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MCR/ETH 750

Ethical Issues in Clinical Research and Epidemiology

 

Course Placement:               Fall 2015

 

Credit:                                  1 Semester Hour

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

 

Instructors:                         Dr. Andrea Boan (Course Director)  boan@musc.edu , 843-876-1064

            

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 Objectives:   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, informed consent, protecting vulnerable populations, 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 Research Ethics Certificate Program homepage: http://academicdepartments.musc.edu/humanvalues/cre%20fellowship%20program/Core%20Competencies.

                                                                                        

Learning Experience:           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 dealing with ethical violations.

3. have the knowledge to incorporate ethical considerations in all aspects of clinical and translational research.

 

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: 9780195368246ISBN10: 019536824X

Paperback, 440 pages. Jan 2009.

  1. Participation in case presentation
  2. Completion of CITI course
  3. Completion of weekly quizzes and assignments

 

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.


 

MCR/ETH 750

Ethical Issues in Clinical Research and Epidemiology

Fall Semester, 2015

MCR 750: Tuesdays, 12-1pm in EL 107 / ETH 750: online

(Additional materials available in Moodle)

 

 

DATE

SPEAKER*

 

TOPIC

AUG

 

25

Dr. Andrea Boan

Course Introduction

SEP

  1

Dr. Andrea Boan

Historical development of research ethics

 

 

     8

Dr Andrea Boan

 

Academic misconduct

 

 

15

Dr. Robert Sade

Historical development of informed consent

 

 

22

Dr. Susan Sonne

 

Overview of Institutional Review Board

 

29

Dr Susan Sonne

 

Informed consent

OCT

 6

Mary Evelyn Armstrong

 

Conflicts of Interest

 

13

Dr. Daniel Lackland

 

Research misconduct: data fabrication/ falsification

 

20

Dr. Andrea Boan

Ethics and study design, DSMB

 

 

27

Dr Andrea Boan

 

Ethics of clinical trials and placebo use

NOV

  3

Dr. Susan Sonne

 

Protecting vulnerable human subjects

 

 10

Dr Susan Newman

 

Community-engaged research

 

17

Dr. Laura Carpenter

 

Research in individuals with developmental disabilities

 

24

THANKSGIVING

 

No Class

 

DEC

   1

Dr. Teresa Atz

 

Therapeutic misconception

 

 

   8

Dr. Susan Sonne

Final - Informed Consent Project Discussion

 

*Speakers and schedule are subject to change.

 


 
 

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ETH 750
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