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

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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

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Biomedical -  FDA Regulated Research, IND/IDE Issues

 

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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

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Behavioral - Privacy and Confidentiality

 

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Joan Sieber, Ph.D. 

 

 

Professor of Psychology, California State University, Member of AAHRPP’s Council on Accreditation

 

 

 

 

 

SESSION 2B:

FACULTY ROOM

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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

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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

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Alan Berkman, M.D.

 

 

Assistant Professor of Clinical Epidemiology, Columbia University Medical Center

 

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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

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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

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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

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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

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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

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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