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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct 3 The Research Environment and Its Impact on Integrity in Research To provide a scientific basis for describing and defining the research environment and its impact on integrity in research, it is necessary to articulate a conceptual framework that delineates the various components of this environment and the relationships between these factors. In this chapter, the committee proposes such a framework based on an opensystems model, which is often used to describe social organizations and the interrelationships between and among the component parts. This model offers a general framework that can be used to guide the specification of factors both internal and external to the research organization that is relevant to understanding integrity in research. After its review of the literature, the committee found that there is little empirical research to guide the development of hypotheses regarding the relationships between environmental factors and the responsible conduct of research. Thus, the committee drew on more general theoretical and research literature to inform its discussion. Relevant literature was found in the areas of organizational behavior and processes, ethical cultures and climates, moral development, adult learning and educational practices, and professional socialization.1 1 For general references on organizational behavior and processes, see Donabedian (1980), Hamner and Organ (1978), Harrison (1994), Katz (1980), Katz and Kahn (1978), Peters (1978), Peters and Waterman (1982), and Pfeffer (1981). For general references on ethical cultures and climate see Ashforth (1985), Schneider and Reichers (1983), and Victor and Cullen
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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct THE OPEN-SYSTEMS MODEL The open-systems model depicts the various elements of a social organization; these elements include the external environment, the organizational divisions or departments, the individuals comprising those divisions, and the reciprocal influences between the various organizational elements and the external environment (Ashforth, 1985; Beer, 1980; Daft, 1992; Harrison, 1994; Katz and Kahn, 1978; Schneider and Reichers, 1983). The underlying assumptions of the open-systems model and its various elements are as follows (Harrison, 1994): External conditions influence the inputs into an organization, affect the reception of outputs from an organization’s activities, and directly affect an organization’s internal operations. All system elements and their subcomponent parts are interrelated and influence one another in a multidirectional fashion (rather than through simple linear relationships). Any element or part of an organization can be viewed as a system in and of itself. There is a feedback loop whereby the system outputs and outcomes are used as system inputs over time, with continual change occurring in the organization. Organizational structure and processes are in part determined by the external environment and are influenced by the dynamics between and among organizational members. An organization’s success depends on its ability to adapt to its environment, to tie individual members to their roles and responsibilities within the organization, to conduct its processes, and to manage its operations over time. THE OPEN-SYSTEMS MODEL OF RESEARCH ORGANIZATIONS Figure 3-1 shows the application of the open-systems model to the research environment, which can include public and private institutions, such as research universities, medical schools, and independent research organizations. As noted above, any element or part of an organization can (1988). For general references on moral development, see Kohlberg (1984), Rest (1983), and Rest et al. (1999). For general references on adult learning and educational practices, see Brookfield (1986), Cross (1981), and Knowles (1970). For general references on professional socialization, see Schein (1968), Siehl and Martin (1984), Van Maanen and Schein (1979), and Wanous (1980).
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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct FIGURE 3-1 Open-systems model of the research organization. This model depicts the internal environmental elements of a research organization (white oval), showing the relationships among the inputs that provide resources for organizational functions, the structures and processes that define an organization’s operation, and the outputs and outcomes of an organization’s activities that are carried out by individual scientists, research groups or teams, and other research-related programs. All of these elements function within the context of an organization’s culture and climate. The internal environment is affected by the external environment (shaded area; see Figure 3-2 for further detail). The system is dynamic, and, as indicated by the feedback arrow, outputs and outcomes affect future inputs and resources.
