6

Steps to Encourage Responsible Research Practices

ACKNOWLEDGING RESPONSIBILITY AND TAKING ACTION

The size, complexity, and diversity of research efforts, among other factors, contribute to excellence in a changing and competitive scientific research environment. However, these same features can provide opportunities for misconduct in science, questionable research practices, and other misconduct. Individual scientists bear the primary responsibility for the conduct of their research, but local research institutions and sponsoring organizations also have responsibilities, in addition to implementing fair, sound, and well-defined mechanisms to investigate allegations of misconduct in science. Research institutions strive to provide a climate that encourages responsible practices and discourages questionable research practices. The challenge to research institutions is to aid faculty in establishing effective systems of values and social controls, to provide individuals with opportunities and incentives to develop and implement these systems, and to safeguard the traditions that foster scientific creativity.

Institutional efforts to encourage responsible research practices have been stimulated by the following factors:

  • Growth and diversification of research, creating situations likely to be sources of increasing disputes about appropriate forms of re-



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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process 6 Steps to Encourage Responsible Research Practices ACKNOWLEDGING RESPONSIBILITY AND TAKING ACTION The size, complexity, and diversity of research efforts, among other factors, contribute to excellence in a changing and competitive scientific research environment. However, these same features can provide opportunities for misconduct in science, questionable research practices, and other misconduct. Individual scientists bear the primary responsibility for the conduct of their research, but local research institutions and sponsoring organizations also have responsibilities, in addition to implementing fair, sound, and well-defined mechanisms to investigate allegations of misconduct in science. Research institutions strive to provide a climate that encourages responsible practices and discourages questionable research practices. The challenge to research institutions is to aid faculty in establishing effective systems of values and social controls, to provide individuals with opportunities and incentives to develop and implement these systems, and to safeguard the traditions that foster scientific creativity. Institutional efforts to encourage responsible research practices have been stimulated by the following factors: Growth and diversification of research, creating situations likely to be sources of increasing disputes about appropriate forms of re-

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process search behavior. In addition to relying on traditional methods of individual instruction and professional example, research institutions are seeking more explicit ways to aid their members' efforts to discriminate between acceptable and unacceptable research practices.1 Recognition that many types of research practices that do not constitute misconduct in science are nevertheless questionable and fall well short of responsible research behavior. Scientists and the public in general are likely to grow dissatisfied with self-serving research practices that erode communal values and standards. Regulations requiring institutions that receive research funds from the Public Health Service (PHS) to establish an environment that discourages misconduct in science.2 In addition, applicants for biomedical training grants funded by the National Institutes of Health (NIH) and by the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) must now demonstrate that they provide instruction in the “responsible conduct of research ” in their training programs 3 Belief that sustained efforts by the research community to strengthen the accountability and integrity of the research environment may obviate the need for additional federal intervention. Some research institutions have sought to develop educational programs or guidelines intended to foster responsible research practices. The effectiveness, desirability, and need for such programs and guidelines have been debated and discussed within the research community. Although many advocate expansion of the research institution's role in fostering responsible research practices, others—often individual faculty members —have expressed caution based on the following assumptions: Institutional efforts designed to foster integrity in the research environment may be misinterpreted as an admission that the system is not working well or that faculty are not exercising their responsibilities. Institution-wide programs designed to encourage responsible research practices may weaken individual and departmental efforts to achieve the same goals. Institutional programs may all too easily intrude on and replace the more personal—and possibly more effective—efforts of individual scientists who regard the fostering of scientific responsibility as a professional obligation. Self-imposed institutional guidelines or educational programs may encourage government to utilize this mechanism for inappropriate oversight.

