Columbia University Human Research Protection Program

Annual Educational Conference

2012 Institutional Review Board Annual Educational Conference

May 7 - May 8, 2012

       Printable Version of Conference Agenda

Day 1: Monday, May 7, 2012

7:30AM to 8:15AM                Registration  (Roone Arldge Auditorium Reception)

7:30AM to 8:30AM                Continental Breakfast (Broadway Lobby)

8:15AM 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                                                  

8:30AM to 9:15AM                     Keynote Address (Roone Arldge Auditorium)

                                          How Relevant is the Belmont Report Now and in the Future?

                                          Tom Beauchamp, Ph.D., Professor of Philosophy and Senior Research Scholar, Kennedy Institute of 

                                          Ethics, Georgetown University

                                                   Powerpoint Presentation

9:15AM to 10:00AM             Plenary session #1 (Roone Arldge Auditorium)

Central IRBs: More Efficient for Whom?

Pearl O’Rourke, M.D., Director of Human Research Affairs at Partners HealthCare Systems, Associate Professor of Pediatrics, Harvard Medical School

 

Central IRBs are increasingly being proposed as a way to increase efficiency of IRB review for multi-site research by limiting duplication of review.  The discussion is complicated by the fact that there are several models of central IRBs in academia and that there has been little experience with anything other than the existing commercial IRB model. 

This talk will include 1) a description of existing models of central IRBs and 2) a discussion of the practical challenges of creating a central IRB in an academic setting. 

 

Powerpoint Presentation 

10:00AM to 10:45AM            Plenary session #2 (Roone Arldge Auditorium)

The ANPRM – The AAHRPP View

 

Marjorie Speers, Ph.D., President and CEO, Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP)

Powerpoint Presentation

10:45AM to 11:00AM                Break (Broadway Lobby)

11:00AM to 11:45AM            Plenary session #3 (Roone Arldge Auditorium)      

The ANPRM- A Contrarian Perspective

Greg Koski, M.D., Ph.D., Director of Clinical Research, Division of Cardiovascular Anesthesia, Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Senior Scientist, James Mongan Institute for Health Policy, Massachusetts General Hospital and Partners HealthCare System

 

Powerpoint Presentation

11:45AM to 12:30PM            Plenary session #4 (Roone Arldge Auditorium)

Question & Answer Session:
 

Moderator:

Ivor Pritchard, Ph.D., Senior Advisor to the Director,

Office for Human Research Protections (OHRP)

             

Panelists:

Tom Beauchamp, Ph.D., Professor of Philosophy and Senior Research Scholar, Kennedy Institute of Ethics, Georgetown University

 

Greg Koski, M.D., Ph.D., Director of Clinical Research, Division of Cardiovascular Anesthesia, Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Senior Scientist, James Mongan Institute for Health Policy, Massachusetts General Hospital and Partners HealthCare System

 

Pearl O’Rourke, M.D., Director of Human Research Affairs at Partners HealthCare Systems, Associate Professor of Pediatrics, Harvard Medical School

 

Marjorie Speers, Ph.D., President and CEO, The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP)

12:30PM to 1:30PM                   Lunch  (Roone Arldge Auditorium)

1:30PM– 2:15PM                  Plenary Session #5 (Roone Arldge Auditorium)                                         

Protection, Over-Protection, and Psuedo-Protection

Alan Wertheimer, Ph.D., Senior Research Scholar, Department of Bioethics, National Institutes of Health

                                                   Powerpoint Presentation 

2:15PM to 3:15PM           Breakout Session A1(Room TBD)                                      

Challenging Issues Regarding Informed Consent:

Communicating Risk

Pearl O’Rourke, M.D., Director of Human Research Affairs at Partners HealthCare Systems, Associate Professor of Pediatrics, Harvard Medical School

 

Powerpoint Presentation

Misconceptions about Coercion and Undue Influence:

Reflections on a Survey of IRB Members

 Alan Wertheimer, Ph.D., Senior Research Scholar, Department of Bioethics, National Institute of Health

 

 

Powerpoint Presentation 

 

Publication/Relevant Reading

 

 

Breakout session #A2 (Room TBD)

