Responsible Conduct in Research
The training program in Ethical Conduct in Biomedical Research has three major educational components: the online Symposium in Bioethics; the program literature and reference source guide; and small group discussion workshops. Participation in all three phases of this training program is mandatory for graduate students and for selected postdoctoral research and clinical fellows.
The training program is introduced during the candidate's first year through the Symposium in Bioethics. The online Symposium is designed to provide all participants with an introduction to bioethics and, more specifically, ethics in biomedical research. The Symposium—jointly sponsored by Biomedical Graduate Studies, Biomedical Postdoctoral Programs, and the Center for Bioethics—is divided into eight lectures. The topics presented are:
- Animal Experimentation: Ethical Arguments, Investigators and Institutional Responsibilities
- Conflicts of Interest
- Keeping a Lab Notebook: Ownership of Data and Materials
- Keeping a Laboratory Notebook: What You Need to Know From an Intellectual Property Perspective
- Misconduct in Science
- Peer Review
- Responsible Authorship
- The Ethics of Human Subjects Research
The online Symposium includes speakers’ audios, handouts, slides, and a web-based quiz to assess and document participation.
The program literature consists of two primary documents: ON BEING A SCIENTIST: Responsible Conduct in Research, second edition (National Academy Press, Washington, DC, 1995), and ETHICAL CONDUCT IN BIOMEDICAL RESEARCH: A Handbook for Biomedical Graduate Students and Research Fellows (Biomedical Graduate Studies [BGS], University of Pennsylvania, 2004). The organization and intent of these two documents are similar. The BGS handbook includes topics that are not included in ON BEING A SCIENTIST but are judged to be important to the training of graduate students and research fellows at the University of Pennsylvania. These topics include discussions of peer review, mentoring, and research on human and animal subjects. The BGS handbook also includes a practical guide to assist students and fellows in the guidelines and procedures regarding alleged misconduct at the University of Pennsylvania and to identify the appropriate source for contact when questions arise. Copies of these handbooks, and more detailed reference materials, are disseminated by the BGS Office.
Small group discussions on the major topics of ethical conduct in biomedical research, as outlined in the documents, are discussed using the case study approach. Small group workshops of 12-15 trainees are organized with two faculty preceptors each. The workshops meet for two hours. Successful case-based learning offers considerable workshop flexibility. One of its benefits is that students and faculty become engaged in a process of discovery together. Research integrity includes not only learning rules, but also exploration of the preceptors’ own attitudes and prejudices and recognition of conflicting ethical principles. This method also provides the opportunity to directly illustrate the avoidance of misconduct through good laboratory practice. The participation of active investigators is essential in this exercise. Indeed, participation in bioethics training is required of all BGS faculty. Their involvement lends credibility to the process and may influence their own research practices.
Graduate students are required to participate in the online Bioethics Symposium in year 1 and to participate in the workshops in years 2, 3, and 4. Second year students discuss case studies in mentorship and laboratory supervision; data management and lab notebooks; and research misconduct and plagiarism. Third year students discuss case studies in human subjects research; animal research; and discrimination and harassment. Fourth year students discuss case studies in authorship; peer review; and conflicts of interest. Beginning in year 5, students elect to participate in a workshop or request permission from the Director of BGS to fulfill the bioethics training requirement in some other manner, such as directed readings.
The program staff determines if trainees are to be involved in any research project entailing potentially hazardous procedures. Any trainee using hazardous radioisotopes must participate in a training session sponsored by the Office of Radiation Safety. Trainees working with potentially infectious material (human blood products or tissues) are required to attend a similar session on biohazard safety. Trainees working with laboratory animals are required to attend training sessions conducted by the Unit for Laboratory Animal Research.
All trainees are subject to Penn’s Procedures Regarding Misconduct in Research for Non Faculty Members of the Research Community.