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National Research Council (US) and Institute of Medicine (US) Committee on Assessing Integrity in Research Environments. Integrity in Scientific Research: Creating an Environment That Promotes Responsible Conduct. Washington (DC): National Academies Press (US); 2002.

Integrity in Scientific Research: Creating an Environment That Promotes Responsible Conduct.

• Hardcopy Version at National Academies Press

2 Integrity in Research

The pursuit and dissemination of knowledge enjoy a place of distinction in American culture, and the public expects to reap considerable benefit from the creative and innovative contributions of scientists. As science becomes increasingly intertwined with major social, philosophical, economic, and political issues, scientists become more accountable to the larger society of which they are a part. As a consequence, it is more important than ever that individual scientists and their institutions periodically reassess the values and professional practices that guide their research as well as their efforts to perform their work with integrity.

Society's confidence in and support of research rest in large part on public trust in the integrities of individual researchers and their supporting institutions. The National Academies' report On Being a Scientist states: “The level of trust that has characterized science and its relationship with society has contributed to a period of unparalleled scientific productivity. But this trust will endure only if the scientific community devotes itself to exemplifying and transmitting the values associated with ethical scientific conduct” (NAS, 1995, preface). It is therefore incumbent on all scientists and scientific institutions to create and nurture a research environment that promotes high ethical standards, contributes to ongoing professional development, and preserves public confidence in the scientific enterprise (Grinnell, 1999; IOM, 2001; Resnik, 1998; Yarborough and Sharp, 2002).

Government oversight of scientific research is important, but such oversight, often in the form of administrative rules, typically stipulates what cannot be done; it rarely prescribes what should be done (see Chapter 4 for further discussion of the strengths and limitations of a regulatory approach). In essence, government rules define the floor of expected behavior. More, however, should be expected from scientists when it comes to the responsible conduct of research. By appealing to the conscience of individual scientists, the scientific community as a whole should seek to evoke the highest possible standard of research behavior. When institutions committed to promoting integrity in research support those standards, the likelihood of creating an environment that advances responsible research practices is greatly enhanced. It is essential that institutions foster a culture of integrity in which students and trainees, as well as senior researchers and administrators, have an understanding of and commitment to integrity in research.

The committee's task was to define integrity for the particular activity of research as conducted within contemporary society. Integrity has two general senses. The first sense concerns wholeness; the second, soundness of moral principle ( Oxford English Dictionary , 1989). Plato and subsequent philosophers have argued that leading the good life depends on a person's success in integrating moral, religious, and philosophical convictions. In conversations with experts in ethics and others, the committee found no consensus regarding whether a person could exhibit high integrity in research but not in other aspects of his life. Consequently, the committee decided to focus on the second aspect of integrity—namely, soundness of moral principle in the specific context of research practice.

• INTEGRITY IN RESEARCH

Integrity characterizes both individual researchers and the institutions in which they work. For individuals, it is an aspect of moral character and experience. 1 For institutions, it is a matter of creating an environment that promotes responsible conduct by embracing standards of excellence, trustworthiness, and lawfulness that inform institutional practices.

For the individual scientist, integrity embodies above all a commitment to intellectual honesty and personal responsibility for one's actions and to a range of practices that characterize responsible research conduct. These practices include:

• intellectual honesty in proposing, performing, and reporting research;
• accuracy in representing contributions to research proposals and reports;
• fairness in peer review;
• collegiality in scientific interactions, including communications and sharing of resources;
• transparency in conflicts of interest or potential conflicts of interest;
• protection of human subjects in the conduct of research;
• humane care of animals in the conduct of research; and
• adherence to the mutual responsibilities between investigators and their research teams.

Individual scientists work within complex organizational structures. (These structures and their interactions are described in detail in Chapter 3 .) Factors that promote responsible conduct can exert their influences at the level of the individual; at the level of the work group (e.g., the research group); and at the level of the research institution itself. These different organizational levels are interdependent in the conduct of research. Institutions seeking to create an environment that promotes responsible conduct by individual scientists and that fosters integrity must establish and continuously monitor structures, processes, policies, and procedures that:

• provide leadership in support of responsible conduct of research;
• encourage respect for everyone involved in the research enterprise;
• promote productive interactions between trainees and mentors;
• advocate adherence to the rules regarding all aspects of the conduct of research, especially research involving human subjects and animals;
• anticipate, reveal, and manage individual and institutional conflicts of interest;
• arrange timely and thorough inquiries and investigations of allegations of scientific misconduct and apply appropriate administrative sanctions;
• offer educational opportunities pertaining to integrity in the conduct of research; and
• monitor and evaluate the institutional environment supporting integrity in the conduct of research and use this knowledge for continuous quality improvement.

Leadership by individuals of high personal integrity helps to foster an environment in which scientists can openly discuss responsible research practices in the face of conflicting pressures. All those involved in the research enterprise should acknowledge that integrity is a key dimension of the essence of being a scientist and not a set of externally imposed regulatory constraints.

• INTEGRITY OF THE INDIVIDUAL SCIENTIST

As noted above, the committee has identified a range of key practices that pertain to the responsible conduct of research by individual scientists. The following sections elucidate the practices. 2

Intellectual Honesty in Proposing, Performing, and Reporting Research

Intellectual honesty in proposing, performing, and reporting research refers to honesty with respect to the meaning of one's research. It is expected that researchers present proposals and data honestly and communicate their best understanding of the work in writing and verbally. The descriptions of an individual's work found in such communications frequently present selected data from the work organized into frameworks that emphasize conceptual understanding rather than the chronology of the discovery process. Clear and accurate research records must underlie these descriptions, however. Researchers must be advocates for their research conclusions in the face of collegial skepticism and must acknowledge errors.

Accuracy in Representing Contributions to Research Proposals and Reports

Accuracy in representing one's contributions to research proposals and reports requires the assignment of credit. It is expected that researchers will not report the work of others as if it were their own. This is plagiarism. Furthermore, they should be honest with respect to the contributions of colleagues and collaborators. Decisions regarding authorship are best anticipated at the outset of projects rather than at their completion. In publications, it should be possible in principle to specify each author's contribution to the work. It also is expected that researchers honestly acknowledge the precedents on which their research is based.

Fairness in Peer Review

Fairness in peer review means that researchers should agree to be peer reviewers only when they can be impartial in their judgments and only when have revealed their conflicts of interest. Peer review functions to maintain the excellence of published scientific work and ensure a merit-based system of support for research. A delicate balance pervades the peer-review system, because the best reviewers are precisely those individuals who have the most to gain from “insider information”: they are doing similar work and they will be unable to “strike” from memory and thought what they learn through the review process. Investigators serving as peer reviewers should treat submitted manuscripts and grant applications fairly and confidentially and avoid using them inappropriately.

Collegiality in Scientific Interactions, Including Communications and Sharing of Resources

Collegiality in scientific interactions, including communications and sharing of resources requires that investigators report research findings to the scientific community in a full, open, and timely fashion. At the same time, it should be recognized that the scientific community is highly competitive. The investigator who first reports new and important findings gets credited with the discovery.

It is not obvious that rapid reporting is the approach that is always the most conducive to progress. Intellectual property provisions and secrecy allow for patents and licensure and encourage private investment in research. Furthermore, even for publicly funded research, a degree of discretion may permit a research group to move ahead more efficiently. Conversely, an investigator who delays reporting important new findings risks having others publish similar results first and receiving little recognition for the discovery. Knowing when and how much to tell will always remain a challenge in scientific communication.

Once scientific work is published, researchers are expected to share unique materials with other scientists in a reasonable fashion to facilitate confirmation of their results. (The committee recognizes that there are limits to sharing, especially when doing so requires a time or cost commitment that interferes with the function of the research group.) When materials are developed through public funding, the requirement for sharing is even greater. Public funding is based on the principle that the public good is advanced by science conducted in the interest of humanity. This commitment to the public good implies a responsibility to share materials with others to demonstrate reproducibility and to facilitate the replication and validation of one's work by responding constructively to inquiries from other scientists, particularly regarding methodologies.

