10
Guidelines for the Responsible Conduct of Research

University of Michigan Medical School

Introduction

This document represents the work of a Medical School ad hoc committee that was charged with the task of developing a set of guidelines for the conduct of research that would promote adherence to the highest scientific and ethical standards. The committee consisted of senior and junior members of both the clinical and basic science faculties and included a postdoctoral trainee. There are two important points to highlight from the charge to the committee. First, this document is meant to serve as a useful guideline for the conduct of research. It is neither a specific policy statement with legal ramifications nor a rulebook with an attached set of punishments. The document is meant merely to structure and reiterate the collective wisdom of a representative group of faculty members of the Medical School regarding scholarly practices directed at maintaining the highest aspirations of the medical academic profession. The second feature of this document that is worthy of note is its intention to promote the highest scientific and ethical standards. Although it is undeniable that the recent national focus of attention on misconduct in research influenced the decision to form this committee, the committee was not charged with the negative goal of preventing or prosecuting unacceptable behavior in the biomedical sciences. Ours is a profession that is constructed with intrinsic safeguards against misconduct. The extensive system of peer review that begins within our own laboratories or institutions and intensifies upon application for grant funding or following submission of a manuscript for publication, limits the viability of a biomedical scientist who does not adhere strictly to open and honest practices. In the final analysis, the veracity of the work of a biomedical scientist is judged by

NOTE: Dated March 1989; reprinted with permission from the University of Michigan, Ann Arbor.



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Responsible Science: Ensuring the Integrity of the Research Process, Volume II 10 Guidelines for the Responsible Conduct of Research University of Michigan Medical School Introduction This document represents the work of a Medical School ad hoc committee that was charged with the task of developing a set of guidelines for the conduct of research that would promote adherence to the highest scientific and ethical standards. The committee consisted of senior and junior members of both the clinical and basic science faculties and included a postdoctoral trainee. There are two important points to highlight from the charge to the committee. First, this document is meant to serve as a useful guideline for the conduct of research. It is neither a specific policy statement with legal ramifications nor a rulebook with an attached set of punishments. The document is meant merely to structure and reiterate the collective wisdom of a representative group of faculty members of the Medical School regarding scholarly practices directed at maintaining the highest aspirations of the medical academic profession. The second feature of this document that is worthy of note is its intention to promote the highest scientific and ethical standards. Although it is undeniable that the recent national focus of attention on misconduct in research influenced the decision to form this committee, the committee was not charged with the negative goal of preventing or prosecuting unacceptable behavior in the biomedical sciences. Ours is a profession that is constructed with intrinsic safeguards against misconduct. The extensive system of peer review that begins within our own laboratories or institutions and intensifies upon application for grant funding or following submission of a manuscript for publication, limits the viability of a biomedical scientist who does not adhere strictly to open and honest practices. In the final analysis, the veracity of the work of a biomedical scientist is judged by NOTE: Dated March 1989; reprinted with permission from the University of Michigan, Ann Arbor.

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Responsible Science: Ensuring the Integrity of the Research Process, Volume II the test of time. Against this background, it is clear that no external review committee, however menacing or powerful, could function better than the mechanisms by which we biomedical scientists already police ourselves. The presumption of the committee, therefore, was that the biomedical scientific enterprise is basically healthy, sound, and honest. Thus, the task at hand was to provide useful suggestions on maintaining and promoting the prevailing spirit of integrity. A previous report prepared by the University of Michigan Joint Task Force on Integrity in Scholarship in 1984 (Steneck Report) already has addressed many important areas pertaining to the ethical conduct of research (see Appendix I [of that report]). It defined the ethical obligations of a scholar and the pressures that can discourage integrity in scholarship. Moreover, it articulated specific procedures to be followed when misconduct is alleged. In this document, we have chosen to focus our attention on promoting the best qualities of the scientific environment so as to discourage misconduct at its source. Since the essentials of appropriate conduct in science should be taught by the mentor to his pupils, we begin our report by identifying the responsibilities of mentorship and then continue with a discussion of the appropriate handling of data. Authorship defines our output as scholars; thus this important subject, as well as the related area of peer review, is covered in considerable detail. A consideration of the rules of proper conduct in the general discussion of the academic environment, the responsibilities of the institution to its faculty members, and guidelines for academic advancement are presented. Responsibilities of a Mentor Initial Stages of Training Make certain that the mentor's particular laboratory is appropriate for the trainee and his1 goals. Make an effort to provide sufficient funding, instrumentation, and space for the conduct of the trainee's research. Have a plan for the overall training of the fellow/student as well as an outline for a research project. 1   The pronoun "his" is understood throughout this document to stand for "his or her."

