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Responsible Conduct of Research Training


Training in the Responsible Conduct of Research


Effective January 4, 2010 the National Science Foundation is requiring that all postdoctoral scholars who are submitting new proposals for NSF funding receive training in the Responsible Conduct of Research (RCR).

A CITI web-based course in the Responsible Conduct of Research (RCR) is available to USF researchers at no cost. Please see Instructions for Accessing the CITI RCR Course.


UNIVERSITY OF SOUTH FLORIDA
Office of Research
Prepared by the USF Research Council
Policies, Procedures, and Guidelines

Guidelines for the Responsible Conduct of Research
Effective: October 1997

Introduction

The purpose of research at the University of South Florida (USF) is to create new knowledge in all disciplines represented within the University and to foster an active learning environment to enable students to acquire the tools for lifelong learning. Society expects that research reflects an honest attempt to describe the world accurately without bias and that the results of research can be trusted. In order that these expectations can be met, it is necessary that all who engage in research within the University community ascribe to a standard set of ethical principles. It is the responsibility of each and every researcher to become informed of these principles and behave in accord with them. Faculty members are to serve as role models concerning the ethical practice of research for students and colleagues.

These guidelines describe a standard of practice for the ethical conduct of all research at the University of South Florida. These guidelines are based on three important principles.

  1. The University is obligated to protect and foster the academic freedom and intellectual integrity of all members of the University community in the pursuit of knowledge.
  2. The University is accountable to extramural funding sources that often support the research and scholarship of the faculty and the university must comply with all applicable laws and regulations.
  3. Each researcher has ultimate responsibility for the accuracy and validity of their own work. Each researcher shares this responsibility with colleagues and students with whom they establish collaborative or mentorship relationships.

This document applies to all research engaged in by faculty and students. These guidelines are intended to heighten awareness of potential ethical problems. The purpose is to emphasize that the individual researcher has an obligation to maintain high scholarly and ethical standards, and a commitment to foster those standards in collaborators, students, and trainees.

Research can take many forms and vary across disciplines. The issues addressed by these guidelines are essential to all research within the University community. Research responsibility, quality of scholarly activity, security of scholarly contributions and their sources, responsible authorship, and provision for training in ethics are issues inherent to all areas. The implications of these guidelines apply as fully to the scholar who uncovers an ancient civilization or authors a history textbook as to the laboratory scientist who reports a biological discovery or the clinician who publishes a case report.

Establishing a Responsible Research Environment

All faculty members are ultimately responsible for the scholarly character, accuracy, and reliability of their own research and for that conducted under their supervision. Each researcher is also responsible for the integrity and originality of their own research. Faculty should contribute to an intellectual atmosphere that promotes high academic and ethical standards and one in which issues of social responsibility and professional ethics are addressed. The most effective single process for ensuring research of high quality is peer review, both formal and informal. Informal review occurs through departmental and interest group seminars and interdisciplinary research discussion groups. Each division, department, or program should encourage such informal review procedures. Formal review is accomplished by peer review committees that are charged with the task of evaluation of the merit of research. An example of an external committee is a NIH study section.

Research misconduct is significant misbehavior that improperly appropriates the intellectual property or contributions of others, that intentionally impedes the progress of research, or that risks corrupting the scientific record or compromising the integrity of scientific practices. (The record encompasses any documentation or presentation of research, oral or written, published or unpublished.) Such behaviors are unethical and unacceptable in proposing, conducting, or reporting research, or in reviewing the proposals or research reports of others. Examples of research misconduct include, but are not limited to, the following:

    Fabrication: Making up data or results.

    Falsification: Intentionally misreporting data or results.

    Plagiarism: Using ideas or words of another person without giving     appropriate credit.

Research misconduct does not include honest errors or differences of opinion and interpretation. When such honest errors are discovered, they should be acknowledged, preferably in the same journal or venue in which the mistaken information was published. Colleagues rarely condemn researchers who make such acknowledgments promptly and openly.

Determination and Responsibilities of Authorship

Authorship should be confined to those persons who have made significant contributions to the conceptualization, design, execution, interpretation, or writing of the work reported. All authors should be able to explain and defend the work. They must take responsibility as well as credit for the work. Some journals require the signatures of all authors on a form stating that all have seen and agree with the material being submitted. Individuals who have made lesser contributions such as providing advice, analysis, subject material, or who may have supported the research in other ways, should be acknowledged. In some fields, written permission may be required for acknowledgments. In factual or scientific reports, authors should take care to cite relevant data including that which does not support the hypothesis being presented. It is an author's responsibility to be familiar with and to accurately cite other publications relevant to his or her work.