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process INTEGRATING ETHICS INTO THE EDUCATION OF SCIENTISTS The entire scientific community bears a responsibility for ensuring that the customs, traditions, and ethical standards that guide responsible research practices are systematically communicated to research scientists and trainees. As mentors, practicing scientists often impart these values to their students and associates, who thus can learn through direct guidance and also by example the customs of responsible research practice. But formal or explicit definition of standards governing the responsible conduct of research is infrequent. Benefits of Education in Ethics Although data reviewed in Chapter 4 indicate that young investigators or students are perhaps less likely than older researchers to engage in misconduct in science—in fact, many cases of misconduct have involved senior researchers—early education can be a primary means of instilling responsible practices. Studies in the literature on ethics education suggest that ethical development is not complete or fixed by the time students go to graduate school (Rest, 1988). Thus, although ethics education alone is unlikely to change individual moral character, teaching ethics in a professional setting can foster awareness and can reinforce the importance of actions that constitute appropriate behavior in the conduct of research. For example, informal and formal discussions of genuine ethical problems that arise in the research environment—such as the allocation of credit for a collaborative effort that involves specialized contributions —can teach both students and faculty about the significance and consequences of alternate responses to difficult situations. Moreover, the public nature of educational discussions can create a climate that may discourage individuals from engaging in questionable practices, as students and colleagues examine the potential harm that such practices can cause. Regularly held graduate seminars, faculty colloquia, and informal discussions in the laboratory and the classroom can also provide opportunities to test perceptions of observed practices against the expected norms of science, can help all members of the research community to define and clarify the fundamental norms that guide research practice, can ameliorate misunderstandings that could escalate into unfounded accusations, and can stimulate open and frank consideration of conflicting values. Exploring a case of poor authorship practices in the context of a classroom discussion of questionable research practices, for example, might be less threatening to a

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process concerned student than approaching an institutional officer or departmental superior. Finally, education in research ethics can help all involved in the research process to become informed participants in the self-governance of the scientific community. The ideal of informed participation is as important for members of the scientific community as it is for citizens of the larger political community. Approaches to Teaching Ethics Various approaches can be adopted in teaching research ethics. One involves examining the special obligations scientists have by virtue of their expert knowledge and profession and clarifying how practices and standards may differ among disciplines or among institutions. Instruction based on this approach could include discussions of standards of good practice, misconduct in science, questionable research practices, and other misconduct. Specific topics that should be addressed include the following: The necessity of honesty, skepticism, error correction, and verification in science; Principles of data selection, management, and storage, including rights and responsibilities with respect to sharing and granting access to research data, and the special status of data that support published findings; Publication practices, including the importance of timely and appropriate release of significant research findings and the harm that can result from premature or fragmentary publication of results or from publication in multiple forms; Authorship practices, particularly criteria for and obligations of authorship and the proper allocation of credit for specialized contributions; and Training and mentorship practices, including the responsibilities of supervision and the principles that guide collaboration between senior and junior personnel. Some honorary and professional societies have prepared educational materials to encourage discussions of such topics. The National Academy of Sciences, for example, has published On Being a Scientist (NAS, 1989), an essay written to instruct graduate students in the values and practices of scientists, and Sigma Xi has made its educational essay on ethics and science, Honor in Science (Sigma Xi, 1986), widely available. Scientific Freedom and Responsibility, prepared by Harvard biologist John T. Edsall (1975) for the American Association

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process for the Advancement of Science, was an early report that still would enhance the quality of current discussions about appropriate behavior in science. A second approach to teaching ethics focuses on examining laws, institutional policies, and professional standards that guide certain fields of activity (such as the use of human subjects in biomedical, social, or behavioral research or the use of hazardous materials in the natural sciences). Such an approach can clarify the justification for adopting particular rules and also can explain the context and some of the abuses and value conflicts that spurred the development of specific rules and standards. Discussions of institutional policies should be explicit about appropriate channels for raising concerns when one witnesses misconduct in science, questionable research practices, or other misconduct. Such discussions may help prevent conflicts that can result from poor communication or poorly understood expectations about what behaviors constitute misconduct in science or questionable research practices. A third approach involves going beyond laboratory and classroom discussions of responsibility in research to consider specific ethical questions in the broader context of competing rights and obligations in the research community. University-wide forums can provide opportunities to discuss authorship, communication, and datahandling practices that may both educate faculty and students and allow comparison of different disciplinary practices. Research institutions could also provide funds to graduate students, interns, and other junior scientists to organize discussion sessions and to prepare case studies to highlight current ethical dilemmas. Such forums and sessions could also facilitate interdisciplinary discussions of the philosophy, history, and social studies of science that bear on scientific conduct. Experience gained in teaching engineering ethics and biomedical ethics suggests that the following principles can contribute to the success of ethical discussions as they are integrated into scientific or engineering programs: More than generalities should be taught. Specific examples, preferably local case histories, are the preferred way to provide guidance on matters important in the profession. Education must aim at influencing behavior. Professional training cannot assure that people will make correct moral judgments, but it can provide the opportunity to learn from experts who can explain the reasoning behind certain moral judgments or professional practices.