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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct be viewed as a system in and of itself. For research organizations, then, this includes not only the institution itself, but also any of its departments, divisions, research groups, and so on. Figure 3-1 illustrates the research environment as a system that functions within an external environment, whereas Figure 3-2 depicts the specific factors within the external environment and their influence on the research organization. These factors within the external environment are discussed later in this section. An organization’s internal environment consists of a number of key elements—specifically, the inputs that provide resources for organizational functions, the organizational structure and processes that define an organization’s setup and operations, and the outputs and outcomes that are the results of an organization’s activities. The system is dynamic, and, as indicated by the feedback arrow in Figure 3-1, outputs and outcomes affect future inputs and resources. However, all of these components exist within the context of an organization’s culture and specific climate dimensions—that is, the prevailing norms and values that inform individuals within the organization about acceptable and unacceptable behaviors. With respect to the committee’s focus on integrity in research, the ethical dimension of the organizational culture and climate is very important. Structurally, organizations are compartmentalized into various subunits, including work groups or divisions (the research group or team), along with other defined sets of organizational activities and responsibilities (e.g., programs that educate members about the responsible conduct of research, institutional review boards [IRBs], and mechanisms for disclosing and managing conflicts of interest). The operation of these programs and their overall effectiveness influence researchers’ perceptions of the organization’s ethical climate. Individuals within an organization exist both within and across these defined groups and sets of activities. Given this, it is important to differentiate between an organizational level of analysis (e.g., the research university, medical school, and independent research organization) vis-à-vis the group level of analysis (e.g., the research group or team) and the individual level of analysis (e.g., the individual scientist or researcher). Inputs and Resources In its examination of research environments, the committee focused on two input and resource factors of importance: the levels and sources of funding for scientific research, and the characteristics of human resources. These inputs and resources are obtained from an organization’s external environment and are used in the production of an organization’s outputs.
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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct Funding The research funding that an organization receives is distributed to research groups or teams and to individual scientists. Funding levels may increase and decrease over the years, both for the organization as a whole and for individual research groups. Just as the overall level of funding available for research within society affects the scientific enterprise as a whole, the level of funding coming into a particular research organization or research team also affects behavior. The impacts that the level of funding and the competition over funding have on the responsible conduct of research are not clearly understood. There is some limited evidence that in highly competitive environments, individuals with a high “competitive achievement striving” are at risk for engaging in misconduct, particularly when they are faced with situations in which their expectations for success cannot be reached by exerting additional effort (Heitman, 2000; Perry et al., 1990). Encouraging a high level of individual integrity in research, despite vigorous competition for funding, presents a significant challenge for research organizations. Human Resources The human resources available to a research organization are also important to the analysis of integrity in research. The background characteristics of scientists coming into a research organization influence its structure and processes as well as its overall culture and climate, and these factors, in turn, influence the responsible conduct of research by individual scientists. Scientists (whether they are trainees, junior researchers, or senior researchers) entering into a research organization will have competing professional demands (e.g., research, teaching, practice, and professional service), and thus there are likely to be conflicting commitments. The dynamics of these competing demands and conflicting commitments change as individual scientists become integrated into the research organization, taking on specific roles and responsibilities. Also, scientists enter into an organization with various educational and cultural backgrounds. They have different conceptions of the collaborative and competitive roles of the scientist, different abilities to interpret the moral dimensions of problems, and different capacities to reason about and effectively resolve ethical problems. These individual differences will influence organizational behavior, in general, and research conduct, in particular, in complex and dynamic ways. Given this variation in human resource input into the research organization, it is particularly important for institutions to socialize newcom-