Conflicts of Interest

Naomi Schrag, J.D., Associate Vice President, Research Compliance, Columbia University

Powerpoint Presentation

             

Breakout session #A3 (Room TBD)

Globalization of Research: Enhancing Excellence and Safety

Greg Koski, M.D., Ph.D., Director of Clinical Research, Division of Cardiovascular Anesthesia, Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Senior Scientist, James Mongan Institute for Health Policy, Massachusetts General Hospital and Partners HealthCare System

 

Powerpoint Presentation

Breakout session #A4 (Room TBD)

Research Coordinator Workshop with Association of Clinical Research Professionals (ACRP) – Part I:

Clinical Trial Document Management: Lessons Learned & Tips and Tricks for Compliance

 

Powerpoint Presentation

Moderator

Esther Daemen, BSN, CPP, CPM, PG, Director of Professional Development, Association for Clinical Research Professionals (ACRP)

 

Presenters:

Janet Ellen Holwell, CCRC, CCRA, Clinical Quality Lead (CQL), US Clinical Operations, Pfizer, President, New York Metropolitan Chapter of ACRP

Powerpoint Presentation

 

Sherif Ibrahim, M.D., Principal Clinical Research Specialist, Medtronic, Inc.

Powerpoint Presentation

3:15PM to 3:30PM                    Break (COFFEE AND REFRESHMENTS PROVIDED IN BROADWAY LOBBY)

3:30PM – 4:30PM                 Breakout session #B1 (Room TBD)

                                          Contract Issues

Jean Gabeau, J.D., Manager of Contracts, Clinical Trials Office, Columbia University

Powerpoint Presentation

                                          Breakout session #B2 (Room TBD)

                                          Community-Based Participatory Research

           Rafael Lantigua, M.D., Associate Director of the Division of General

           Medicine, Director for Medical Research at Columbia 's Stroud

Center for Geriatric Research, and Medical Director of the Associates of Internal Medicine (AIM) Practice, NewYork-Presbyterian Hospital

Joyce Moon Howard, Dr.P.H., Assistant Professor of 

Clinical Sociomedical Sciences, Mailman School of Public Health

 

Powerpoint Presentation

Breakout session #B3 (Room TBD)

User Studies on the Internet

Steven Bellovin, Ph.D., Professor of Computer Science, Columbia University

Powerpoint Presentation

 

Youth and New Media:  New and Old Challenges for Human Subjects Protection

John Santelli, M.D., M.P.H., Professor of Clinical Population and Family  Health, Mailman School of Public Health; Professor of Clinical Pediatrics, Columbia University College of Physicians and Surgeons

 

Powerpoint Presentation

Breakout session #B4 (Room TBD)

Research Coordinator Workshop with Association of Clinical Research Professionals (ACRP) – Part II

Moderator

Esther Daemen, BSN, CPP, CPM, PG, Director of Professional Development, Association for Clinical Research Professionals (ACRP)

 

Presenters:

Janet Ellen Holwell, CCRC, CCRA, Clinical Quality Lead (CQL), US Clinical Operations, Pfizer, President, New York Metropolitan Chapter of ACRP

 

Sherif Ibrahim, M.D., Principal Clinical Research Specialist, Medtronic, Inc.

 

4:30PM – 5:30PM                Wine and Cheese Reception  (Room TBD)

Day 2: Tuesday, May 8, 2012

 

 

7:30AM to 8:15AM                Registration  (Roone Arldge Auditorium Reception)

7:30AM to 8:30AM                Continental Breakfast (Broadway Lobby)

8:15AM to 8:30AM                     Welcome and Institutional Remarks  (Roone Arldge Auditorium)

                                           George Gasparis, Executive Director, HRPP, Columbia University

                                           Steven Shea, M.D., Senior Vice Dean, Columbia University Medical Center

8:30AM to 9:15AM                     Keynote Address (Roone Arldge Auditorium)

Microbe Hunting

Ian Lipkin, M.D., Director, Center for Infection & Immunity,  John Snow 

Professor of Epidemiology, Mailman School of Public Health, Professor

of Neurology andPathology, Columbia University

                   

 

Powerpoint Presentation

 

 

9:15AM to 10:00AM              Plenary session #6  (Roone Arldge Auditorium)

