Columbia University in the City of New York
Institutional Review Board Educational Conference
Thursday, April 14, 2005
Current IRB Challenges: Practical Knowledge and Solutions
8:00 - 8:30 a.m.	REGISTRATION & CONTINENTAL BREAKFAST	ROTUNDA
8:30 - 9:45 a.m.	PLENARY SESSIONS 1
	SESSION 1A:	LERNER, ROOM 555
click to view powerpoint	Behavioral - Issues of Concern to Behavioral / Social Science IRBs:  Oral History and Review of Field Research
	Helen McGough, M.A., CIP
	Director of Human Subjects Division, University of Washington
	Mary Marshall Clark, M.A.
	Director, Columbia University Oral History Research Office
	SESSION 1B:	FACULTY ROOM
click to view powerpoint	Biomedical -  FDA Regulated Research, IND/IDE Issues
click to view powerpoint	and Data Monitoring Plans
	David Roeder, M.S.
	Associate Director for Regulatory Affairs, Office of Drug Evaluation IV, CDER, FDA
	Stephen Schmitz, M.D., M.P.H.
	Director, Medical & Regulatory Affairs, Averion Inc
10:00 -11:00 a.m.	PLENARY SESSIONS 2
	SESSION 2A:	LERNER, ROOM 555
click to view powerpoint	Behavioral - Privacy and Confidentiality
click to view powerpoint	Joan Sieber, Ph.D.
	Professor of Psychology, California State University, Member of AAHRPP’s Council on Accreditation
	SESSION 2B:	FACULTY ROOM
click to view powerpoint	Biomedical - Genetic Research
	Harold Frucht, M.D.
	Associate Professor of Clinical Medicine, Columbia University Medical Center
11:15 -11:30 a.m.	WELCOME	FACULTY ROOM
	George Gasparis, CIP
	Executive Director, Columbia University Human Subjects Protection Program
11:30 a.m. -12:30 p.m.	RESEARCH WITH MINORS: SUBPART D DETERMINATIONS	FACULTY ROOM
click to view powerpoint	Susan Kornetsky, M.P.H., CIP
	Director of Clinical Research Compliance, Children’s Hospital Boston
12:30 -1:45 p.m.	LUNCH	ROTUNDA
	Institutional Remarks
	David Hirsh, Ph.D.
	Executive Vice President for Research, Columbia University
	Harvey Colten, M.D.
	Vice President and Senior Associate Dean for Academic Affairs in the Faculties of Health Sciences and Medicine, Columbia University Medical Center
2:00 - 3:00 p.m.	INTERNATIONAL RESEARCH	FACULTY ROOM
click to view powerpoint	Alan Berkman, M.D.
	Assistant Professor of Clinical Epidemiology, Columbia University Medical Center
click to view powerpoint	Helen McGough, M.A., CIP
	Director of Human Subjects Division, University of Washington
3:15 - 4:00 p.m.	BREAKOUT SESSIONS 1
	SESSION 1A:	TRUSTEES ROOM
	Stem Cell Research
	David Hirsh, Ph.D.
	Executive Vice President for Research, Columbia University
	Ruth Fischbach, Ph.D., M.P.E.
	Director, Center for BioEthics, CUMC
	SESSION 1B:	BURDEN ROOM
	Waiver of Informed Consent
	Susan Kornetsky, M.P.H., CIP
	Director of Clinical Research Compliance, Children's Hospital Boston
	SESSION 1C:	LERNER, ROOM 477
click to view powerpoint	Not Human Subjects Research, Exempt and Expedited Review
	Brenda Ruotolo, CIP, CIM
	Associate Director, Columbia University IRB
	SESSION 1D:	LERNER, ROOM 569
	Students & Employees as Subjects
	Jeffrey Cohen, Ph.D., CIP
	President, HRP Associates, Inc.
	Alison Dewhurst, CIP
	Manager, Columbia University Morningside IRB
4:15 - 5:00 p.m.	BREAKOUT SESSIONS 2
	SESSION 2A:	BURDEN ROOM
click to view powerpoint	Gene Transfer Research
	Howard Kaufman, M.D.
	Associate Professor of Clinical Surgery, Director of Clinical Research,
	Herbert Irving Comprehensive Cancer Center, CUMC
	SESSION 2B:	LERNER, ROOM 477
click to view powerpoint	Data Protection and Security
	Jeffrey Cohen, Ph.D., CIP
	President, HRP Associates, Inc.
	Soumitra Sengupta, Ph.D.
	Asst. Professor, Department of Medical Informatics, Columbia University
	SESSION 2C:	LERNER, ROOM 569
click to view powerpoint	Contract Language
	Darnell Benjamin, J.D.
	Manager of Contracts, Clinical Trials Office, CUMC/NYPH
	Heather Butts, M.P.H., J.D.
	Regulatory Specialist, Columbia University IRB
	SESSION 2D:	TRUSTEES ROOM
click to view powerpoint	Review of Adverse Event Reports
	George Gasparis, CIP
	Executive Director, Columbia University Human Subjects Protection Program
5:00 p.m.	WINE AND CHEESE	FACULTY ROOM