NIH - Institutional Biosafety Committees: Roles, Responsibilities, Opportunities, and Challenges

The Future Face of Institutional Biosafety Committees: Evolving Roles and Responsibilities, Upcoming Challenges and Opportunities - A Professional Development Conference and Training Session

February 20-22, 2003 - Town and Country Resort Hotel - San Diego, California

Sponsored by: NIH Office of Biotechnology Activities - NIH Office of Laboratory Animal Welfare - American Biological Safety Asociation - Applied Research Ethics National Association

PRECONFERENCE EVENT: INTRODUCTION TO THE FUNDAMENTALS

A Training Session
Training session for new Institutional Biosafety Committee (IBC) members, staff, and others who wish to learn basic information about recombinant DNA oversight.

Thursday, February 20, 2003

1:00 p.m. - 1:15 p.m. Welcome and Orientation to Training Session
(PowerPoint Presentation - File Size: 1.8 MB)

1:15 p.m. - 2:00 p.m. Introduction to the National Institutes of Health Office of Biotechnology Activities
(PowerPoint Presentation - File Size: 9.5 MB)

2:00 p.m. - 2:30 p.m. History and Evolution of IBCs: Asilomar to the Present*
(PowerPoint Presentation - File Size: 5 MB)

2:30 p.m. - 3:00 p.m. Overview of the Current NIH Guidelines
(PowerPoint Presentation - File Size: 1.8 MB)

3:00 p.m. - 3:30 p.m. Break

3:30 p.m. - 4:00 p.m. Requirements for IBCs in the NIH Guidelines
(PowerPoint Presentation - File Size: 3.8 MB)

4:00 p.m. - 4:30 p.m. Review of the Recombinant DNA Advisory Committee and the Protocol Review Process
(PowerPoint Presentation - File Size: 1.8 MB)

4:30 p.m. - 5:00 p.m. Ask the Faculty: Open Forum for Your Questions
All Faculty

5:30 p.m. - 6:30 p.m. Reception
Trellises Poolside (If inclement weather, Terrace Pavilion)
Dinner (On Your Own)

* Slides for this segment were prepared and delivered by W. Emmett Barkley, Ph.D., Director, Office of Laboratory Safety, Howard Hughes Medical Institute.

CONFERENCE **

Friday, February 21, 2003

8:00 a.m. - 8:15 a.m. Welcome From the Conference Organizers (Regency Ballroom)

8:15 a.m. - 9:00 a.m. Keynote Address: At the Cutting Edge of Biotechnology: Emerging Promises and New Oversight Challenges (Regency Ballroom)
(PowerPoint Presentation - File Size: 8 MB)
Theodore C. Friedmann, M.D.
Professor of Pediatrics and Director
Human Gene Therapy Program
Center for Molecular Genetics
School of Medicine
University of California, San Diego

9:00 a.m. - 11:00 a.m. Biodefense Research, Select Biological Agents and Toxins, and IBCs (Regency Ballroom)
This panel will provide an update on the Centers for Disease Control and Prevention (CDC) Select Biological Agents and Toxins Rule, new NIH biodefense research programs, and the possible implications of these initiatives for institutional biosafety programs, including IBCs.
Moderator: Brian W.J. Mahy, Ph.D., Sc.D., D.Sc.
Senior Scientific Advisor
National Center for Infectious Diseases
CDC
An Update on Revisions to the CDC Select Biological Agents and Toxins Rule
(PowerPoint Presentation - File Size: 171 kb)
Mark L. Hemphill, M.S.
Chief of Policy and Training
Select Agent Program
CDC
New National Institute of Allergy and Infectious Diseases Programs of Biodefense Research: The Importance of Institutional Oversight
John R. LaMontagne, Ph.D.
Deputy Director
National Institute of Allergy and Infectious Diseases
NIH
Implications of New Biodefense Initiatives for IBCs
(PowerPoint Presentation - File Size: 4.7 MB)
Peter F. Wright, M.D.
Chair
Institutional Biosafety Committee
Professor of Pediatrics, Pathology, Microbiology, and
Immunology
Head
Pediatric Infectious Disease Division
Vanderbilt University Hospital

