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  Pre-Conference

  Day One

  Day Two

 

Agenda: Day 1
Monday, March 25, 2002


8:00 a.m.

Welcome and Introduction

Robert M. "Skip" Nelson, M.D., Ph.D.
Associate Professor of Anesthesia and Pediatrics
Chair, Committee for the Protection of Human Subjects
The Children's Hospital of Philadelphia
Philadelphia, PA

Michele Russell-Einhorn, Esq.
Director, Clinical Research Consulting Team
PricewaterhouseCoopers LLP
Former Director of Regulatory Affairs Office for Human Research Protection
Department of Health Human Services
Bethesda, MD
(Conference Co-chairs)


8:05 a.m.

FDA Data Monitoring Guidance

Susan B. Ellenberg, Ph.D.
Director
Office of Biostatistics and Epidemiology
Center for Biologics Evaluation and Research
Food and Drug Administration
Rockville, MD
Presentation Material (Acrobat)
Presentation Material (Powerpoint)


8:30 a.m.

Medical Research and the Human Genome Project

Alan E. Guttmacher, MD
Senior Clinical Advisor
National Human Genome Research Institute
National Institutes of Health
Bethesda, MD
Presentation Material (Acrobat)
Presentation Material (Powerpoint)


9:15 a.m.

Health Care Fraud Investigations Update

Richard Kusserow
President
Strategic Management Systems
Former Inspector General
Department of Health and Human Services
Alexandria, VA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)


9:45 a.m.

Health Care Enforcement Update

David Hoffman, Esq.
Assistant U.S. Attorney
Civil Division
Eastern District of Pennsylvania
Philadelphia, PA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)


10:15 a.m.

Office for Human Research Protections Initiatives

Greg Koski, MD
Director
Office for Human Research Protections
Department of Health and Human Services
Rockville, MD


10:45 a.m.

BREAK


11:00 a.m.

CONCURRENT SESSIONS I




1.01 A Primer on the Regulation of Human Subject Research

Michele Russell-Einhorn, Esq.
Director
Clinical Research Consulting Team
PricewaterhouseCoopers LLP
Former Director of Regulatory Affairs Office for Human Research Protection
Department of Health Human Services
Bethesda, MD
Presentation Material (Acrobat)
Presentation Material (Powerpoint)




1.02 Advanced Compliance Strategies for Academic Medical Centers

Dr. Kenneth L. Dretchen
Director
Office of Regulatory Affairs
Professor and Chairman
Department of Pharmacology
Georgetown University Medical Center
Washington, DC

Sheila Cohen Zimmet
Director
Research Assurance and Compliance
Georgetown University Medical Center
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)




1.03 Responding to Medical Research Misconduct

Nancy Davidian, Ph.D.
Senior Scientist
Division of Investigative Oversight
Department of Health and Human Services
Rockville, MD
Presentation Material (Acrobat)
Presentation Material (Microsoft Word)

Kendra Dimond, Esq.
Partner
Epstein Becker and Green
Former Investigative Counsel
Senate Special Committee on Aging
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)




1.04 The Effect of HIPAA on Human Subjects Research

Mark Barnes, Esq.
Partner
Ropes & Gray
Member
National Human Research Protections Advisory Committee
New York, NY
Presentation Material (Acrobat)
Presentation Material (Powerpoint)




1.05 IRBs in the Community Hospital Setting

Cynthia G. Kenny, CMSC, CP, CIM
President and Chief Executive Officer
IRB Specialists, Inc.
Battle Ground, WA

Harry Shulman, Esq.
Partner
Davis Wright Tremaine LLP
San Francisco, CA
Presentation Material (Acrobat)
Presentation Material (Microsoft Word)
Presentation Material (Acrobat)
Presentation Material (Microsoft Word)
Presentation Material (Acrobat)
Presentation Material (Powerpoint)


12:00 p.m.

Luncheon and Presentations

John Iglehart
Founding Editor
Health Affairs
National Correspondent
New England Journal of Medicine
Washington, DC
(Conference Co-chair)


12:30 p.m.

The New National Human Research Protections Advisory Committee's Role in Protecting Human Subjects

Mary Faith Marshall, Ph.D.
Chairperson, National Human Research Protections Advisory Committee
Director of Programs in Bioethics
Professor of Medicine and Bioethics
Kansas University Medical Center
Kansas City, KS


1:15 p.m.