Collegiality and sharing of resources is also an important aspect of the interaction between trainees and their graduate or postdoctoral advisers. Students and fellows will ultimately depart the research team, and discussion of and planning for departure should occur over the course of their education. Expectations about such issues as who inherits intellectual property rights to a project or to the project itself upon the trainee's departure should be discussed when the trainee first joins the research group and should be revisited periodically over the course of the project (NAS, 2000).

Transparency in Conflicts of Interest or Potential Conflicts of Interest

A conflict of interest in research exists when the individual has interests in the outcome of the research that may lead to a personal advantage and that might therefore, in actuality or appearance, compromise the integrity of the research. The most compelling example is competition between financial reward and the integrity of the research process. Religious, political, or social beliefs can also be undisclosed sources of research bias.

Many scientific advances that reach the public often involve extensive collaboration between academia and industry (Blumenthal et al., 1996; Campbell et al., 1998; Cho et al., 2000). Such collaborations involve consulting and advisory services as well as the development of specific inventions, and they can result in direct financial benefit to both individuals and institutions. Conflicts of interest reside in a situation itself, not in any behavior of members of a research team. Thus, researchers should disclose all conflicts of interest to their institutions so that the researchers and their work can be properly managed. They should also voluntarily disclose conflicts of interest in all publications and presentations resulting from the research. The committee believes that scientific institutions, including universities, research institutes, professional societies, and professional and lay journals, should embrace disclosure of conflicts of interest as an essential component of integrity in research.

Protection of Human Subjects in the Conduct of Research

The protection of individuals who volunteer to participate in research is essential to integrity in research. The ethical principles underlying such research have been elaborated on in international codes and have been integrated into national regulatory frameworks (in the United States, 45 C.F.R. § 46, 2001). Elements included in such frameworks pertain to the quality and importance of the science, its risks and benefits, fairness in the selection of subjects, and, above all, the voluntary participation and informed consent of subjects. To ensure the conformance of research efforts with these goals, institutions carry out extensive research subject protection programs. To be successful, such programs require high-level, functioning institutional review boards, knowledgeable investigators, ongoing performance assessment through monitoring and feedback, and educational programs (IOM, 2001). The IOM report Preserving Public Trust (IOM, 2001) focuses specifically on the important topic of research involving human subjects, and further discussion is not included here.

Humane Care of Animals in the Conduct of Research

The humane care of animals is essential for producing sound science and its social benefits. Researchers have a responsibility to engage in the humane care of animals in the conduct of research. This means evaluating the need for animals in any particular protocol, ensuring that research animals' basic needs for life are met prior to research, and carefully considering the benefits of the research to society or to animals versus the likely harms to any animals included as part of the research protocol. Procedures that minimize animal pain, suffering, and distress should be implemented. Research protocols involving animals must be reviewed and approved by properly constituted bodies, as required by law (Animal Welfare Act of 1966 [PL 89-544], inclusive of amendments passed in 1970 [PL 91-579], 1976 [PL 94-279], 1985 [PL 99-198], and 1990 [PL 101-624] and subsequent amendments) and professional standards (AAALAC, 2001; NRC, 1996).

Adherence to the Mutual Responsibilities Between Investigators and Their Research Teams

Adherence to the mutual responsibilities between investigators and members of their research teams refers to both scientific and interpersonal interactions. The research team might include other faculty members, colleagues (including coinvestigators), and trainees (undergraduate students, graduate and medical students, postdoctoral fellows), as well as employed staff (e.g., technicians, statisticians, study coordinators, nurses, animal handlers, and administrative personnel). The head of the research team should encourage all members of the team to achieve their career goals. The interpersonal interactions should reflect mutual respect among members of the team, fairness in assignment of responsibilities and effort, open and frequent communication, and accountability. In this regard, scientists should also conduct disputes professionally (Gunsalus, 1998). (The American Association of University Professors (AAUP) guidelines on academic freedom and professional ethics articulate the obligation of members of the academic community to root their statements in fact and to respect the opinions of others [AAUP, 1987, 1999].)

Mentoring and Advising

Mentor is often used interchangeably with faculty adviser . However, a mentor is more than a supervisor or an adviser (Bird, 2001; Swazey and Anderson, 1998). 3 An investigator or research adviser may or may not be a mentor. Some advisers may be accomplished researchers but do not have the time, training, or ability to be good mentors (NAS, 2000). For a trainee, “a mentoring relationship is a close, individualized relationship that develops over time between a graduate student (or other trainee) and a faculty member (or others) that includes both caring and guidance” (University of Michigan, 1999, p. 5). A successful mentoring relationship is based on mutual respect, trust, understanding, and empathy (NAS, 1997). Mentoring relationships can extend throughout all phases of a science career, and, as such, they are sometimes referred to as mentor-protégé or mentor-apprentice relationships, rather than mentor-trainee relationships.

The committee believes that mentor should be the dominant and usual role of the laboratory director or research advisor in regard to his or her trainee. With regard to such mentor-trainee relationships, responsibilities include a commitment to continuous education and guidance of trainees, appropriate delegation of responsibility, regular review and constructive appraisal of trainees, fair attribution of accomplishment and authorship, and career guidance, as well as help in creating opportunities for employment and funding. For the trainee, essential elements include respect for the mentor, loyalty to the research group, a strong commitment to science, dedication to the project, careful performance of experiments, precise and complete record keeping, accurate reporting of results, and a commitment to oral and written presentations and publication. It should be noted that most academic research institutions play a dual role. On the one hand, they are concerned with producing original research; on the other, with educating students. The two goals are compatible, but when they come in conflict, it is important that the educational needs of the students not be forgotten. If students are exploited, then they will learn by example that such behavior is acceptable.

• SUPPORT OF INTEGRITY BY THE RESEARCH INSTITUTION

The individual investigator and the laboratory or research unit carry out their functions in institutions that are responsible for the management and support of the research carried out within their domains. The institutions, in turn, are regulated by governmental and other bodies that impose rules and responsibilities (see Chapter 3 for further discussion). The vigor, resources, and attitudes with which institutions carry out their responsibilities will influence investigators' commitment and adherence to responsible research practices.

Provide Leadership in Support of Responsible Conduct of Research

It takes the leadership of an institution to promulgate a culture of responsible research. This involves the development of a vision for the research enterprise and a strategic plan. It is the responsibility of the institution leadership to develop programs to orient new researchers to institutional policies, rules, and guidelines; to sponsor opportunities for dialogue about new and emerging issues; and to sponsor continuing education about new policies and regulations as they are developed. Furthermore, institutional leaders have the responsibility to ensure that such programs are carried out, with appropriate delegation of responsibility and accountability and with adequate resources.

The observed actions of institutions in problem situations communicate as strongly (or perhaps more strongly) about responsible conduct as do any policies or programs. Institutional leaders (e.g., chancellor, president, dean, CEO) set the tone for the institutions with their own actions. Research leaders 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 (Sigma Xi, 1999). McCabe and Pavela note that “faculty members who seek to instill a sense of social obligation without affirming personal virtues are planting trees without roots” (McCabe and Pavela, 1998, p.101).

Encourage Respect for Everyone Involved in the Research Enterprise

An environment that fosters competence and honest interactions among all participants in the investigative process supports the integrity of research. Institutions have many legally mandated policies that foster mutual respect and trust—for example, policies concerning harassment, occupational health and safety, fair employment practices, pay and benefits, protection of research subjects, exposure to ionizing radiation, and due process regarding allegations of research misconduct. State and local policies and guidelines governing research may be in effect as well. It is anticipated that through a process of self-assessment, institutions can identify issues and develop programs that further integrity in research (see Chapter 6 for further discussion). Fair enforcement of all institutional policies is a critical element of the institutional commitment to integrity in research. That is not enough, however.