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Responsible Science: Ensuring the Integrity of the Research Process, Volume II Make certain that the trainee is educated in all matters of laboratory safety, humane treatment of animals, and safe conduct of human research. Inform the trainee of the publication policies of the laboratory. Identify a responsibility/supervisory structure in the laboratory. Ongoing Responsibilities Maintain an environment for the free and open discussion of data. Hold regularly scheduled meetings for the critical evaluation of the laboratory's output. Meet individually with the trainee on a regular basis. Make certain that all data are properly recorded and stored. Accept responsibility for all of the trainee's work. Limit the laboratory group to a size that can be managed educationally, intellectually, and financially by the mentor. Treat the trainee with respect as a colleague. Preparing for Departure Assist in career counseling and job placement for the trainee. Assist postdoctoral trainees in defining independent areas of research to pursue. Assist the postdoctoral trainee in obtaining independent funding. The essence of biomedical science, whether clinical or basic in nature, is learning and teaching, as exemplified best in the relationship between the trainee and the mentor. The process of learning the meaning of quality and integrity in science begins early in a trainee's scientific life and continues on a daily basis. As in any aspect of life, good habits last a lifetime and bad habits are perpetually difficult to overcome. Thus, the conduct, expectations, goals, and aspirations of a mentor are reflected, often forever, in his trainees. For this reason, no other aspect of biomedical science is quite as crucial for its healthy future as the trainee-mentor relationship. The responsibilities of a trainee to his mentor are simple; to learn, to carry on research, and to create. Those of a mentor are somewhat more mundane but require thoughtful planning. The needs of a trainee vary depending on the stage of his evolution; thus the responsibilities of a mentor can be divided into the early, middle, and late stages of the trainee's stay under his care. When a trainee seeks to pursue his education in a particular laboratory, it is usually viewed as a blessing by the mentor. The trainee

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Responsible Science: Ensuring the Integrity of the Research Process, Volume II represents a companion, a scientific colleagues with whom to exchange ideas, and a source of inspiration and new ideas, not to mention an additional pair of willing hands. It is not surprising that the temptation is to accept the trainee without too much deliberation. However, it is of critical importance that the mentor consider several important issues before taking this step. First, he must carefully evaluate whether the scientific capabilities, directions, and goals of the laboratory are appropriate for the trainee in light of his own aspirations. Secondly, the mentor must have sufficient resources, including salary funding, instrumentation, and space, with which to support the trainee and his work. Finally, the mentor must have a well-considered plan for the overall education of this trainee, including a general outline for a research project. Inability to fulfill any one of these three important responsibilities should steer the mentor away from acceptance of the trainee in question. After a trainee is accepted into the laboratory, it is important to identify a supervisory structure into which the trainee can fit so that he is able to obtain assistance when it is needed and so that the lines of responsibility are understood. To avoid any future disagreements, it is essential that the publications policies of the laboratory are openly discussed at the onset (see "Guidelines for Authorship" section below). Before the research efforts of the trainee commence, the mentor must take special care to educate him in all matters related to laboratory safety, humane treatment of animals, and safe conduct of human research. The responsibilities of a mentor during the bulk of the trainee's time with him relate to the general maintenance of high standards of laboratory research. It is understood that the mentor will treat the trainee with respect as a colleague, rather than as a simple technician. Furthermore, the mentor must assume responsibility for all of the trainee's work, keeping in mind that the trainee's contributions to any laboratory effort should be credited appropriately. It is of critical importance to maintain in the laboratory an environment that is conducive to the free and open discussion of data so that the trainee can benefit from the experience and wisdom of the others that work with him. Toward this end, regularly scheduled meetings should be held so that the laboratory's output, and more specifically the trainee's efforts, can be evaluated critically. The mentor's contacts with the trainee should not be limited to these laboratory meetings. Less formal interactions between the mentor and his trainee to discuss research are of great importance, although the frequency of these meetings may vary with the seniority and experience of the trainee. Through direct contact, the mentor should strive to maintain quality control over the trainee's efforts, with a special emphasis on the proper recording and storage of

