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ETH 738      SEMINAR SERIES IN CLINICAL AND TRANSLATIONAL RESEARCH ETHICS

2013-2014

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

Course Placement: Fall & Spring 2013-2014

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

Instructors:                         
Dr. Robert Sade (Course Director), sader@musc.edu
Others: see attached schedule.
TA:
Andrea D. Boan, PhD,boan@musc.edu

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.

Grading:
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 2013

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

(The scheduled speakers are subject to change.)



SPEAKER

TOPIC

AUG

21

Dr. Robert Sade, Director: SCTR Clinical Research Ethics Core

Honesty and integrity in research


28

Dr. Walter Limehouse, Chair, MUHA Ethics Committee and Clinical Research Ethics Consultation Service

Research Ethics Consultation

SEP

4

Dr. Kathryn Magruder, Director, MUSC Office of Research Integrity

Research Integrity 


11

Dr. Jihad Obeid, Interim Director, SCTR Institute Biomedical Informatics

Biomedical Informatics


18

Dr. Susan Newman, SCTR Director: Community Engagement Program

Community engagement


25

Dr. Daniel Lackland, Director: Neuroscience Graduate Training & Education

Perspective from Neuroscience Graduate Training

OCT

2

Dr. Etta Pisano, Vice President for Medical Affairs and Dean, College of Medicine

Research relations with industry


9

Dr. Susan Sonne, Clinical & Translational Research Center and Chair, IRB 2

The Institutional Review Board


16

Dr. Herman Blake, MUSC Humanities Scholar in Residence

The humanities in research


23

Dr. Mark Sothmann, Interim President and Provost

Conflicts of interest and of obligation


30

Dr. Etta Pisano, Vice President for Medical Affairs and Dean, College of Medicine

Research relations with industry

NOV

5
Tues

Dr. Susan Sonne, Clinical & Translational Research Center and Chair, IRB 2

The Institutional Review Board


12
Tues

Dr. Raymond Anton, Director, Center for Drug and Alcohol Programs

Drug and alcohol research


20

Planning Case Analyses—Small Groups (Dr. Edward Krug)


27

NO ON-CAMPUS CLASS
Final part one available in moodle

DEC

4

Case Analyses (Dr. Edward Krug)


IP 738/ETH 738      Seminar Series in Clinical and Translational Research Ethics

Spring 2014

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

(The scheduled speakers are subject to change.)

JAN

8

Mr. Robert Donato, Esq., Executive Director
Foundation for Research Development

Research Development


15

Dr. Joseph Romagnuolo, President, MUSC Faculty Senate

The Faculty Senate


22

Dr. Robert Sade, Director: SCTR Clinical Research Ethics Core

Clinical Research Ethics


29

Ms. Cynthia Teeter, University Compliance Officer

Compliance

FEB

5

Robert Malcolm, Associate Dean for Continuing Medical Education

Continuing Medical Education


12

Ms. Lisa Kindy, Esq., Director, Clinical Risk Management, University Counsel

Research risk management


19

Dr. John Arthur, Former Director, SCTR Biobank

Biobanking


26

Dr. Kathleen Brady, Director, South Carolina Clinical and Translational Research Institute

South Carolina Clinical and Translational Research Institute R

MAR

5

Dr. John J. Sanders, Dean, College of Dental Medicine

Dental Research


11

SPRING BREAK



19

Dr. Daniel Wueste, Director, Clemson University’s Rutland Institute for Ethics

Perspective from Clemson’s Rutland Institute for Ethics


26

Dr. Rita Ryan, Chair, Department of Pediatrics

Perspective from the Department of Pediatrics

APR

2

Dr. Robert Sade, Director, Clinical Research Ethics Core, SCTR

Perspective from the Clinical Research Ethics Core, SCTR


9

Dr. Daniel Lackland, Director: Neuroscience Graduate Training & Education

Perspective from Neuroscience


16

Dr. Daynna Wolff, Director, Cytogenetics, Pathology Department

Perspective from Cytogenetics


23

Dr. John Arthur, Former Director, SCTR Biobank

Perspective from SCTR Biobank


30

Classes ended April 29