9
Rules and Guidelines for Responsible Conduct of Research

Johns Hopkins University School of Medicine

The distinction this School of Medicine has achieved as a center for research in the biomedical sciences is the result of dedication throughout the institution to the highest standards of professional conduct. In a time-honored system, the ethics of science are transmitted, along with practical and theoretical knowledge, to junior researchers by their senior colleagues. The atmosphere of truthfulness, accountability, and free exchange of ideas characteristic of this School has been considered sufficient to ensure responsible conduct of research. However, growth of the School and the greater complexity of regulations governing research make it increasingly likely that some researchers may not be fully aware of established norms. The purpose of this document is (1) to set forth principles and practices generally known and followed by researchers in the School of Medicine, (2) to ensure that all researchers in the School of Medicine are informed of institutional and governmental regulations that affect their work, and (3) to establish procedures designed to protect against fraudulent research, or unjustified charges thereof, with the least possible hindrance to scientific investigation.

This document is addressed to all faculty, postdoctoral fellows, students, and other research personnel in the School of Medicine. Everyone engaged in research in the School of Medicine should become familiar with its contents.

I. ORIENTATION AND GUIDANCE FOR FACULTY

General expectations for the academic conduct of faculty members and many specific requirements governing the conduct of research are set forth in the following documents:

NOTE: Issued in 1990; reprinted with permission from Johns Hopkins University, Baltimore, Md.



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Responsible Science: Ensuring the Integrity of the Research Process, Volume II 9 Rules and Guidelines for Responsible Conduct of Research Johns Hopkins University School of Medicine The distinction this School of Medicine has achieved as a center for research in the biomedical sciences is the result of dedication throughout the institution to the highest standards of professional conduct. In a time-honored system, the ethics of science are transmitted, along with practical and theoretical knowledge, to junior researchers by their senior colleagues. The atmosphere of truthfulness, accountability, and free exchange of ideas characteristic of this School has been considered sufficient to ensure responsible conduct of research. However, growth of the School and the greater complexity of regulations governing research make it increasingly likely that some researchers may not be fully aware of established norms. The purpose of this document is (1) to set forth principles and practices generally known and followed by researchers in the School of Medicine, (2) to ensure that all researchers in the School of Medicine are informed of institutional and governmental regulations that affect their work, and (3) to establish procedures designed to protect against fraudulent research, or unjustified charges thereof, with the least possible hindrance to scientific investigation. This document is addressed to all faculty, postdoctoral fellows, students, and other research personnel in the School of Medicine. Everyone engaged in research in the School of Medicine should become familiar with its contents. I. ORIENTATION AND GUIDANCE FOR FACULTY General expectations for the academic conduct of faculty members and many specific requirements governing the conduct of research are set forth in the following documents: NOTE: Issued in 1990; reprinted with permission from Johns Hopkins University, Baltimore, Md.

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Responsible Science: Ensuring the Integrity of the Research Process, Volume II Policies and Guidelines Governing Appointments, Promotions, & Professional Activities of Faculty Members of The Johns Hopkins University School of Medicine The Sponsored Projects Handbook The Faculty Handbook of The Johns Hopkins University School of Medicine Guidelines of the Joint Committee on Clinical Investigation Use of Experimental Animals at the Johns Hopkins Medical Institutions and University Policy on Conflict of Commitment and Conflict of Interest Rules and Guidelines for Responsible Conduct of Research Procedures for Dealing with Issues of Professional Misconduct Grievance Procedure for Faculty, Fellows, and the Student Body All faculty members should have copies of these documents and should be familiar with their contents.1 As teachers and researchers, faculty should be informed about ethical issues in research. Because these issues have rarely been part of their formal training, both current and new faculty should devote some effort and time to their study. They will thus be better able to inculcate in their trainees a clear understanding of the principles of academic integrity. Faculty also serve as role models, and the manner in which they conduct their own research must be above reproach. Discussion of research ethics should be a regular part of department and division meetings. A. RULE The Office of the Registrar of the School of Medicine will distribute to each new faculty member the documents listed above and the booklet Honor in Science published by Sigma Xi. Faculty will be required to sign an acknowledgment of receipt of the above at the time they respond to their initial letter of appointment from the dean. II. SUPERVISION OF STUDENTS, POSTDOCTORAL FELLOWS, AND OTHER RESEARCH PERSONNEL Preceptors are responsible for the careful supervision of their trainees and other research personnel. The complexity of scientific methods and the need for careful experimental design, caution in

