Course Syllabus:

This course syllabus is a general plan for the course; deviations announced to the class by the instructor may be necessary.

In .pdf format

Contents:

Instructor information:
Name: Stuart Feldman, Ph.D., Professor and Director, The Interdisciplinary Toxicology Program
Email: sfeldman@rx.uga.edu
Office location: Room 220, Veterinary Medicine
Phone: (706) 542-5250

Name: Kyndra Cottingham, Teaching Assistant
Email: cottingk@mail.rx.uga.edu

Course Support (including technical support):
Name: Johnna Hodges, M.Ed., Regulatory Affairs Program Manager
Email: jhodges@rx.uga.edu or Phone & Fax: 678-407-5180

Name: Angie McVey, Regulatory Affairs Program Coordinator
Email: amcvey@rx.uga.edu or Phone & Fax: 678-407-5277

When emailing faculty and staff, please allow a reply time of 24-48 hours if you submit your email during the week. If you submit a question over the weekend, please allow additional time.

Course Description:
This course provides an introduction to bioethical principles used to make decisions when confronted with ethical issues involving research in animals and human subjects, fraud, scientific misconduct, and conflicts of interest. The goal is to develop a framework for decision making to predict and solve ethical dilemmas within the pharmaceutical, biotechnology and medical device fields. Students will be introduced to fundamental bioethical review systems, including the theory of peer review and moral and ethical responsibilities of leadership. The course will use NIH materials and Poytner Center information as well as hypothetical case study format to analyze and apply these principles to the industry.

Prerequisites: None

Course Materials and Recommended Reading:
Readings: There is no required text book for this course. The readings will come from a bibliography list and many of these will be available from the internet or library.

Materials: A variety of materials and methods will be employed in providing the information for PHRM 7230. These may include audio tapes, lectures, power point presentations, reading materials and interactive web exercises.

Policies and Academic Honesty:
All academic work must meet the standards contained in A Culture of Honesty. Each student is responsible to inform themselves about those standards before performing any academic work. A Culture of Honesty is the University of Georgia's policy and procedures for handling cases of suspected dishonesty and can be found online at mailto:amcvey@rx.uga.edu. UGA Student Honor Code states "I will be academically honest in all of my academic work and will not tolerate academic dishonesty of others."

Grading Formula:

100-point scale Grade:

100-94 = A

93-90 = A-

89-88 = B+

87-84 = B

83-80 = B-

79-78 = C+

77-74 = C

73-70 = C-

69< D

59< F

Online and Classroom participation – 50%
Final Presentation – 30%
Final Paper – 20%

Objectives for course participants are to:

1. Understand historical, legal, and cultural contexts of ethical decision-making relevant to conducting research with human subjects.

2. Identify and understand important ethical concepts in conducting research and be capable of appropriately applying the concepts to their research.

3. Learn strategies for addressing and minimizing ethical conflicts in conducting research.

4. Understand the importance and function of the Institutional Review Board (IRB) process and gain experience in carrying out IRB reviews.

5. Understand historical, legal, and cultural contexts of ethical decision-making relevant to conducting research in animals.

6. Understand ethical issues that arise in drug development and clinical testing of pharmaceuticals, biotechnology products and medical devices.

7. Identify and understand important issues involving conflicts of interest and develop strategies to resolve identified conflicts.

8. Examine issues of scientific integrity and processes used to resolve reported cases of misconduct.