personal privacy. As a result of the various elements and issues related to research and the research environment discussed above, running a laboratory requires more than the management of daily scientific activities. Success requires not only the intellectual ability to conduct research but also the capability to manage people and finances (and related conflicts of interest and commitment), adhere to regulations, and ensure such outputs as publications and intellectual property (Davis, 1999). As part of these responsibilities, research leaders and administrators should foster a climate that supports the responsible conduct of research. However, despite the importance of integrity to sound research, the means of promoting integrity in the individual

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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct researcher and developing an institutional climate that fosters integrity are not precisely known. One of the more difficult situations that a research manager or administrator faces is how to handle situations of questionable research practices or outright misconduct. Unfortunately, fabrication, falsification, and plagiarism—even though they are relatively rare—garner significant attention. Although the federal government plays an important role in the management of misconduct in research, regulation alone cannot foster integrity. The commitment must come from individuals, the broad scientific community, and its institutions. The “where,” “what,” and “who” in scientific research are very broad categories. Research is conducted everywhere, often collaboratively: in institutions of higher education, government facilities, and industry settings. Within each of these settings there can be multiple smaller units (e.g., departments, divisions within a department, research groups within a division). The research disciplines span the life, physical, earth, and social sciences. Each discipline has different cultures, populations, and “generations” of scientists, including students, trainees, junior faculty and researchers, tenured faculty, staff scientists, technical assistants, and administrators. The research enterprise includes not only those actively conducting research but also research sponsors, human research subjects, administrative and financial support staff, statisticians, animal handlers, intellectual property and business development managers, suppliers, manufacturers, professional organizations, publishers of scientific journals, and a host of other players. All of these players and their actions must be taken into account when considering the responsible conduct of research. FOCUS OF THE REPORT As with any system being scientifically examined, the research environment itself contains variables and constants. The most unpredictable and influential variable is the individual scientist. The human contribution to the research environment is greatly shaped by each individual’s professional integrity, which in turn is influenced by the individual’s educational background and cultural and ethical upbringing. These result in values and attitudes that contribute to the formation of the individual’s identity, unique personality traits, and ethical decision-making abilities. Because each researcher brings unique qualities to the research environment, the constants must come from the environment itself. 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 consequences of each individual’s conduct or misconduct should be clear. Anyone needing as-

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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct sistance should have ready access to knowledgeable leaders and be able to seek help without fear of retribution. This report therefore focuses 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 upon entry into that organization, to act with integrity. Although integrity and misconduct are related, the focus of this report is on integrity. The committee does not discuss or draw conclusions about current or proposed regulations or definitions relating to misconduct. The committee’s goal was not to advocate any specific policy or process but, rather, was to define the desired outcome and to set forth a set of initiatives that it believes will increase the levels of integrity among individuals in research institutions. The committee considered approaches that could be used to foster integrity and methods that could be used to assess the effectiveness of those approaches. The majority of these approaches can and should be proactively initiated and administered by research institutions. The committee’s focus on the responsible conduct of research within academic institutions does not imply lack of interest in the environment for integrity in other research contexts, such as private research institutes or research at for-profit organizations. However, virtually all investigators begin their research careers in a university setting; therefore, the university research group can be considered the crucible for education in research. Additionally, as the principal recipients of public research funds, academic research groups have been the major focus of concern for integrity in research. It should also be noted that this report emphasizes the education of trainees (graduate and medical students and postdoctoral fellows), not because the committee believes this is where a problem exists but, rather, because this is where the future lies. The committee hopes that focusing efforts on the next generation of researchers and scientific leaders will yield the greatest and most enduring change. This is not to say that senior researchers, faculty, and administrators cannot change or improve, and educational efforts should certainly be designed to reach all those involved in scientific research at all levels. As noted in a previous report, “the educational process should begin early in the training of future scientists and continue through the most senior stages” (DHHS, 1995, p. 15). The principles of adult learning and the discussion of the development of abilities that give rise to responsible conduct described in Chapter 5 are applicable to educational efforts at all levels of adult education and across all scientific disciples. The committee acknowledges the difficulty of changing an organization’s culture and ethical climate. The history of “reforms” in medical education has led to numerous reports, recommendations, and attempted

