390.673.01 ETHICAL AND REGULATORY ISSUES IN CLINICAL RESEARCH
- Clinical Investigation
- 1st term
- 3 credits
- Academic Year:
- 2012 - 2013
- East Baltimore
- Class Times:
- Monday, 5:30 - 8:30pm
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:
- 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
- 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.