                                          Public Health Research and Public Health Practice: A CDC Perspective

Ron Otten, Ph.D., Director of the Office of Scientific Integrity (OSI), Centers for Disease Control and Prevention (CDC)

Powerpoint Presentation

 

10:00AM to 10:45AM            Plenary session #7  (Roone Arldge Auditorium)

 

Disaster/Rapid Review Research

David Abramson, Ph.D., M.P.H., Deputy Director, National Center for Disaster Preparedness, Assistant Professor of Clinical Sociomedical Sciences, Mailman School of Public Health

 

Powerpoint Presentation

 

10:45AM to 11:00AM                Break (COFFEE AND REFRESHMENTS PROVIDED IN BROADWAY LOBBY)

11:00AM to 12:15PM            Plenary Session #8 (Roone Arldge Auditorium)

Exploring the Boundaries Between Practice and Research in

Public Health

 

Moderator:

Hugh Tilson, M.D., M.P.H., Dr.P.H., Adjunct Professor and Senior Advisor, University of

North Carolina at Chapel Hill, School of Public Health

Powerpoint Presentation

 

Presenters:

Ron Otten, Ph.D., Director of the Office of Scientific Integrity (OSI), Centers for Disease

Control and Prevention (CDC)

 

Ivor Pritchard, Ph.D., Senior Advisor to the Director,

Office for Human Research Protections (OHRP)

Marjorie Speers, Ph.D., President and CEO, Association for the Accreditation of

Human Research Protection Programs, Inc. (AAHRPP)        

12:15PM to 1:15PM                  Lunch(Roone Arldge Auditorium)

1:15PM to 2:00PM               Plenary Session #9 (Roone Arldge Auditorium)

                         Social Media – Facebook Privacy

             Latanya Sweeney, Ph.D., Visiting Professor and Scholar,

                                          Director of the Data Privacy Lab, Harvard University

Powerpoint Presentation

2:00PM to 2:15PM                   Commuting Time               

2:15PM to 3:15PM               Breakout session #C1 (Room TBD)

                                        Database Security: Considerations for Research

          Moderator:

                                        Latanya Sweeney, Ph.D., Visiting Professor and Scholar,

                                        Director of the Data Privacy Lab, Harvard University

          Presenters:

                                        Erik Decker, M.S., CCISSP, Assistant Director, Information Security,

                                        Columbia University Medical Center

                                       Karen Pagliaro-Meyer, Privacy Officer, Columbia University

Powerpoint Presentation

                                        Breakout session #C2 (Room TBD)

       

        NYC DOE IRB FAQs

        Mary Mattis, Ph.D., Chair, Institutional Review Board, Research & Policy   

        Support Group, New York City Department of Education  

       

Powerpoint Presentation

        Breakout  session #C3 (Room TBD)

       

        Responsibilities of the Sponsor Investigator

        Helen Kim, Pharm.D., Director of Regulatory Affairs & Clinical Development,

        Clinical Trials, Office, Columbia University

Powerpoint Presentation

                                       Breakout session #C4 (Room TBD)

                                       IRB Review and Responsibilities for Atypical Submission Types

                                       George Gasparis, Executive Director, Human Research Protection Program,

                                       Columbia University

3:15PM to 3:30PM                 Break  (COFFEE AND REFRESHMENTS PROVIDED in THE BROADWAY LOBBY)

3:30PM to 5:00PM             Plenary session #10 (Roone Arledge Auditorium)

NYC IRB CONSORTIUM PANEL

 

Panelists:

        Elan Czeisler, IRB Director, NYU Langone Medical Center

        Alison Dewhurst, Human Research Compliance Director, NYU

        George Gasparis, Executive Director, Columbia University HRPP

        Raffaella Hart, IRB Director, BRANY

        Rosemary Kraemer, Ph.D., Director, Human Subjects Protections,

        Weill-Cornell Medical College

        David Strauss, M.D., Deputy Director for Research, New York State Psychiatric    

         Institute

        David Wallach, IRB Director, Albert Einstein College of Medicine

        Ilene Wilets, Ph.D., Assistant Director, IRB Chair, Mount Sinai School of Medicine

         Program for the Protection of Human Subjects