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process Perspectives gained from looking beyond science itself are valuable in examining ethical issues in the research environment. Studies in ethics, moral philosophy, history, and the social studies of science can contribute to a broader outlook that can aid in rethinking controversial issues and establishing values in research. If properly structured, topics and teaching materials related to ethics in science and research can be intellectually stimulating for students and faculty. Such topics can be taught in dedicated courses or included in courses within the broad curriculum. The panel 's discussions with students and faculty indicate that both approaches are desired by the larger community. As noted above, universities that have applied for NIH or AD-AMHA training grants must develop educational programs to foster broad discussions of responsible research practices. The NIH has convened several workshops to examine the strengths and limitations of various approaches to fulfilling the training grant requirement.4 Some departments and universities have sponsored forums and seminars that offer students the benefit of learning from watching faculty grapple seriously with issues involving responsible practice. Real or hypothetical case studies are also useful devices for examining selected research practices. Relevant instruction and the message that responsibility in research is to be taken seriously can also be given in orientation programs for new graduate students, postdoctoral fellows, and faculty. Interdisciplinary training workshops may improve the quality of instruction and curriculum materials for teaching ethics in scientific research. After a period of years, and when a significant number of schools have developed curricula on research ethics, it could be useful to review and to improve as necessary the quality of teaching and of the curriculum materials used for instruction in research ethics. 5 Such a review could draw on the expertise and judgments of a consensus panel representing those engaged in ethics instruction as well as those who are respected scientists in the fields under study. CONSIDERING GUIDELINES FOR RESPONSIBLE RESEARCH PRACTICES Current Means for Providing Guidance Even though most research institutions do not have written guidelines for the conduct of research, their faculty usually act individually and

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process informally to encourage responsible research practices.6 In addition, most universities have (1) general codes of academic conduct or honor codes that apply broadly to faculty, administrators, staff, and students7 and that provide for disciplinary action by the institution in the event of serious violations and (2) written policies dealing with specific issues in the research environment, such as conflict of interest, intellectual property rights, use of humans and animals in experimentation, and computer use.8 Most academic institutions that conduct significant amounts of research have also adopted policies and procedures for handling allegations of misconduct in science.9 The normative rules and monitoring requirements scattered throughout university policies and documents relating to science and engineering research are an important first step for promoting the responsible conduct of research. In defining what is illegal, unethical, and irresponsible, these rules suggest what is legal, ethical, and responsible. For example, the University of Maryland policy on misconduct defines “improprieties of authorship” as “improper assignment of credit, such as excluding others; misrepresentation of the same material as original in more than one publication; inclusion of individuals as authors who have not made a definite contribution to the work published; or submission of multi-authored publications without the concurrence of all authors” (University of Maryland at Baltimore, 1989, p. 2). This statement could be interpreted as a guideline for responsible behavior in research, since it encourages the proper assignment of credit for research performance and urges authors to include the names of co-authors only with their permission. Therefore, although most research institutions do not have comprehensive codes of conduct for science and engineering research, they do provide ethical and policy guidance to researchers. If these policies are considered along with the various federal regulations, statements of professional societies about professional conduct in research, and other literature prepared by professional and scientific societies (such as the National Academy of Sciences' essay On Being a Scientist and Sigma Xi's essay Honor in Science), the total package provides a strong foundation for describing what is responsible and irresponsible in the conduct of research. However, the currently existing set of normative rules designed to foster responsibility in science has limitations. Research policies are often disjointed and piecemeal, they may be administered by different academic units, and they may vary substantially among institutions. It is difficult for researchers to comprehend and consider all the legal and professional responsibilities raised by modern science and engineering. Yet integrating rules and resolving contradictions