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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct ers and provide them with an understanding of the organization and how to act within it. As in any organization, newcomers must learn the logistics of their organization, the general expectations of their roles by peers, the formal and informal norms governing behavior, the status and power structures, the reward and communication systems, various organizational policies, and so on (Katz, 1980). Within research organizations, individual differences are complicated by the international nature of the scientific workforce and the corresponding sociocultural differences. Therefore, it is particularly important for research 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 the culture, to understand the importance of professional norms, to acquire the capacity to resolve ethical dilemmas, and to recognize and be able to address conflicting standards of research conduct. Organizational Structure and Processes Structure To better understand the impact of the research environment on integrity in research, it is important to focus on the organizational elements that characterize its structure—those elements that are more enduring and less prone to change on a day-to-day basis. These elements include an organization’s policies and procedures; the roles and responsibilities of members of the organization; decision-making practices; mission, goals and objectives, including the strategies and plans of the organization; and technology. Policies, Procedures, and Codes The formalization of policies and practices to support the responsible conduct of research is important in the analysis of research environments and their influence on integrity in research. Chapter 2 identified a number of the practices that are essential to the research environment. Specifically, a research organization should have explicit (versus implicit or nonexistent) procedures and systems in place to fairly (1) monitor and evaluate research performance, (2) distribute the resources needed for research, and (3) reward achievement. These policies and procedures should include criteria related to the responsible conduct of research that are applied consistently. Furthermore, research organizations support integrity in research when they have efficient and effective systems in place to review research involving humans and animals, manage conflicts of interest, respond to misconduct, and socialize trainees and other scientists into responsible research practices. The speci-
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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct fication of these policies and procedures helps to regulate and maintain group control and reduce uncertainty about acceptable and unacceptable behaviors (Hamner and Organ, 1978). Research has shown that strongly implemented and embedded ethical codes of conduct within organizations are associated with ethical behavior in the workplace. McCabe and Pavela (1998) describe the University of Maryland at College Park as one example where implementation of a strong “modified”2 honor code has proven to be a successful strategy for creating a culture where cheating is viewed as socially unacceptable. Major elements of the Maryland model include (1) involving students in educating their peers and resolving academic dishonesty allegations, (2) treating academic integrity as a moral issue, and (3) promoting enhanced student-faculty contact and better teaching. The mere presence of an honor code, however, is generally not sufficient. Rather, the honor code is used as a vehicle to create a shared understanding and acceptance of the policies on academic integrity among both faculty and students (McCabe and Trevino, 1993). Corporate codes have a similar effect in the workplace. An original study by McCabe demonstrated that self-reported unethical behavior was lower for survey respondents who worked in a company with a corporate code of conduct (McCabe et al., 1996). Self-reported unethical behavior was inversely correlated with the degree to which the codes were embedded in corporate philosophy and the strength with which the code was implemented (determined by survey questionnaire of employee perceptions). Roles and Responsibilities The specification of roles and responsibilities within various research groups and teams and relevant research programs (e.g., education in the responsible conduct of research, IRBs, and conflict-of-interest review committees) provides a blueprint for researcher behavior. It is particularly important to clearly define researchers’ responsibilities related to the responsible conduct of research. Furthermore, the 2 Traditional honor codes generally include a pledge that students sign attesting to the integrity of their work, a strong, often exclusive role for students in the judicial process that addresses dishonesty allegations, and provisions such as unproctored exams. Some also require students to report any cheating observed. Modified honor codes generally include a strong or exclusive role for students in the academic judicial system, but do not usually require unproctored exams or that students sign a pledge. Modified codes do place a strong campus focus on the issue of academic integrity and students are reminded frequently that their institution places a high value on integrity (McCabe, 2000).
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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct relative positions of these responsibilities within the organizational hierarchy and the status of persons who operate them will send a clear message to the research community about the importance of such endeavors. For example, if a highly respected scientist with high status spearheads the program of education in the responsible conduct of research, and sufficient resources (in terms of both staff and financial resources) are available to carry out the program’s work, then there is a greater likelihood that its efforts will be taken seriously. Again, these factors have great symbolic value within the organization and provide compelling images of the organization’s ethical culture, which affects the degree to which members of the organization will internalize the norms associated with the responsible conduct of research (Pfeffer, 1981; Siehl and Martin, 1984). Decision-Making Practices How an organization reaches decisions and formulates policies will affect individuals’ perceptions of these policies and their behavioral compliance with them. Individuals are more likely to accept and adhere to policies and practices when they have played a role in their development and implementation. Hence, scientists are more likely to buy into various research policy decisions that are reached through a collaborative process among key stakeholder groups, rather than being imposed by a top-level centralized authority (Anderson et al., 1995, Saraph et al., 1989). Organizational research that focuses on the pursuit of quality and that explicitly values cooperation and collaboration to achieve