7
Concluding Remarks and Recommendations

OVERARCHING CONCLUSIONS

Several overarching conclusions emerged as the Committee on Assessing Integrity in Research Environments addressed the need of the U.S. Department of Health and Human Services (DHHS) to develop means for assessing and tracking the state of integrity in the research environment:

  • Attention to issues of integrity in scientific research is very important to the public, scientists, the institutions in which they work, and the scientific enterprise itself.

  • No established measures for assessing integrity in the research environment exist.

  • Promulgation of and adherence to policies and procedures are necessary, but they are not sufficient means to ensure the responsible conduct of research.

  • There is a lack of evidence to definitively support any one way to approach the problem of promoting and evaluating research integrity.

  • Education in the responsible conduct of research is critical, but if not done appropriately and in a creative way, education is likely to be of only modest help and may be ineffective.

  • Institutional self-assessment is one promising approach to assessing and continually improving integrity in research.



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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct 7 Concluding Remarks and Recommendations OVERARCHING CONCLUSIONS Several overarching conclusions emerged as the Committee on Assessing Integrity in Research Environments addressed the need of the U.S. Department of Health and Human Services (DHHS) to develop means for assessing and tracking the state of integrity in the research environment: Attention to issues of integrity in scientific research is very important to the public, scientists, the institutions in which they work, and the scientific enterprise itself. No established measures for assessing integrity in the research environment exist. Promulgation of and adherence to policies and procedures are necessary, but they are not sufficient means to ensure the responsible conduct of research. There is a lack of evidence to definitively support any one way to approach the problem of promoting and evaluating research integrity. Education in the responsible conduct of research is critical, but if not done appropriately and in a creative way, education is likely to be of only modest help and may be ineffective. Institutional self-assessment is one promising approach to assessing and continually improving integrity in research.

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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct RESEARCH AGENDA The committee found that existing data are insufficient to enable it to draw definitive conclusions as to which elements of the research environment promote integrity. The elements discussed in Chapter 2 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; as a consequence, the decision to implement particular programs is often based on anecdotal evidence. True misconduct is rare, and statistics on misconduct are approximate. Thus, looking for a decrease in rates of misconduct is not a viable way to assess the effectiveness of measures implemented to foster integrity in research. In addition, although it is relatively easy to catalog lists of policies and procedures, it is much less straightforward to measure performance and outcomes in the research environment. Because of the limited empirical data on factors influencing responsible 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 this report. The findings and conclusions are based on the committee’s collective knowledge and experience after its review of the available literature in the science and business arenas as well as its discussions with experts who presented talks at the committee’s open meetings. On the basis of the available information, the committee has described practices that promote the responsible conduct of research (Chapter 2) and has presented a theoretical model (Chapter 3) that contains many of the key components of the research environment and their interactivity. However, this is relatively new territory that needs to be examined with greater precision. Generating specific empirical data on integrity in scientific research is essential to help institutions determine the effectiveness of their efforts to foster a research climate that promotes integrity. Such data will also aid them in the development of better programs and policies in the future. The request for applications issued by the Office of Research Integrity (ORI) of DHHS on May 2, 2001 (Research on Research Integrity. RFA-NS-02-005), is an important first step toward this goal, as it highlights a variety of potentially productive research topics, as does the ORI website (http://www.ori.dhhs.gov/html/programs/potentialrestopics.asp). The committee believes these topics are best studied in the context of the model presented in Figures 3-1 and 3-2. In addition to the important research questions identified by ORI in its program announcements, the committee identified additional topics that warrant further study.

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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct Methods and Measures Gaining the methodological expertise needed to carry out research on the relationship between the research environment and integrity in research will require the development and validation of measures, particularly indicators that are observable and quantifiable within the research environment. For example, existing means of conceptualization and measurement of the organizational climate will have to be adapted to the specific context of the assessment of the ethical climate within the research environment. Furthermore, to measure the outcomes of efforts related to fostering integrity in the research environment, either new instruments must be designed and validated, or existing outcomes and measures (see Appendix B for examples) must be modified and validated in the specific context of the assessment of the ethical climate within the research environment. This development of reliable and valid measures can take considerable time and effort, but it is a necessary first step in a research process leading to a better understanding of the relationship between 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 (see Chapter 2 and Appendix B). Existing methods and measures, examples of which are described in Appendix B, provide models that could be adopted or adapted to evaluate the factors of culture and climate that promote integrity in research. Similarly, Appendix B also provides examples of measures that have successfully been used to assess learning outcomes in professional ethics programs. Elements of the Research Environment Research is needed to fully understand the roles of the various elements of the environment that foster the responsible conduct of research. Questions to be considered include the following: Organizational structure In what ways do variations in organizational structure (e.g., the size of an institution, the importance of research within the institution, institutional review board composition and procedures, and reward systems) affect the ethical and moral climate and the responsible conduct of research?