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process are often left to the individual, who is expected to read through three, four, or more separate policies to determine what is proper. The use of examples or case studies that deal with difficult rather than obvious issues is a valuable method of interpreting and explaining policy statements about normative or ideal conduct. Few doubt that manufacturing data or forging experimental results is wrong. It may be less clear, however, how preliminary results should be presented in grant applications, when “enough data” are needed to give confidence that a project will succeed but “enough work” remains to be done to justify the grant award. Most normative rules provide important general principles but leave significant questions unanswered. This void has prompted some universities to take additional steps to foster responsible conduct in research, such as developing guidelines for the conduct of research. Scope and Purpose of Institutional Guidelines for the Conduct of Research By “guidelines for the conduct of research,” the panel means institutional policies that address practices such as those related to data management (including data collection, storage, retention, and accessibility), publication (including authorship policies), peer review and refereeing, and training and mentorship. Some institutions have guidelines that focus on a single topic, such as authorship, whereas others adopt a more comprehensive approach. The guidelines may be voluntary or compulsory, and they are administered through a variety of organizational units. Several major research institutions, such as the National Institutes of Health (for its intramural research program), Harvard Medical School, Johns Hopkins University Medical School, and the University of Michigan Medical School, have formulated comprehensive guidelines for the conduct of research.10 Nevertheless, comprehensive guidelines for research conduct are not common. One study of 133 medical institutions indicated that 17 (13 percent) had such guidelines and that 25 (19 percent) were considering developing guidelines, while 91 (68 percent) were not (Nobel, 1990). Guidelines for the conduct of research differ from institutional policies that are designed to address misconduct in science or conflict of interest or that, in response to regulatory requirements, govern research involving human subjects, hazardous materials, or recombinant DNA.11 Research conduct guidelines are intended to promote responsible conduct of research and, to the extent that questionable practices and misconduct in science are linked, to reduce the amount

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process of misconduct in science. However, although there are positive advantages associated with the adoption of such guidelines, this approach, by itself, may not be effective in fostering responsible research conduct. The imposition of guidelines also carries certain risks and limitations in the collegial academic environment. Benefits of Institutional Guidelines for the Conduct of Research Research conduct guidelines represent an important, but not necessarily the best, means by which research institutions can demonstrate awareness of and support for principles of good research practice. Properly constructed and used, research guidelines can help articulate and strengthen the fundamental values of scientists, especially in an increasingly diverse and changing research environment.12 In principle, research conduct guidelines can help scientists to understand the criteria that should be considered in, for example, making decisions about how long research data should be retained. They can also help clarify for scientists and trainees what constitutes “good practice,” although many research practices are, by virtue of their complexity, subject to varying interpretations. Government agencies already require research institutions to play a stronger role in fostering responsible research practices, and it is possible that such guidelines may one day be required as a condition of governmental funding. Thus it may be wiser to have research conduct guidelines developed internally by faculty and research scientists who are most familiar with their own institutional research environment than to have them imposed by higher authorities to fulfill funding or regulatory requirements. Guidelines may help inform members of a research institution about what constitutes questionable practices or misconduct in science in an academic research environment. For example, by issuing guidelines that state the criteria for authorship, universities can fulfill a due process obligation to provide notice to their members of the unacceptable authorship practices, such as plagiarism, that may constitute grounds for disciplinary actions. Disadvantages of Institutional Guidelines for the Conduct of Research Many scientists believe that research conduct guidelines are unnecessary and ineffective, and they point out that research practices are often too complex and too varied to be governed by a few general

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process principles. Moreover, adopting such principles is a time-consuming process that requires the efforts of active researchers who are already burdened by other obligations. Some are concerned that focusing on guidelines diverts attention from the consideration of complex ethical issues and genuine dilemmas in the research environment. The concept of research guidelines cuts against faculty autonomy and other values associated with academic freedom as ideals of the academic environment. In the past, steps that might restrict scholarly or scientific independence were taken only when there was clear evidence that inappropriate behaviors or hazardous situations might persist in the absence of institutional policies. Although they themselves may not require new administrative procedures, guidelines may encourage implementation of rules and rigid regulations, as well as “cookbook” approaches to scientific endeavors. Some institutional officers are also concerned that guidelines that describe appropriate research conduct will expose them to additional litigation and administrative vexations (Nobel, 1990). Many scientists believe that explicit guidelines can add little of substance to the material already included in publications such as On Being A Scientist and Honor in Science. Others think that guidelines may not be necessary because the norms of science are self-evident and because existing policies provide abundant advice to determine how to conduct research responsibly. Another drawback is the effort needed to bring to the attention of faculty and students any research conduct guidelines that have been adopted. If research conduct policies are not appropriately implemented, they can be viewed as empty gestures or “window dressing” that will serve little purpose. Conclusions About Institutional Guidelines for the Conduct of Research In considering the advantages and disadvantages of guidelines for research conduct, the panel concluded the following: Guidelines that are relevant and appropriate to research may be widely disparate depending on the research field, the nature of the work, and other factors. Written guidelines are unlikely to influence academic research behavior if they are imposed from above or from outside. The process of formulating guidelines may be extremely valuable for those who participate; however, efforts will need to be made to ensure that the final statements express the fundamental ideas and potential conflicts inherent in such guidelines.

