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Emerging Ethical and Regulatory Issues in Clinical Research

1st Term
Clinical Investigation
Academic Year
2024 - 2025
Instruction Method
Synchronous Online
Class Time(s)
Monday, 5:30 - 8:30pm
Auditors Allowed
Available to Undergraduate
Grading Restriction
Letter Grade or Pass/Fail
Course Instructor(s)
Contact Name
Frequency Schedule
Every Year
Explores and examines the ethical issues central to clinical research, reviews current and emerging regulations for clinical investigation and human subjects protections, and promotes understanding of the function and procedures of Institutional Review Boards.
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 whether research proposals adhere to these principles
  2. Characterize the fundamentals of informed consent from the ethical, legal, and regulatory perspectives
  3. Identify the requirements and procedures for IRB approval of human subject research, including HIPAA regulations
  4. Critique emerging ethical and regulatory issues in clinical research using big health data, artificial intelligence, software as medical devices
  5. Evaluate the impact of law and policy on clinical research
Methods of Assessment
This course is evaluated as follows:
  • 15% Participation
  • 30% Midterm
  • 15% Written Assignment(s)
  • 40% Final Exam
Special Comments

The dates for 2024-25 are: 8/26, 9/3 (TUES), 9/9, 9/16, 9/23, 9/30, 10/7, 10/14