Columbia University Human Research Protection Program
Annual Educational Conference
2011 Institutional Review Board Annual Educational Conference
March 31 - April 1, 2011
March 31, 2011
7:30 to 8:15am Registration (Faculty House Reception)
7:30 am Continental Breakfast (Ivy Lounge)
8:15 to 8:30am Welcome and Institutional Remarks (Presidential Ballroom)
George Gasparis, Executive Director, HRPP, Columbia University
G. Michael Purdy, Ph.D., Executive Vice President for Research, Columbia University
8:30 to 9:15am Keynote Address (Presidential Ballroom)
Regulatory Challenges:
Lessons Learned from the OTC Gene Transfer Trial
James Wilson, M.D., Ph.D.
Professor and Director of the Gene Therapy Program in the
Department of Pathology and Laboratory Medicine; Professor in the
Department of Internal Medicine at the University of Pennsylvania
Powerpoint Presentation
9:15 to 10:00am Plenary session #1 (Presidential Ballroom)
Hot Topics in Genomics Research
Ellen Wright Clayton, M.D., J.D.
Craig-Weaver Professor of Pediatrics; Director, Center for Biomedical Ethics and Society Professor of Pediatrics Professor of Law,
Vanderbilt University
Powerpoint Presentation
10:00 to 10:45am Panel session #1 (Presidential Ballroom)
Anticipated Regulatory & Ethical Challenges Over the Next Decade: Open Discussion
Moderator:
Elaine Larson, R.N., Ph.D., FAAN, CIC
Associate Dean for Research, Columbia University School of Nursing
Panelists:
Ellen Wright Clayton, M.D., J.D.
Craig-Weaver Professor of Pediatrics; Director, Center for Biomedical Ethics and Society Professor of Pediatrics Professor of Law,
Vanderbilt University
James Wilson, M.D., Ph.D.
Professor and Director of the Gene Therapy Program in the
Department of Pathology and Laboratory Medicine; Professor in the
Department of Internal Medicine at the University of Pennsylvania
10:45 to 11:00AM Break (Presidential Ballroom and Seminar Room)
11:00 to 12:30pm Panel session #2 (Presidential Ballroom)
HIV Research in International Settings
Moderator:
George Gasparis
Executive Director, HRPP, Columbia University
Panelists:
Solomon Benatar, M.D.
Emeritus Professor of Medicine & Chairman of the Department
of Internal Medicine, University of Capetown
Powerpoint Presentation
Wafaa El-Sadr, M.D., M.P.H.
Professor of Clinical Medicine and Epidemiology, Director of the International Center for AIDS Care and Treatment Programs (ICAP),
Director of the Center for Infectious Disease Epidemiologic Research (CIDER), Columbia University
Powerpoint Presentation
Panel session #3 (Seminar Room)
Internet Research Ethics
Elizabeth Buchanan, Ph.D.
Endowed Chair, Director, Center for Applied Ethics,
University of Wisconsin-Stout
Maritza Johnson
Doctoral Candidate, Department of Computer Science,
Columbia University
Powerpoint Presentation
12:30 to 1:45pm Lunch (Presidential Ballroom)
1:45 – 3:00pm Panel session #4 (Presidential Ballroom)
Incidental Findings in Research
Moderator:
Ellen Wright Clayton, M.D., J.D.
Rosalind E. Franklin Professor of Genetics and Health Policy,
Director, Center for Biomedical Ethics and Society, Vanderbilt University
Panelists:
Robert Delapaz, M.D., Professor, Department of Radiology,
Columbia University
Powerpoint Presentation
Kevin Ochsner, Ph.D., Associate Professor of Psychology,
Columbia University
Powerpoint Presentation
Panel Session #5 (Seminar Room)
IRB Review of Embryonic Stem Cells in Therapeutic Research Studies - Nearer Than You Think
Patrick Taylor, J.D.
Fellow, Petrie-Flom Center, Harvard Law School Staff Scientist &
Director, Ethics Analysis and Applications, Children's Hospital Informatics
Program Asst Clinical Professor, Department of Pediatrics,
Harvard Medical School
Powerpoint Presentation
3:00 to 3:15pm Break (COFFEE AND REFRESHMENTS PROVIDED AT PRESIDENTIAL BALLROOM AND IVY LOUNGE)
3:15 – 4:30pm Panel Session #6 (Presidential Ballroom)
Waiver of Consent in Emergency Research
Susan Fish, Pharm.D., M.P.H.