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Responsible Science: Ensuring the Integrity of the Research Process, Volume II all data obtained. In order to ensure this level of supervision over his trainees, the mentor should make every effort to limit the size of his laboratory group to one that he can manage comfortably in meeting its educational, intellectual, and financial needs. The role of the mentor changes as the trainee prepares to depart from the laboratory. The mentor is often judged by the later performance of his former trainees; thus he may find that his responsibilities to them last a lifetime. It is of equal importance, then, to both mentor and trainee that the former provide career counseling and assist with appropriate job placement for the latter. A potential problem with departing postdoctoral trainees can be avoided if the mentor and trainee together define independent areas of research that the trainee can pursue. In this regard, it should be noted that the intellectual "property" of a laboratory group normally stays with the laboratory unless the mentor willingly parts with some aspect of it by ceding it openly to a trainee. A final and most important level of instruction that should be offered by the mentor to his trainee is assistance in obtaining independent funding. Success in this endeavor will provide the ultimate evidence as to the effectiveness of the training offered in the mentor's laboratory. Data Collection and Management Collection of Data Make certain that all laboratory staff are appropriately trained for the experimental procedures being utilized. Clearly outline the responsibilities of each participant in the collection of data. Make certain that all staff are aware of any calibration or routine maintenance procedures associated with experimental instrumentation. Detailed documentation of all experimental protocols should be maintained. All data should be recorded in a consistent format established by the investigators. Where appropriate, laboratory notebooks should be kept in sequence by date.

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Responsible Science: Ensuring the Integrity of the Research Process, Volume II Data Analysis The statistical analyses utilized should be clearly documented for all experiments. Inclusion or exclusion of data in the analysis should be noted. When necessary, strong consideration should be given to seeking statistical consultation. Data Storage Stored documentation should allow investigators to easily reconstruct experiments. Investigators should determine the quantity and time of raw data storage. (The NIH has suggested at least five years.) Two major processes govern biomedical research: discovery and dissemination. In order to adequately sustain these tasks, the method and manner in which data are collected and analyzed must be considered carefully. The issues related to data collection and analysis are divided into three major categories: collection of data, data analysis, and data storage. It is important to recognize that the specific methodology and format of data collection and analysis are a function of the scientific discipline as well as of the types of experiments being performed. Common to all experimentation, however, is the need for well-organized and well-documented procedures, results, and analyses. It should be recognized that all scientific efforts, in the final analysis, are judged by the interpretation and results expressed in published or presented documents. Careful attention to both the organization and the details of data collection, analysis, and storage will assist in the maintenance of the highest quality and quantity of research to be disseminated. It is of critical importance to establish the responsibility of technicians, collaborators, graduate students, and fellows involved in the collection of research data. Inherent in those responsibilities is the necessity for adequate training in all techniques and procedures for which they are well- trained within the expectation of the principal investigator. Since the quality of data may correlate with the expertise of the involved technicians, consistency in task assignment is recommended. The principal investigator must assume the ultimate responsibility for establishing the level of expertise required of all individuals involved in the performance of scientific study. Frequently, research necessitates the use of sophisticated systems or instruments in the collection of routine data. It is important that all laboratory personnel involved in the utilization of these systems be

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Responsible Science: Ensuring the Integrity of the Research Process, Volume II aware of any calibration or routine maintenance or procedures associated with proper use of the instrumentation. Some instrumentation requires frequent calibration or validation procedures to be performed. Documentation of these procedures as part of the experimental protocol in the laboratory notebooks is suggested. Experiments usually begin with an experimental design. A protocol of the experimental design should be available for all personnel involved and become part of the scientific notebook. Many issues may arise, however, during the conduct of an experiment requiring revision of the protocol or an evolution of the experimental design. The rationale for any protocol revision and how and when it occurs should be documented clearly. All aspects of scientific study should be recorded carefully and consistently in laboratory notebooks. The format of this documentation is dependent on the character of the research being performed. Maintenance of a journal is recommended for appropriate documentation of procedures and results on a daily basis. Although bound notebooks with numbered pages may be most appropriate for many types of laboratory experiments, others necessitate dependence on output from specialized instruments and computer systems which cannot be stored conveniently in bound format. It is recommended that all investigators carefully consider the appropriate format for their data and develop a consistent documentation system which will enable well-organized, long-term recording of their scientific pursuits. The organization of the notebook should be such that it would permit the investigators to reconstruct the experiments or procedures that have been performed. Once the experimental data have been collected, the interpretation and statistical analysis of these data are important aspects of the scientific study. Since any data set can be interpreted and statistically analyzed in a variety of ways, it is very important that the specific procedures, analysis methods, and criteria for significance be well documented and described. In particular, the criteria and/or rationale for inclusion or exclusion of data from the analyses should be noted. When necessary, strong consideration should be given to seeking statistical consultation for final analysis and interpretation. It is important that all research data be stored after the conclusion of the study. According to the most recent guidelines put forth by the National Institutes of Health, it is suggested that raw data be stored for at least five years. The medium on which the data are stored is much less important than maintaining effective documentation. All investigators should determine the quantity of data required for storage to enable the reconstruction of the experiments.

