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 ETH 789

Advanced Ethical Issues in Clinical Research

Course Placement:Spring 2014

Credit: 1 Semester Hour

Prerequisites: 
Completion of ETH750/MCR 750;
Student in MSCR Program, Graduate Studies, Fellow in Clinical Research Ethics, or instructor permission.

Course Description:  
This course is intended as a follow-up for ETH 750.
Emphasis will be placed on current ethical issues associated with clinical and translational research and practice. The class will focus on review of the core competencies involved in the conduct of ethically responsible research. Some topics covered in ETH 750 will be covered in more detail. Additional topics associated with ethics in clinical and translational research will also be covered.

Course Objective:   
To familiarize students with the specific ethical issues involved in the planning, implementation and completion of clinical and translational research.  Emphasis will be placed on advanced topics in clinical research as a follow-up to ETH 750. The Clinical Research Ethics Core Competencies in the responsible conduct of clinical and translational research will be explicitly addressed. A list of the competencies can be found on the MUSC Fellowship in Clinical Research Ethics Certificate Program homepage: http://academicdepartments.musc.edu/humanvalues/cre%20fellowship%20program/Core%20Competencies.

Learning Experience:          
1.   Lectures, seminars, discussions, panels
2.   Assigned readings
3    Participation in case discussions in the classroom or online

Terminal Behavior:               
1. The student will be able to identify ethical issues    associated with the practice and conduct of clinical and translational research.                                                                                
2. The student will be able to identify the process for ethical violations.
3. The student will have the knowledge to incorporate ethical considerations in all aspects of research and academics.

Course Outline:                    
General Topics Include:
Mentoring and collaboration
Academia-industry collaboration
Controversies in clinical equipoise
Issues in global health research and genetic research
Intellectual Property
Ethical issues in genetic research
Cloning and stem cell research
Authorship in publication of research
Data Safety and Monitoring Boards
Privacy and confidentiality issues in research
Compensation for research-related injury
Deception in research
Therapeutic misconception
Use of animals in research

Instructors:
Professor Daniel Lackland                  lackland@musc.edu
Professor Robert M. Sade                   sader@musc.edu
Professor Kathryn Magruder              magrudkm@musc.edu
Professor Susan Sonne                        sonnesc@musc.edu
Professor Cynthia Wright                   wrightcf@musc.edu
Professor Edward Krug                      krugel@musc.edu
Professor Jennifer Baker                     bakerja@cofc.edu
Robert Donato, Esq                            donator@musc.edu
Dr. Andrea Boan                                boan@musc.edu

Partial Listing of Student Responsibilities:

1.Reading – Assigned References
Required text: Responsible Conduct of Research, Second Edition
Adil E. Shamoo and David B. Resnik
Paperback, 440 pages, Jan 2009
ISBN13: 9780195368246ISBN10: 019536824X

2. Participation in case presentation
Grading:
50%     Weekly case assignments
25%     Final Case Review
25%     Class Participation

Case Review – 3 cases will be presented regarding the varying topics discussed throughout the semester.  The cases will be reviewed and assessed for possible ethics policy infractions or inappropriate ethical interpretations.  A short written opinion for each case will be submitted