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Course Catalog

390.673.01 Ethical and Regulatory Issues in Clinical Research

Clinical Investigation
1st term
3 credits
Academic Year:
2013 - 2014
East Baltimore
Class Times:
  • Monday,  5:30 - 8:30pm
Auditors Allowed:
Grading Restriction:
Letter Grade or Pass/Fail
Cristina DeNardo
Course Instructor:
  • Franklin Adkinson

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 trails, including the use of standard operating procedures
  3. Identify the requirements and procedures for IRB approval of human subject research, including recent HPPA 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

Enrollment Restriction:

Restricted to individuals in the SOCI certificate program or GTPCI students.

Instructor Consent:

Consent required for all students

For consent, contact:

Special Comments:

Second in a five-course series in the science of clinical investigation.