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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct reforms, which overall have amounted to “reform without change” (Bloom, 1988). One explanation is the focus on change in curriculum without concurrent change in the environment for teaching and learning. Bloom (1995, p. 907) notes that change “cannot be accomplished only by adding to or changing existing curriculum components. It must include a change in the teaching and learning environment, or in what we mean by socialization for a profession.” Teaching of values is important, but “only when students can see those values operative within their schools’ service and research programs will the lesson become fully effective” (Bloom, 1995, p. 908). As such, the committee discusses education in the responsible conduct of research as an integral component of conducting scientific research (Chapter 5). For its evaluation of the elements that are most likely to foster integrity, the committee analyzed the available literature; consulted with experts in science, education, and organizational development; and commissioned papers (see Appendix A). In looking for evidence to inform its deliberations, the committee focused on what is known about the assessment of a moral climate and what is known about the effectiveness of attempts to teach responsible conduct. The committee members also drew heavily from their own experiences, those of their institutions, and those of invited experts. ORGANIZATION OF THE REPORT Following this introductory chapter, a discussion of assessing integrity in the research environment begins in Chapter 2 with the committee’s definition of integrity as it applies to both individuals and institutions. The committee describes practices that embody these definitions. Chapter 3 presents an organizational framework for the research environment and discusses some of the key elements in more detail, including education, policies, culture, and assessment and quality improvement. In Chapter 4, the committee presents elements that in combination can foster integrity in the research environment and discusses the advantages and disadvantages of each. Chapter 5 expands the discussion of education as an important element in fostering integrity. Chapter 6 furthers the discussion of self-assessment as a preferred method for assessing integrity in the research environment. Concluding remarks, recommendations, and areas for further research are presented in Chapter 7. The report includes five supplementary appendixes to provide the reader with additional information: Appendix A discusses the committee’s data sources and summarizes the findings of its literature review. Appendix B describes existing outcome measures that might be used as a framework to develop instruments to assess integrity in the research environment. Appendix C provides a brief historical overview of integrity

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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct and misconduct over the past 10 years. Appendix D lists additional reading and resources. Biographical information on the committee members is presented in Appendix E. Table 1-4 lists each of the individual tasks that the committee ad TABLE 1-4 Addressing the Charge Task Committee Action Define the concept “research integrity.” Chapter 2 describes integrity in research as it relates to both individual researchers and the institutions in which they work. Describe and define the concept “research environment.” Chapter 3 uses an open-systems model (often used to describe social organizations) to provide a general framework within which the “research environment” can be understood. Identify elements of the research environment that promote integrity in research. Chapters 2 and 3 identify the elements within a research organization that are relevant to integrity in research. Chapter 5 expands upon the discussion of education as an important element. Indicate how the elements may be measured. Chapter 6 describes an approach for evaluation of the environment for integrity in research based on methods of self-assessment and peer review that are incorporated into existing processes for accreditation of educational and research institutions. Appendix B presents examples of the types of instruments that could be used to collect data as part of a self-assessment and examples of elements and outcomes assessed in other models. Suggest an appropriate methodology for collection of the data. Cite appropriate outcome measures. Make recommendations regarding the adoption and implementation by research institutions, government agencies, scientific societies, and others (as appropriate) of those elements of the research environment identified to promote integrity in research. Chapter 4 presents three approaches that represent alternative ways of influencing behavior and improving outcomes and the strengths and weaknesses of each. Chapters 5 and 6 discuss the implementation of education in responsible conduct and evaluation by self-assessment, respectively. Chapter 7 includes recommendations and identifies areas in which more research is needed to further identify, characterize, and measure elements of the research environment that promote integrity. Convene a public meeting to discuss the IOM report, its recommendations, and potential strategies for their implementation. A public meeting will be held in the fall of 2002.

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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct BOX 1-1 Glossary of Terms Used in This Report educational programs: programs that aim to develop students mentally, morally, or aesthetically through instruction ethical (or moral) climate: the prevailing moral beliefs that provide the context for conduct (i.e., the prescribed behaviors, beliefs, and attitudes within the community and the sanctions expressed); the stable, psychologically meaningful, and shared perceptions of organizational members are used as indicators of climate ethical (or moral) reasoning: the ability to examine systematically the ethical dimensions of a situation and then choose and defend a position on the issue on ethical or moral grounds ethics: principles of character often believed to transcend particular communities morals*: normative principles of right or wrong in behavior adopted within particular communities organizational culture: the set of shared norms, values, beliefs, and assumptions along with the behavior and other artifacts that express these orientations— including symbols, rituals, stories, and language research: systematic investigation or experimentation aimed at generating generalizable information and knowledge research environment: the combined social and cultural conditions that influence the life of an individual investigator, research unit, or research institution research institution: all organizations conducting research, including, for example, colleges and universities, intramural federal research laboratories, federally funded research and development centers, industrial laboratories, and other research institutes science: knowledge or a system of knowledge covering general “truths” or the operation of general laws, especially those obtained and tested through the scientific method training programs: programs that provide a set of skills and experiences *   Although morals and ethics have different meanings as technical terms, they are often used interchangeably. dresses in this report and the chapter(s) that contains the majority of the committee’s response to them. The committee notes that tasks four, five, and six are particularly demanding. Professional consulting firms can spend years, and a significant budget, developing and validating assessment instruments. As such, the committee was not equipped to recommend specific methods and measures. Instead, the committee recommends an overall approach—institutional self-assessment followed by peer review, preferably as part of the standard accreditation process—as a means to collect and assess data (Chapter 6). The committee also provides information on relevant assessment tools that might be adapted to