Multiple authorship raises issues such as criteria for inclusion as an author, ability of each author to evaluate all aspects of a study, and sequence of listing of authors. Authors should discuss these issues openly before initiating a multi-author project and repeatedly during the course of such work. The submitting or primary author has responsibility for coordinating the completion and submission of the work, and for assuring that the contributions of all collaborators are appropriately recognized. All authors should approve the final version of a manuscript and should take public responsibility for the work.

Supervision of Student Research

The academic institution's responsibility to educate and prepare students to enter society and to practice their disciplines with high ethical standards does not cease with formal course work. The University and its faculty have an obligation to the academic community, the public, and the student to ensure that all students and trainees engage in research responsibly and use the highest professional standards.

Dissertation advisors, research directors, and administrative heads share responsibility for providing the best possible research environment. Students should be given due recognition for their original work. Demands made upon students should be reasonable and they should be treated with professional courtesy. Avenues must be available for students who feel their supervision or training is inadequate. They should feel free to bring this to the attention of the advisor, director or, if necessary, to the appropriate administrative head. Dissertation advisors and research directors should meet regularly with students, fellows, and other collaborators to review their work and progress. Dissertation advisors and research directors should serve as role models and maintain the highest ethical standards in performance of research. They should encourage students to exchange ideas and information with other members of the research community. The experience of the students should serve to prepare them to become independent scholars and researchers.

Education in Ethics and Integrity

Ethical issues and questions in the conduct of research should be an integral part of the education of all graduate students and the continuing education of faculty. Research directors are responsible for establishing a training environment in which ethical issues are discussed freely. The director should expect and foster familiarity with ethics as related to research. The goals should be to teach students and other trainees how to identify ethical issues and how to address ethical dilemmas that arise in the course of investigation and publication. An excellent resource to help in this process is the booklet "On Being a Scientist: Responsible Conduct in Research" published by the National Academy Press, Washington, D.C.

Heads of departments, divisions, and programs should encourage the teaching of ethics within their unit. An ethics component of the curriculum should provide students and faculty with the intellectual tools and interactional skills to apply ethical decision-making to everyday problems encountered in their research. Ethical issues, concepts, and theoretical grounding should be introduced as part of the orientation of all graduate students and trainees.

Responsibilities of Research Directors

The research director is responsible for close personal supervision of students, staff, and the research project in general, including: the design of research protocols; informing each new staff person and investigator (faculty, student, or fellow) of applicable federal, state, and institutional regulations for conducting studies involving humans, animals, radioactive and other hazardous materials, recombinant DNA; informing students of the process used to obtain approval by appropriate committees, data gathering and recording, statistical analysis, interpretation of results, preparation of manuscripts, submission and revision of manuscripts for publication and presentations at scholarly meetings. Research directors are responsible for informing personnel about USF policies and procedures related to research as well as the guidelines set forth in this document. The research director is also responsible for explaining and discussing the relevant requirements for the responsible conduct of research with trainees, fellows, and visiting scientists and to ensure that such requirements are met.

Treatment of Research Data

Consistent with academic freedom, the investigator/researcher has the authority to make judgments involving the use and dissemination of her or his research data. Each faculty member/research director is ultimately responsible for the maintenance and proper retention of research records. These records should include sufficient detail to permit examination for the purposes of replicating the research, responding to questions that may result from unintentional error or misinterpretation, establishing their authenticity, and confirming the validity of the conclusions. Each research director should maintain a laboratory manual that describes all major procedures. Correspondence with institutional review committees and records of the use of controlled substances and radioactive materials should be maintained as part of the research record in accordance with governmental, regulatory, and University policies. A standardized system of data organization should be adopted and should be communicated to all members of the research group and to the appropriate administrative person.

Where feasible, all original primary data are to be retained by the faculty member or by his or her designee. Accepted practices for retaining data vary among disciplines and depend on the perishability, nature, and logistics of retaining each type of data. Each investigator should treat data properly to ensure authenticity, reproducibility, and validity and to meet the requirements of granting agencies or agreements concerning the retention of data. Primary data should be maintained for a reasonable period of time to ensure that any questions raised by researchers, colleagues, or readers of any published results can be answered. It is recommended that data be retained for at least three years. Potentially patentable data should be signed and dated by the researcher at the time they are entered into notebooks. A witness should also sign these pages. In the event the researcher leaves the University, the researcher and the department chair or dean must together arrange for the researcher's data, notebooks, and other data retention materials (other than clinical research records) to be transferred to the new institution. In such cases an individual written agreement shall be signed which preserves the scholar's right to access and copy (where practical) such data. In cases of multi-institutional studies, the institution of the primary study director is ultimately responsible for guaranteeing appropriate access to, use of, and retention of original data.