Support Systems

Within the research institution, there can be multiple smaller units (e.g., departments, divisions within a department, research groups within a division). Within these institutional subunits, there will always be power differences between members of the group. Consequently, research institutions require support mechanisms—for example, ombudspersons—that research team members can turn to for help when they feel they are being treated unfairly. Institutions need to provide guidance and recourse to anyone with concerns about research integrity (e.g., a student who observes a lack of responsible conduct by a senior faculty member). Support systems should be accessible (multiple entry points for those with questions) and have a record of reaching objective, fact-based decisions untainted by personal bias or conflicts of interest (Gunsalus, 1993). Lack of recourse within the institution for those individuals who have concerns about possible misconduct will undermine efforts to foster a climate of integrity. Equally important to having support systems in place is the dissemination of information on how and where individuals may seek such support.

The ultimate goal for institutions should be to create a culture within which all persons on a research team can work effectively and realize their full potential.

Promote Productive Interactions Between Trainees and Mentors

Mentors play a special role in the development of new scientists. A mentor must consider the student's core interests and needs in preference to his or her own. Trainees and mentors are codependent and, at times, competitive. Trainees depend on their mentors for scientific education and training, for support, and, eventually, for career guidance and references. Mentors tend to be role models as well. Mentors depend on trainees for performing work and bringing fresh ideas and approaches to the research group. They can enhance the mentor's reputation as a teacher and as an investigator. Institutions should establish programs that foster productive relations between mentors and trainees, including training in mentoring and advising for faculty. Moreover, institutions should work to ensure that trainees are properly paid, receive reasonable benefits (including health insurance), and are protected from exploitation. Written guidelines, ombudspersons, and mutual evaluations can help to reduce problems and identify situations requiring remediation. As mentioned earlier in this chapter, the dual role academic research institutions play in both producing original research and educating students can be balanced, but when they come in conflict, educational interests of the student should take precedence.

Advocate Adherence to the Rules Regarding All Aspects of the Conduct of Research, Especially Research Involving Human Subjects and Animals

Effective advocacy by an institution of the rules involving the use of human subjects and animals in research involves much more than simply posting the relevant federal, state, and local regulations and providing “damage control” and formal sanctions when irregularities are discovered. At all levels of the institution, including the level of the dean, department chair, research group leader, and individual research group member, regular affirmation of the guiding principles underlying the rules is essential. The goal is to create an institutional climate such that anyone who violates these guiding principles through words or deeds is immediately made aware of the behavior and, when indicated, appropriately sanctioned.

Anticipate, Reveal, and Manage Individual and Institutional Conflicts of Interest

Research institutions must conduct their work in a manner that earns public trust. To do so, they must be sensitive to any conflict of interest that might affect or appear to affect their decisions and behavior in ways that could compromise their roles as trustworthy sources of information and policy advice or their obligations to ensure the protection of human research subjects. As research partnerships between industry and academic institutions continue to expand, with the promise of considerable public benefit, the management of real or perceived conflicts of interest in research requires that institutions have a written policy on such conflicts. The policy should apply to both institutions and individual investigators.

Institutional Conflicts of Interest

Institutions should have clearly stated policies and procedures by which they will guard against compromise by external influences. As with individual conflicts of interest, institutional leadership is not in the best position to determine whether a particular arrangement represents an unacceptable or manageable conflict of interest. Institutions should draw on independent reviews by external bodies and should have appropriate procedures for such reviews. Factors of concern include not only direct influences on institutional policy but also indirect influences on the use of resources, educational balance, and hiring of faculty, for example (AAU, 2001).

Institutional Responsibility for Investigator Conflicts of Interest

The policy on conflicts of interest should apply to individuals who are directly involved in the conduct, design, and review of research, including faculty, trainees, students, and administrators, and should clearly state their disclosure responsibilities. The policy should define conflicts of interest and should have means to convey an understanding of the term to the parties involved. It should delineate the activities and the levels and kinds of research-related financial interests that are and are not permissible, as well as those that require review and approval. The special circumstances associated with research involving human subjects should be specifically addressed. Beyond meeting their responsibility to ensure the dissemination and understanding of their policies, institutions should develop means to monitor compliance equitably. Detailed descriptions of institutional responsibilities in this area were recently reported by the Association of American Universities (AAU, 2001) and the Association of American Medical Colleges (AAMC, 2001), as described in Box 2-1 .

Definition of Institutional Conflict of Interest.

Arrange Timely and Thorough Inquiries and Investigations of Allegations of Scientific Misconduct and Apply Appropriate Sanctions

Every institution receiving federal funds for research and related activities must have in place policies and procedures for responding to allegations of research misconduct (42 C.F.R. § 50, §§ A, 1989; 45 C.F.R. § 689, 1996). Although the federal government imposes these requirements, the institutions must implement them. Their effectiveness depends on investigation of allegations of misconduct with vigor and fairness. The institution should embrace the notion that it is important to the quality and integrity of science that individuals report possible research misconduct. Means of protecting any individual who reports possible misconduct in good faith must be instituted.

In carrying out their responsibilities, institutions must ensure that faculty, students, and staff are properly informed of their rights and responsibilities. Those likely to receive allegations—for example, administrators, department chairs, and research group chiefs—must be fully informed of institutional provisions and trained in dealing with issues related to research conduct or misconduct. Mechanisms must be in place to protect the public's interest in the research record, the research subjects' health, and the financial interests of the institution, as well as to ensure notification of appropriate authorities. Clear lines of authority for management of the institution's response must exist, and, where indicated, appropriate sanctions should be applied or efforts should be made to protect or restore the reputations of innocent parties.

Offer Educational Opportunities Pertaining to Integrity in the Conduct of Research

Research institutions should provide students, faculty, and staff with educational opportunities related to the responsible conduct of research. These are mandatory for those involved in clinical research (NIH, 2000) and for recipients of Public Health Service training grants (NIH, 1989). These offerings should encourage open discussion of the values at stake and the ethical standards that promote responsible research practices. The core objective of such education is to increase participants' knowledge and sensitivity to the issues associated with integrity in research and to improve their ability to make ethical choices. It should give them an appreciation for the diversity of views that may be brought to bear on issues, inform them about the institutional rules and government regulations that apply to research, and instill in them the scientific community's expectations regarding proper research practice. Educational offerings should be flexible in their approach and be cognizant of normative differences among disciplines. Such programs should offer opportunities for the participants to explore the underlying values that shape the research enterprise and to analyze how those values are manifested in behaviors in different research environments

It is expected that effective educational programs will empower individual researchers, students, and staff in making responsible choices in the course of their research. Regular evaluation and improvement of the educational and behavioral effectiveness of these educational offerings should be a part of an institutional assessment. (See Chapter 5 for further discussion of education in the responsible conduct of research.)

Monitor and Evaluate the Institutional Environment Supporting Integrity in the Conduct of Research and Use This Knowledge for Continuous Quality Improvement

The main thrust of this report reflects the need for continuing attention toward sustaining and improving a culture of integrity in research. This requires diligent oversight by institutional management to ensure that the practices associated with integrity described above are carried out. It also requires examination of the policy-making process, the policies themselves, their execution, and the degree to which they are understood and adhered to by those affected. If researchers and administrators believe that the rules are excellent and that the institution applies them equitably, then the institutional commitment to integrity will be clear. Chapter 6 addresses ways to help identify those elements critical to establishment of the perception of moral commitment and determination of whether such commitments have been made.

