Second Annual Medical Research Summit: Agenda: Day 1

  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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