11:00 a.m. - 11:15 a.m. Break and Transition to Breakout Sessions

11:15 a.m. - 12:15 p.m. Breakout Sessions—Series 1

BREAKOUT SESSION A1* (Garden Salon 2):
Resources Matter: What IBCs Need To Do Their Jobs Effectively
Discussion Leaders:
Harriet Izenberg, RBP
Institutional Biosafety Officer and Biosafety Program Manager
Office of Environmental Health and Radiation Safety
University of Pennsylvania
Terry Kwan, M.S.Ed.
Community Member
Harvard Committee on Microbiological Safety
Community Member
Dana-Farber Cancer Institute Biosafety Committee
Harvard University
BREAKOUT SESSION B1* (Crescent):
Open Forum on Clinical Protocol Submission and Review: Ask the OBA Staff
Discussion Leaders:
Stephen M. Rose, Ph.D.
Deputy Director
Recombinant DNA Program
Office of Biotechnology Activities
NIH
BREAKOUT SESSION C1* (Garden Salon 1):
CDC Select Biological Agents and Toxins Rule: What IBCs Need To Know
(PDF Document - File Size: 49 kb)
Discussion Leaders:
Mark L. Hemphill, M.S.
Chief of Policy and Training
Select Agent Program
CDC
Brian W.J. Mahy, Ph.D., Sc.D., D.Sc.
Senior Scientific Adviser
National Center for Infectious Diseases
CDC

12:15 p.m. - 1:40 p.m. Luncheon Address: Today's IBC: Report on a National Survey of IBCs (California)
(PowerPoint Presentation - File Size: 235 kb)
Raymond W. Hackney, Dr.P.H., CIH, CBSP
Industrial Hygiene Manager
University of North Carolina, Chapel Hill

1:40 p.m. - 3:40 p.m. When You've Seen One IBC, You've Seen One IBC: A Roundtable Discussion of Various Approaches to Review and Oversight (Regency Ballroom)
Speakers in this session represent diverse institutions that handle IBC responsibilities in different ways. Presenters will discuss the scope of IBC responsibilities, institutional review process, oversight of gene transfer, coordination with other institutional committees, and related topics.
Moderator: Terry Kwan, M.S.Ed.
Community Member
Harvard Committee on Microbiological Safety
Community Member
Dana-Farber Cancer Institute Biosafety Committee
Harvard University
Large Academic Institution
(PowerPoint Presentation - File Size: 1 MB)
Ellyn D. Segal, Ph.D.
Biosafety Manager
Office of Environmental Health and Safety
Stanford University
Private Biotechnology Company
(PowerPoint Presentation - File Size: 2.5 MB)
Oswaldo da Costa e Silva, Ph.D.
Head of Research Services and Former IBC Chair
BASF Plant Science
Private Research Institute
(PowerPoint Presentation - File Size: 445 kb)
Donald E. Mosier, Ph.D., M.D.
Chair
Institutional Biosafety Committee
Professor
Department of Immunology
The Scripps Research Institute

3:40 p.m. - 4:00 p.m. Break and Transition to Breakout Sessions

4:00 p.m. - 5:30 p.m. Breakout Sessions—Series 2
BREAKOUT SESSION A2* (Garden Salon 1):
Beyond Recombinant DNA: The Broadening Institutional Responsibilities of IBCs
(PDF Document - File Size: 161 kb)
Discussion Leaders:
Andrew G. Braun, Sc.D., M.S.
Director of Biosafety
Office for Research
Harvard Medical School
Deborah E. Wilson, Dr.P.H., CBSP, SM
Chief
Occupational Safety and Health Branch
NIH Biosafety Officer
Division of Safety
Office of Research Services
Office of the Director
NIH
Brenda J. Wong
Biosafety Officer
Environmental Health and Safety
University of California, San Diego
BREAKOUT SESSION B2* (Crescent):
Coordination of IBC and Institutional Review Board Reviews: Respective Roles and Responsibilities
(PowerPoint Presentation - File Size: 385 kb)
Discussion Leaders:
Claudia A. Mickelson, Ph.D.
Deputy Director of Environmental Health and Safety
Massachusetts Institute of Technology (MIT)
Daniel K. Nelson, M.S., CIP
Associate Professor of Social Medicine and Pediatrics
School of Medicine
Director
Office of Human Research Studies
University of North Carolina, Chapel Hill
BREAKOUT SESSION C2* (Garden Salon 2):
Special Issues With Transgenic Animals, IBCs, and Institutional Animal Care and Use Committees
Presentations:

