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