This chapter is intended to provide additional information to build on the discussion in Chapter 1 of the development of concepts of scientific responsibility and the ways in which those concepts are taught to students and practitioners. The integrity of research and ethical grounding of science have been prominent concerns of international research institutions, professional societies, and funding agencies for the past three decades. In the 1980s, professional and governmental attention to the growth and increasing complexity of life sciences research led to multidisciplinary efforts to define research integrity and responsible conduct of research in concrete terms. Much of this effort started in the United States, where it gained prominence in response to high-profile cases of research misconduct—the fabrication or falsification of research data and the theft of others’ ideas, words, and data through plagiarism. Since those early years, a large and increasingly comprehensive body of standards for ethical and scientifically sound research practices has developed, and researchers at many levels are encouraged to pursue formal study and dissemination of these practices. Ongoing instruction in responsible conduct of research is now commonly accepted in science education, particularly in pre- and postdoctoral training. The integrity of the research process is recognized to be “critical for excellence, as well as public trust, in science” (NSF, 2009).
EVOLVING TERMINOLOGY AND DEFINITIONS
As with most new concepts, key terminology related to research integrity has evolved with discussion of its central themes and specific issues. The larger concept of integrity in science was first formally defined in two reports from the National Academies (IOM, 1989; NRC, 1992). Both used the term integrity in a way that emphasized researchers’ honesty. In 1989, the Institute of Medicine’s Committee on the Responsible Conduct of Research in the Health Sciences defined integrity in research to mean “that the reported results are honest and accurate and are in keeping with generally accepted research practices” (IOM, 1989:v). In 1992, the Panel on Scientific Responsibility and the Conduct of Research published the report Responsible Science, which highlighted the integrity of the research process. In this context, the committee defined integrity as “the adherence by scientists and their institutions to honest and verifiable methods in proposing, performing, evaluating, and reporting research activities” (NRC, 1992:17).
While honesty remains the focal point of research integrity, today’s definitions typically include regulatory compliance and adherence to professional standards in the research process. For example, the U.S. National Institutes of Health policy guide defines research integrity as:
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Chapter 2 Responsible Conduct and Integrity in Science This chapter is intended to provide additional EVOLVING TERMINOLOGY AND information to build on the discussion in DEFINITIONS Chapter 1 of the development of concepts of scientific responsibility and the ways in which As with most new concepts, key terminology those concepts are taught to students and related to research integrity has evolved with practitioners. The integrity of research and discussion of its central themes and specific ethical grounding of science have been issues. The larger concept of integrity in science prominent concerns of international research was first formally defined in two reports from institutions, professional societies, and funding the National Academies (IOM, 1989; NRC, agencies for the past three decades. In the 1980s, 1992). Both used the term integrity in a way that professional and governmental attention to the emphasized researchers’ honesty. In 1989, the growth and increasing complexity of life sciences Institute of Medicine’s Committee on the research led to multidisciplinary efforts to define Responsible Conduct of Research in the Health research integrity and responsible conduct of Sciences defined integrity in research to mean research in concrete terms. Much of this effort “that the reported results are honest and started in the United States, where it gained accurate and are in keeping with generally prominence in response to high-profile cases of accepted research practices” (IOM, 1989:v). In research misconduct—the fabrication or 1992, the Panel on Scientific Responsibility and falsification of research data and the theft of the Conduct of Research published the report others’ ideas, words, and data through Responsible Science, which highlighted the plagiarism. Since those early years, a large and integrity of the research process. In this context, increasingly comprehensive body of standards the committee defined integrity as “the for ethical and scientifically sound research adherence by scientists and their institutions to practices has developed, and researchers at many honest and verifiable methods in proposing, levels are encouraged to pursue formal study and performing, evaluating, and reporting research dissemination of these practices. Ongoing activities” (NRC, 1992:17). instruction in responsible conduct of research is While honesty remains the focal point of now commonly accepted in science education, research integrity, today’s definitions typically particularly in pre- and postdoctoral training. include regulatory compliance and adherence to The integrity of the research process is professional standards in the research process. recognized to be “critical for excellence, as well For example, the U.S. National Institutes of as public trust, in science” (NSF, 2009). Health policy guide defines research integrity as: 23
