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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) boan@musc.edu,  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: http://academicdepartments.musc.edu/humanvalues/cre%20fellowship%20program/Core%20Competencies.

                                               

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

 

Grading:

                        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

 

 

WEEK OF

SPEAKER

 

TOPIC

JAN

11

Dr. Jennifer Baker, Assoc. Professor Philosophy, CofC

 

Principles of clinical research ethics

 

18

Dr. Daniel Lackland, Professor Neurosciences

 

Global Health Research (videos)

 

25

Dr. Robert Sade, Professor Surgery

 

Clinical Equipoise

FEB

  1

Dr Edward Krug, Assoc. Professor, MCBP

 

Essential Scientific Practices: Responsible Conduct of Research

 

 

 8

Dr. Daniel Lackland, Professor Neurosciences

 

Data Analysis

 

15

Dr. Daniel Lackland, Professor Neuroscience

 

Disclosure and resolution of COI

 

22

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

 

Intellectual Property, Copyright, & Patents

 

29

Mike Wheeler, University Compliance

 

HIPAA, Penalties, and Health Information Security

MAR

  7

Dr. Carmela Epright, Professor Philosophy, Furman University

 

The New Revision of  the Helsinki Declaration

 

14

SPRING BREAK

 

No Class

 

21

Dr. David Wendler, Department of Bioethics, NIH

 

Deception in research

 

28

Dr. Daniel Lackland, Professor Neurosciences

 

Authorship on manuscripts

APR

  4

Dr. Daniel Lackland, Professor Neurosciences

 

Whistle Blower Protection in Scientific Misconduct

 

11

Dr. John Ikonomidis, Professor Cardiothoracic Surgery

 

Reviewing Science: Grants and Manuscripts

 

18

Dr. Daniel Lackland, Professor Neurosciences

 

Compensation for Research Participation

 

25

Part I: Final Case Study Write-up Due

 

May

 2

Part II: Peer Case Study Critique Due

 


 
 

Application
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ETH 750
ETH 789
ETH 738
ETH 705
Core Competencies
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