maximum effectiveness leads to better decisions, higher quality, and higher morale within an organization (NIST, 1999). Classically, faculty and administrators both have governing roles in academic institutions, and this shared responsibility facilitates the bottom-up establishment of rules of research behavior. Missions, Goals and Objectives, and Strategies and Plans The mission and goals of an organization specify its desired end states (e.g., becoming a “best-practice” site in terms of the protection of human research subjects). Objectives are the specific targets and indicators of goal attainment (e.g., becoming an accredited program and receiving recognitions and awards through scientific associations). Strategies and plans are the overall routes and specific courses of action (e.g., allocating the resources to comply with the standards for accreditation and ensuring that the program has leadership support) to the achievement of goals. If the responsible conduct of research is a prominent part of the mission and goals of a research organization, along with associated objectives, strategies, and plans, then the prominence of this issue sets the tone for the organization’s
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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct ethical climate and sends a message to scientists that the responsible conduct of research is important. Research has shown that the most successful organizations are those that have a vision and goals that are clearly defined, consistent, and shared among their members (Anderson et al., 1995; Deming, 1986; Freuberg, 1986; Hackman and Wageman, 1995). Technology An organization’s technology offers the methods for transforming system resources into system outputs. It consists of such aspects of an organization’s infrastructure as facilities, tools and equipment, and techniques. These aspects can be mental and social, mechanical, chemical, physical, or electronic. Research environments not only need the necessary tools and equipment for their respective types of scientific research, but they must also establish technologies (e.g., accounting systems and library and information retrieval systems) within the organization for the effective and efficient operation of the research. There may be competition within an organization to acquire the various forms of technology that are of sufficient quantity and quality to facilitate research production. The availability of this technology may, in turn, attract highly skilled scientists who hope to carry out research at the cutting edge of technology. As already mentioned, the effective management of competition—in this case, for technologies—is an important element of promoting the responsible conduct of research. Processes Organizational processes, as opposed to an organization’s more stable and enduring structural elements, are the patterned forms of interaction between and among groups or individuals within an organization. Processes represent the dynamic aspects of an organization. The processes that characterize organizational dynamics are too numerous to mention here. However, in the committee’s examination of research organizations, the processes of most interest consist of (1) leadership, (2) competition, (3) supervision, (4) communication, (5) socialization, and (6) organizational learning. Leadership The level of support for high ethical standards by the leadership of an organization or research group can vary; leaders can be extremely supportive, can show ambivalence, or can be nonsupportive. Leaders at every level serve as role models for organizational members and set the tone for an organization’s ethical climate (Ashforth, 1985; OGE, 2000; Treviño et al., 1996). Therefore, when leaders support high ethical standards, pay attention to responsible conduct of research, and
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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct are openly and strongly committed to integrity in research, they send a clear message about the importance of adhering to responsible research practices (Wimbush and Shepard, 1994). Considerable evidence from the organizational research literature supports the relationship between supervisor behavior and the ethical conduct of the members of an organization (Posner and Schmidt, 1982, 1984; Walker et al., 1979). Supervisors provide a model for how subordinates should act in an organization. Furthermore, supervisors have a primary influence over their subordinates, an influence that is greater than that of an ethics policy. Even if a company or profession has an ethics policy or code of conduct, subordinates follow the leads of their supervisors (Andrews, 1989). Competition The extent to which the organization is highly competitive, along with the extent to which its rewards (e.g., funding, recognition, access to quality trainees, and power and influence over others) are based on extramural funding and short-term research production, may have negative impacts on integrity in research. Evidence from organizational research indicates that reward systems based on self-interest and commitment only to self rather than to coworkers and the organization are negatively associated with ethical conduct (Kurland, 1996; Treviño et al., 1996). In addition, the level of unethical behavior increases in organizations where there is a high degree of competitiveness among workers (Hegarty and Sims, 1978, 1979). Given these facts, one might expect that a research environment in which competition for resources is fierce and rewards accrue to those who produce the most over the short term sends a wrong message, a message that says “produce at all costs.” Creating a reward system and policies that promote being the “best” within the scientific enterprise, and within a context that encourages the responsible conduct of research, represents a challenge in research environments. Supervision The extent to which research behavior is monitored and quality control systems are operational will affect the level of adherence to ethical standards. Scientists need to see that policies about responsible research behavior are not just window dressing and that the organization has implemented practices that follow up stated policies. Consistency between words and deeds encourages the members of an organization to take policies seriously. Organizations vary widely in terms of their efforts to communicate codes of conduct to members, as well as to implement mechanisms to ensure compliance. When implementation is forceful and the policies and practices become deeply embedded in an organization’s culture, there is a greater likelihood that they will be effective in prevent-