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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct the research environment (Appendix B). As noted throughout the report, empirical data on evaluating ethical climate before and after implementation of specific practices or policies are lacking, and the committee believes that it went as far as the current data would responsibly allow in making its recommendations. REFERENCES AAAS (American Association for the Advancement of Science). 2000. The Role and Activities of Scientific Societies in Promoting Research Integrity. A report of a conference, April 10, 2000, Washington, DC. [Online]. Available: http://www.aaas.org/spp/dspp/sfrl/projects/integrity.htm [Accessed January 7, 2002]. American Association of Medical Colleges. 1982. The maintenance of high ethical standards in the conduct of research. A policy statement. American Association of Medical Colleges, Washington, DC. Bloom SW. 1988. Structure and ideology in medical education: An analysis of resistance to change. Journal of Health and Social Behavior 29:294–306. Bloom SW. 1995. Editorial: Reform without change? Look beyond the curriculum. American Journal of Public Health 85:907–908. Davis B. 1991. Is the Office of Scientific Integrity too zealous? The Scientist 5 (10):12. Davis TP, ed. 1999. Management of Biomedical Research Laboratories. Proceedings of a national conference. October 1–3, 1999, The University of Arizona, Tucson. DHHS (U.S. Department of Health and Human Services). 1995. Integrity and Misconduct in Research: Report of the Commission on Research Integrity. Rockville, MD: Office of the Secretary, Office of Research Integrity, DHHS. DHHS. 2000. Statement of Organization, Functions, and Delegations of Authority. Federal Register 65:30600–30601. Grinnell F. 1992. The Scientific Attitude, 2nd ed. New York, NY: The Guilford Press. Grinnell F. 1999a. Ambiguity, trust, and responsible conduct of research. Science and Engineering Ethics 5:205–214. Grinnell F. 1999b. Responsibility, conflict and ambiguity in the management of biomedical research laboratories. In: Davis TP, ed. Management of Biomedical Research Laboratories. Tucson, AZ: University of Arizona. Pp. 29–35. Guston DH. 2000. Between Politics and Science: Assuring the Integrity and Productivity of Research. New York, NY: Cambridge University Press. Hamilton DP. 1991. Can OSI withstand a scientific backlash? Science 253:1084–1086. IOM (Institute of Medicine). 2001. Preserving Public Trust. Washington, DC: National Academy Press. Koenig R. 2001. Wellcome rules widen the net. Science 293:1411–1412. Macrina FL. 2000. Scientific Integrity: An Introductory Text with Cases, 2nd ed. Washington, DC: ASM Press. NAS (National Academy of Sciences). 1989a. On Being a Scientist. Washington, DC: National Academy Press. NAS. 1989b. The Responsible Conduct of Research in the Health Sciences. Washington, DC: National Academy Press. NAS. 1992. Responsible Science: Ensuring the Integrity of the Research Process, Vol. 1. Washington, DC: National Academy Press. NAS. 1993. Responsible Science: Ensuring the Integrity of the Research Process, Vol. 2. Washington, DC: National Academy Press. NAS. 1995. On Being a Scientist, 2nd ed. Washington, DC: National Academy Press.

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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct NIH (National Institutes of Health). 1996. Estimates of National Support for Health R&D by Source or Performer, FY 1986–1995. [Online]. Available: http://grants.nih.gov/grants/award/trends96/pdfdocs/FEDTABLA.PDF [Accessed December 6, 2001]. NSF (National Science Foundation). 2000a. U.S. and international research and development: funds and alliances. In: Science and Engineering Indicators-2000. Arlington, VA: NSF. [Online]. Available: http://www.nsf.gov/sbe/srs/seind00/start.htm [Accessed December 5, 2001]. NSF. 2000b. Science and Technology: Public Attitudes and Public Understanding. In: Science and Engineering Indicators-2000. Arlington, VA: NSF. [Online]. Available: http://www.nsf.gov/sbe/srs/seind00/start.htm [Accessed September 28, 2001]. ORI (Office of Research Integrity). 1999. Review group recommendations being implemented rapidly. ORI Newsletter 8(1):5–6. ORI. 2000. PHS Policy on Instruction in the Responsible Conduct of Research (RCR). [Online]. Available: http://ori.dhhs.gov/html/programs/finalpolicy.asp [Accessed November 2001]. ORI. 2001a. Seven Studies Funded by Research Integrity Program. ORI Newsletter 9(4):1, 4. ORI. 2001b. Research on Research Integrity. NIH Guide. RFA-NS-02-005. [Online] Available: http://grants2.nih.gov/grants/guide/rfa-files/RFA-NS-02-005.html [Accessed March 18, 2002]. OSTP (Office of Science and Technology Policy). 2000. Federal policy on research misconduct; Preamble for research misconduct policy. Notification of Final Policy. Federal Register 65:76260–76264. Wellcome Trust. 2001. Good Practice in Biomedical Research. Draft guidelines. [Online]. Available: http://www.wellcome.ac.uk/en/1/awtvispolgrp.html [Accessed March 14, 2002]. Yarborough M, Sharp RR. 2002. Restoring and preserving trust in biomedical research. Academic Medicine 77:8–14.