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Course Catalog

390.673.01 ETHICAL AND REGULATORY ISSUES IN CLINICAL RESEARCH

Department: Clinical Investigation
Term: 1st term
Credits: (3 credits)
Contact: Cristina DeNardo
Academic Year: 2013 - 2014
Course Instructor:
  • Franklin Adkinson
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.
Student Evaluation: Student evaluation based on written homework assignments and a final paper
Learning Objective:

Upon successfully completing this course, students will be able to: • Observe the ethical underpinnings of human subjects research. • Identify good clinical practices for clinical trails, including the use of standard operating procedures. • Identify the requirements and procedures for IRB approval of human subject research, including recent HPPA regulations. • Integrate modern ethical standards and regulatory requirements into design of a clinical investigation.
Location: Baltimore
Class Times:
  • Monday 5:30 - 8:30
Enrollment Minimum: 10
Enrollment Maximum: 30
Enrollment Restriction: Restricted to individuals in the SOCI certificate program or GTPCI students.
Instructor Consent: Consent required for all students
For consent, contact: gtpci@jhsph.edu
Auditors Allowed: No
Grading Restriction: Letter Grade or Pass/Fail
Special Comments: Second in a five-course series in the science of clinical investigation.