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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct ing unethical behavior (McCabe and Treviño, 1993; Treviño, 1990; OGE, 2000). Communication Communication among members of a research organization or research group that is frequent and open, versus infrequent and closed, should have a positive influence on integrity in research. A positive ethical climate is supported by open discussions about ethical issues (Jendrek, 1992; OGE, 2000). Frequent and open communication enhances awareness of issues, encourages individuals to seek advice when faced with ethical dilemmas, and establishes the importance of resolving issues before they become something to be hidden. Socialization Mentoring relationships between research trainees and their advisers are important in the socialization of young scientists (Anderson et al., 2001; Swazey and Anderson, 1998). These relationships can be characterized by a variety of factors, including the level of trust, communication patterns, and the fulfillment of responsibilities as a mentor or trainee. In addition to mentoring relationships, education in research and professional ethics is an aspect of socialization (Anderson, 1996; Anderson and Louis, 1994; Anderson et al., 1994; Louis et al., 1995; Swazey et al., 1993). Socialization practices can be formal or informal, but they are essential to helping individuals internalize the norms and values associated with the responsible conduct of research. Research that examines the effect of more formalized methods of socialization—for example, education—reveals that interactive techniques (e.g., case discussion, roleplaying, and hands-on practice sessions) are generally more effective in producing behavioral change than are activities with minimal participant interaction or discussion (e.g., lectures or presentations [Davis et al., 1999]). Furthermore, sequenced education has a greater impact than single educational sessions (Davis et al., 1999; OGE, 2000). These findings substantiate the principles of adult education; these principles describe successful practices as being learner-centered, active rather than passive, relevant to the learner’s needs, engaging, and reinforcing (Brookfield, 1986; Cross, 1981; Knowles, 1970) (Chapter 5). Organizational Learning Organizations that learn from their operations and that continuously seek to improve their performance are better able to adapt to a changing environment (Anderson et al., 1994; Deming, 1986; Hackman and Wageman, 1995; Schön, 1983). All organizations change over time, but for some this can be an excruciating and painful process if it comes about through reaction to a crisis situation. For example, when a research subject dies or a researcher is accused of data fabrication, the
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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct Outputs and Outcomes Outputs The outputs of research organizations are produced at all levels—the organizational level, the research group or team level, and the individual scientist level. The outputs are the products produced, the services delivered, and the ideas developed and tested. The most obvious outputs are the number and quality of research projects completed, reports written, publications produced, patents filed, and students graduated. For the committee’s purposes, however, it is important to focus on the outputs of activities or programs related to integrity in research—for example, institutional review boards, conflict-of-interest review committees, and programs that provide education in the responsible conduct of research. Outputs from these programs are generally measured in terms of the quantity and the quality of activities—for example, the number of workshops and seminars offered, the number of scientists who participate, and the number of research proposals reviewed by IRBs and the dispositions of those proposals. Research organizations that design and implement high-quality activities related to integrity in research—and in a quantity that is sufficient to meet their needs—are more likely to achieve the outcomes that they seek (e.g., adherence to responsible research practices). Although these activities will not be the sole factors that determine the responsible conduct of research, their implementation becomes a symbol for the members of an organization, serving as an indicator of the leadership’s commitment to the establishment of a culture and a climate that supports the responsible conduct of research. Outcomes The outcomes of organizational activities refer to the specific results that reflect the achievement of goals and objectives. As with organizational outputs, outcomes can be associated with the organization as a whole, the research group, or the individual scientist. However, the committee’s primary interest is in the individual scientist’s level of integrity in research. As discussed in Chapter 2, the committee defines integrity in research as the individual scientist’s adherence to a number of normative practices for the responsible conduct of research. Adherence to these practices provides a set of behavioral indicators of an individual’s integrity in research. However, behavioral compliance is assumed to be associated with an understanding of the norms, rules, and practices of science. In addition, judgments about an individual’s integrity are based on the extent to which intellectual honesty, accuracy, fair-