Professor of Biostatistics and Epidemiology, Director of the MA in Clinical Investigation, Boston University School of Public Health &
Boston University School of Medicine
Marilyn Morris, M.D., M.P.H.
Assistant Professor of Clinical Pediatrics, Medical Director,
Clinical Trials Office, Columbia University
Powerpoint Presentation
Panel session #7 (Seminar Room)
Challenges of Student Research
Dean Gallant, A.B.
Assistant Dean for Research Policy, Harvard University
Powerpoint Presentation
"CUHS Guidelines for Small R Research"
Hazel May, Ph.D.
Senior Associate Dean of Academic Affairs, Columbia College
4:30 – 5:30pm Wine and Cheese Reception (Seminar Room)
April 1, 2011
7:30 to 8:15am Registration (Faculty House Reception)
7:30 am Continental breakfast (Ivy Lounge)
8:15 to 8:30am Welcome and Institutional Remarks (Presidential Ballroom)
George Gasparis, Executive Director, HRPP, Columbia University
8:30 to 9:30am Keynote Address (Presidential Ballroom)
Alex Capron, LLB
Professor of Law and Medicine, Co-Director of the Pacific Center for
Health Policy an Ethics, University of Southern California
Powerpoint Presentation
9:30 to 10:45am Plenary session #3 (Presidential Ballroom)
Quality Improvement/Program Evaluation vs Research
Moderator:
Alex Capron, LLB
Professor of Law and Medicine, Co-Director of the Pacific Center for
Health Policy an Ethics, University of Southern California
Panelists:
Mary Ann Baily, Ph.D.
Fellow and former staff member, The Hastings Center
Powerpoint Presentation
Ivor Pritchard, Ph.D.
Senior Advisor to the Director
Office for Human Research Protections (OHRP)
Powerpoint Presentation
10:45 to 11:00AM Break (Presidential Ballroom and Seminar Room)
11:00 to 12:30pm Plenary session #2 (Presidential Ballroom)
Deception in Research: An Interesting Case Study
Moderator:
Ivor Pritchard, Ph.D.
Senior Advisor to the Director,
Office for Human Research Protections (OHRP)
Panelists:
Modupe Akinola, Ph.D.
Assistant Professor, Columbia University
George Gasparis
Executive Director, HRPP, Columbia University
Yvonne Higgins, CIP
Executive Director, Human Research Protections,
University of Pennsylvania
Katherine L. Milkman, Ph.D.
Assistant Professor at the Wharton School,
University of Pennsylvania
12:30 to 1:15pm Box Lunch (Presidential Ballroom)
1:15 to 2:30pm Panel session #8
Urban Research (Seminar Room)
Ellen Marakowitz, Ph.D.
Lecturer, Department of Anthropology, Columbia University
Miguel Muñoz-Laboy, Dr.P.H.
Assistant Professor, Columbia University
Panel session #9 (Presidential Ballroom)
Surrogate Consent – Assessing Capacity
Paul Appelbaum, M.D.
Elizabeth K. Dollard Professor of Psychiatry, Medicine and Law;
Director, Division of Law, Ethics & Psychiatry Department of Psychiatry,
Columbia University College of Physicians and Surgeons
Federal regulations permit consent by a "legally authorized representative" (LAR) when a potential research subject is incompetent. This session will review the rules on LARs, their implementation at the state level, and the practical issues that arise. In particular, it will focus on research assessing how to determine whether a person retains the capacity to appoint an LAR, even if the person no longer has capacity to make a decision about entering the research study.
Powerpoint Presentation
Panel session #10 (Garden Room 1)
Contract Issues: Research Related Injuries
Jean Gabeau, Esq.
Manager of Contracts, Clinical Trials Office, Columbia University
Powerpoint Presentation
Patrick Taylor, J.D.
Fellow, Petrie-Flom Center, Harvard Law School Staff Scientist;
Director, Ethics Analysis and Applications, Children's Hospital Informatics
Program; Assistant Clinical Professor, Department of Pediatrics,
Harvard Medical School
Powerpoint Presentation
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