These guidelines and expectations are designed to help new and experienced investigators manage their work so as to safeguard the integrity of the research process. The policy provides a framework for the fair and open conduct of research, assures scientific freedom, and supports creativity. In addition, the policy reflects the institutional commitment to quality in the search for new knowledge.

By its design and nature, this policy addresses broad aspects of research conduct. Additional information is contained in the Drexel Policy and Procedures for Responding to Allegations of Scientific Misconduct. Also, additional sources of information regarding standards of research conduct are contained in relevant federal, state, and local regulations, and similar guidelines developed by other research organizations. These sources of information are listed at the end of this policy and are available upon request from the Drexel Office of Research and Graduate Studies.

The Drexel Policy for the Conduct of Research applies to any person paid by, under the control of, or affiliated with Drexel, such as employed or volunteer faculty, trainees, technicians, and other staff members, students, fellows, guest researchers, or collaborators at affiliated institutions.

II. Scientific Misconduct

For the purposes of this policy, scientific misconduct is defined as fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgments of data. In addition, the institution reserves the right to require adherence to other definitions of scientific misconduct as required by contractual obligations with external sponsors of research.

Rather than focusing on issues or examples of misconduct, the following guidelines specify desirable behaviors and make explicit patterns of scientific practice that have been developed over many years and are followed by the vast majority of scientists. These guidelines state general expectations with regard to data management, publication practices, authorship, peer review, use of privileged information, use of research funds, supervision of trainees, and lab practice guidelines.

III. Data Management

As stated in the Guidelines for the Conduct of Research at the National Institutes of Health, "research data, including detailed experimental protocols, primary data from laboratory instruments, and procedures of reduction and analysis of primary data, are the essential components of scientific progress. Scientific integrity is inseparable from meticulous attention to the acquisition and maintenance of these research data" (p.5). In addition, other guidelines (see ref. 2, page 2) specify that "a scientist must have access to his/her original results in order to respond to questions including, but not limited to, those that may arise without any implication of impropriety. Moreover, errors may be mistaken for misconduct when the primary experimental results are unavailable." It is, therefore, expected that original experimental results should be recorded, when possible, in bound notebooks with numbered pages. An index should be maintained to facilitate access to data. Machine printouts should be affixed to or referenced from the laboratory notebook. All data, even from observations and experiments not directly leading to publication, should be treated comparably.

Primary data should be retained for a sufficient period to allow analysis and repetition by others of published material from those data. In some fields, five to seven years are specified as the minimum period of retention but this may vary under different circumstances. The director of each research unit must decide whether to preserve primary data for a given number of years or for the life of the unit.

Research data and supporting materials, such as unique reagents, belong to the institution where the research is conducted (i.e., Drexel) and should be maintained in the laboratory in which they were developed. Departing investigators may take copies of notebooks or other materials for further work. If the investigator departs the laboratory, it is the responsibility of the Drexel department chairperson (or Center director, if applicable) to provide for the appropriate maintenance and accessibility of the data and unique reagents.

IV. Publication Practices

Publication of experimental results is an integral and essential component of research. Other than presentation at scientific meetings or other considerations related to intellectual property matters, publication in a scientific journal should usually be the mechanism of first disclosure of new findings.

Each paper should contain sufficient information for the reader to assess its validity and to replicate the experiments. All cases registered in a clinical trial or records reviewed in a retrospective study must be accounted for. The number of cases not used in the analysis of outcome data should be identified and the reasons for exclusion noted in the manuscript. In addition, each paper should acknowledge all sponsors of the research and disclose any financial interests that the authors have in these sponsors.

Although the timely publication of research findings is important, haste in disseminating results without adequate tests of reproducibility or assessment of significance or by submitting multiple manuscripts differing only slightly in content should be avoided. In such circumstances, if any of the work is questioned, it is difficult to determine whether the research was done inaccurately, the methods were described imperfectly, the statistical analyses were flawed, or inappropriate conclusions were drawn.

Given these publication principles, it follows that professional staff appointment and promotion decisions should be based more on the importance of the scientific accomplishments and less on the number of publications in which those accomplishments were reported.