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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct ness, and collegiality consistently characterize the dispositions and attitudes reflected in a researcher’s practice. Judgments about a person’s integrity are less about strict adherence to the rules of practice and are more about the disposition to be intellectually honest, accurate, and fair in the practice of science (i.e., in the willingness to admit and correct one’s errors and shortcomings). The committee resisted defining integrity in terms of (1) adherence to the normative practices listed in Chapter 2, (2) the knowledge and awareness of the practices of responsible research, and (3) the attitudes and orientation toward the practices of responsible research (i.e., the degree to which individuals agree with the practices, the level of importance that they attach to them, and the extent to which they are subject to conflicting sets of practices), as has been common in the social sciences.3 These three conceptually distinct categories of outcomes fail to capture the complexity of the process through which individuals interact with their environment and make ethical decisions. One simply cannot assume that as scientists gain awareness of standards of practice, they will be positively oriented to them or will be more likely to adhere to the behavioral requirements. The committee recognizes that although researchers might be well intentioned, there is truth in what psychologists (Rest, 1983) have observed: that everyone is capable of missing a moral issue (moral blindness); developing elaborate and internally persuasive arguments to justify questionable actions (defective reasoning); failing to prioritize a moral value over a personal one (lack of motivation or commitment); being ineffectual, devious, or careless (character or personality defects, often implied when someone is referred to as “a jerk”); or having ineffectual skills at problem solving or interpersonal communication (incompetence). For this reason, focusing on the processes that give rise to the responsible conduct of research are important individual-level outcomes of organizational activities within the research environment. Components of the process of ethical decision making include ethical sensitivity, reason- 3 A recent review of approaches to the study of morality (Bebeau et al., 1999) has challenged the usefulness of the usual tripartite view that assumes that the elements to be studied and assessed are attitudes, knowledge, and behavior. When researchers have studied the connections among these elements, they usually do not find significant connections and are left with the conclusion that attitudes do not have much to do with knowing and behavior is often devoid of feeling and thinking. A more profitable approach is to assume that many types of cognitions, many types of affects, and many kinds of observable behaviors are involved in morality or integrity. All behavior is the result of cognitive-affective processes. Instead of studying cognitions, affects, and behaviors as separate elements, psychologists suggest that researchers study functional processes that must arise to produce moral behavior (Rest, 1983).
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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct ing, moral motivation and commitment, and character and competence (Bebeau, 2001). Educational programs that train scientists in the responsible conduct of research are often premised on the assumption that these essential capacities for ethical decision making are well developed by the time individuals begin their research education, and that one simply needs to teach the rules of the responsible conduct of research. Research on ethical development in the professions demonstrates that even mature professionals show considerable variability on performance assessments that measure ethical sensitivity, moral reasoning and judgment, professional role orientation, and appropriate character and competence to implement action plans effectively. Therefore, if a research environment implements educational programs to foster integrity in research, then these programs should promote sensitivity to issues that are likely to arise in the research setting by building a capacity for reasoning carefully about conflicts inherent in proposing, conducting, and reporting research; by developing a sense of personal identity that incorporates the norms and values of the research culture; and by building competence in problem solving and interpersonal communication (see Chapter 5 for further discussion). External Environment The external environment of a research organization consists of both an external-task environment and a general environment (Figure 3-2). The external-task environment includes all the organizations and conditions that are directly related to an organization’s main operations and its technologies. The systems and subsystems of the external-task environment are embedded within the larger sociocultural, political, and economic environment and have a more indirect impact on an organization. It is important to recognize that relationships also exist between and among all elements within the external environment. For example, government policies and regulations can affect the areas and levels of funding. Journal policies can be affected by decisions made within scientific associations, and these decisions can be driven by government regulation (or pending regulation). External-Task Environment A number of factors within the external-task environment have a significant impact on scientists’ responsible conduct of research. These factors include government regulation, funding for scientific work, job opportunities for trainees and researchers, journal policies and practices, and the policies and practices of scientific societies.
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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct FIGURE 3-2 Environmental influences on integrity in research that are external to research organizations. The external-task environment includes all of the organizations and conditions that are directly related to an organization’s main operations and technologies. The double arrows depict the interrelatedness between the research organization and the various external influences (unshaded circles) that are hypothesized to have an impact on integrity in research. The general environment has a more indirect impact on an organization. The systems and subsystems of the external-task environment are embedded within the larger, general sociocultural, political, and economic environment (shaded area). Although not specifically shown in this figure, it is important to recognize that relationships exist between and among the elements within the external environment.