The committee believes that integrity in research is essential for maintaining scientific excellence and keeping the public's trust. The concept of integrity in research cannot, however, be reduced to a one-line definition. For a scientist, integrity embodies above all the individual's commitment to intellectual honesty and personal responsibility. It is an aspect of moral character and experience. For an institution, it is a commitment to creating an environment that promotes responsible conduct by embracing standards of excellence, trustworthiness, and lawfulness and then assessing whether researchers and administrators perceive that an environment with high levels of integrity has been created. This chapter has described multiple practices that are most likely to promote responsible conduct. Individuals and institutions should use these practices with the goal of fostering a culture in which high ethical standards are the norm, ongoing professional development is encouraged, and public confidence in the scientific enterprise is preserved.

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• AAMC (Association of American Medical Colleges). 2001. Protecting Subjects, Preserving Trust, Promoting Progress . [Online] Available: http://www ​.aamc.org/coitf [Accessed December 18, 2001].
• AAU (Association of American Universities). 2001. Report on Individual and Institutional Con flict of Interest . [Online] Available: http://www ​.aau.edu/research/conflict ​.html [Accessed January 31, 2002].
• AAUP (American Association of University Professors). 1987. Statement on Professional Eth ics . [Online]. Available: http://www ​.aaup.org/statements ​/Redbook/Rbethics.htm [Accessed May 14, 2002].
• AAUP. 1999. Recommended Institutional Regulations on Academic Freedom and Tenure . [Online]. Available: http://www aaup.org/statements/Redbook/Rbrir.htm [Accessed May 14, 2002].
• Bird SJ. 2001. Mentors, advisors and supervisors: Their role in teaching responsible research conduct. Science and Engineering Ethics7:455–468. [ PubMed : 11697001 ]
• Blumenthal D, Causino N, Campbell E, Seashore Louis K. 1996. Relationships between academic institutions and industry in the life sciences: An industry survey. New En gland Journal of Medicine334:368–373. [ PubMed : 8538709 ]
• Campbell EG, Seashore Louis K, Blumenthal D. 1998. Looking a gift horse in the mouth. Corporate gifts supporting life sciences research. Journal of the American Medical Asso ciation279:995–999. [ PubMed : 9533497 ]
• Cho MK, Shohara R, Schissel A, Rennie D. 2000. Policies on faculty conflicts of interest at U.S. universities. Journal of the American Medical Association284:2203–2208. [ PubMed : 11056591 ]
• Grinnell F. 1999. Ambiguity, trust, and responsible conduct of research. Science and Engi neering Ethics5:205–214. [ PubMed : 11657858 ]
• Gunsalus CK. 1993. Institutional structure to ensure research integrity. Academic Medicine68:S33–S38. [ PubMed : 8373489 ]
• Gunsalus CK. 1998. How to blow the whistle and still have a career afterwards. Science and Engineering Ethics4:51–64.
• IOM (Institute of Medicine). 2001. Preserving Public Trust . Washington, DC: National Academy Press.
• McCabe DL, Pavela GM. 1998. The effect of institutional policies and procedures on academic integrity. In: Burnett DD, Rudolph L, Clifford KO, eds. Academic Integrity Mat ters . Washington, DC: National Association of Student Personnel Administrators, Inc. Pp.93–108.
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• NAS. 2000. Enhancing the Postdoctoral Experience for Scientists and Engineers . Washington, DC: National Academy Press.
• NIH (National Institutes of Health). 1989. Requirement for programs on the responsible conduct of research in National Research Service Award Institutional Training Programs, p. 1 . In: NIH Guide for Grants and Contracts, Vol. 18:1 , December 22, 1989. Rockville, MD: NIH.
• NIH. 2000. Required Education in the Protection of Human Research Participants NIH Guide for Grants and Contracts , June 5, 2000 (Revised August 25, 2000). [Online]. Available: http: //grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html [Accessed December 10, 2001].
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Further discussion of moral character and behavior and the development of abilities that give rise to responsible conduct can be found in Chapter 5 .

See the section of Appendix D entitled Responsible Scientific Conduct for resources with case studies that can be used in a teaching setting to further illustrate the topics discussed here.

A special issue of Science and Engineering Ethics (7:451–640, 2001) is devoted to the relationship between mentoring and responsible conduct.

• Cite this Page National Research Council (US) and Institute of Medicine (US) Committee on Assessing Integrity in Research Environments. Integrity in Scientific Research: Creating an Environment That Promotes Responsible Conduct. Washington (DC): National Academies Press (US); 2002. 2, Integrity in Research.
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Research Integrity: Where We Are and Where We Are Heading

Affiliations.

• 1 Department of Scientific and Clinical Work, Doctoral and Master's Studies, South Kazakhstan Medical Academy, Shymkent, Kazakhstan.
• 2 Department of Clinical Rheumatology and Immunology, University Hospital in Krakow, Krakow, Poland.
• 3 National Institute of Geriatrics, Rheumatology and Rehabilitation, Warsaw, Poland.
• 4 Department of Internal Medicine N2, Danylo Halytsky Lviv National Medical University, Lviv, Ukraine.
• 5 Department of Biology and Biochemistry, South Kazakhstan Medical Academy, Shymkent, Kazakhstan.
• 6 Department of Physical Medicine and Rehabilitation, University of Health Sciences, Adana City Research and Training Hospital, Adana, Turkiye. [email protected].
• PMID: 38050915
• PMCID: PMC10695751
• DOI: 10.3346/jkms.2023.38.e405

The concept of research integrity (RI) refers to a set of moral and ethical standards that serve as the foundation for the execution of research activities. Integrity in research is the incorporation of principles of honesty, transparency, and respect for ethical standards and norms throughout all stages of the research endeavor, encompassing study design, data collecting, analysis, reporting, and publishing. The preservation of RI is of utmost importance to uphold the credibility and amplify the influence of scientific research while also preventing and dealing with instances of scientific misconduct. Researchers, institutions, journals, and readers share responsibilities for preserving RI. Researchers must adhere to the highest ethical standards. Institutions have a role in establishing an atmosphere that supports integrity ideals while also providing useful guidance, instruction, and assistance to researchers. Editors and reviewers act as protectors, upholding quality and ethical standards in the dissemination of research results through publishing. Readers play a key role in the detection and reporting of fraudulent activity by critically evaluating content. The struggle against scientific misconduct has multiple dimensions and is continuous. It requires a collaborative effort and adherence to the principles of honesty, transparency, and rigorous science. By supporting a culture of RI, the scientific community may preserve its core principles and continue to contribute appropriately to society's well-being. It not only aids present research but also lays the foundation for future scientific advancements.

Keywords: Ethics in Publishing; Plagiarism; Research Misconduct; Scientific Dishonesty; Scientific Fraud; Scientific Misconduct.

© 2023 The Korean Academy of Medical Sciences.

Publication types

• Biomedical Research*
• Research Design
• Research Personnel
• Scientific Misconduct*

Integrity in Scientific Research: Creating an Environment That Promotes Responsible Conduct (2002)

Chapter: 2 integrity in research.

Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

2 Integrity in Research The pursuit and dissemination of knowledge enjoy a place of distinc- tion in American culture, and the public expects to reap considerable benefit from the creative and innovative contributions of scientists. As science becomes increasingly intertwined with major social, philosophi- cal, economic, and political issues, scientists become more accountable to the larger society of which they are a part. As a consequence, it is more important than ever that individual scientists and their institutions peri- odically reassess the values and professional practices that guide their research as well as their efforts to perform their work with integrity. Society’s confidence in and support of research rest in large part on public trust in the integrities of individual researchers and their support- ing institutions. The National Academies’ report On Being a Scientist states: “The level of trust that has characterized science and its relationship with society has contributed to a period of unparalleled scientific productivity. But this trust will endure only if the scientific community devotes itself to exemplifying and transmitting the values associated with ethical scien- tific conduct” (NAS, 1995, preface). It is therefore incumbent on all scien- tists and scientific institutions to create and nurture a research environ- ment that promotes high ethical standards, contributes to ongoing professional development, and preserves public confidence in the scien- tific enterprise (Grinnell, 1999; IOM, 2001; Resnik, 1998; Yarborough and Sharp, 2002). Government oversight of scientific research is important, but such oversight, often in the form of administrative rules, typically stipulates 33 

34 INTEGRITY IN SCIENTIFIC RESEARCH what cannot be done; it rarely prescribes what should be done (see Chap- ter 4 for further discussion of the strengths and limitations of a regulatory approach). In essence, government rules define the floor of expected be- havior. More, however, should be expected from scientists when it comes to the responsible conduct of research. By appealing to the conscience of individual scientists, the scientific community as a whole should seek to evoke the highest possible standard of research behavior. When institu- tions committed to promoting integrity in research support those stan- dards, the likelihood of creating an environment that advances respon- sible research practices is greatly enhanced. It is essential that institutions foster a culture of integrity in which students and trainees, as well as senior researchers and administrators, have an understanding of and com- mitment to integrity in research. The committee’s task was to define integrity for the particular activity of research as conducted within contemporary society. Integrity has two general senses. The first sense concerns wholeness; the second, soundness of moral principle (Oxford English Dictionary, 1989). Plato and subsequent philosophers have argued that leading the good life depends on a person’s success in integrating moral, religious, and philosophical convictions. In conversations with experts in ethics and others, the committee found no consensus regarding whether a person could exhibit high integrity in research but not in other aspects of his life. Consequently, the committee decided to focus on the second aspect of integrity—namely, soundness of moral principle in the specific context of research practice. INTEGRITY IN RESEARCH Integrity characterizes both individual researchers and the institu- tions in which they work. For individuals, it is an aspect of moral charac- ter and experience.1 For institutions, it is a matter of creating an environ- ment that promotes responsible conduct by embracing standards of excellence, trustworthiness, and lawfulness that inform institutional prac- tices. For the individual scientist, integrity embodies above all a commit- ment to intellectual honesty and personal responsibility for one’s actions and to a range of practices that characterize responsible research conduct. These practices include: • intellectual honesty in proposing, performing, and reporting research; 1Further discussion of moral character and behavior and the development of abilities that give rise to responsible conduct can be found in Chapter 5. 

INTEGRITY IN RESEARCH 35 • accuracy in representing contributions to research proposals and reports; • fairness in peer review; • collegiality in scientific interactions, including communications and sharing of resources; • transparency in conflicts of interest or potential conflicts of interest; • protection of human subjects in the conduct of research; • humane care of animals in the conduct of research; and • adherence to the mutual responsibilities between investigators and their research teams. Individual scientists work within complex organizational structures. (These structures and their interactions are described in detail in Chapter 3.) Factors that promote responsible conduct can exert their influences at the level of the individual; at the level of the work group (e.g., the re- search group); and at the level of the research institution itself. These different organizational levels are interdependent in the conduct of re- search. Institutions seeking to create an environment that promotes re- sponsible conduct by individual scientists and that fosters integrity must establish and continuously monitor structures, processes, policies, and procedures that: • provide leadership in support of responsible conduct of research; • encourage respect for everyone involved in the research enterprise; • promote productive interactions between trainees and mentors; • advocate adherence to the rules regarding all aspects of the conduct of research, especially research involving human subjects and animals; • anticipate, reveal, and manage individual and institutional con- flicts of interest; • arrange timely and thorough inquiries and investigations of alle- gations of scientific misconduct and apply appropriate administrative sanctions; • offer educational opportunities pertaining to integrity in the con- duct of research; and • monitor and evaluate the institutional environment supporting in- tegrity in the conduct of research and use this knowledge for continuous quality improvement. Leadership by individuals of high personal integrity helps to foster an environment in which scientists can openly discuss responsible re- search practices in the face of conflicting pressures. All those involved in 

36 INTEGRITY IN SCIENTIFIC RESEARCH the research enterprise should acknowledge that integrity is a key dimen- sion of the essence of being a scientist and not a set of externally imposed regulatory constraints. INTEGRITY OF THE INDIVIDUAL SCIENTIST As noted above, the committee has identified a range of key practices that pertain to the responsible conduct of research by individual scien- tists. The following sections elucidate the practices.2 Intellectual Honesty in Proposing, Performing, and Reporting Research Intellectual honesty in proposing, performing, and reporting research refers to honesty with respect to the meaning of one’s research. It is ex- pected that researchers present proposals and data honestly and commu- nicate their best understanding of the work in writing and verbally. The descriptions of an individual’s work found in such communications fre- quently present selected data from the work organized into frameworks that emphasize conceptual understanding rather than the chronology of the discovery process. Clear and accurate research records must underlie these descriptions, however. Researchers must be advocates for their re- search conclusions in the face of collegial skepticism and must acknowl- edge errors. Accuracy in Representing Contributions to Research Proposals and Reports Accuracy in representing one’s contributions to research proposals and reports requires the assignment of credit. It is expected that research- ers will not report the work of others as if it were their own. This is plagiarism. Furthermore, they should be honest with respect to the contri- butions of colleagues and collaborators. Decisions regarding authorship are best anticipated at the outset of projects rather than at their comple- tion. In publications, it should be possible in principle to specify each author’s contribution to the work. It also is expected that researchers honestly acknowledge the precedents on which their research is based. 2See the section of Appendix D entitled Responsible Scientific Conduct for resources with case studies that can be used in a teaching setting to further illustrate the topics discussed here. 

INTEGRITY IN RESEARCH 37 Fairness in Peer Review Fairness in peer review means that researchers should agree to be peer reviewers only when they can be impartial in their judgments and only when have revealed their conflicts of interest. Peer review functions to maintain the excellence of published scientific work and ensure a merit- based system of support for research. A delicate balance pervades the peer-review system, because the best reviewers are precisely those indi- viduals who have the most to gain from “insider information”: they are doing similar work and they will be unable to “strike” from memory and thought what they learn through the review process. Investigators serv- ing as peer reviewers should treat submitted manuscripts and grant ap- plications fairly and confidentially and avoid using them inappropriately. Collegiality in Scientific Interactions, Including Communications and Sharing of Resources Collegiality in scientific interactions, including communications and sharing of resources requires that investigators report research findings to the scientific community in a full, open, and timely fashion. At the same time, it should be recognized that the scientific community is highly competitive. The investigator who first reports new and important find- ings gets credited with the discovery. It is not obvious that rapid reporting is the approach that is always the most conducive to progress. Intellectual property provisions and se- crecy allow for patents and licensure and encourage private investment in research. Furthermore, even for publicly funded research, a degree of discretion may permit a research group to move ahead more efficiently. Conversely, an investigator who delays reporting important new find- ings risks having others publish similar results first and receiving little recognition for the discovery. Knowing when and how much to tell will always remain a challenge in scientific communication. Once scientific work is published, researchers are expected to share unique materials with other scientists in a reasonable fashion to facilitate confirmation of their results. (The committee recognizes that there are limits to sharing, especially when doing so requires a time or cost com- mitment that interferes with the function of the research group.) When materials are developed through public funding, the requirement for shar- ing is even greater. Public funding is based on the principle that the public good is advanced by science conducted in the interest of humanity. This commitment to the public good implies a responsibility to share materials with others to demonstrate reproducibility and to facilitate the replication and validation of one’s work by responding constructively to inquiries from other scientists, particularly regarding methodologies. 

