COURSE
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Executive Chair, Federation of Pediatric Organizations
Clinical Professor of Pediatrics
Stanford University School of Medicine
and University of California at San Francisco
February 17, 2005
2:00 to 4:00 p.m.
SRB Auditorium, Stabile Research Building
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida
Jointly Sponsored By:
  
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| Course
Description |
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Clinical research with children is an important step in the noble cause to
advance medical care in children. As we endeavor to make such advances, we must
respect and protect the children who serve as subjects in scientific research.
In this Fifth USF Symposium on Bioethics, Richard Behrman, Chairman, Committee
on the Ethical Conduct of Clinical Research Involving Children and Professor of
Pediatrics, will present an overview of the Institute of Medicine Committee Report
and discuss its recommendations concerning the roles and responsibilities of investigators.
Dr. Behrman will also discuss the challenges facing investigators as they attempt
to balance the need to advance research involving children with the need to protect
children from the risks of participation in research.
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| Objectives |
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Upon the completion of this program, the participant will be able
to:
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Identify four major regulatory protections for
child research participants.
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Define minimal risk.
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Discuss minor increase over minimal risk.
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Define “condition” under regulations.
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Relate parental permission and child assent
to informed consent.
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Understand interrelated responsibilities of
investigators, IRBs, parents, and institutions.
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| Target
Audience |
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This program has been designed for research investigators, study
coordinators, physicians, nurses, health care workers, bioethicists, professional
staff, volunteers, IRB members, medical students, residents, and others involved
in or interested in human subject research with children.
Attendance meets the 2005 continuing education requirement for
USF IRB-approved education in Human Subject Protection.
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| Accreditation |
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Physicians: This activity has been planned
and implemented in accordance with the Essential Areas and Policies of the Accreditation
Council for Continuing Medical Education (ACCME) through the joint sponsorship
of the University of South Florida College of Medicine, All Children’s Hospital,
H. Lee Mof. tt Cancer Center and Research Institute, and Tampa General Hospital.
The University of South Florida College of Medicine is accredited by the ACCME
to provide continuing medical education for physicians.
The University of South Florida College of Medicine designates this educational
activity for a maximum of 2.0 category 1 credits towards the AMA Physician’s Recognition
Award. Each physician should claim only those credits that he/she actually spent
in the activity.
Nurses: This activity for 2.4 contact hours
is provided by the University of South Florida College of Nursing, which is accredited
as a provider of continuing education in nursing by the American Nurses Credentialing
Center’s Commission on Accreditation. Each nurse should claim only those hours
of credit that he/she actually spent in the educational activity.
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| Program
Agenda |
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DATE
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1:30 to 2:00 p.m. – Registration
2:00 to 2:15 p.m. – Introduction/Overview of Research in Children
Dr. Ian Phillips and Dr. Barry Bercu
2:15 to 3:00 p.m. – Keynote Presentation
Dr. Richard E. Behrman
3:00 to 3:15 p.m. – Questions and Answers
Dr. Behrman
3:15 to 4:00 p.m. – Panel Discussion
Drs. Behrman, Bercu, Simpson, Stiles, Walker, and Ms. Epley
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| Faculty |
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Course Directors
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Barry B. Bercu, M.D.
Norma Epley, M.S.
Lisa Simpson, M.D.
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Course Faculty
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Richard E. Behrman, J.D., M.D.
Executive Chair
Federation of Pediatric Organizations
Clinical Professor of Pediatrics
Stanford University School of Medicine
and University of California School of Medicine, San Francisco. Dr. Berhman
is editor-in-chief of the Nelson Textbook of Pediatrics.
Barry B. Bercu, M.D.
Chairperson, USF Biomedical IRBs,
Professor of Pediatrics, Biochemistry, and Molecular Biology, Pharmacology, and
Therapeutics
University of South Florida
College of Medicine
Norma Epley, M.S.
Assistant Director
Division of Research Compliance
University of South Florida
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M. Ian Phillips, Ph.D., D.Sc.
Vice President for Research
Professor, Physiology and Biophysics
University of South Florida
College of Medicine
Lisa Simpson, M.D., M.P.H.
Professor and
All Children’s Hospital Guild Chair
Division of Child Health Outcomes
Pediatrics
University of South Florida
College of Medicine
Paul Stiles, J.D., Ph.D.
Chairperson, USF Social/Behavioral IRB
Professor, Department of Mental Health Policy and Law
Louis de la Parte
Florida Mental Health Institute
University of South Florida
Robert Walker, M.D.
Director, Division of Medical Ethics
and Humanities
University of South Florida
College of Medicine
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| Registration |
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Registration is complimentary.
Seating is limited.
For more information, call 813-974-4296.
The CPE Office at USF College of Medicine reserves the right to
cancel this activity due to unforeseen circumstances.
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| Location
& Parking |
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SRB Auditorium
Stabile Research Building
H . Lee Moffitt Cancer Center
and Research Institute
University of South Florida
Tampa, Florida.
Parking: Go into the main hospital entrance driveway on Magnolia
Drive and follow the Gold Valet signs.
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| Accommodations |
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Accommodations for Disabilities: Please notify the CPE Office,
12901 Bruce B. Downs Blvd., MDC Box 60, Tampa, Florida, 33612 or call (813) 974-4296
a minimum of ten working days in advance of the event if a reasonable accommodation
for a disability is needed. Events, activities and facilities of the University
of South Florida are available without regard to race, color, sex, national origin,
disability, age, or Vietnam veteran status as provided by law and in accordance
with the University's respect for personal dignity.
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