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390.673.01
Ethical and Regulatory Issues in Clinical Research

Location
East Baltimore
Term
1st Term
Department
Clinical Investigation
Credit(s)
3
Academic Year
2019 - 2020
Instruction Method
TBD
Class Time(s)
Monday, 5:30 - 8:30pm
Auditors Allowed
No
Available to Undergraduate
No
Grading Restriction
Letter Grade or Pass/Fail
Contact Name
Frequency Schedule
Every Year
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. Observe the ethical underpinnings of human subjects research
  2. Identify good clinical practices for clinical trials, including the use of standard operating procedures
  3. Identify the requirements and procedures for IRB approval of human subject research, including recent HIPAA regulations
  4. Integrate modern ethical standards and regulatory requirements into design of a clinical investigation
Special Comments

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