38 INTEGRITY IN SCIENTIFIC RESEARCH Collegiality and sharing of resources is also an important aspect of the interaction between trainees and their graduate or postdoctoral advis- ers. Students and fellows will ultimately depart the research team, and discussion of and planning for departure should occur over the course of their education. Expectations about such issues as who inherits intellec- tual property rights to a project or to the project itself upon the trainee’s departure should be discussed when the trainee first joins the research group and should be revisited periodically over the course of the project (NAS, 2000). Transparency in Conflicts of Interest or Potential Conflicts of Interest A conflict of interest in research exists when the individual has inter- ests in the outcome of the research that may lead to a personal advantage and that might therefore, in actuality or appearance, compromise the integrity of the research. The most compelling example is competition between financial reward and the integrity of the research process. Reli- gious, political, or social beliefs can also be undisclosed sources of re- search bias. Many scientific advances that reach the public often involve extensive collaboration between academia and industry (Blumenthal et al., 1996; Campbell et al., 1998; Cho et al., 2000). Such collaborations involve con- sulting and advisory services as well as the development of specific in- ventions, and they can result in direct financial benefit to both individuals and institutions. Conflicts of interest reside in a situation itself, not in any behavior of members of a research team. Thus, researchers should dis- close all conflicts of interest to their institutions so that the researchers and their work can be properly managed. They should also voluntarily disclose conflicts of interest in all publications and presentations resulting from the research. The committee believes that scientific institutions, in- cluding universities, research institutes, professional societies, and pro- fessional and lay journals, should embrace disclosure of conflicts of inter- est as an essential component of integrity in research. Protection of Human Subjects in the Conduct of Research The protection of individuals who volunteer to participate in research is essential to integrity in research. The ethical principles underlying such research have been elaborated on in international codes and have been integrated into national regulatory frameworks (in the United States, 45 C.F.R. § 46, 2001). Elements included in such frameworks pertain to the quality and importance of the science, its risks and benefits, fairness in the selection of subjects, and, above all, the voluntary participation and in- 

INTEGRITY IN RESEARCH 39 formed consent of subjects. To ensure the conformance of research efforts with these goals, institutions carry out extensive research subject pro- tection programs. To be successful, such programs require high-level, functioning institutional review boards, knowledgeable investigators, on- going performance assessment through monitoring and feedback, and educational programs (IOM, 2001). The IOM report Preserving Public Trust (IOM, 2001) focuses specifically on the important topic of research involv- ing human subjects, and further discussion is not included here. Humane Care of Animals in the Conduct of Research The humane care of animals is essential for producing sound science and its social benefits. Researchers have a responsibility to engage in the humane care of animals in the conduct of research. This means evaluating the need for animals in any particular protocol, ensuring that research animals’ basic needs for life are met prior to research, and carefully con- sidering the benefits of the research to society or to animals versus the likely harms to any animals included as part of the research protocol. Procedures that minimize animal pain, suffering, and distress should be implemented. Research protocols involving animals must be reviewed and approved by properly constituted bodies, as required by law (Animal Welfare Act of 1966 [PL 89-544], inclusive of amendments passed in 1970 [PL 91-579], 1976 [PL 94-279], 1985 [PL 99-198], and 1990 [PL 101-624] and subsequent amendments) and professional standards (AAALAC, 2001; NRC, 1996). Adherence to the Mutual Responsibilities Between Investigators and Their Research Teams Adherence to the mutual responsibilities between investigators and members of their research teams refers to both scientific and interper- sonal interactions. The research team might include other faculty mem- bers, colleagues (including coinvestigators), and trainees (undergraduate students, graduate and medical students, postdoctoral fellows), as well as employed staff (e.g., technicians, statisticians, study coordinators, nurses, animal handlers, and administrative personnel). The head of the research team should encourage all members of the team to achieve their career goals. The interpersonal interactions should reflect mutual respect among members of the team, fairness in assignment of responsibilities and effort, open and frequent communication, and accountability. In this regard, scientists should also conduct disputes professionally (Gunsalus, 1998). (The American Association of University Professors (AAUP) guidelines on academic freedom and professional ethics articulate the obligation of 

40 INTEGRITY IN SCIENTIFIC RESEARCH members of the academic community to root their statements in fact and to respect the opinions of others [AAUP, 1987, 1999].) Mentoring and Advising Mentor is often used interchangeably with faculty adviser. However, a mentor is more than a supervisor or an adviser (Bird, 2001; Swazey and Anderson, 1998).3 An investigator or research adviser may or may not be a mentor. Some advisers may be accomplished researchers but do not have the time, training, or ability to be good mentors (NAS, 2000). For a trainee, “a mentoring relationship is a close, individualized relationship that develops over time between a graduate student (or other trainee) and a faculty member (or others) that includes both caring and guidance” (University of Michigan, 1999, p. 5). A successful mentoring relationship is based on mutual respect, trust, understanding, and empathy (NAS, 1997). Mentoring relationships can extend throughout all phases of a sci- ence career, and, as such, they are sometimes referred to as mentor- protégé or mentor-apprentice relationships, rather than mentor-trainee relationships. The committee believes that mentor should be the dominant and usual role of the laboratory director or research advisor in regard to his or her trainee. With regard to such mentor-trainee relationships, responsibilities include a commitment to continuous education and guidance of trainees, appropriate delegation of responsibility, regular review and constructive appraisal of trainees, fair attribution of accomplishment and authorship, and career guidance, as well as help in creating opportunities for employ- ment and funding. For the trainee, essential elements include respect for the mentor, loyalty to the research group, a strong commitment to sci- ence, dedication to the project, careful performance of experiments, pre- cise and complete record keeping, accurate reporting of results, and a commitment to oral and written presentations and publication. It should be noted that most academic research institutions play a dual role. On the one hand, they are concerned with producing original research; on the other, with educating students. The two goals are compatible, but when they come in conflict, it is important that the educational needs of the students not be forgotten. If students are exploited, then they will learn by example that such behavior is acceptable. 3A special issue of Science and Engineering Ethics (7:451–640, 2001) is devoted to the rela- tionship between mentoring and responsible conduct. 

INTEGRITY IN RESEARCH 41 SUPPORT OF INTEGRITY BY THE RESEARCH INSTITUTION The individual investigator and the laboratory or research unit carry out their functions in institutions that are responsible for the management and support of the research carried out within their domains. The institu- tions, in turn, are regulated by governmental and other bodies that im- pose rules and responsibilities (see Chapter 3 for further discussion). The vigor, resources, and attitudes with which institutions carry out their responsibilities will influence investigators’ commitment and adherence to responsible research practices. Provide Leadership in Support of Responsible Conduct of Research It takes the leadership of an institution to promulgate a culture of responsible research. This involves the development of a vision for the research enterprise and a strategic plan. It is the responsibility of the institution leadership to develop programs to orient new researchers to institutional policies, rules, and guidelines; to sponsor opportunities for dialogue about new and emerging issues; and to sponsor continuing edu- cation about new policies and regulations as they are developed. Further- more, institutional leaders have the responsibility to ensure that such programs are carried out, with appropriate delegation of responsibility and accountability and with adequate resources. The observed actions of institutions in problem situations communi- cate as strongly (or perhaps more strongly) about responsible conduct as do any policies or programs. Institutional leaders (e.g., chancellor, presi- dent, dean, CEO) set the tone for the institutions with their own actions. Research leaders 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 (Sigma Xi, 1999). McCabe and Pavela note that “fac- ulty members who seek to instill a sense of social obligation without affirming personal virtues are planting trees without roots” (McCabe and Pavela, 1998, p.101). Encourage Respect for Everyone Involved in the Research Enterprise An environment that fosters competence and honest interactions among all participants in the investigative process supports the integrity of research. Institutions have many legally mandated policies that foster mutual respect and trust—for example, policies concerning harassment, occupational health and safety, fair employment practices, pay and ben- efits, protection of research subjects, exposure to ionizing radiation, and due process regarding allegations of research misconduct. State and local 