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Responsible Science: Ensuring the Integrity of the Research Process, Volume II Rights and Responsibilities of Peer Review Rights Anonymity should be guaranteed to the reviewer. Responsibilities Accept material for review only if qualified to do so. Preserve the integrity of the review process. Maintain confidentiality at all times. Insure impartiality by identifying any potential conflicts of interest. Document the basis for negative evaluations. Strive to be reasonable and fair, particularly in requesting additional data. Submit reviews in timely fashion. The process of peer review is of vital importance in maintaining the quality and integrity of the biomedical sciences. Indeed, it is on the basis of this time-honored process that the field has been self-policed. By living up to the responsibilities of peer review, it is possible to advance any field of scientific study while at the same time preventing faulty or fraudulent research from achieving the impetus of recognition. Indeed, it is only through effective peer review that scientists and scholars can guarantee the highest standards of their profession. The peer review system, both in the process of deciding on awards of research grants and in the review of scientific manuscripts, relies on the unpaid and voluntary efforts, often very time-consuming, of fellow scientists. In order for this system to work optimally, the reviewer should be a recognized authority on the subject under review. If the reviewer feels that he is not sufficiently knowledgeable to review the subject in an expert fashion, he should not accept the manuscript or grant application for review. In many instances he will know the applicant; it is, therefore, an obvious right and an obligation that he remain anonymous before and after publication. Above all, 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 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. A closely related responsibility

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Responsible Science: Ensuring the Integrity of the Research Process, Volume II of the reviewer is to maintain the confidentiality of the review process. 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. Under these circumstances, it is appropriate for the reviewer to identify to the overseer of the review (e.g., editor or study section) the various colleagues who assisted with the review. It is the responsibility of the reviewer to give a fair and impartial consideration of the material under review. If he feels that he has a conflict of interest, he should identify it immediately and return the grant application or manuscript. Conflicts of interest under these circumstances might include situations in which the reviewer is a direct competitor or a mentor of the party submitting work for review or, alternatively, if the reviewer may derive a direct personal benefit from the review. If, on the other hand, the reviewer is convinced that he can provide an unbiased opinion of the submitted material and the overseer of the review (e.g., editor or study section) concurs, then it would be appropriate for the opinion to be provided with full disclosure of the potential conflict of interest. In providing a review, whether positive or negative, it is important for the reviewer to document the reasons for the opinions. It is inappropriate for a reviewer to provide a negative opinion of a submitted work without demonstrating the logic for the conclusion so that the submitting party can respond with appropriate revisions or a reasonable rebuttal. In most instances, the reviewer should be able to provide direct evidence, either by citation from the published literature or from his own research efforts, to support his conclusions. It is the duty of the reviewer to be reasonable in the evaluation and judgment of a submitted work. If he thinks that the manuscript or grant proposal would be improved substantially by more experimental evidence, it is obviously fair to suggest such experiments. However, if such extra evidence would only add marginally to an already strong case, or would be beyond the scope of the project or the facilities available to the investigator, it would be unreasonable for the reviewer to request or demand such extra evidence. Finally, the reviewer has the responsibility of carrying out his review in timely fashion. If he knows that he will not be able to meet the deadline set by the director or grant agency, he should return the manuscript or proposal.

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Responsible Science: Ensuring the Integrity of the Research Process, Volume II Guidelines for Authorship Individuals should be considered for inclusion as authors on work submitted for publication if they have provided: Significant contributions affecting the direction, scope, or depth of research; Long-term guidance and development of the project; Creative contributions to the project with clear understanding of its goals; Development of methodologies necessary for timely completion of the project; Data analysis or interpretation vital to conclusions of the project. Individuals should not be included as authors for contributions strictly limited to: Providing lab space or use of instrumentation; Providing funding: Services, consulting, or materials provided for a fee, or reimbursement; Involvement in patient care or providing patient sample; Routine technical work (as provided by any individual in the lab); Status as supervisor, section head, or department chairperson; Proofreading or editing of manuscripts; Advice given to solve problems that are narrowly defined or unrelated to the project objective. Responsibilities Primary author: Inform all authors and contributors as to how their contributions will be acknowledged. Be able to identify the specific contribution of each author. Understand the general principles of all work included in the paper. Be willing to share openly the data obtained and methodology utilized in the investigation.

