390.673.01 Ethical and Regulatory Issues in Clinical Research
- Clinical Investigation
- 1st term
- 3 credits
- Academic Year:
- 2019 - 2020
- 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 trials, including the use of standard operating procedures
- Identify the requirements and procedures for IRB approval of human subject research, including recent HIPAA 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
- 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.