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process To be effective, guidelines must be incorporated into the process of research and education and become an operational part of day-to-day activities. If faculty desire to develop guidelines for the conduct of research, such policies should be formulated by those who will be directly affected and should be adapted to specific research fields and protocols. Institutional guidelines are likely to be less effective than ones formulated at the group or laboratory level. However, research institutions may wish to adopt an overarching set of general principles for their members to provide a common frame of reference. The panel recognizes that the formulation of written guidelines is an exacting task that requires substantial time and effort. Guidelines may help clarify the professional obligations of faculty and research staff, but the panel believes that the development of such guidelines should be left to the discretion and initiative of individual faculty and research institutions. In any case, care should be taken to avoid adopting constraints that could be damaging to the research process. A FRAMEWORK OF SUBJECTS TO CONSIDER IN ENCOURAGING RESPONSIBLE RESEARCH PRACTICES The panel has identified a set of subjects that should be considered in any efforts aimed at developing educational discussions or guidelines for the conduct of scientific research. This set of subjects is not meant to be comprehensive but rather to suggest particular topics and examples of “best scientific practice” that should be considered in formulating statements on research conduct. Examples of selected guidelines are paraphrased below to illustrate ways in which different institutions have addressed these topics.13 Data management. Acquisition and maintenance of research data should be addressed since they provide the foundation for scientific discovery and experimentation. Research data include detailed experimental protocols, primary data from laboratory instruments, and the procedures applied to reduce and analyze primary data. Subjects to be addressed: Availability of data to scientific collaborators or supervisors Retention of data for specified periods of time Accessibility of data after publication Examples of good practice: Research data, including the primary experimental results, should be retained for a sufficient period to allow analysis and repetition by others of published material from those data. In

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process some fields, 5 or 7 years are specified as the minimum period of retention, but this may vary under different circumstances. (NIH, 1990) Custody of all original primary laboratory data must be retained by the unit in which they are generated. An investigator may make copies of the primary data for his/her own use. (Harvard University Faculty of Medicine, 1988) All primary data are to be entered into a notebook provided by the institute for this purpose. The investigator is responsible for all data entries. The notebook will contain lined, numbered pages; no pages are to be removed or made illegible. Entries must be dated and signed. (Dana–Farber Cancer Institute, 1987) All data, even from observations and experiments not leading directly to publication, should be treated comparably. Research data should always be immediately available to scientific collaborators and supervisors for review. In collaborative projects involving different units, all investigators should know the status of all contributing data and have direct access to them. (NIH, 1990) Publication practices. Science is a cumulative activity in which each scientist builds on the work of others. Publication of results is an integral and essential component of research because it enables others to gain access to each scientist's contribution. Subjects to be addressed: Methods of publication and disclosure of new findings Correction of errors and retraction of published findings Treatment of fragmentary results of a scientific investigation Multiple publications of same or similar findings Completeness of publication so that repetition and evaluation are feasible Examples of points to be kept in mind: Certain practices make it difficult for reviewer and reader to follow a complete experimental sequence. Among these are the premature publication of data without adequate tests of reproducibility or assessments of significance, the publication of fragments of a study, and the submission of multiple similar abstracts or manuscripts differing only slightly in content. In such circumstances, if any of the work is questioned, it is difficult to determine whether the research was done accurately, the methods were described properly, the statistical analyses were adequate, or appropriate conclusions were drawn. In-

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process vestigators should review each proposed manuscript with these principles in mind. (Johns Hopkins University School of Medicine, 1990) In a publication, all data pertinent to the project should be reported, whether supportive or unsupportive of the thesis or conclusions. Except for review articles, publishing the same material in more than one paper should be avoided. Unnecessary fragmentation of a complete body of work into separate publications should be avoided. Prior work in the field should be referenced appropriately. (University of Michigan Medical School, 1989) Authorship. Authorship and allocation of credit are primary benchmarks of achievement and rewards for scientists. Subjects to be addressed: Criteria for authorship and identification of contributors Order of listing of authors Responsibility for authorship: collective and individual Examples of good practice: For each individual the privilege of authorship should be based on a significant contribution to the conceptualization, design, execution, and/or interpretation of the research study, as well as a willingness to take responsibility for the defense of the study should the need arise. In contrast, other individuals who participate in part of a study may more appropriately be acknowledged as having contributed certain advice, reagents, analyses, patient material, support, and so on, but not be listed as authors. It is expected that such distinctions will be increasingly important in the future and should be explicitly considered more frequently now. (NIH, 1990) Criteria for authorship of a manuscript should be determined and announced by each department or research unit. The [Harvard University Faculty] committee considers the only reasonable criterion to be that the co-author has made a significant intellectual or practical contribution. The concept of “honorary authorship” is deplorable. The first author should assure the head of each research unit or department chairperson that s/he has reviewed all the primary data on which the report is based and provide a brief description of the role of each co-author. (Harvard University Faculty of Medicine, 1988) Peer review. Peer review is used to guide decisions on the funding of research and on the publication of research results. It is an essential component of the scientific research process.