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Responsible Science: Ensuring the Integrity of the Research Process, Volume II All authors: Be able to defend the methodology and data pertinent to their specific contributions to the project. Agree with the general conclusions and interpretations of the paper. Content All manuscripts should serve to represent an accurate and complete reflection of the methods utilized and the data obtained in the investigative effort. 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. When ideas, concepts, or the text of others are used, appropriate citations should be made. Prior work in the field should be referenced appropriately. The source of funding should be identified when a work is published. Authorship is the ultimate recognition of the contribution of an investigator to a completed body of scientific work. Authorship is objective evidence of an academician's scholarly activity. There is prestige attached not only to authorship per se but also to the order in which authors appear on a publication. For these reasons, decisions regarding the inclusion and exclusion of authors are of utmost importance and must be made with great care and consideration. It is of importance that the contributions of those who have contributed significantly to a project be appropriately acknowledged in some fashion, if not by authorship itself. In order to avoid conflicts or misunderstanding, the publication policy of each laboratory should be discussed openly, and, whenever possible, the principal author should apprise all contributors to a project of the manner in which their input will be recognized before commencing with their efforts. Individuals should be included as authors on a work submitted for publication if they have provided significant contributions affecting its direction, scope, or depth. These contributions may take many different forms. Generally, the principal author will have designed many of the

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Responsible Science: Ensuring the Integrity of the Research Process, Volume II experiments, performed much of the work, analyzed most of the data, and written the manuscript. In some cases, a senior author or mentor may have provided much of the work involved in the development of a project and, after it was initiated, provided long-term guidance to its completion. Other advisors may have provided the creative spark or the idea that was carried forward in the work. Some mentors may have developed and performed methodologies without which the project may not have reached a timely completion. It is imperative, as noted below, that this methodological input extend beyond the performance of routine assays by a technician, sometimes for a prearranged fee. The contribution of other authors to a manuscript may be in the analysis or interpretation of the data. The conclusions of some projects might not have been reached without this vital input. While it may be difficult in some instances to decide whether specific contributions warrant authorship, there are clear circumstances under which individuals should not be included as authors. The simple provision of resources such as laboratory space, instrumentation, or even research funding without direct involvement in a project should not of itself be grounds for authorship. If a ''collaborator" provides services, consulting, or materials for a fee or reimbursement under a contractual arrangement, he might not be considered as an author on a scientific project. This principle should also extend to the provision of routine technical work, as may be provided by any paid technician in a laboratory, without significant input into the design or conduct of a study. In clinical areas, contributions limited to involvement in the care of a patient or to the provision of specimens from a patient should not be grounds for inclusion as an author on a manuscript. Occasionally, supervisors, section heads, or departmental chairpersons insist upon inclusion as authors simply in recognition of their status, but this is inappropriate unless there are other grounds that warrant such recognition. Simple proofreading or editing of manuscripts should provide no basis for inclusion as an author. Occasionally, a principal investigator on a project may seek advice on narrowly defined problems or on problems unrelated to the project's objective. Provision of such advice should not provide grounds for authorship. In addition to the benefits of prestige, authorship carries with it the burdens of certain responsibilities. The responsibilities of authorship should apply not only to written and published documents but also to verbal communications in public forums including the press. The principal author must be responsible for establishing the list and order of authors. He must be able to identify the specific contributions of each author and understand the significance of each contribution to the conclusion of the project. The principal author, representing all of the

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Responsible Science: Ensuring the Integrity of the Research Process, Volume II authors, must be willing to share details of the methodologies and data used in the course of investigation. Currently, it is the policy of many journals that publication also implies a willingness to share reagents such as antisera and recombinant clones; thus it is important that the authors recognize the specific policies of a journal before submitting their work to it for publication. In any case, the unselfish exchange of information and reagents is a basic assumption of science, and every effort should be made to adhere to it provided that it does not compromise an individual scientist's research efforts. Each author should be able to defend the methods and data pertinent to his specific contribution. On a larger scale, each author has the responsibility to be able to agree with the general conclusions and interpretations of the paper. Any disagreements should be resolved prior to submission of the work for review. Ultimately, any individual author has the right and the responsibility to remove his name from a manuscript if he has substantial concerns with its conclusions. Authors have additional responsibilities regarding the content of their manuscripts. Above all, the manuscripts must represent an accurate and complete reflection of the methods utilized and the data obtained. Sketchy outlines of methodology make it impossible for others to duplicate important experiments and may lead to unwarranted controversy over the results obtained. It is of importance to report data that are both supportive and unsupportive of the general conclusions of the paper. Withholding unsupportive data may suggest selection bias in reporting the results of an experiment. Despite the academic pressure, real or imagined, to demonstrate excellence with quantity rather than quality of publications, every effort should be made to avoid fragmentation of a complete body of work into separate publications. Moreover, the practice of publishing the same materials in more than one manuscript is inappropriate except in clearly identified review articles with citations of the original work. When ideas, concepts, or the text of others are used in a manuscript, appropriate citations should be made. Furthermore, prior work that served as the basis for a manuscript must be cited. In their citations, authors must strive to acknowledge data that conflict with their own theories as well as data that are generally supportive. It is important to acknowledge the sources of funding for a publication to ensure that the funding agencies are appropriately credited and, moreover, that any potential conflict of interest is identified. In general, abstracts may be somewhat less detailed because of their brevity; however, they must be considered as scientific publications and, as such, are subject to the same considerations regarding responsibility of authorship as full-length manuscripts.

