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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
Academic Year:
2013 - 2014
Location:
East Baltimore
Class Times:
  • Monday,  5:30 - 8:30pm

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Auditors Allowed:
No
Grading Restriction:
Letter Grade or Pass/Fail
Contact:
Cristina DeNardo
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.

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:

gtpci@jhsph.edu

Special Comments:

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