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process Subjects to be addressed: Responsibility to participate in the peer review process Considerations of confidentiality and proprietary interests in peer review Conflicts of interest and need for disclosure in peer review of competitive proposals Objectivity of peer reviews; inclusion of nonpublic information Examples of good practice: It is important that reviewers and readers be informed of the sponsorship of research projects in order that they may be alert to possible bias in the research arising from a sponsor's financial interest in the results. (Johns Hopkins University School of Medicine, 1990) The reviewer has the responsibility for preserving the integrity of the review process. In receiving a manuscript or a grant proposal, he is entrusted with privileged information that is unavailable to anyone outside of the laboratory of the submitting scientist(s). It is of obvious importance for the reviewer not to make use of information gained in the review for his own purposes until it is published or, prior to that, only by consent of the author. The contents of a work under review should not be distributed to other colleagues. There are certain exceptions to this general rule, however. For example, it should be permissible to discuss parts or even all of a submitted work with trusted colleagues to obtain a second opinion in instances when the reviewer is unfamiliar with the methodology or considers the author to be mistaken. (University of Michigan Medical School, 1989) Training and supervision. Scientists in universities accept the obligation to pass along knowledge and skills to the next generation of scientists. Subjects to be addressed: Assignment of mentors to students Availability of mentors and appropriate forms of supervision Degree of independence and responsibility for students and postdoctoral trainees Types of duties assignable to students by mentors and supervisors Appraisals and communication of student and trainee performance Examples of good practice: Each trainee should have a designated primary scientific

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process mentor. The mentor has the responsibility to supervise the trainee's progress closely and to interact personally with the trainee on a regular basis in such a way as to make the training experience a meaningful one. Mentors should limit the number of trainees in their laboratory to the number for whom they can provide an appropriate research experience. (NIH, 1990) The preceptor should provide each new investigator (whether student, postdoctoral fellow, or junior faculty) with applicable government and institutional requirements for conduct of studies involving healthy volunteers or patients, animals, radioactive or other hazardous substances, and recombinant DNA. (Harvard University Medical School Faculty, 1988) The preceptor should supervise the design of experiments and the processes of acquiring, recording, examining, interpreting, and storing data. A preceptor who limits his/her role to the editing of manuscripts does not provide adequate supervision. (Harvard University Medical School Faculty, 1988) DISCOURAGING QUESTIONABLE RESEARCH PRACTICES Many scientists and students do not believe that they will experience situations involving fabrication, falsification, or plagiarism. Yet, sometimes on a daily basis, they face situations that require ethical judgment and professional guidance. Students and young scientific investigators, in particular, may experience questionable practices, sometimes encouraged by their mentors, that cause them to question the fundamental values that should guide the responsible conduct of research. Requests for co-authorship in exchange for the preparation of unique samples or reagents for complicated experiments, for example, can be problematic for inexperienced as well as senior investigators. Rules and regulations often do not provide appropriate guidance for resolving such problems, which nevertheless cannot simply be tolerated or ignored. It is important to recognize that junior investigators may be particularly at risk in failing to distinguish, or prevent, unacceptable research practices. Although questionable research practices are not appropriate for treatment as incidents of misconduct in science, they require the sustained attention of scientists and responses by institutional officers when there is general agreement that specific practices are not to be tolerated. The panel points out that the methods for addressing questionable research practices should be different from those for handling misconduct in science or other misconduct. At tention to questionable research practices should be rationalized