42 INTEGRITY IN SCIENTIFIC RESEARCH policies and guidelines governing research may be in effect as well. It is anticipated that through a process of self-assessment, institutions can identify issues and develop programs that further integrity in research (see Chapter 6 for further discussion). Fair enforcement of all institutional policies is a critical element of the institutional commitment to integrity in research. That is not enough, however. Support Systems Within the research institution, there can be multiple smaller units (e.g., departments, divisions within a department, research groups within a division). Within these institutional subunits, there will always be power differences between members of the group. Consequently, research insti- tutions require support mechanisms—for example, ombudspersons—that research team members can turn to for help when they feel they are being treated unfairly. Institutions need to provide guidance and recourse to anyone with concerns about research integrity (e.g., a student who ob- serves a lack of responsible conduct by a senior faculty member). Support systems should be accessible (multiple entry points for those with ques- tions) and have a record of reaching objective, fact-based decisions un- tainted by personal bias or conflicts of interest (Gunsalus, 1993). Lack of recourse within the institution for those individuals who have concerns about possible misconduct will undermine efforts to foster a climate of integrity. Equally important to having support systems in place is the dissemination of information on how and where individuals may seek such support. The ultimate goal for institutions should be to create a culture within which all persons on a research team can work effectively and realize their full potential. Promote Productive Interactions Between Trainees and Mentors Mentors play a special role in the development of new scientists. A mentor must consider the student’s core interests and needs in preference to his or her own. Trainees and mentors are codependent and, at times, competitive. Trainees depend on their mentors for scientific education and training, for support, and, eventually, for career guidance and refer- ences. Mentors tend to be role models as well. Mentors depend on train- ees for performing work and bringing fresh ideas and approaches to the research group. They can enhance the mentor’s reputation as a teacher and as an investigator. Institutions should establish programs that foster productive relations between mentors and trainees, including training in mentoring and advising for faculty. Moreover, institutions should work 

INTEGRITY IN RESEARCH 43 to ensure that trainees are properly paid, receive reasonable benefits (in- cluding health insurance), and are protected from exploitation. Written guidelines, ombudspersons, and mutual evaluations can help to reduce problems and identify situations requiring remediation. As mentioned earlier in this chapter, the dual role academic research institutions play in both producing original research and educating students can be balanced, but when they come in conflict, educational interests of the student should take precedence. Advocate Adherence to the Rules Regarding All Aspects of the Conduct of Research, Especially Research Involving Human Subjects and Animals Effective advocacy by an institution of the rules involving the use of human subjects and animals in research involves much more than simply posting the relevant federal, state, and local regulations and providing “damage control” and formal sanctions when irregularities are discov- ered. At all levels of the institution, including the level of the dean, de- partment chair, research group leader, and individual research group member, regular affirmation of the guiding principles underlying the rules is essential. The goal is to create an institutional climate such that anyone who violates these guiding principles through words or deeds is immedi- ately made aware of the behavior and, when indicated, appropriately sanctioned. Anticipate, Reveal, and Manage Individual and Institutional Conflicts of Interest Research institutions must conduct their work in a manner that earns public trust. To do so, they must be sensitive to any conflict of interest that might affect or appear to affect their decisions and behavior in ways that could compromise their roles as trustworthy sources of information and policy advice or their obligations to ensure the protection of human re- search subjects. As research partnerships between industry and academic institutions continue to expand, with the promise of considerable public benefit, the management of real or perceived conflicts of interest in re- search requires that institutions have a written policy on such conflicts. The policy should apply to both institutions and individual investigators. Institutional Conflicts of Interest Institutions should have clearly stated policies and procedures by which they will guard against compromise by external influences. As 

44 INTEGRITY IN SCIENTIFIC RESEARCH with individual conflicts of interest, institutional leadership is not in the best position to determine whether a particular arrangement represents an unacceptable or manageable conflict of interest. Institutions should draw on independent reviews by external bodies and should have appro- priate procedures for such reviews. Factors of concern include not only direct influences on institutional policy but also indirect influences on the use of resources, educational balance, and hiring of faculty, for example (AAU, 2001). Institutional Responsibility for Investigator Conflicts of Interest The policy on conflicts of interest should apply to individuals who are directly involved in the conduct, design, and review of research, in- cluding faculty, trainees, students, and administrators, and should clearly state their disclosure responsibilities. The policy should define conflicts of interest and should have means to convey an understanding of the term to the parties involved. It should delineate the activities and the levels and kinds of research-related financial interests that are and are not per- missible, as well as those that require review and approval. The special circumstances associated with research involving human subjects should be specifically addressed. Beyond meeting their responsibility to ensure the dissemination and understanding of their policies, institutions should develop means to monitor compliance equitably. Detailed descriptions of institutional responsibilities in this area were recently reported by the Association of American Universities (AAU, 2001) and the Association of American Medical Colleges (AAMC, 2001), as described in Box 2-1. BOX 2-1 Definition of Institutional Conflict of Interest An “institutional conflict of interest . . . may occur when the institution, any of its senior management or trustees, or a department, school, or other sub-unit, or an affiliated foundation or organization, has an external relationship or financial inter- est in a company that itself has a financial or other interest in a faculty research project. Senior managers or trustees may also have conflicts when they serve on the boards of (or otherwise have an official relationship with) organizations that have significant business relationships with the university. The existence (or ap- pearance) of such conflicts can lead to actual bias, or suspicion about possible bias, in the review or conduct of research at the university. If they are not evaluated or managed, they may result in choices or actions that are incongruent with the missions, obligations, or the values of the university” (AAU, 2001, p. i). 

INTEGRITY IN RESEARCH 45 Arrange Timely and Thorough Inquiries and Investigations of Allegations of Scientific Misconduct and Apply Appropriate Sanctions Every institution receiving federal funds for research and related ac- tivities must have in place policies and procedures for responding to allegations of research misconduct (42 C.F.R. § 50, §§ A, 1989; 45 C.F.R. § 689, 1996). Although the federal government imposes these requirements, the institutions must implement them. Their effectiveness depends on investigation of allegations of misconduct with vigor and fairness. The institution should embrace the notion that it is important to the quality and integrity of science that individuals report possible research miscon- duct. Means of protecting any individual who reports possible miscon- duct in good faith must be instituted. In carrying out their responsibilities, institutions must ensure that faculty, students, and staff are properly informed of their rights and re- sponsibilities. Those likely to receive allegations—for example, adminis- trators, department chairs, and research group chiefs—must be fully in- formed of institutional provisions and trained in dealing with issues related to research conduct or misconduct. Mechanisms must be in place to protect the public’s interest in the research record, the research sub- jects’ health, and the financial interests of the institution, as well as to ensure notification of appropriate authorities. Clear lines of authority for management of the institution’s response must exist, and, where indi- cated, appropriate sanctions should be applied or efforts should be made to protect or restore the reputations of innocent parties. Offer Educational Opportunities Pertaining to Integrity in the Conduct of Research Research institutions should provide students, faculty, and staff with educational opportunities related to the responsible conduct of research. These are mandatory for those involved in clinical research (NIH, 2000) and for recipients of Public Health Service training grants (NIH, 1989). These offerings should encourage open discussion of the values at stake and the ethical standards that promote responsible research practices. The core objective of such education is to increase participants’ knowl- edge and sensitivity to the issues associated with integrity in research and to improve their ability to make ethical choices. It should give them an appreciation for the diversity of views that may be brought to bear on issues, inform them about the institutional rules and government regula- tions that apply to research, and instill in them the scientific community’s expectations regarding proper research practice. Educational offerings 