Research Materials and Commercial Applications

The open sharing of research materials and information facilitates the acquisition of new knowledge in diverse disciplines. In keeping with the principle of fostering reproducibility, and in the absence of patent or copyright considerations, novel compounds and reagents, cell lines, cDNA clones, etc., should be made available to qualified investigators requesting these materials. In lieu of this, appropriately described means for obtaining these materials should be given to other competent members of the research community upon request. The senior investigator should have the latitude to make a fair and balanced response to requests for all research substances.

In some instances, research leads to a product that may have commercial value or be patentable. The researcher is referred to the U.S.F. Division of Patents & Licensing for assistance.

Many respected faculty are committed to developing and to studying tools, techniques, and processes whose primary purpose is to promote the health or welfare of society in areas having potential commercial value. The research director is responsible for assuring that such investigations meet the same standards of quality and reproducibility as investigations of a more basic nature. Furthermore, any faculty member who has financial interests in a company sponsoring his or her research must disclose such financial interests to the chair and dean/director to avoid potential conflicts of interest.

The Association of American Medical Colleges employs this characterization of conflict of interest: ".... the term conflict of interest in science refers to a situation in which financial or other personal considerations may compromise, or have the appearance of compromising, an investigator's professional judgment in conducting or reporting research.... The bias such conflicts may conceivably depart not only affects collection, analysis, and interpretation of data, but also the hiring of staff, procurement of materials, sharing of results, choice of protocol, and use of statistical methods.... Individual conflicts of interest in research arise in large part because of the interplay between a faculty member's personal and financial interests and the opportunity to conduct externally-funded research".... .

Clinical Researchs

Clinical research requires special attention to issues of informed consent and confidentiality. Because patients have a right to assume that decisions about their treatments are made in their best interests, the physician-investigator should disclose all significant alternatives and risks to patient-subjects so that they can make an informed judgment about participation. Signed copies of informed consent must be placed in the patient's clinical records as well as with research records. Clinical research records remain the property of the University; the administrative heads of the department/division of the faculty conducting clinical trials are responsible for maintenance of the records. Faculty members may make copies of the records upon departure from the University, as may the company that sponsors the clinical trials.

Social Responsibilities of Researchers

The outcomes of research have become integral parts of modern society. Researchers have an obligation to relate this new knowledge to society in such a way that the general public can make informed decisions. The general public provides the financial support that makes all research possible. The occurrence and consequences of research discoveries are essentially impossible to foresee. If a discovery is found to have important implications for the public, researchers have a responsibility to call attention to the public issues involved. Public forums involving experts with different perspectives may be held. Ultimately, a consensus of informed judgment can be reached and disseminated to the public.

The research enterprise has grown enormously since the end of World War II. Yet the core ethical values upon which this enterprise is based -- honesty, skepticism, fairness, collegiality, openness -- remain unchanged. These values have helped produce a research enterprise of unparalleled productivity and creativity. As long as these values remain prominent, research and the society which it serves will prosper.

References
For further information the researcher is referred to the following publications:
  1. On Being a Scientist: Responsible Conduct in Research, National Academy of Science
  2. The Responsible Conduct of Research, Dore Beach, Wiley-VCH, New York; Weinheim, Germany, 1996.
  3. How to Write and Publish a Scientific Paper, Robert A. Day, Oryx Press, Phoenix, AZ.
  4. How to Write and Publish Papers in the Medical Sciences, Edward J. Huth, Williams and Wilkins.
  5. Guide for the Care and Use of Laboratory Animals, National Research Council, National Academy Press, Washington, D.C.
  6. Report of the Commission on Research Integrity.

  7. Scientific conduct, Bruce Alberts, Robert White and Kenneth Shrine. Proc. Natl. Acad. Sci. USA 91, 3479-3480, 1994.
  8. "Policies and Procedures for Investigation of Misconduct in Research", Emory University, 2 March 1989.
  9. Modified from "Ethical Guidelines for Publication of Research", Endocrine Reviews, 10: 1, 1989.
  10. "Authorship and Other Credits", N. Fotion and C. C. Conrad, Annals of Internal Medicine, 100:592, 1984.
  11. Adapted from S. J. Bird, President's Remarks, "Professional Responsibility", AWIS Magazine, 20:2, 1991.
  12. "Ownership of Research Data", Estelle A. Fishbein, Academic Medicine, 66:129. 1992.
  13. "Workshop Summary", L. J. Rhoades, Data Management in Biomedical Research: Report of a Workshop, USPHS, pp. 2-9, 1990.