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24 Developing Capacities for Teaching Responsible Science in the MENA Region The use of honest and verifiable methods in more instruction on professional standards of proposing, performing, and evaluating practice and the scientist’s role in society (NRC, research; 1995). Reporting research results with particular Over the past two decades, however, attention to adherence to rules, regulations, instruction in responsible conduct of research guidelines; and has increasingly focused on the elements of Following commonly accepted professional research practice and the ethical values and codes or norms. (NIH, 2012) professional norms of science. Current NIH policy on research training grants defines responsible conduct of research as “the practice EDUCATION IN THE RESPONSIBLE of scientific investigation with integrity,” which CONDUCT OF RESEARCH includes “awareness and application of established professional norms and ethical The term responsible conduct of research— principles in the performance of all activities frequently referred to by its acronym RCR— related to scientific research” (NIH, 2009). emerged during this same period as research In 2000, a decade after NIH’s initial training funders and academic research institutions grant mandate for instruction in responsible endeavored to distinguish research misconduct conduct of research, the Department of Health from the processes and activities that constituted and Human Services’ Office of Research good scientific practice (IOM, 1989; NIH, 1990; Integrity (ORI) proposed a new educational NRC, 1992). The concept became particularly policy to extend NIH’s requirement for RCR important in education policy following a 1990 instruction in training grants to everyone funded amendment to the NIH’s policies on research by Public Health Service grants, not just research training grants. The amendment required the trainees (ORI, 2000). This policy was short lived, mandatory instruction in RCR that was part of due largely to the anticipated costs of providing all institutional research training grants to add such an extensive educational activity across the instruction on professional ethics and regulatory federally funded research enterprise (Steneck standards (NIH, 1990). and Bulger, 2007). Nonetheless, the policy’s Initially the content of such instruction was impact on education was significant in that ORI not defined. Formal textbooks and other defined nine core areas for instruction that curricular materials developed both before and contained the knowledge, skills, and attitudes in response to the training grant mandate essential to responsible conduct. These nine core covered a wide array of issues that grew both areas were: broader and more concrete over time (Heitman and Bulger, 2005). For example, the first edition Data acquisition, management, sharing, and of the National Academies’ On Being a Scientist, ownership published in 1989, examined the nature of Mentor/trainee responsibilities scientific research and the social mechanisms of Publication practices and responsible science from a largely historical and sociological authorship perspective (NRC, 1989). In 1995, the second Peer review edition, subtitled Responsible Conduct in Collaborative science Research, expanded its discussion of the social Human subjects and historical context of science to incorporate Research involving animals
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Responsible Conduct and Integrity in Science 25 Research misconduct Responsible authorship and publication Conflict of interest and commitment.27 practices and The scientist as a responsible member of Although ORI suspended the policy in 2001, society, contemporary ethical issues in its nine core instructional areas provided a biomedical research, and the environmental common framework for the development of and societal impacts of scientific research.28 practice standards and research policy, as well as a wide range of educational resources. Even after the policy was withdrawn, various curricular INTERNATIONAL PERSPECTIVES ON materials, including the National Academies’ RESEARCH INTEGRITY AND third edition of On Being a Scientist (NRC, RESPONSIBLE CONDUCT OF RESEARCH 2009c), were revised and expanded to address the nine core areas and explore case studies in Since the early 2000s, several multinational which relevant professional standards were at professional organizations have worked to issue. elaborate practice standards and ethical norms In 2009, both NIH and the U.S. National for worldwide adoption, particularly in the life Science Foundation updated their requirements sciences. The European Science Foundation