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Responsible Science: Ensuring the Integrity of the Research Process, Volume II Industrial-Academic Interface: Issues of Integrity and Misconduct Trainees should not be used to conduct contractual work that does not support their educational or scientific goals. University legal counsel should be sought in issues arising over patents. Contractual arrangements that would result in conflicts of interest should be avoided. Individual entrepreneurial ventures should not interfere with a faculty member's responsibilities to the academic mission of the University. During the past two decades, universities have undergone a notable transition in their attitude toward and interactions with the industrial sector of our society. They have all but abandoned their traditional aloofness and are playing an important and active role in interfacing with industrial firms. Entrepreneurial interactions are developing as a means of seeking funds in our competitive environment and as an appropriate mechanism for keeping pace with advancing technology. These interactions vary from the formation of industrial consultantships to the long-term contracts for evaluation of drugs for human use. Industrial contracts involving the testing of materials and processes and the conduct of research are also common. All of these interactions and developments are accompanied by questions regarding appropriate rewards and obligations, and by mandates established by copyright and patent legislation. The fundamental premise of any guidelines in this area is that all scientific findings should have the greatest potential benefit to the public and therefore should be disseminated readily. The use of students or fellows to conduct industrial research is appropriate only if the work has educational value. The free dissemination and/or discussion of the results of a student's or fellow's research on industrial contract work must be allowed. It is expected that all such work will have an educational value. Students should not be exploited by their mentors for the conduct of industrial research or contracts, and the work should fit within the interests or expertise of the laboratory. The sponsors of all such work must be disclosed. Care should be taken to ensure that all those individuals directly involved in the development of a concept or device resulting in a patent should be so acknowledged. In this regard, the Intellectual Properties Office of the University of Michigan should be consulted in all matters involving patent application and processing. Each grant funding agency has its own guidelines for the filing and granting of patents. It is necessary to be aware of these guidelines and to adhere to them should a patentable device or process result from research funded by a specific

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Responsible Science: Ensuring the Integrity of the Research Process, Volume II agency. Any questions regarding potential situations of conflict of interest (including patents, stockholding, etc.) should be referred to the appropriate legal office of the University. The University has established policy regarding time spent in consulting and other enterprises external to the normal or expected performance of University personnel in discharging their primary responsibilities. Members of the Faculty should not engage in excessive outside efforts solely to enrich themselves financially. In discharging their service functions, many faculty members engage in industrial consultation. This is an activity that may be a stimulating and intellectually enriching experience to the faculty member, as well as a major benefit to industry. It is expected that University personnel will be ever mindful of their primary University responsibilities and adhere to the guidelines established by the University. University personnel establishing research contracts with industry also should be mindful of situations involving conflict of interest as defined in the next section. All consultantships or industrial affiliations must be disclosed to the University. Individual entrepreneurial activities should not interfere with the University's academic mission. An excessive focus on personal financial gain within an academic setting could hamper the collegiality that is fundamental to investigative interchange. It is inappropriate to use University facilities and personnel to run any private enterprise. The educational mission and the overall goals of the University should be kept in mind when patent development is being encouraged at the University. The Academic Environment Commitment to Ethical Standards Encourage open communication at all levels of scholarly activity. Maintain scientific quality by a process of peer review. Educate students, faculty, and technical staff in ethical standards. Avoid conflicts of interest. Discourage unwarranted competitive practices. Institutional Responsibilities (University, Department, Section) Maintain consistent standards for evaluation of performance. Inform faculty of expectations and criteria for promotion.

