A quarterly informational session for our human subjects research community. This session provides: •A history of human subjects protection and the ethical principles that guide human subjects research; •An overview of the federal regulations for the protection of human subjects in research; •Criteria for IRB review; •Tips for submitting complete and understandable new protocols, modifications, renewals, and adverse event reports; •An overview of the RASCAL system and process; •Special considerations for vulnerable populations; and •The IRB Review process, continuing review and oversight monitoring at CU. Who should attend? •New research personnel •Research Personnel new to Columbia •Researcher personnel who have not yet attended Part I of the IRB 101 series in the past •All those who wish to gain a historical perspective and learn the ethical and regulatory guidelines for Human Subjects Research