46 INTEGRITY IN SCIENTIFIC RESEARCH should be flexible in their approach and be cognizant of normative differ- ences among disciplines. Such programs should offer opportunities for the participants to explore the underlying values that shape the research enterprise and to analyze how those values are manifested in behaviors in different research environments It is expected that effective educational programs will empower indi- vidual researchers, students, and staff in making responsible choices in the course of their research. Regular evaluation and improvement of the educational and behavioral effectiveness of these educational offerings should be a part of an institutional assessment. (See Chapter 5 for further discussion of education in the responsible conduct of research.) Monitor and Evaluate the Institutional Environment Supporting Integrity in the Conduct of Research and Use This Knowledge for Continuous Quality Improvement The main thrust of this report reflects the need for continuing atten- tion toward sustaining and improving a culture of integrity in research. This requires diligent oversight by institutional management to ensure that the practices associated with integrity described above are carried out. It also requires examination of the policy-making process, the poli- cies themselves, their execution, and the degree to which they are under- stood and adhered to by those affected. If researchers and administrators believe that the rules are excellent and that the institution applies them equitably, then the institutional commitment to integrity will be clear. Chapter 6 addresses ways to help identify those elements critical to estab- lishment of the perception of moral commitment and determination of whether such commitments have been made. SUMMARY The committee believes that integrity in research is essential for main- taining scientific excellence and keeping the public’s trust. The concept of integrity in research cannot, however, be reduced to a one-line definition. For a scientist, integrity embodies above all the individual’s commitment to intellectual honesty and personal responsibility. It is an aspect of moral character and experience. For an institution, it is a commitment to creat- ing an environment that promotes responsible conduct by embracing stan- dards of excellence, trustworthiness, and lawfulness and then assessing whether researchers and administrators perceive that an environment with high levels of integrity has been created. This chapter has described multiple practices that are most likely to promote responsible conduct. Individuals and institutions should use these practices with the goal of 

INTEGRITY IN RESEARCH 47 fostering a culture in which high ethical standards are the norm, ongoing professional development is encouraged, and public confidence in the scientific enterprise is preserved. REFERENCES AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care). 2001. AAALAC International Rules of Accreditation. [Online]. Available: http://www.aaalac. org/rules.htm [Accessed January 31, 2002]. AAMC (Association of American Medical Colleges). 2001. Protecting Subjects, Preserving Trust, Promoting Progress. [Online] Available: http://www.aamc.org/coitf [Accessed December 18, 2001]. AAU (Association of American Universities). 2001. Report on Individual and Institutional Con- flict of Interest. [Online] Available: http://www.aau.edu/research/conflict.html [Ac- cessed January 31, 2002]. AAUP (American Association of University Professors). 1987. Statement on Professional Eth- ics. [Online]. Available: http://www.aaup.org/statements/Redbook/Rbethics.htm [Accessed May 14, 2002]. AAUP. 1999. Recommended Institutional Regulations on Academic Freedom and Tenure. [Online]. Available: http://www aaup.org/statements/Redbook/Rbrir.htm [Accessed May 14, 2002]. Bird SJ. 2001. Mentors, advisors and supervisors: Their role in teaching responsible research conduct. Science and Engineering Ethics 7:455–468. Blumenthal D, Causino N, Campbell E, Seashore Louis K. 1996. Relationships between academic institutions and industry in the life sciences: An industry survey. New En- gland Journal of Medicine 334:368–373. Campbell EG, Seashore Louis K, Blumenthal D. 1998. Looking a gift horse in the mouth. Corporate gifts supporting life sciences research. Journal of the American Medical Asso- ciation 279:995–999. Cho MK, Shohara R, Schissel A, Rennie D. 2000. Policies on faculty conflicts of interest at U.S. universities. Journal of the American Medical Association 284:2203–2208. Grinnell F. 1999. Ambiguity, trust, and responsible conduct of research. Science and Engi- neering Ethics 5:205–214. Gunsalus CK. 1993. Institutional structure to ensure research integrity. Academic Medicine 68:S33–S38. Gunsalus CK. 1998. How to blow the whistle and still have a career afterwards. Science and Engineering Ethics 4:51–64. IOM (Institute of Medicine). 2001. Preserving Public Trust. Washington, DC: National Acad- emy Press. McCabe DL, Pavela GM. 1998. The effect of institutional policies and procedures on aca- demic integrity. In: Burnett DD, Rudolph L, Clifford KO, eds. Academic Integrity Mat- ters. Washington, DC: National Association of Student Personnel Administrators, Inc. Pp. 93–108. NAS (National Academy of Sciences). 1995. On Being a Scientist, 2nd ed. Washington, DC: National Academy Press. NAS. 1997. Advisor, Teacher, Role Model, Friend: On Being a Mentor to Students in Science and Engineering. Washington, DC: National Academy Press. NAS. 2000. Enhancing the Postdoctoral Experience for Scientists and Engineers. Washington, DC: National Academy Press. 

48 INTEGRITY IN SCIENTIFIC RESEARCH NIH (National Institutes of Health). 1989. Requirement for programs on the responsible conduct of research in National Research Service Award Institutional Training Pro- grams, p. 1. In: NIH Guide for Grants and Contracts, Vol. 18:1, December 22, 1989. Rockville, MD: NIH. NIH. 2000. Required Education in the Protection of Human Research Participants NIH Guide for Grants and Contracts, June 5, 2000 (Revised August 25, 2000). [Online]. Available: http: //grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html [Accessed Decem- ber 10, 2001]. NRC (National Research Council). 1996. Guide for the Care and Use of Laboratory Animals. Washington, DC: National Academy Press. Oxford English Dictionary, 2nd ed. 1989. Oxford: Oxford University Press. Resnik DB. 1998. The Ethics of Science: An Introduction. New York: Routledge. Sigma Xi. 1999. The Responsible Researcher: Paths and Pitfalls. Research Triangle Park, NC: Sigma Xi, the Scientific Research Society. Swazey JP, Anderson MS. 1998. Mentors, advisors, and role models in graduate and profes- sional education. In: Rubin ER, ed. Mission Management. Washington, DC: Association of Academic Health Centers. Pp. 165–185. University of Michigan. 1999. How to Get the Mentoring You Want: A Guide for Graduate Students at a Diverse University. [Online] Available: http://www.rackham.umich.edu/ StudentInfo/Publications/StudentMentoring/mentoring.pdf [Accessed March 15, 2002]. Yarborough M, Sharp RR. 2002. Restoring and preserving trust in biomedical research. Academic Medicine 77:8–14. 

"Most people say that it is the intellect which makes a great scientist. They are wrong: it is character."—Albert Einstein

Integrity in Scientific Research attempts to define and describe those elements that encourage individuals involved with scientific research to act with integrity.

Recognizing the inconsistency of human behavior, it stresses the important role that research institutions play in providing an integrity—rich environment, citing the need for institutions to provide staff with training and education, policies and procedures, and tools and support systems. It identifies practices that characterize integrity in such areas as peer review and research on human subjects and weighs the strengths and limitations of self—evaluation efforts by these institutions. In addition, it details an approach to promoting integrity during the education of researchers, including how to develop an effective curriculum. Providing a framework for research and educational institutions, this important book will be essential for anyone concerned about ethics in the scientific community.

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Research Integrity: Responsible Conduct of Research

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• Amruthesh C. Shivachar   ORCID: orcid.org/0000-0002-4111-9863 4  

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The legitimacy of research in any field is boosted by three crucial elements: research ethics, responsible behavior and integrity. These are the very aspects that make up the three faces of a prism lens through which a researcher investigates analyze/solve any research problems. None of these three faces is separable, each one of them is dependent on one another. In general, it is historically assumed in human behavior that “good ethical” thinking will lead to the “responsible conduct or behavior” that will enhance the “integrity” of a person’s character. This notion is intricately applicable to any research endeavor: good research ethics will reflect in the responsible conduct of research (RCR), which in turn establishes research integrity (RI). Therefore, the purpose of this chapter is to review the influence of research ethics and the RCR on RI. The author also thinks this overview will provide a basic knowledge on the global efforts for the development and establishment of universal codes or unified norms for research ethics, and RCR for RI worldwide. By emphasizing the efforts on RCR in different regions and countries, the chapter will guide a beginning researcher such as a graduate student, and an established researcher from deviating from any ethical boundaries.

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Shivachar, A.C. (2023). Research Integrity: Responsible Conduct of Research. In: Jagadeesh, G., Balakumar, P., Senatore, F. (eds) The Quintessence of Basic and Clinical Research and Scientific Publishing. Springer, Singapore. https://doi.org/10.1007/978-981-99-1284-1_58

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