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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct Physical structure Does the physical structure and layout of the research space, or how the space is allocated, affect the ethical and moral climate and the responsible conduct of research? For example, what are the effects of open spaces versus closed spaces for conducting research? What are the effects of various groupings of people within these spaces? Funding What is the relationship between the availability of and competition for funding and the responsible conduct of research? Incentives and rewards How do existing incentive and reward systems within and outside universities affect the responsible conduct of research? What, if any, aspects of these systems are counterproductive in fostering integrity in research? Collaboration How is integrity in research affected by collaborations within and across institutions? Effectiveness of codes of conduct and honor codes Do honor codes and professional codes of conduct foster integrity in research? If so, under what conditions do they have an impact? RECOMMENDATIONS To facilitate the assessment and promotion of integrity in the research environment, the committee makes several recommendations, which are presented in the sections that follow. In combination, these recommendations are aimed at efforts to foster integrity in research at the individual and institutional levels and to ensure continuous institutional self-assessment and quality improvement. Future Research RECOMMENDATION 1: Funding agencies should establish re-

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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct search grant programs to identify, measure, and assess those factors that influence integrity in research. The Office of Research Integrity should broaden its current support for research to fund studies that explore new approaches to monitoring and evaluating the integrity of the research environment. Federal agencies and foundations that fund extramural research should include in their funding portfolios support for research designed to assess the factors that promote integrity in research across different disciplines and institutions. Federal agencies and foundations should fund research designed to assess the relationship between various elements of the research environment and integrity in research; similarities and differences across disciplines and institutions should be determined. As discussed earlier in this chapter, further research in needed to (1) develop and validate assessment methods and measures and (2) fully understand the roles of the various elements of the research environment in the responsible conduct of research. The results of such research will allow for more effective implementation of the following recommendations. Institutional Commitment to Integrity RECOMMENDATION 2: Each research institution should develop and implement a comprehensive program designed to promote integrity in research, using multiple approaches adapted to the specific environments within each institution. It is incumbent upon institutions to take a more active role in the development and maintenance of climate and culture within their research environments that promote and support the responsible conduct of research. The factors within the research environment that institutions should consider in the development and maintenance of such a culture and climate include, but are not limited to, supportive leadership, appropriate policies and procedures, effective educational programs, and evaluation of any efforts devoted to fostering integrity in research. Federal research agencies and private foundations should work with educational institutions to develop funding mechanisms to provide support for programs that promote the responsible conduct of research. Integrity in research is critical to the progress and acceptance of sci-

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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct ence. Although a high level of integrity generally characterizes the research community today, lapses in integrity do occur, and some are destructive. It is in the interest of the entire research community that there be sustained, systematic, and explicit efforts to ensure integrity in research. It is important that all institutions have a clear organizational structure and an unambiguous designation of who has the authority and responsibility for research integrity. Institutional leaders should set the tone for their institutions with their own actions. Senior researchers should set an example, not only in their own research practices but also in their willingness to engage in dialogue about ethical questions that arise. Because of the ever-changing nature of science, the research community needs to continuously adapt and improve upon its traditions of responsible behavior, communication, education, and policies with regard to integrity in research. Federal research agencies and private foundations are appropriate sponsors of grant programs to support research into the development of programs to promote integrity in research and the assessment of the effectiveness of such approaches. In addition to funding the process of development and validation of programs, financial resources are needed for the ongoing implementation of the programs themselves. In principle, costs associated with federally sponsored research could be supported through the indirect costs associated with federal research grants and contracts. However, administrative costs on grants and contracts to educational institutions (but not to other research entities) have been capped, and universities alone now bear the additional costs associated with the development or enhancement of programs that promote or evaluate integrity in research. Education RECOMMENDATION 3: Institutions should implement effective educational programs that enhance the responsible conduct of research. Educational programs should be built around the development of abilities that give rise to the responsible conduct of research. The design of programs should be guided by basic principles of adult learning. Integrity in research should be developed within the context of other relevant aspects of an overall research education program, and instruction in the responsible conduct of research should be provided by faculty who are actively engaged in research related to that of the trainees.