Medical Research Accreditation Roundtable

Jeffrey M. Cohen, Ph.D.
Associate Director of Education
Office for Human Research Protection
Department of Health and Human Services
Rockville, MD
(Moderator)

John H. Mather, MD
Chief Officer
Office of Research Compliance and Assurance
Department of Veterans Affairs
Washington, DC

Sandra M. Sanford, RN, MSN, CCRC, CIP
Director of Human Research Protection Accreditation Program
National Committee on Quality Assurance
Washington, DC

Paul M. Schyve, MD
Senior Vice President
Joint Commission on Accreditation of Healthcare Organizations
Oakbrook Terrace, IL

Marjorie A. Speers, Ph.D.
Executive Director
Association for Accreditation of Human Research Protection Programs
Washington, DC


2:15 p.m.

TRANSITION BREAK


2:30 p.m.

CONCURRENT SESSIONS II




2.01 Coverage and Billing Issues for Clinical Research

John E. Steiner, Jr., Esq.
Chief Compliance Officer
Cleveland Clinic Health System
Cleveland, OH
Presentation Material (Acrobat)
Presentation Material (Powerpoint)




2.02 Issues in Human Subject Research Compliance

James A. Moran, Esq.
CPA
Executive Director
Compliance
School of Medicine
University of Pennsylvania
Philadelphia, PA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)




2.03 Financial Conflicts of Interest in Medical Research

Irene Stith-Coleman
Public Health Advisor & Assistant Secretary of Health
US HHS Office for Human Research Protections
Rockville, MD
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Karen Santoro, Esq.
Deputy Ethics Counselor
National Institute for Allergies and Infectious Diseases
Bethesda, MD
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Sheila Cohen Zimmet
Director, Research Assurance and Compliance
Georgetown University Medical Center
Washington DC




2.04 HIPAA's Implications for Medical Research

Julie A. Kaneshiro
Senior Policy Analyst
Office for Human Research Protection
Department of Health and Human Services
Rockville, MD
Presentation Material (Acrobat)
Presentation Material (Powerpoint)




2.05 Approaches to Human Research Protection Program Accreditation: A Comparison of the NCQA and AHHRPP Standards

Carole Klove, Esq.
Partner
Deloitte & Touche LLP
Los Angeles, CA

Diane Lee, Esq.
Partner
Davis Wright Tremaine LLP
San Francisco, CA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)


3:30 p.m.

TRANSITION BREAK


3:45 p.m.

CONCURRENT SESSIONS III




3.01 The Context of Clinical Research: Challenges and Opportunities

Eric G. Campbell, Ph.D.
Instructor in Health Policy
Harvard Medical School
Cambridge, MA

Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Leslie A. Platt, JD
Principal and Leader
Health Sciences Research Compliance Group
Ernst & Young LLP
McLean, VA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)




3.02 Making Your IRBs and Clinical Investigators HIPAA-Ready

Thomas E. Jeffry, Esq.
Partner
Davis Wright Tremaine LLP
Los Angeles, CA

John E. Steiner, Jr., Esq.
Chief Compliance Officer
Cleveland Clinic Health System
Cleveland, OH
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Presentation Material (Acrobat)
Presentation Material (Microsoft Word)
Presentation Material (Acrobat)
Presentation Material (Microsoft Word)




3.03 Conducting a Clinical Compliance Risk Assessment in the Pharmaceutical Industry

John Bentivoglio, Esq.
Partner
Arnold and Porter
Former Special Counsel for Healthcare Fraud
Chief Privacy Officer
United States Department of Justice
Washington, DC

Brenton Saunders, JD, MBA
Partner
PricewaterhouseCoopers LLP
Past President
Health Care Compliance Association
Founder
International Association of Privacy Officers
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)




3.04 Clinical Research Integrity - A Practical Approach to Investigating and Acting upon Alleged Improprieties

Dr. Gary T. Chiodo, DMD
Associate Director
Center for Ethics in Health Care
Corporate Compliance Officer
Oregon Health & Science University
Portland, OR

Carol Pratt, JD, PhD
Associate
Davis Wright Tremaine
Portland, OR
Presentation Material (Acrobat)
Presentation Material (Powerpoint)




3.05 Update on OIG Investigations Regarding Clinical Research

Mark R. Yessian, Ph.D
Regional Inspector General for Evaluation and Inspections
U.S. Department of Health and Human Services
Boston, MA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)


4:45 p.m.

TRANSITION BREAK


5:00 p.m.

Healthcare Privacy, Data Security and HIPAA Compliance in the Medical Research Context

William R. Braithwaite, MD, PhD
Director
PricewaterhouseCoopers LLP
Former Senior Advisor on Health Information Policy
Department of Health and Human Services
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)


6:00 p.m.

Adjournment and Networking Reception


7:30 p.m.

Performance by the Capitol Steps

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