390.673.81
Emerging Ethical and Regulatory Issues in Clinical Research

Location
Internet
Term
2nd Term
Department
Clinical Investigation
Credit(s)
3
Academic Year
2024 - 2025
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)
Megan Singleton
Course Instructor(s)
Melania Bembea
Contact Name
Cristina DeNardo
Frequency Schedule
Every Year
Prerequisite
Description
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% Assignments
  • 40% Final Paper
Instructor Consent
No consent required