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Responsible Science: Ensuring the Integrity of the Research Process, Volume II Guarantee adequate time and resources for pursuit of scholarly activities according to specified expectations. Focus attention on quality, as opposed to quantity, of scholarly activity. Evaluation for Promotion2 Initiation The candidate should state his goals and purposes upon appointment to the institution. Thr chairman should initiate the process of appointment or promotion. A departmental committee should review all matters of academic advancement. The evaluation process should consider the candidate's research productivity, teaching excellence, administrative or other responsibilities, and evidence of peer recognition. The departmental chairman should assume responsibility for the appointment/promotion proposal and insure its completeness and timely submission. The review process should proceed according to University guidelines. The University has the responsibility of establishing an environment that will nurture ethical behavior in any academic activity, whether it be teaching, research, patient care, or administration. Institutional policies and procedures must promote innovation and excellence while safeguarding against misconduct. Therefore, it is essential that universities assume the leadership role in identifying and eliminating the environmental factors that encourage unacceptable behavior. Over the long run, it will be the positive, rather than the punitive, measures that encourage creativity and progress and decrease the likelihood of scientific misconduct. All members of the faculty should be expected to engage in investigative efforts and scholarly work. Scholarly investigation need not be the exclusive domain of those who have acquired research support. The importance of the scientific questions being asked, the 2   Suggested criteria for promotion proposed by this committee are contained in Appendix E.

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Responsible Science: Ensuring the Integrity of the Research Process, Volume II soundness of proposed hypotheses, the search for better understanding of human disease, or the caring for the sick should be among the most important measures of a faculty member's performance. Above all, the training of students and the dissemination of new knowledge are the most important functions of an institution of higher learning. Attention should be focused on results that have been subjected to intensive editorial review and placed in full view of a critical scientific community. The responsibility for maintaining the highest ethical standards in science rests within individual institutions and with all persons engaged in research: professionals, trainees, and support personnel. Proper attitudes must be established so that all parties recognize the demands of the public trust that the system police itself. Constant reinforcement must be obtained through dialogue at all levels. Open discussions regarding all aspects of the work environment are essential. Science depends upon openness and the willingness of individual investigators to accept constructive criticism of work that has been conducted in earnest and with the serious intent of advancing scientific knowledge. Students and staff personnel at all levels should be encouraged to engage in critical discussions of laboratory data during regularly scheduled group meetings. Data that do not support current hypotheses should be evaluated as intensely as those that show favorable results. Errors in experimental design or interpretation should be reviewed critically. A clear distinction must be made between error and fraud. The former, if truly accidental, can be tolerated, but once recognized must be corrected. The latter cannot be condoned under any circumstances. Trainees and staff should be considered as part of the overall team that shares the common goals of learning and enjoying the successes of research. Professional evaluation and review of a trainee's work are fundamental aspects of the peer review process. Mentors and other members of the faculty should have an opportunity to hear presentations by trainees in the setting of laboratory discussions or in a more formal seminar format. Through open discussion and critical commentary, the research team will learn to correct previously unrecognized errors in design or concept. On a more formal level, the institution should conduct educational sessions directed at teaching the highest ethical standards of scholarship. Attendance at such courses should be requested of all trainees and laboratory associates. Faculty members should be encouraged to participate actively in this educational effort. A major principle in the ethical conduct of research is the avoidance of conflicts of interest. Specifically, this refers to situations in which a

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Responsible Science: Ensuring the Integrity of the Research Process, Volume II faculty member stands to gain personally or professionally from a decision that he actively participates in making. The situation may involve the review of manuscripts or grants, discussions over the purchase of products from a corporation, or the hiring, appointment, or promotion of personnel. Additional aspects of this issue vis-à-vis academic-industry relationships have been explored above. It is imperative that a potential conflict of interest be identified voluntarily and immediately upon its recognition. Every effort should be made to redress any possible wrongs that may have occurred as a result of such a situation should it be identified after the fact. The institution should not encourage and must avoid situations that lead to competition among scientists who hope to gain preferential status. Encouraging secrecy among research groups should be considered as an inappropriate method of stimulating productivity. The basis for rewarding performance should be made known to all participants. The institution should encourage its faculty to seek the advice and consultation of other members of the faculty and to discuss their research data with the aim of gaining a better understanding of the scientific problem. Likewise, trainees and staff should be encouraged and welcomed to work in other laboratories in order to gain the added expertise needed for the conduct of their respective research projects. Evaluation of individual performance within the academic environment is a source of unavoidable pressure, particularly among young scholars. In order to minimize the negative aspects of this pressure, it is the responsibility of the University to maintain standards of evaluation that are widely and explicitly understood, rational, and applied in a consistent manner. The departmental chairmen must be responsible for maintaining consistency within their respective departments, while the dean and executive committee must ensure rational and consistent handling of evaluations at the levels of the Medical School and the University as a whole. All members of the faculty should be informed at the time of initial appointment, and regularly thereafter, of the expectations and the criteria by which their academic activities will be judged. Thus, it is the duty of chairmen and/or section heads to formulate for members of the faculty clear job descriptions, which explicitly focus on the proportional mix of various activities including teaching, administration, service, and research. These expectations, while reflecting institutional standards of excellence, must in toto be attainable. Once agreement is reached on the academic responsibilities of each faculty member, it is the duty of the chairman and/or section head to assist in providing the necessary resources and to guarantee and safeguard time assigned for scholarly activities.