Discussion Leaders:
Charles E. Benson, Ph.D., M.S.
(PowerPoint Presentation - File Size: 96 kb)
Charles E. Benson, Ph.D., M.S.
Chair
Institutional Biosafety Committee
Professor of Microbiology
School of Veterinary Medicine
University of Pennsylvania
Nelson L. Garnett, D.V.M., DACLAM
(PowerPoint Presentation - File Size: 2.9 MB)
Nelson L. Garnett, D.V.M., DACLAM
Director
Office of Laboratory Animal Welfare
NIH
Robert F. Hoyt, Jr., D.V.M., M.S., DACLAM
Chief
Laboratory of Animal Medicine and Surgery
National Heart, Lung, and Blood Institute
NIH

5:30 p.m. - 6:30 p.m. Reception (Trellises Poolside [If inclement weather, Sunrise/Sunset])
Dinner (On Your Own)

Saturday, February 22, 2003

8:30 a.m. - 9:30 a.m. Managing Biosafety Concerns in Human Gene Transfer Research (Regency Ballroom)
(PowerPoint Presentation - File Size: 1 MB)
David Jay Weber, M.D., M.P.H.
Professor of Medicine, Pediatrics, and Epidemiology
Schools of Medicine and Public Health
Medical Director
Departments of Hospital Epidemiology, Occupational Health,
and Environmental Health and Safety
UNC Hospitals
University of North Carolina, Chapel Hill

9:30 a.m. - 10:30 a.m. Breakout Sessions—Series 3
BREAKOUT SESSION A3* (Garden Salon 2):
Effective Organizational Models: Reporting Structure, Staffing, Responsible Officials, and Other Key Characteristics
Presentations:
Charles E. Benson, Ph.D., M.S.
(PowerPoint Presentation - File Size: 96 kb)
Beverly L. Harding
(PowerPoint Presentation - File Size: 79 kb)
Discussion Leaders:
Charles E. Benson, Ph.D., M.S.
Chair
Institutional Biosafety Committee
Professor of Microbiology
School of Veterinary Medicine
University of Pennsylvania
Beverly L. Harding
Director
Institutional Biosafety (rDNA) Office
Research Conduct and Compliance Office
University of Pittsburgh
BREAKOUT SESSION B3* (Crescent):
GeMCRIS: An Interactive Introduction to a Gene Transfer Information Tool for Adverse Event Reporting and More
Discussion Leaders:
Jim Foss, M.S.
Program Manager
The Stellar Corporation
Stephen M. Rose, Ph.D.
Deputy Director
Recombinant DNA Program
Office of Biotechnology Activities
NIH
BREAKOUT SESSION C3* (Garden Salon 1):
Assisting Your IBC in the Assessment and Review of Biosafety Levels in Research With Recombinant DNA
(PowerPoint Presentation - File Size: 98 kb)
Discussion Leaders:
LouAnn C. Burnett, M.S., CBSP
Biosafety Program Manager
Vanderbilt University
Philip G. Hauck, M.S., M.S.H.S., CIH, CBSP, SM(NRM)
Institutional Biosafety Officer
Mount Sinai School of Medicine

10:30 a.m. - 11:00 a.m. Break

11:00 a.m. - 12:15 p.m. Ethics Matter: Attending to Our Responsibilities To Ensure the Responsible Conduct of Research With Recombinant DNA (Regency Ballroom)
As part of their review responsibilities, IBCs should take into account, among other issues, community attitudes, environmental concerns, and—in human gene transfer—informed consent. Implicit in many of these matters are questions of ethics, as well as safety, which will be explored by speakers in this session.
Moderator: Claudia A. Mickelson, Ph.D.
Deputy Director of Environmental Health and Safety
MIT
The Ethics of Preclinical Recombinant DNA Research
(PowerPoint Presentation - File Size: 4.7 MB)
David C. Magnus, Ph.D.
Director of Graduate Studies and Professor of Bioethics
School of Medicine
Center for Bioethics
University of Pennsylvania
Ethical Considerations in Human Gene Transfer Research
(PowerPoint Presentation - File Size: 36 kb)
Nancy M.P. King, J.D.
Professor of Social Medicine
School of Medicine
University of North Carolina, Chapel Hill

12:15 p.m. - 12:45 p.m. Open Mike: Suggestions for Future Activities

12:45 p.m. - 1:00 p.m. Concluding Remarks

* Track A: IBCs and Institutions

Track B: Issues in Clinical Gene Transfer Trials

Track C: Special Research Oversight Challenges

** The presentations and other materials provided by conference speakers do not necessarily represent an official NIH view on matters germane to the NIH Guidelines or the oversight of recombinant DNA research. Any questions concerning official policy should be directed to the NIH Office of Biotechnology Activities at oba@od.nih.gov

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