390.673.81
Ethical and Regulatory Issues in Clinical Research

Location
Internet
Term
2nd Term
Department
Clinical Investigation
Credit(s)
3
Academic Year
2022 - 2023
Instruction Method
Asynchronous Online with Some Synchronous Online
Auditors Allowed
No
Available to Undergraduate
No
Grading Restriction
Letter Grade or Pass/Fail
Course Instructor(s)
Norman Fost
Melania Bembea
Contact Name
Melania Bembea
Frequency Schedule
Every Year
Prerequisite
Description
Explores and examines the ethical issues central to clinical research, reviews current regulations for clinical investigation, promotes understanding of the function and procedures of Institutional Review Boards, and better appreciation of the role of good clinical practices for clinical trials.
Learning Objectives
Upon successfully completing this course, students will be able to:
  1. Reflect on the fundamental ethical principles that govern biomedical research and judge the adequacy of research proposals within the context of these principles
  2. Identify good clinical practices for clinical trials, including the use of standard operating procedures
  3. Characterize the fundamentals of informed consent from the ethical, legal, and regulatory perspectives
  4. Identify the requirements and procedures for IRB approval of human subject research, including recent HIPAA regulations
Methods of Assessment
This course is evaluated as follows:
  • 50% Assignments
  • 25% Final Paper
  • 25% Participation
Instructor Consent
No consent required
Special Comments

Part of the four-course series in the Science of Clinical Investigation award program.