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ETH 789

Advanced Ethical Issues in Clinical Research


Course Placement:                Spring 2016


Credit:                                    1 Semester Hour

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

Instructors:                            Dr. Andrea Boan (Course Director),  843-876-1064

Course Description:             
This course is intended as a follow-up for MCR/ETH 750.
Emphasis is placed on current ethical issues associated with clinical and translational research and practice. The class focuses on review of the competencies involved in the conduct of ethically responsible research. Some topics covered in MCR 750 are discussed in more detail. Additional topics associated with ethics in clinical and translational research are 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 is placed on advanced topics in clinical research as a follow-up to MCR 750. The Clinical Research Ethics Core Competencies in the responsible conduct of clinical and translational research are explicitly addressed. A list of the competencies can be found on the MUSC Fellowship in Clinical Research Ethics Certificate Program homepage:


Learning Activities:
Two major learning activities are:
1.   Lectures and discussions
2.   Assigned readings
3.   Participation in case discussions

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


Partial listing of student responsibilities

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

  1. Weekly case assignments
  2. Participation in final case write-up and critique



                        30%     Weekly quizzes

                        30%     Weekly assignments

                        10%     Completion of web-based certification

                        30%     Informed Consent Final Project


Honor Code:
The faculty of the MUSC College of Graduate Studies endorse the campus Honor Code and expect students to be familiar with and abide by its provisions. The Honor Code policy applies to all tests, written assignments, clinical behavior, clinical logs, medical record entries, and verbal and electronic communication. The Honor Code document can be viewed in the Student Handbook.


Plagiarism statement:
Plagiarism is a form of academic misconduct and is the use of another person’s words or ideas without providing credit to that person. It is the theft of another person’s words or ideas to give the impression that you created them. These words and ideas may be from a variety of sources including printed works, speeches, presentations, and/or Internet sites and documents. Appropriate and complete referencing of words and ideas obtained from others is a requirement in ALL courses. If a work is anonymous, as may be the case with some Internet documents, it still must be fully referenced.


Accommodation for disabilities:
Section 504 of the Rehabilitation Act of and the Americans with Disabilities Act of 1990 requires MUSC to provide academic adjustments or accommodations for students with documented disabilities.  Students seeking academic adjustments or accommodations must self-identify with the Associate Dean for Academics in the College of Graduate Studies. The Disability Accommodation Request form may be found in the Office of Student services. After consulting with the Associate Dean for Academics, students are encouraged to meet with instructors to discuss their needs and, if applicable, any clinical safety concerns related to their disabilities.

     ETH 789:  Special Topics: Advanced Ethical Issues in Clinical Research

Spring Semester, 2016

Online Course









Dr. Jennifer Baker, Assoc. Professor Philosophy, CofC


Principles of clinical research ethics



Dr. Daniel Lackland, Professor Neurosciences


Global Health Research (videos)



Dr. Robert Sade, Professor Surgery


Clinical Equipoise



Dr Edward Krug, Assoc. Professor, MCBP


Essential Scientific Practices: Responsible Conduct of Research




Dr. Daniel Lackland, Professor Neurosciences


Data Analysis



Dr. Daniel Lackland, Professor Neuroscience


Disclosure and resolution of COI



Dr. Jesse Goodwin, Assoc. Director, Foundation R&D


Intellectual Property, Copyright, & Patents



Mike Wheeler, University Compliance


HIPAA, Penalties, and Health Information Security



Dr. Carmela Epright, Professor Philosophy, Furman University


The New Revision of  the Helsinki Declaration





No Class



Dr. David Wendler, Department of Bioethics, NIH


Deception in research



Dr. Daniel Lackland, Professor Neurosciences


Authorship on manuscripts



Dr. Daniel Lackland, Professor Neurosciences


Whistle Blower Protection in Scientific Misconduct



Dr. John Ikonomidis, Professor Cardiothoracic Surgery


Reviewing Science: Grants and Manuscripts



Dr. Daniel Lackland, Professor Neurosciences


Compensation for Research Participation



Part I: Final Case Study Write-up Due




Part II: Peer Case Study Critique Due



Application Process
ETH 750
ETH 789
ETH 738
ETH 705
Core Competencies