PROTECTING HUMAN SUBJECTS FOCUS OF NATIONAL
FDA CONFERENCE AT UH
Streamlining, Increasing Medical Device Approvals Goal of Two-day
Event
HOUSTON, March 17, 2005 – New medical devices have to be
tested on human subjects, but protecting the rights of those subjects
can present considerable challenges for researchers. A national
conference devoted to exploring the FDA critical pathway for approval
of new medical products while protecting human subjects,
co-sponsored by the Food and Drug Administration and the University
of Houston, will be held at UH April 21-22.
One of only three annual conferences sponsored by the U.S. Department
of Health and Human Services’ Office of Human Research Protections
(OHRP), UH is hosting “The Critical Path to New Medical Products:
The Challenges in Protecting Human Subjects.” The two days
of presentations, panels and breakout sessions will be held at the
Hilton UH Hotel and Conference Center.
“While the increased potential is tremendous for new medicines,
biologicals and genomic-based treatments and devices that prevent
and cure diseases, fewer new medical devices are reaching the marketplace,”
said Isaac D. Montoya, clinical professor in the UH College of Pharmacy.
“The shortest distance between two points is a straight line;
however, the line that leads to developing new medical devices is
rarely short or straight. This conference will explore options and
approaches for meeting this challenge while protecting human subjects.”
The “critical path” of medical product development
includes the process and crucial steps that determine whether and
how quickly a medical discovery becomes a reliable device for patient
use. With a number of challenges and issues concerning the protection
of human subjects, this “critical path” will be thoroughly
examined. Participants will be given practical information about
conducting biomedical research, as well as being provided an update
on the regulations and presented with an overview of the challenges,
issues and potential solutions facing government and the private
sector in conducting federally funded research involving human subjects.
The conference is designed to benefit principal investigators, research
staff and coordinators, those involved in institutional review boards
(IRBs), institutional officials, pharmaceutical research personnel
and medical personnel with an interest in human subjects protection,
as well as graduate and undergraduate students. In completing the
two-day program, participants can expect to demonstrate a better
overall understanding of the Code of Federal Regulations from the
Office for Protection from Research Risks that govern research funded
by Title 45 Part 46 on public welfare and the protection of human
subjects.
Additional benefits include the ability to apply ethical principles
and regulations to research involving human subjects, identify opportunities
and solutions to compliance issues in human research studies conducted
by academia and the private sector, apply examples and definitions
provided to complex and difficult research issues, and demonstrate
knowledge of government initiatives such as the “critical
path” of medical product development and marketing. Poster
sessions will begin at 8 a.m. each day that represent student work
in the area.
Montoya, the conference moderator and coordinator, will introduce
Jay Gogue, chancellor of the UH System and president of UH, who
will officially open the conference at 9 a.m., April 21. To kick
off day one, OHRP Director Bernard A. Schwetz, D.V.M, will deliver
the first keynote address – “Aspects of the Human Subjects
Enterprise.” Following, will be David A. Lepay, M.D., senior
adviser for clinical science at the FDA, who will provide insight
to FDA regulations involving the protection of human subjects in
clinical trials and the organization’s oversight role.
Offering a number of panel discussions that provide a wide range
of perspectives from the federal government, private industry and
academia, many notable figures will be in attendance, as well as
giving presentations on topics such as the use of unapproved devices,
bioterrorism and space research. Included in this prestigious list
is Charles F. Sawin, the chief NASA scientist serving as chair of
the Committee for Protection of Human Subjects and chair of the
Human Research Multilateral Review Board at NASA’s Johnson
Space Center (JSC). As a top figure in the IRBs of JSC and the International
Space Station, Sawin will discuss issues relating to conducting
research in space that involves human subjects. In addition, CEO’s
from MicroMed Technology, Pharma Frontiers and BioHouston also will
be on hand to discuss issues experienced facing the private sector.
Additional topics will cover FDA monitoring and sanctions, new
issues that are arising with the developing bionanotechnology field
and bioterrorism issues faced by the U.S. Department of Homeland
Security.
“While UH is the host, the conference is very much a community
effort,” Montoya said. “Among an impressive array of
speakers will be top Texas Medical Center representatives and faculty
from The University of Texas Health Science Center, Baylor College
of Medicine and M.D. Anderson Cancer Center. We’ve also had
pre-med students from the local chapter of the American Medical
Student Association sign on as volunteers. I’m really pleased
with the level of involvement and the unity exhibited by so many
in this important event.”
For conference information, including the agenda, registration
materials and hotel information, visit www.uh.edu/pharmacy/ohrp
or call 713-795-8387.
About the University of Houston
The University of Houston, Texas’ premier metropolitan research
and teaching institution, is home to more than 40 research centers
and institutes and sponsors more than 300 partnerships with corporate,
civic and governmental entities. UH, the most diverse research university
in the country, stands at the forefront of education, research and
service with more than 35,000 students.
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For more information about UH visit the universitys Newsroom at www.uh.edu/admin/media/newsroom.
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