V. Authorship

The Guidelines for the Conduct of Research at the National Institutes of Health define authorship as “the listing of names of participants in all communications, oral and written, of experimental results and their interpretation to scientific colleagues...(it is) also the primary mechanism for determining the allocation of credit for scientific advances and thus the primary basis for assessing a scientist's contributions to developing new knowledge” (p. 8). Authorship should be based on whether the individual made a significant contribution, such as 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 the study may be more appropriately acknowledged as having contributed certain advice, reagents, analyses, patient material, space, support, etc., but not listed as authors.

It is expected that each research group or laboratory will freely discuss and resolve questions of authorship before and during the course of a study. Each author should review fully material that is to be presented in public forums or submitted (originally or in revised form) for publication. The submitting author has the additional responsibility of coordinating the completion and submission of the work, satisfying pertinent rules of submission, and coordinating responses of the group to inquiries or challenges. The submitting author should assure that the contributions of all collaborators are appropriately recognized and must be able to certify that each author has reviewed and authorized the submission of the manuscript.

VI. Peer Review and Privileged Information

Peer review can be defined as expert evaluation of a scientific treatise, such as a manuscript prepared or submitted for publication, a research grant proposal, a clinical research protocol, or an investigator's research program, as in a site visit. Peer review is an essential component of the conduct of science. Decisions on the funding of research proposals and on the publication of experimental results must be based on thorough, fair and objective evaluations by recognized experts. Therefore, although it is often difficult and time-consuming, scientists have an obligation to participate in the peer review process, and in doing so, they make an important contribution to science.

A peer reviewer should avoid any real or perceived conflict of interest that might result from a direct competitive, collaborative or other close relationship with one or more of the authors. To prevent opportunities for conflict of interest, it is advisable to keep the identities of the primary peer reviewers unknown to the authors (particularly in the case of a manuscript or a grant proposal) or at the very least prohibit author-initiated contact with the peer reviewers. When serving as a peer reviewer, investigators are expected to follow the policies of the reviewing entity. Normally, a conflict of interest on the part of a peer reviewer would require a decision not to participate in the review process and to return any material unread.

All material under review is privileged information and should be maintained in a secured location at all times. It should not be shared with anyone unless necessary to the review process, in which case, the names of those with whom the information is shared should be made known to those managing the review process. Material under review should not be copied and retained or used in any manner by the reviewer unless specifically permitted by the journal or reviewing organization and the author.

VII. Use of Research Funds

Drexel has the responsibility for monitoring grant/contract-related expenditures. Generally, it is expected that investigators pursue the research for which the funds, whether intramural or extramural, have been reasonably allocated. This does not preclude pilot or preliminary studies related to or deriving from a project's major purpose or changes in methods as a result of preliminary findings. Nevertheless, disregard for the intent or purpose of a defined project by using funds or resources for an unrelated purpose is contrary to well-accepted standards of research conduct.

VIII. Supervision of Trainees

The following statement from the Guidelines for the Conduct of Research at the National Institutes of Health summarizes the research training process:

Research training is a complex process, the central aspect of which is an extended period of research carried out under the supervision of an experienced scientific mentor. This supervised research experience represents not merely performance of tasks assigned by the supervisor, but rather a process wherein the trainee takes on an increasingly independent role in the choice of research projects, development of hypotheses, and the performance of the work. Indeed, if training is to prepare a young scientist for a successful career as a research investigator, it must be geared toward providing the trainee with the aforementioned skills and experiences. It is particularly critical that the mentor recognize that the trainee is not simply an additional laboratory worker.

Each trainee should have a designated primary scientific mentor. The mentor should provide an environment whereby the trainee has the opportunity to acquire the requisite skills, both technical and conceptual, and to undertake a significant research project, which has the potential to yield new knowledge of importance to the field. The mentor should supervise the design of experiments and the processes of acquiring, recording, examining, interpreting and storing data. The mentor should interact personally with the trainee on a regular basis. Finally, the mentor should provide frequent feedback on performance and impart appropriate standards of scientific conduct (e.g. by example and through dissemination of applicable governmental and institutional regulations/policies).

IX. Laboratory Guidelines

Each research unit addresses different scientific problems with different methods. Therefore, each unit should develop its own specific guidelines to identify practices that seem most likely to enhance the quality of research conducted by its members. These guidelines should be provided to each new investigator when he/she joins the unit.