1. IRB – Investigator/Research Coordinators Monthly Meeting Gerald D. Fischbach, M.D. Executive Vice President for Health and Biomedical Sciences and Dean of the Faculty of Medicine Henry Ginsberg, M.D. Director, Irving Center for Clinical Research December 9, 2003

2. Objectives 1)Provide Educational Training to Ensure that all Human Research at Columbia is Conducted in Accordance with Regulatory Requirements and in an Ethical Manner. 2)Provide Educational Training to Improve the Quality of Submissions to the IRB. 3)Create a Network for Investigators and Research Coordinators to Address and Solve Challenges.

3. When Does Human Subjects Research Need IRB Review? Not Human Subjects No IRB Review Research Needed HHS Regulations Human Subjects Research that is not exempt Needs IRB Review Exempt Research Needs Determination of Status by Someone Other Than The Investigator

4. Definition of Human Subject -A Living Individual about who an investigator (whether professional or student) conducting research obtains: -A Living Individual about who an investigator (whether professional or student) conducting research obtains: 1. Data through intervention or interaction with the individual, or 2. Identifiable private information

5. Definition of Research -A systematic investigation, -A systematic investigation, including research development, testing and evaluation, designed to contribute to generalizable knowledge

6. When does Human Subjects Research Need IRB Review? When does Human Subjects Research Need IRB Review? Not Human Subjects Research (No IRB Review) Oral History Evaluation Oral History Evaluation Polling QA Gray Area Human Research IRB Review Ethnography Pedagogical Res. Ethnography Pedagogical Res.

7. IRB – Investigator/Research Coordinators Monthly Meeting Gerald D. Fischbach, M.D. Executive Vice President for Health and Biomedical Sciences and Dean of the Faculty of Medicine Henry Ginsberg, M.D. Director, Irving Center for Clinical Research December 9, 2003