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ETH 750–Ethical Issues in Clinical Research

Course Placement:  Fall 2013

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

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.
    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           

Grading:
                        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, 2013

Thursday 12:00 – 1:00 pm

EL 103



SPEAKER*

TOPIC

AUG

22

Dr. Daniel Lackland

Introduction to Ethical Issues in Clinical Research


29

Dr. Robert Sade

Historical development of informed consent

SEP

5

Dr. Jennifer Baker

Principles of clinical research ethics


12

Dr. Susan Sonne

IRB process


19

Dr. Andrea Boan

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


26

Dr. Andrea Boan

Plagiarism and reference citations

OCT

3

Dr. Edward Krug

Responsible conduct of research


10

Dr. Kathryn Magruder

Conducting ethically responsible research


17

Dr. Daniel Lackland

Data fabrication and falsification


24

Dr. Daniel Lackland

Ethics and study design


31

Dr. Daniel Lackland

Disclosure and resolution of conflicts of interest

NOV

7

Dr. Daniel Lackland

Disclosure and resolution of conflicts of interest II


14

Dr. Daniel Lackland

Authorship on Manuscripts


21

Dr. Daniel Lackland

DSMB


28

THANKSGIVING

No Class

DEC

5

Dr. Daniel Lackland

Final Case Review Discussion

*Speakers and schedule are subject to change.