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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct Government Regulation Governmental bodies, particularly at the federal level, have been promulgating regulations concerning the conduct of research for many years. Most widely known and recognized are the regulations regarding the protection of human research subjects (45 C.F.R. § 46, 1999; 21 C.F.R. § 50 and 56, 1998) and the protection of animals in research (7 U.S.C. §§ 2131, 1966, et seq.). Furthermore, regulations have been promulgated regarding the evaluation of allegations and the reporting of scientific misconduct (42 C.F.R. § 50, §§A, 1989; Federal Register, 2000) and the handling and disposal of hazardous chemicals in the laboratory (29 C.F.R. § 1910.1450, 1996), to name just two. As these government regulations come into force, they have direct impacts on a research organization and individual scientists. Specifically, organizations and individuals must be in compliance with the regulations or face sanctions. Funding for Scientific Work Research organizations are directly affected by both the level and the source of funding that is available for scientific work (e.g., they are affected by the balances between government and corporate support and between industry and foundation support). Most funding sources provide support for specific research proposals rather than particular investigators. Although proposals are usually ranked on a relative scale, more typically they are funded in an all-or-none fashion. At the same time, funding needs always outpace funding opportunities. For instance, only one in three investigator-initiated grant proposals (see http://silk.nih.gov/public/cbz2zoz.@www.com.rpg.act.dsncc) to the National Institutes of Health is successful. In this situation, even investigators who succeed in their research sometimes lose funding, a fate that threatens the very existence of their projects and often threatens their personal incomes. The task for research organizations is to develop structures that help their scientists deal with this competitive research situation while maintaining the responsible conduct of research. Similarly, when corporate or industry funds are involved, research organizations should require strategies for the management and disclosure of conflicts of interest to reduce problems related to publication rights, ownership of intellectual property, and research involving human subjects. Job Opportunities When the job market is tight and there is more competition for every research position, researchers will be pressured to achieve higher levels of productivity and recognition. This situation challenges scientists to be the best while maintaining the highest levels of integrity in research. Similarly, research programs must compete for students and postdoctoral fellows, who, in turn, enhance a program’s accomplishments and overall status. The ability of researchers to gain rec-
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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct ognition often is believed to be the best path to attracting high-quality trainees to a program. The organizational challenge is to help researchers develop competitive programs while maintaining a high level of commitment to integrity in research. Journal Policies and Practices Journal editors can be more or less rigorous in their implementation of the review process and the extent to which they insist on high levels of adherence to scientific standards. Furthermore, journals may have specific policies in such areas as authorship practices, disclosure of conflicts of interest, duplicate publication, and reporting of research methodologies. The scientific community receives an important message about integrity in research when journal policies and practices regarding these practices are clear and are required as a condition of publication—and when the most prestigious journals adopt such practices. For example, members of the International Committee of Medical Journal Editors recently revised their submission policies related to industry-sponsored research. Authors are now required to sign a statement accepting full responsibility for the conduct of a clinical trial, and they must confirm that they had access to the original data and had full control over the decision to publish (Davidoff et al., 2001). Policies and Practices of Scientific Societies Scientific societies are in a position to influence the behaviors of their members in ways that could promote integrity in research4 (AAAS, 2000). The societies vary extensively, however, in their development of codes of conduct, their enforcement of such codes, and their socialization of members with regard to these standards of behavior. To aid in this process, the Association of American Medical Colleges has published a guide to help societies in the development of ethical codes (AAMC, 1997). Other associations develop standards for accreditation—for example, standards for science education programs, research laboratories, and programs for the protection of human and animal research subjects. These accreditation standards generally have specific statements regarding the responsible conduct of research and stipulate the structures within the organization that must be in place to ensure compliance with the standards. Scientists who are part of such accredited programs will be subject to the influences of these external controls. 4 See Chapter 6 for further discussion of the role professional and scientific societies can play in fostering an environment that promotes integrity in research.