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Responsible Science: Ensuring the Integrity of the Research Process, Volume II interpreting possibly ambiguous data, and advanced statistical analysis all require that the preceptor assume an active role of guidance and supervision. Preceptors should be prepared to give additional attention to a trainee or an employee who arrives in a research unit without substantial experience in laboratory science. A. RULES Responsibility for supervision of each student, fellow, or other (non-faculty) member of a research unit must be assigned to a specific faculty preceptor. For particular research projects, supervision should be carried out by the responsible investigator; overall supervision of each student or fellow must be assigned to a faculty advisor. As a part of their orientation the Office of the Registrar of the School of Medicine must provide each new medical student and graduate student with a copy of this statement and also Procedures for Dealing with Issues of Professional Misconduct and the booklet Honor in Science published by Sigma Xi. At the time of registration these documents must also be given to all postdoctoral fellows, whose written acknowledgment of receipt of the documents will be kept on file in the Office of the Registrar. Preceptors should familiarize trainees and other research personnel with relevant governmental and institutional requirements for conduct of studies involving healthy volunteers or patients, animals, radioactive or other hazardous substances, and recombinant DNA. B. RECOMMENDATIONS The ratio of trainees to faculty members should be small enough that close interaction is possible for scientific interchange as well as supervision of the research at all stages. The degree of supervision by the preceptors should take into account the experience and skill of trainees. A preceptor should help the trainee develop not only good research practices and technical expertise, but also good research ethics. The preceptor should supervise the design of experiments and the processes of acquiring, recording, examining, interpreting, and storing data. The editing of manuscripts alone does not constitute adequate supervision by the preceptor.

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Responsible Science: Ensuring the Integrity of the Research Process, Volume II Preceptors should have realistic expectations regarding the performance of trainees and other research personnel and should inform them of these expectations. Collegial discussions among all preceptors and trainees constituting a research unit should be held regularly both to contribute to the scientific efforts of the members of the group and to provide informal peer review. Preceptors should be alert to behavioral changes in trainees or other research personnel that may indicate inordinate personal or academic stress or substance abuse. Stresses are particularly likely to occur at times of transition or as deadlines approach. Since the care with which research activities are conducted may be adversely affected by stress, a trainee or employee may need closer supervision at such times. III. DATA GATHERING, STORAGE, RETENTION The retention of accurately recorded results is of utmost importance for the progress of scientific research. Original laboratory data2 must be retrievable not only to answer scientific questions but also to respond to questions that may arise about the propriety of research conduct. Errors may be mistakenly characterized as misconduct when the primary experimental results are unavailable. Moreover, a common denominator in most cases of alleged research fraud has been the absence of a complete set of verifiable data. The rules and recommendations in this section are designed to ensure that all research data are recorded appropriately and that access to them will be available when necessary. The University is aware that scientific investigation may be impeded if undue conditions are placed on the ability of departing investigators to retain custody of original data generated in the course of work performed here. Nevertheless, there are pragmatic reasons for preserving the University's ready access to original data. For example, access to original data may be necessary if the University is to render the most effective assistance in rebutting unjustified claims of fraud made against its researchers. Then, too, the University is responsible for promoting the collective reputation for integrity of its researchers with public and private granting agencies. The inability to produce original data is always considered the best evidence for purposes of avoiding questions of admissibility in administrative or judicial proceedings.

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Responsible Science: Ensuring the Integrity of the Research Process, Volume II A. RULES Custody of all original data must be retained by the unit in which they are generated. When hospital records, which cannot be kept in the research unit, are used in research projects, summaries must be maintained by the investigator. An investigator who moves to another institution must submit to the department director a written request to remove original data from the University. This request must contain an itemized description of the data and must specify where the data will be located in the future. In granting such requests, the department director must remind the researchers that legally the data are the property of the University, that any inventions made here must be disclosed to the appropriate patent office of The Johns Hopkins University, and that original data must be made available for review if questions of scientific misconduct should arise. If the department director does not approve the removal of data, an appeal may be made to the dean. To date, no governmental regulations prescribe the length of time researchers must maintain original data. Until governmental regulations appear on this issue, the School will require that original data be retained for at least five years from the date of publication. Beyond that, where questions have been raised regarding the validity of published data, investigators must preserve original data until such questions have been resolved to the satisfaction of the School and any involved government agencies. The chief of each research unit must decide whether to preserve original data for a given number of additional years or for the life of the unit. B. RECOMMENDATIONS Original experimental results should be kept in an orderly fashion in such a way that they are accessible and can be easily reviewed by peers. Records should identify when experiments were done and by whom. Machine print-outs or other primary data (e.g., an autoradiogram) should be affixed to or referenced from the laboratory notebook. IV. AUTHORSHIP Two critical safeguards in the publication of accurate scientific reports are the active participation of each coauthor in verifying any part