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process and regularized to encourage responsible research behaviors and to discourage questionable practices. These questionable practices might include, for example, not giving colleagues access to data or research materials; failing to retain, for a reasonable period, data or research materials that support reported findings; designating as an author one who has made no significant contribution to a paper, as well as failing to acknowledge as an author an individual who has made a significant contribution to the work reported in a paper; or exploiting graduate students. Recognizing that specific approaches may have important limitations, the panel nevertheless concludes that it is essential for scientists and research institutions to exercise a stronger role in providing an environment that encourages responsible research practices and also discourages misconduct in science. In considering different approaches to dealing with questionable research practices, the panel concluded that questionable practices are best discouraged through (1) the effective use of peer review and the system of appointments, evaluations, and other rewards in the research environment and (2) educational programs that emphasize responsible behavior in the research environment. Such approaches build on the strengths of self-regulation, rely on those who are most knowledgeable about the intricacies of the scientific research process to maintain the quality of the research environment, and preserve the diverse disciplinary traditions that foster integrity in the research process. By encouraging the development of educational programs that emphasize responsible research behavior, the panel seeks to foster more deliberate and informed communication, discussion, criticism, and reflection of the basic values that guide scientific practices and judgments. The role of government should be confined to one of providing oversight of institutional efforts to handle and prevent episodes of misconduct in science. Government should not seek to regulate questionable research practices. NOTES 1. See, for example, the report of the Massachusetts Institute of Technology's Committee on Academic Responsibility included in Volume II of this report. 2. See, for example, Section 50.105 of the final PHS rule on responsibilities for dealing with possible misconduct (DHHS, 1989a, p. 32451): Institutions shall foster a research environment that discourages misconduct in all research and that deals forthrightly with possible misconduct associated with research for which PHS funds have been provided or requested. An institution's failure to comply with its assurance and the requirements of this

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RESPONSIBLE SCIENCE: Ensuring the Integrity of the Research Process subpart may result in enforcement action against the institutions, including loss of funding, and may lead to the OSI's conducting its own investigation. 3. The policy, issued jointly by NIH and ADAMHA, became effective July 1, 1990. See National Institutes of Health and Alcohol, Drug Abuse, and Mental Health Administration (1989, 1990). 4. The deadline for the first applications affected by this rule was January 10, 1991. Thus at the time this report is being written, these applications are being reviewed. It will therefore be some months before the initial impact of the new requirement can be reviewed. For the NIH's initial thoughts on compliance, see Department of Health and Human Services (1990b). 5. See, for example, the experience in biomedical ethics reported in Culver et al. (1985). 6. Much of this section draws on a paper prepared for the panel by Nicholas Steneck, “Fostering Responsible Conduct in Science and Engineering Research: Current University Policies and Actions,” which is included in Volume II of this report. 7. Other institutions have not adopted policies on integrity or responsibility, but they have adopted rules of academic discipline. See especially the compendium of student honor codes in Codes and Regulations, published as part of the Princeton Conference on Honor Systems, March 1988. 8. For more information on university policies and the research environment, see, in Volume II of this report, Barbara Mishkin's “Factors Enhancing Acceptance of Federal Regulation of Research” and Nicholas Steneck 's “Fostering Responsible Conduct in Science and Engineering Research: Current University Policies and Actions.” For examples, see policy statements from Harvard University School of Medicine, the University of Michigan, the Johns Hopkins University, and the University of California, San Diego, also in Volume II of this report. 9. See Department of Health and Human Services (1989d). Also see National Science Foundation (1990b) and prior semiannual reports (NSF, 1989c, 1990a). 10. See Harvard University Faculty of Medicine (1988), University of Michigan Medical School (1989), Johns Hopkins University School of Medicine (1990), and National Institutes of Health (1990). 11. Many researchers and academic administrators report a positive experience with other institutional policies that define appropriate research behavior. This is particularly true with the regulations for research involving human subjects and regulations on laboratory safety. 12. It is useful to review the findings presented in Institute of Medicine (1989a). The IOM report states: Increasing budgetary and competitive pressures in science demand that local research institutions and government research funders develop standards to ensure responsible research practices to ensure the integrity of the academic research enterprise. [emphasis in original] [The IOM committee expressed] consensus that, although the fundamental values and standards of the research community are appropriate, the expression and implementation of these standards are insufficient to promote responsible research practices in an increasingly large, heterogeneous, and competitive research environment. New and comprehensive guidelines should be developed by the research community to clarify traditional practices, to strengthen the mix of formal policies and informal practices currently in place, and to correct actions that seriously deviate from these standards. 13. The full texts of these institutional guidelines and additional examples are included in Volume II of this report.