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Tuesdays:  12:00 – 1:00 PM  Ashley River Tower 7033

Course Placement: Fall & Spring 2014-2015

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 research 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. Students who are on campus and are taking the course for academic credit are expected to attend the classroom seminar; all others are encouraged to attend if on campus or participate online.

Course Objectives: Each weekly seminar focuses on the relation of CRE relative to the particular office, position, or research domain of the speaker.

Specific Objectives:
1.  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.
2.  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.
3.  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.
4. To sharpen the sense of teamwork by working in small groups with other Fellows to develop case studies in Clinical Research Ethics.

Learning activities:           
Two major learning activities are:
1.   The seminars begin with 5-10 minute presentations by the speakers, in which they describe the relation of their position to CRE. Relevant cases from the speakers’ own experience or from the literature may be discussed. Each student is expected to participate actively by leading the discussion.
2.   The last one or two sessions each semester are spent in small groups developing case studies in Clinical Research Ethics. The class is divided into groups that work collaboratively in developing their cases.
Major content areas:        
The content areas encompass the full range of core competencies 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 & Location: Tuesdays, 12:00 – 1:00 pm, Ashley River Tower 7033

Dr. Robert Sade (Course Director),
Others: see attached schedule.
Andrea D. Boan, PhD,

Evaluation of Students:     To obtain credit for this course, students must complete all exercises for each session, as posted in Moodle, within one week after the session is posted. Late completion results in loss of 5 percentage points on the grading scale.

Those required to attend class:
50% Attendance and required class participation.
50%    Quality and timely completion of online assignments.

Those participating online:
100% Quality and timely completion of online assignments.

ETH 738      Seminar Series in Clinical and Translational Research Ethics

Fall 2014

Tuesdays:  12:00 – 1:00 PM                           Ashley River Tower 7033
(The scheduled speakers are subject to change)


August21Dr. Daniel Lackland, Director: Director, MSCRIntroduction and research misconduct
 28Dr. Susan Sonne, Clinical & Translational Research Center and Chair, IRB 2The Institutional Review Board
September4Dr. Kathryn Magruder, Director, MUSC Office of Research IntegrityResearch Integrity  
 11Dr. Mark Sothmann, Interim President and ProvostConflicts of interest and of obligation 
 18Dr. Etta Pisano, Vice President for Medical Affairs and Dean, College of Medicine Research relations with industry
 25Dr. Herman Blake, MUSC Humanities Scholar in ResidenceThe humanities in research
October2Ms. Lisa Kindy, Esq., Director, Clinical Risk Management, University CounselResearch risk management
 9Dr. Susan Sonne, Clinical & Translational Research Center and Chair, IRB 2The Institutional Review Board
 16Dr. Robert Sade, Director: SCTR Clinical Research Ethics CoreHonesty and integrity in research
 23Dr. Jihad Obeid, Interim Director, SCTR Institute Biomedical InformaticsBiomedical Informatics
 30Dr. Susan Newman, SCTR Director: Community Engagement Program Community engagement 
November5Dr. Walter Limehouse, Chair, MUHA Ethics Committee and Clinical Research Ethics Consultation ServiceResearch Ethics Consultation 
 12Dr. Raymond Anton, Director, Center for Drug and Alcohol ProgramsDrug and alcohol research
 20Planning Case Analyses—Small Groups (Dr. Edward Krug) 
Decmeber4Case Analyses (Dr. Edward Krug) 


Application Process

ETH 750
ETH 789
ETH 738
Core Competencies