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Responsible Science: Ensuring the Integrity of the Research Process, Volume II It is the responsibility of the chairman and/or section head to ensure that each individual is evaluated for his performance in the entire spectrum of his or her activities. To the extent that teaching, administration, and service are expected or assigned parts of a faculty member's scholarly activities, it should be the responsibility of that person's superiors to evaluate each of these activities in addition to research productivity. As individuals are evaluated, those responsible for the process must focus on qualitative as well as quantitative criteria. Emphasis in the evaluation process must be on excellence of teaching and its significance to the educational enterprise of the Department and School, on the quality of patient care rather than on the volume of revenue, and on the quality and impact of scholarly research rather than on the number of publications or grant dollars generated. Since the responsibility for initiating promotion recommendations resides within individual departments, chairmen, ordinarily in concert with a departmental Committee on Appointments, Promotions and Titles, must regularly monitor the academic progress of all faculty members at regular intervals to discuss advancement toward promotion and to assemble the necessary documents in a timely fashion when an individual is deemed deserving of promotion. The criteria of promotion should be rigorous enough to ensure that the faculty of the University of Michigan is of premiere quality, but flexible and comprehensive enough to be applied fairly to the broad spectrum of individuals who are working in this institution. Individuals proposed for appointment to the faculty or for academic promotion should be requested to provide a personal statement to the promotions committee. The statement should reflect the individual's assessment of past achievements in investigation, teaching, administration, and institutional service. The assessment should also attempt to define the individual's role within the institution and commitment to the welfare of the institution. Future goals, research interests, and teaching efforts should also be recorded. This personal statement should accompany the promotion packet prepared by the departmental chairman. The review of individuals for appointment or promotion will follow existing University guidelines. Suggested criteria by which individuals should be judged are presented in Appendix E.

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Responsible Science: Ensuring the Integrity of the Research Process, Volume II Appendix E—Criteria for Promotion A candidate for promotion or appointment to the rank of assistant professor should have: Completed formal training, Demonstrated a willingness and potential to contribute to the academic environment, Shown an ability to work independently, and Submitted to the review committee one first-authored manuscript or evidence of a principal role in a manuscript. Candidates for the rank of assistant professor should have completed their formal training and demonstrated their potential to become independent investigators. They should be able to contribute to the academic environment of the institution, most importantly by carrying out the teaching and service missions of the departments they are joining. One manuscript for which the candidate is the primary author (or for which the candidate had a principal role) should be deemed sufficient for the institution to evaluate the candidate's potential for independent academic activity. A candidate for promotion or appointment to the rank of associate professor should have: Demonstrated independence, Demonstrated a clear contribution to the academic environment, Demonstrated peer recognition, and Submitted to the review committee five first- or principal-authored manuscripts. Candidates for the rank of associate professor will have achieved independence in investigative and scholarly activities. They will have demonstrated contributions to the academic environment, including the teaching and service activities of the department to which they belong. Candidates for associate professor will have peer recognition for their scholarship. Such recognition might include independent grant funding, membership in scholarly societies, or editorial work for scholarly journals. Instead of evaluating the quantity of manuscripts the focus should be placed on their quality, originality, and importance. Five manuscripts should be deemed sufficient for the institution to evaluate the candidate's scholarly activities.

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Responsible Science: Ensuring the Integrity of the Research Process, Volume II A candidate for promotion or appointment to the rank of professor should have: Demonstrated a leadership role in contributing to the academic environment, Achieved a national and international reputation for excellence, and Submitted to the review committee ten representative principal-authored publications. Candidates for the post of professor will have demonstrated a leadership role in contributing to the academic environment at the University of Michigan. They must have achieved national or international recognition for their scholarly activities. Candidates must have developed a focused program of scholarly investigation. Ten selected manuscripts should be deemed as sufficient for the institution to judge the maturity of the scholarly output of an individual prepared for advancement to professor.