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Ethical and Regulatory Issues in Clinical Research

East Baltimore
1st term
Clinical Investigation
3 credits
Academic Year:
2019 - 2020
Class Times:
  • Monday,  5:30 - 8:30pm
Auditors Allowed:
Grading Restriction:
Letter Grade or Pass/Fail
Course Instructor s:
  • Franklin Adkinson
  • Norman Fost
  • Jennifer L. Dodson
Cristina DeNardo

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
Methods of Assessment:

Student evaluation based on written homework assignments and a final paper

Instructor Consent:

Consent required for some students

Consent Note:

This course is geared toward GTPCI and SOCI students, however it is open to scientists, clinicians, and other degree students.

For consent, contact:

Special Comments:

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