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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct Given the large variation in the human contribution to the research organization, the committee believes that it is particularly important for institutions to create an environment in which scientists are able to gain an awareness of the responsible conduct of research as it is defined within today’s culture. They need to understand the importance of these standards and expectations, acquire the capacity to resolve ethical dilemmas, and recognize and be able to address conflicting standards of research conduct (see Chapter 5). For lasting change in ethical climate to occur, changes in an institution’s curriculum content alone are not sufficient. Attention also needs to focus on how education in the responsible conduct of research is conducted. The processes that give rise to the responsible conduct of research include the ability to (1) identify the ethical dimensions of situations that arise in the research setting and the laws, regulations, and guidelines that govern one’s field (ethical sensitivity); (2) develop defensible rationales for a choice of action (ethical reasoning); (3) integrate the values of one’s professional discipline with one’s own personal values (identity formation) and appropriately prioritize professional values over personal ones (moral motivation and commitment); and (4) perform with integrity the complex tasks (e.g., communicate ideas and results, obtain funding, teach, and supervise) that are essential to one’s career (survival skills). Education in the responsible conduct of research should (1) be provided within the context of the overall educational program, including as part of mentor-student interactions, the core discipline-specific curriculum, and explicit education in professional skills; (2) take place over an extended period of time—preferably the entire educational program— and include review, practice, and assessment; and (3) involve active learning, including interactions among the instructors and the trainees. Educational efforts related to the responsible conduct of research should be designed to reach all those involved in scientific research at all levels. Without formal training for existing senior researchers and an instructional program for new researchers, an institution will not be able to develop a consistent message to trainees and students. Institutional Self-Assessment RECOMMENDATION 4: Research institutions should evaluate and enhance the integrity of their research environments using a process of self-assessment and external peer review, in an ongoing process that provides input for continuous quality improvement. The importance of external peer review of the institution cannot be overemphasized. Such a process will help to ensure the credibility of the

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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct review, provide suggestions for improvement of the process, and increase public confidence in the research enterprise. Effective self-assessment will require the development and validation of evaluation instruments and measures. Assessment of integrity and the factors associated with it (including educational efforts) should occur at all levels within the institution— for 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. As with any new program, a phase-in or pilot testing period is to be expected, 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. Accreditation provides established procedures, including external peer review, that can be modified to incorporate assessments of efforts related to integrity in research within an institution. 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 institution’s self-assessment of its climate for promotion of integrity in research. These entities include the six regional organizations that accredit institutions of higher education in the United States, as well as the organizations that accredit professional schools or professional educational programs. Federal research agencies and private foundations should support efforts to integrate self-assessment of the research environment into existing accreditation processes, and they also should fund research into the effectiveness of such efforts. Accrediting bodies rely heavily on the process of institutional self-assessment when reviewing an educational institution (Chapter 6). Institutions critically evaluate their strengths and weaknesses and strive for continuous quality improvement. The committee believes that the research mission should be considered as a whole, and that evaluation of institutional culture for promotion of integrity in research should be an important component of the overall process of accreditation of educational institutions that conduct scientific research. Thus, it seems reasonable that entities charged with accrediting the quality of education at institutions of higher learning that conduct scientific research should be charged with reviewing the process and the

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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct outcome data from the institution’s self-assessment of its climate for promotion of integrity in research. In institutions where accreditation is not available (e.g., freestanding research institutes) or where this additional mandate cannot be incorporated into existing institutional processes of accreditation, other approaches to ensuring external validation should be explored. RECOMMENDATION 6: ORI should establish and maintain a public database of institutions that are actively pursuing or employing institutional self-assessment and external peer-review of integrity in research. This database should initially include institutions that receive funding for, or are actively engaged in, the development and validation of self-assessment instruments. A publicly available informational database of ongoing efforts in institutional self-assessment and peer review could serve two purposes. First, the database could serve as a resource for other institutions seeking to develop their own programs, and second, it could serve as an accountability instrument, enabling the public to see which institutions are receiving public funding to develop such programs. ORI, as the federal entity formally charged with developing and implementing activities to promote research integrity as well as being one of the federal agencies that will fund research in this area, is the appropriate locus for this task. ORI would also be a centralized location of the information, which would be preferable to developing multiple databases scattered throughout the professional societies of different disciplines. CONCLUSION Integrity in research is essential for maintaining scientific excellence and keeping the public’s trust. Research institutions bear the primary burden of promoting and monitoring the responsible conduct of research. They must consistently and effectively provide members of research teams with the resources they need to conduct research responsibly. These resources include leadership and example, training and education, and policies and procedures, as well as tools and support systems. What is expected of individuals should be unambiguous, the consequences of one’s conduct should be clear, and anyone needing assistance should have ready access to knowledgeable leaders. Individuals should be able to seek assistance without fear of retribution. Research institutions, accrediting agencies, and public and private organizations that fund research should collaborate to establish and ensure the integrity of the scientific research enterprise.

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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct Appendixes

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