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ETH 750–Ethical Issues in Clinical Research

Course Placement:  Fall 2014

Credit: 1 Semester Hour

Prerequisites: Student in MSCR or Graduate Studies, Fellow in Clinical Research Ethics, or instructor permission.

Course Description: Emphasis will be placed on the ethical issues associated with clinical research and practice. The class will focus on review of the competencies involved in the conduct of ethically responsible research. The process of assessing ethical issues in research and study will be described. The ethical considerations in study design and implementation, data management, data analysis, data interpretation and results presentation and publication will be described. As future educators, the students will be presented with the honor council process, assessment process for unethical classroom and study behavior, and the process for behavior modification and remediation. Ethical considerations in collaborative research will be presented. The course will consider evolving ethical issues in clinical research including human subjects and conflict of interest. The course will include a class participation system and will be available online.

Course Objective: To familiarize students with the specific ethical issues involved in the planning, implementation and completion of research.  Emphasis will be placed on conflict of interests, authorship on abstracts and manuscripts, ethical issues in data interpretation and publication, reference citing and plagiarism, honor code, and the process for resolving ethical issues. In addition, the specific 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 and Traslation Research Ethics Certificate Program homepage.                                                                                        

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 dealing with ethical violations.
3. The student will have the knowledge to incorporate ethical considerations in all aspects of clinical and translational research.

Course Outline:                    
General Topics Include:
1.      Ethical considerations of classroom behavior (cheating, plagiarism, honor code)
2.      Plagiarism and reference citations
3.      Manuscript and abstract authorship (qualifications of authors, order of authors, definition of senior author)
4.      Manuscript, abstract, and grant submission (author/investigator review process, submission of duplicate abstract, manuscript, and/or grants)
5.      Copyright issues with manuscripts and abstracts
6.      Ethical issues in study design
7.      Ethical issues in data and interpretation of results including falsifying data and results
8.      IRB process for pilot studies and secondary data analysis
9.      Conflict of interest and disclosure
10.  Ethical issues in manuscript, grant and abstract reviews
11.  Issues of informed consent and therapeutic misconception

Professor Daniel Lackland                                 
Professor Robert M. Sade         
Professor Kathryn Magruder    
Professor Susan Sonne              
Professor Cynthia Wright         
Professor Edward Krug            
Professor Jennifer Baker           
Robert Donato, Esq                  
Dr. Andrea Boan                      


Partial listing of student responsibilities

  1. Reading – Assigned References
    Required text: Responsible Conduct of Research, Second Edition
    Adil E. Shamoo and David B. Resnik.
    ISBN13: 9780195368246 ISBN10: 019536824X 
    Paperback, 440 pages. Jan 2009.
  1. Participation in case presentation
  2. Completion of CITI course
  3. Completion of case study assignment           

                        25%     Weekly case assignments
                        25%     Final Case Review
                        25%     Completion of web-based certification
                        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.


ETH750 Ethical Issues in Clinical Research

Fall Semester, 2014

Thursday 12:00 – 1:00 pm

Room TBA






Dr. Daniel Lackland

Introduction to Ethical Issues in Clinical Research



Dr. Robert Sade

Historical development of informed consent



Dr. Jennifer Baker

Principles of clinical research ethics



Dr. Susan Sonne

IRB process



Dr. Andrea Boan

Classroom behavior, students and faculty (e.g., honor code, cheating)



Dr. Andrea Boan

Plagiarism and reference citations



Dr. Edward Krug

Responsible conduct of research



Dr. Kathryn Magruder

Conducting ethically responsible research



Dr. Daniel Lackland

Data fabrication and falsification



Dr. Daniel Lackland

Ethics and study design



Dr. Daniel Lackland

Disclosure and resolution of conflicts of interest



Dr. Daniel Lackland

Disclosure and resolution of conflicts of interest II



Dr. Daniel Lackland

Authorship on Manuscripts



Dr. Daniel Lackland





No Class



Dr. Daniel Lackland

Final Case Review Discussion

*Speakers and schedule are subject to change.


Application Process

ETH 750
ETH 789
ETH 738
Core Competencies