IP 738: Clinical Research Ethics Seminar Series 2012-2013
MONDAYS 12:00 - 1:00 PM College of Health Professions Room B-322
(except Aug 20: CHP B-403) |
Course Placement: | Fall and Spring 2012 - 2013
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| Credit: | 2 Semester Hours |
| Prerequisites: | Faculty, staff and registered students of MUSC; instructor permission. |
| Course Description: | This seminar series expands the range of educational opportunities for students who are interested in clinical research ethics (CRE). It comprises hour-long meetings each week with leaders from MUSC administration and clinical/translational investigators, each of whom focuses on the relation of their offices and activities to CRE. It is part of a fellowship program that leads to a Certificate in Clinical Research Ethics. This course is available both in classroom and online; because of the intimate nature of the faculty-student interaction, only 10 Fellows will be able to participate in the classroom discussion. |
| Course Objective: | Each weekly seminar focuses on the relation of CRE relative to the particular office, position, or research domain of the speaker. Specific Ojectives: - To provide the students with a broad view and understanding of CRE from the broadest range of relevant perspectives, from both research-related administrators and deeply engaged clinical and translational investigators.
- To enable the participants to function with optimal efficiency and effectiveness during their own work in research by deepening their understanding of research ethics and responsibilities from a wide variety of viewpoints.
- To interact with faculty, staff, and students from other MUSC colleges to learn about each other and about the values and perspectives of their respective disciplines, preparing them for future collaboration.
- To sharpen sense of teamwork by working in small groups with other Fellows to develop case studies in Clinical Research Ethics.
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Learning Activities:
| Two major learning activities are: - Each seminar begins with 5-10 minute presentations by the speaker, in which he or she describes the relation of their position to CRE. A case describing a problem in CRE will have been distributed to the students and speaker before the session, and the speaker presents his or her perspective on the case. The remainder of the time available, approximately 45-50 minutes, is spent in discussion that maximally engages the participants with the speaker and with each other. The discussions during these sessions is nearly always vigorous and engaging.
- The last two sessions each semester are spent in small groups developing complex case studies in Clinical Research Ethics. The class is divided into groups that work collaboratively in developing their cases.
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Major Content Areas:
| The content areas encompass the full range of topics within CRE. A non-exhaustive list includes conflicts of interest, such as those relating to recruitment of subjects and relations with industry; publication issues, such as authorship, collaboration, plagiarism, duplicate publication, and peer review; research misconduct, including falsification and fabrication of data; protection of human subjects in research including the role of IRBs and the concepts of vulnerability and coercion. Many other areas of CRE will be covered. |
Class Time:
| Mondays 12:00 – 1:00 pm
CHP Room B-322 (except Aug 20: CHP B-403
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Instructors:
| Dr. Robert M. Sade (Course Director) sader@musc.edu
See attached schedule |
TA:
| Andrea D. Boan boan@musc.edu |
Evaluation of Students To obtain credit for this course, students may be absent from no more than 3 sessions a semester. For any session they miss, they will be required to write a 500 word (2-page) essay on the topic of the session they missed. The last two sessions of each semester are devoted to development and presentation of detailed, complex case studies of issues in CRE. Grading: 70% Attendance and Class Participation 30% Case analysis and presentation
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