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Responsible Science: Ensuring the Integrity of the Research Process, Volume II of a manuscript that falls within his or her specialty area and the designation of one author who is responsible for obtaining coauthor verification. A gradual diffusion of responsibility for multi-authored or collaborative studies has led in recent years to the publication of papers for which no single author was prepared to take full responsibility. A. RULES One author from within the School of Medicine must be designated as responsible for obtaining coauthor verification for any manuscript submitted for publication by a faculty member, fellow, or student as part of his or her activity at the School of Medicine. The designated author must give to the director of an appropriate department or division a copy of the title page of the manuscript, upon which a statement is added to the effect that everyone listed as an author has contributed to the paper significantly, has reviewed the manuscript, and stands behind the parts within his or her own area of expertise. Each listed author must sign this statement. These statements must be kept in the permanent files of the department or division. Any faculty member, fellow, or student who submits an abstract must ensure that all named authors have consented to authorship prior to submission of the abstract. Each named author must be given a copy of the abstract. B. RECOMMENDATIONS Criteria for authorship of a manuscript should be determined and announced by each department or research unit. Authorship should be given generously, but only to those who have contributed significantly to the research, are prepared to stand behind their findings, and have reviewed the entire manuscript. The referral of patients included in a clinical study does not, in and of itself, constitute a significant contribution warranting coauthorship status. The practice of permitting ''honorary authorship" is unacceptable and should be actively discouraged by primary investigators and heads of departments and research units. All publications should credit research findings appropriately by citing relevant observations of others, as well as by recognizing the work and input of all contributors in their own environments.

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Responsible Science: Ensuring the Integrity of the Research Process, Volume II V. PUBLICATION PRACTICES 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. Investigators should review each proposed manuscript with these principles in mind. A. RECOMMENDATIONS The number of publications to be reviewed at times of faculty appointment or promotion should be limited in order to encourage and reward bibliographies containing substantive publications rather than those including a large number of insubstantial or fragmented reports. Published papers should credit sponsors of the work, and any acknowledgment requirements in grant and contract documents should be adhered to scrupulously since they are contractual obligations. Moreover, 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. VI. LABORATORY GUIDELINES Because each research unit addresses different scientific problems with different methods, particular units may need to develop their own specific rules or guidelines regarding the prevention of academic misconduct. Such rules or guidelines should be provided to all new investigators when they start work in the unit. VII. REPORTING ACADEMIC MISCONDUCT The trust and good faith traditionally associated with The Johns Hopkins University School of Medicine will flourish only if every member of this community bears responsibility for upholding the highest

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Responsible Science: Ensuring the Integrity of the Research Process, Volume II standards of integrity. Should academic misconduct occur, early identification and intervention are in the best interests of everyone. Steps to be taken by anyone who suspects that another's research conduct has been improper are detailed in Procedures for Dealing with Issues of Professional Misconduct. The institution recognizes the risks to persons who report apparent scientific misconduct and has made every effort to protect them as well as those who might be accused in error. A. RULE It is a professional obligation of faculty, students, or fellows to inform superiors if they have reservations about the integrity of the work of another member of this academic community. NOTES 1.   Copies are available from the Office of the Registrar of the School of Medicine. 2.   While what constitutes "original" or "primary" data may differ from laboratory to laboratory depending on the technology used, in every instance an investigator is expected to maintain an accurate record of experimental data that is as close to the original form of the data as is practical. When the ''original" data are so voluminous or are collected and/or modified in atypical ways (for example, in the case of data collected by computer), individual investigators should seek concurrence of their division or department head in deciding what aspect of their research will constitute primary data, bearing in mind the possible future need to support reported findings. Acknowledgment: "Guidelines for Investigators in Scientific Research," the report of the Committee on Professional Misconduct of Harvard Medical School, was very helpful in the preparation of this statement.