for instruction in responsible conduct of (ESF), a multinational organization with research, enlarging, reconfiguring, and member societies in 23 countries, issued its first reprioritizing the core areas and including, for major statement on research integrity, Good the first time, formal attention to the practices Scientific Practice in Research and Scholarship, in related to biosafety and research with dual use December 2000 (ESF, 2000). At that time, a potential (NIH, 2009; NSF, 2009). Today’s variety of member organizations had developed research integrity educators are now called upon country-specific policies on research misconduct to emphasize the following core areas of and guidelines on responsible research, but these responsible conduct: standards were not well integrated. ESF’s statement emphasized the importance of Conflict of interest professional governance and researchers’ Policies regarding human subjects, live honesty at all stages of scientific inquiry. ESF vertebrate animal subjects in research, and called for member organizations to develop both safe laboratory practices national and European-level codes of good Mentor/mentee relationships and scientific practice and to pursue the responsibilities harmonization of national standards. Collaborative research, including In December 2007, ESF and ORI published collaborations with industry Research Integrity: Global Responsibility to Foster Peer review Common Standards (ESF, 2007), a catalogue of Data acquisition and laboratory tools, international activities in research integrity that management, sharing and ownership also reported on the workshop Best Practices for Research misconduct Ensuring Scientific Integrity and Preventing Misconduct, sponsored by the Organization for 27 28 See http://oprs.usc.edu/files/2013/01/PHS_Policy_on See http://oprs.usc.edu/files/2013/01/PHS_Policy_on _RCR1.pdf. _RCR1.pdf.
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26 Developing Capacities for Teaching Responsible Science in the MENA Region Economic Cooperation and Development’s On a wider, global level, IAP–The Global (OECD) Global Science Forum, which had Network of Science Academies (formerly the sought to foster international cooperation in the InterAcademy Panel on International Issues), an development of policy and administrative organization of over 100 national academies of systems in international science (OECD, 2007). science, has also been a leader in promoting A related expert group from the European research integrity and responsible conduct of Commission (EC) recommended that the research.29 The 2012 policy report Responsible Commission take the lead in developing Conduct in the Global Research Enterprise, European standards, harmonizing definitions produced as a cooperative project with the and principles, and investigate emerging issues InterAcademy Council (IAC), offers an in transnational research. The following year, international consensus statement on the ESF published Stewards of Integrity (ESF, 2008), meaning of responsible conduct and the way to a review of European policies and programs that promote it (IAC and IAP, 2012). The report supported good scientific practices. ESF’s survey concludes that: found governmental and nongovernmental organizations in all of its member countries that Researchers have the primary responsibility had begun to articulate standards of responsible for maintaining standards of responsible research. research and should agree on the standards In 2010, ESF issued a background report, to be observed in multidisciplinary Fostering Research Integrity in Europe, which collaborations. outlined a framework for shared governance of Research institutions should develop clear research integrity and recommended that ESF definitions and rules about responsible and All European Academies (ALLEA) endorse conduct and foster an environment of European standards (ESF, 2010). In 2011, the integrity, including the establishment of ESF Member Organization Forum on Research effective mechanisms for addressing Integrity and ALLEA finalized the European allegations of misconduct. Code of Conduct for Research Integrity (ESF Institutions and agencies should support and ALLEA, 2011). The Code identified eight responsible, high-quality work through principles for all researchers, research funding practices that emphasize quality organizations, universities and funders to over quantity of results. observe: Journals and investigators should publish only original material. Honesty in communication Reliability in performing research Objectivity Impartiality and independence Openness and accessibility 29 IAP was founded in 1993 to help national science Duty of care academies advise their respective national policymakers on global scientific issues; for more information, see Fairness in providing references and giving www.interacademies.net/. The InterAcademy Council credit (IAC) is an IAP Observer organization, established in 2000 Responsibility for the scientists and as a source of expert scientific advice for global researchers of the future. (ESF and ALLEA, organizations such as the United Nations. For further 2011:5) information about IAC, see www.interacademycouncil.net/.
