CRES 740 Ethics and Professional Issues in Clinical Research

The course first provides students with a foundation on the ethical and policy implications of performing different types of clinical research. Topics covered will include foundations of the institutional review board, principles of participant protection, confidentiality and data security, conflict of interest and misconduct in data collection/analysis, sensitive populations, use of human tissue, animals, and biohazardous materials in clinical research, By the end of this course, students will have completed an IRB application and submitted for approval.

Credits

3

Student Learning Outcomes

1. 1. Discuss the history and foundations for institutional review boards (IRB) and protections for human subject research
2. 10. Analyze examples of ethical issues that can be encountered in human subject research and explain why they are ethical issues.
3. 2. Define the function, purposes, and challenges of an IRB.
4. 3. Understand when IRB applications are warranted and know what types of institutions will have IRB applications for approval.
5. 4. Verbalize the difference between exempt, expedited and full reviews.
6. 5. Write a rigorous informed consent form.
7. 6. Formulate an IRB application for a single and multi-site study.
8. 7. Identify the different government agencies that regulate and oversee human subject data and institutional review boards.
9. 8. Understand the process to be followed when research protocols change or when ethical breeches in data collection or analysis occur.
10. 9. Discuss sensitive populations and how to approach research with these populations.