Track 1
IACUC
Track 2
IBC
Track 3
IRB
Track 4
Sponsored Sessions
Conference Agenda
THURSDAY March 5, 2009
REGISTRATION - Continental Breakfast
8:00 AM
8:30 AM
8:35 AM – 9:50 AM
Keynote Address
WELCOME!
Massachusetts Society for Medical Research
Southwest Association for Education in Biomedical Research
Emerging Challenges for Scientists, Biosafety Officers and IBCs
GENERAL SESSION
W. Emmett Barkley, PhD
President
Proven Practices
9:55 AM – 11:00 AM
Advancing and Enhancing Scientific Integrity
GENERAL SESSION
Miriam F. Kelty, PhD
Consultant in Bioethics and Research Management
Retired: NIH, Associate Director, NIA
11:00 AM – 11:15 AM
MORNING BREAK
Plenary Session
11:15 AM - 12:00 PM
Avian Influenza:
Dynamics of the Disease
and Overview of the
Epizootic
Darrel K. Styles, DVM, PhD
Veterinary Medical Officer
USDA/APHIS/AC
Adaptations of the NIH
Guidelines to New
Technology
Kristina C. Borror, Ph.D.
Director
Division of Compliance Oversight
Office for Human Research Protections
Kathryn Harris Ph.D., RBP
Senior Outreach and
Education Specialist
NIH Office of Biotechnology
Activities
LUNCH
12:00 PM – 1:00 PM
1:00 PM – 1:45 PM
Development of PAC
Colleen Cody
Associate Director/ACUC Chair
Animal Welfare Compliance
Novartis Institutes for BioMedical
Research
Policy, Training and
Oversight of High
Containment Facilities
Development of PAC
Continued…
Colleen Cody
Conflict of Interest
Kristina C. Borror, Ph.D.
Director
Division of Compliance Oversight
Office for Human Research Protections
Penny H. Holeman, MPH,
MS, CBSP
Director, Biosafety, Training &
Biosecurity Solutions
Lovelace Respiratory
Research Institute
Development
of an Oversight
Framework
1:50 PM – 2:35 PM
2:35 PM – 2:50 PM
IRB Non-Compliance
Leon Igras, CIH, CSP
Director – EH&S
Shelley M. Jones
Assistant Director, Biosafety
& Biosecurity
Dr. Karen Kibler,
Biosafety/Biosecurity Officer
Arizona State University
WHAT is a Human
Research Protection
Program?
Integrated
Pathway, the
Road to IBC
Compliance
Jeffrey M. Cohen, Ph.D., CIP
President
HRP Associates, Inc.
Training & Consulting in
Human Research Protections
Connie O’Brien
Client Services
Implementation Coordinator
TOPAZ Technologies
AFTERNOON BREAK
2:50 PM – 3:35 PM
Emerging Occupational
Health Issues: MRSA
Infection and Facility
Decontamination
F. Claire Hankenson, DVM, MS
Senior Associate Director
Regulatory Affairs and Planning,
ULAR, UPenn
3:40 PM – 4:25 PM
Euthanasia:
A Compassionate
Farewell
Cindy Buckmaster, PhD, CMAR,
RLATG
Associate Director Training and
Operation
Center for Comparative Medicine
Baylor College of Medicine
4:30 PM
GENERAL S ESSIO N
AAHARP … Going for the
Gold
Dr. Marjorie Speers
AAHARP
ARIZONA STATE
UNIVERSITY
BIODESIGN TOUR
Leon Igras, CIH, CSP
Director – EH&S
Arizona State University
LIMITED 20
Registrations
NIH OBA Site Visit
Program
Kathryn Harris Ph.D., RBP
Senior Outreach and
Education Specialist
NIH Office of Biotechnology
Activities
WHAT Constitutes Substantive IRB Review?
Jeffrey M. Cohen, Ph.D., CIP
President
HRP Associates, Inc.
Training & Consulting in Human Research Protections
Comments – Questions
END OF DAY ONE
DAY TWO BELOW
Track 1
IACUC
Track 2
IBC
Track 3
IRB
Track 4
Sponsored Technology Sessions
Conference Agenda
FRIDAY March 6, 2009
Registration - Continental Breakfast
8:30 am
9:00 AM – 10:30 AM
IRB Oversight of Human Research - What are the Boundaries?
Delia Wolf, MD, JD
Director for the Office of Human Research Administration (OHRA)
Harvard School of Public Health
Assistant Professor of Radiology at Harvard Medical School
Keynote Address
GENERAL SESSION
10:30 AM – 10:45 AM
Morning Break
10:45 AM – 11:45 AM
Lowering Compliance Risk through Technology
A look at enterprise software solutions for lowering compliance risk in IRB, IBC, and IACUC
Plenary Session
Michael Peters
Vice President
TOPAZ
GENERAL SESSION
Lunch Break
11:50 PM – 1:00 PM
1:00 PM – 1:45 PM
Protocol Drift and
Regulatory Creep
Marcy Brown, BS, MA
Director, Animal Care and Use
Committee
Richard Van Sluyters, OD, PhD,
Associate Dean
UC Berkeley
1:50 PM – 2:35 PM
Considerations for the
Institutional Review of
Synthetic Genomic
Experiments
Robert J. Hashimoto, CBSP
Environment, Health and
Safety
UC Berkeley
Protocol Drift Continued …
MURPHY’s LAW… If it can – it will
(dissecting protocols – hands-on)
IRB Compliance
oversight of PI team
delegation
Linda Mottle, MSM-HSA, RN,
CCRP
Director Center for Healthcare
Innovation & Clinical Trials
Arizona State University,
College of Nursing &
Healthcare Innovation
Jane A. McCutcheon DDS PhD
Associate Professor, Dept. Biological Sciences
NYU College of Dentistry
Faculty Liaison for Compliance
Richard Van Sluyters, OD, PhD
Associate Dean
Office of the Senior Vice Provost for Research
Robert Hashimoto
UC Berkeley
Afternoon Break
2:35 PM – 2:50 PM
Preparing for an
AAALAC Site Visit
Barbara Garibaldi, D.V.M.
Director
Animal Research Facility
Beth Israel Deaconess Medical
Center
AAALAC Council Member
3:40 PM
GENERAL SESSION
Emily Thomas, Client
Services Trainer
TOPAZ Technologies
IRB Onus in Minimal Risk Research: Regulatory
Restrictions or Institutional Implementation?
Marcy Brown, BS, MA
Director, Animal Care and Use Committee
2:50 PM – 3:35 PM
IRB Compliance
Pathway for Future
Success
Brief Introduction to
the IBC Alphabet
Soup: PAC, NGO,
CAG, OBA, SOB
Issues Facing Registered Institutions – The
Unfunded Mandate of Compliance
Industry vs. Academia
David Silberman
Director
Health & Safety Programs
Stanford University
School of Medicine
Health & Safety
Round table
Timothy Martin, DVM
Penny H. Holeman, MPH, MS, CBSP
Comments – Questions – FINAL REMARKS
Please pass in EVALUATIONS before you leave! THANK YOU!