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Responsible Conduct and Integrity in Science 27 INCORPORATING STANDARDS OF How the standards of open publication of BIOSAFETY, BIOSECURITY, AND study design and methods as well as research DUAL USE RESEARCH INTO THE results and interpretation may present INTERNATIONAL EDUCATION challenges for work that explores novel INITIATIVES ON RESEARCH INTEGRITY infections or techniques with dual use AND RESPONSIBLE CONDUCT OF potential; and RESEARCH The growing role of scientific and ethical peer review in decisions about funding for Emerging ethical questions and standards of research with dual use potential and practice in biosafety, biosecurity, and research publication of its results. with dual use potential fit readily into the broad spectrum of issues addressed in RCR education. An additional approach to teaching about Three of NIH’s recently defined areas for RCR biosafety, biosecurity, and dual use issues as part education are directly relevant to biosafety and of RCR education has been advocated by dual use issues: policies on safe laboratory proponents of a researcher’s code of ethics. In practices, the scientist as a responsible member 2005, the U.S. National Science Advisory Board of society, and the social and environmental for Biosecurity (NSABB) recommended impacts of research.30 Moreover, as the cases developing a “Code of Ethics for Life Scientists,” discussed in Chapter 4 illustrate, relevant issues and in 2007 published guidelines for developing arise in the majority of the broader core areas. a code of conduct for dual use research (NSABB, For example, RCR education in the life sciences 2007). NSABB later outlined core professional can readily address the following topics: responsibilities and general research responsibilities that could be incorporated into a Mentors’ responsibility for ensuring that code of conduct related to dual use research in trainees work safely in the laboratory, and the life sciences (NSABB, 2010). Several trainees’ responsibility for learning and prominent life scientists and science policy practicing safe laboratory and clinical scholars have also proposed a “Hippocratic Oath methods, asking for guidance when they feel for scientists” that both students and established unsure, and reporting spills and exposures; investigators can use as a point of reference for The secure collection, documentation, and professional behavior (Rotblat, 1999; Jones, management of research data, and policies, 2007; Cressey, 2007; Lehn, 2011). Most such regulations, and best practices regarding codes incorporate a provision against doing ownership and sharing of data and research harm through research, which would prompt tools with dual use potential; reflection on research integrity as well as dual How collaborative research, particularly use potential. across national borders, is governed by As noted in Chapter 1, a strong theme for national and international regulatory education and outreach related to dual use issues standards on the shipping of materials, and is to treat the topic within a broader framework how export controls define security interests of responsible conduct of research. Examples of and threats; how this framing works in practice may be 30 These topics have been addressed, for example, during discussions at meetings of the Biological Weapons Convention.
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28 Developing Capacities for Teaching Responsible Science in the MENA Region found in the activities of the IAP Biosecurity (IAP, 2005). In cooperation with other Working Group, established in 2004 to international scientific organizations, the group undertake IAP’s work at the intersection of organized the 1st and 2nd International Forums science and security, with a focus on dual use on Biosecurity in 2005 and 2008, respectively; issues.31 From the beginning, the group couched education and codes of conduct were discussed its work in the context of responsible conduct of in both meetings.32 These activities led to the science and the social responsibility of science. State Department’s request to hold the workshop The group’s first product, the 2005 IAP on Challenges and Opportunities for Education Statement on Biosecurity, identified About Dual Use Issues in the Life Sciences, which “fundamental issues that should be taken into in turn led to the project that is the subject of account when formulating codes of conduct” this report. 32 The first forum did not produce a report, although the 31 The current membership includes the national academies agenda and participants list are available at http://nas- of Australia, China, Cuba, Egypt, India, Nigeria, Poland sites.org/biosecurity/international/; the report of the second (chair), Pakistan, Russia, the United States, and the United forum was produced by the National Research Council Kingdom. (2009d).