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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct General Environment The general environment has an indirect impact on an organization. This environment includes all of the conditions and institutions that have sustained or infrequent impacts on the organization and its functions (Harrison, 1994). Included are the state or conditions of major social institutions (e.g., the economy, political system, educational system, science and technology system, and legal system) as well as the local, national, and international cultures within which an organization operates. The general public, and more specifically the effects of public trust in the research enterprise, are also important components of the general environment. As reflected in Figure 3-2, the organizations and conditions of the external-task environment (unshaded circles) are embedded within this larger environment (shaded area). An example of how the broader environment can affect the conduct of research is the recent national debate over embryonic stem cell research; this debate reflects a clash of values that affect the characterization of ethical or unethical research (NAS, 2001; National Bioethics Advisory Commission, 1999). In another instance, the new rules governing the privacy of health records that are part of the Health Insurance Portability and Accountability Act are being challenged by scientists as too restrictive in providing access to identifiable data for research (AAMC, 2001; Annas, 2002). Also, society places a high premium on human rights and the protection of vulnerable persons, values that have been translated into federal regulations for the protection of human research subjects (45 C.F.R. § 46, 1993, and 21 C.F.R. § 50 and 56, 1981). Other social institutions also have an indirect impact on research environments. Educational systems produce scientists, and these systems affect not only their quantity but also their quality and how well they have been socialized into professional standards of conduct. The technology systems determine the availability of equipment and the methods used to carry out various types of research, factors that may raise questions about the propriety of certain research endeavors. Ethical conflicts are often created when the development of new technologies requires an answer to the question of whether what can be done should be done. Finally, the legal system and the propensity in the United States to resort to litigation may bring about situations in which scientists are caught between the responsible conduct of research and subpoenas for confidential data. These examples are by no means exhaustive, but they reflect the ways in which major social institutions and cultural values can affect research organizations and a scientist’s practice of research.
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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct SUMMARY The committee found no comprehensive body of research or writing that can guide the development of hypotheses regarding the relationships between the research environment and the responsible conduct of research. However, viewing the research environment as an open-systems model, which is often used in general organizational and administrative theory, makes it possible to hypothesize how various components affect integrity in research. Inputs of funds and other resources can influence behavior both positively and negatively. The organizational structure and processes that typify the mission and activities of an organization can either promote or detract from the responsible conduct of research. The culture and climate that are unique to an organization both promote and perpetuate certain behaviors. Finally, the external environment, over which individuals and, often, institutions have little control, can affect behavior and alter institutional integrity for better or for worse. 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]. AAMC (Association of American Medical Colleges). 1997. Developing a Code of Ethics in Research: A Guide for Scientific Societies. Washington, DC: AAMC. AAMC. 2001. Letter to Secretary Thompson on Impact of Medical Privacy Rule on Research. [Online]. Available: http://www.aamc.org/advocacy/corres/research/thompson.htm [Accessed February 1, 2002]. Anderson J, Rungtusanatham M, Schroeder R, Devaraj S. 1995. A path analytic model of a theory of quality management underlying the Deming management method: Preliminary empirical findings. Decision Sciences 26:637–658. Anderson MS. 1996. Misconduct and departmental context: Evidence from the Acadia Institute’s Graduate Education Project. Journal of Information Ethics 5(1):15–33. Anderson MS, Louis KS. 1994. The graduate student experience and subscription to the norms of science. Research in Higher Education 35:273–299. Anderson MS, Louis KS, Earle J. 1994. Disciplinary and departmental effects on observations of faculty and graduate student misconduct. Journal of Higher Education 65:331– 350. Anderson MS, Oju EC, Falkner TMR. 2001. Help from faculty: Findings from the Acadia Institute Graduate Education Study. Science and Engineering Ethics 7:487–503. Andrews KR. 1989. Ethics in practice. Harvard Business Review Sept-Oct:99–104. Annas GJ. 2002. Medical privacy and medical research—judging the new federal regulations. New England Journal of Medicine 346:216–220. Ashforth BE. 1985. Climate formation: Issues and extensions. Academy of Management Review 10:837–847. Bebeau MJ. 2001. Influencing the moral dimensions of professional practice: Implications for teaching and assessing for research integrity. In: Steneck NH, Scheetz MD, eds. . Investigating Research Integrity: Proceedings of the First ORI Research Conference on
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Representative terms from entire chapter: