Office of External Communications

Houston, TX 77204-5017 Fax: 713.743.8199

FOR IMMEDIATE RELEASE
March 23, 2005

Contact: Lisa Merkl
713.743.8192 (office)
713.605.1757 (pager)

HOUSTON, March 23, 2005 – From glucometers used by diabetics to stents used by cardiologists, new medical devices inevitably must be tested on human subjects. A national conference is seeking student work in the field of contemporary human subjects protection.

Co-sponsored by the Food and Drug Administration and the University of Houston, the April 21-22 event is one of only three annual conferences sponsored by the U.S. Department of Health and Human Services’ Office of Human Research Protections (OHRP). Titled “The Critical Path to New Medical Products: The Challenges in Protecting Human Subjects,” the theme is directed at exploring the FDA critical pathway for approval of new medical products and will be held at the Hilton UH Hotel and Conference Center.

“In order to promote the next generation who will oversee the protection of human subjects in research, we are calling for abstracts on the topic to be presented at poster sessions both days of the conference,” said Isaac D. Montoya, clinical professor in the UH College of Pharmacy. “We intentionally limited the poster session to students so that they have the opportunity to showcase their work to a group of senior researchers. We want to highlight and encourage work in this field and are interested in any work students are doing or have done in the area of protecting human subjects, ethics and other related topic areas.”

Medical and clinical papers also will be accepted, but only if they somehow have to do with protecting human subjects specifically in research. The deadline for submissions is Friday, April 15. Abstracts are submitted online (http://www.uh.edu/pharmacy/ohrp/callforabstracts.htm), and those wishing to submit must also register for the conference (http://www.uh.edu/pharmacy/ohrp/register.htm). While the poster may be one that has been presented at a recent scientific meeting or will be presented at an upcoming meeting, the research or work described by the poster should address protection of human subjects in research and may target one of the categories of the breakout sessions (http://www.uh.edu/pharmacy/ohrp/agenda.htm). The contents of the abstract and poster must present actual research and not simply a product description or announcement.

The conference will explore options to meet the considerable challenges in protecting human subjects during research. Participants will hear contemporary issues facing biomedical researchers, be provided with an update on the regulations and gain insight to the challenges, issues and potential solutions facing government and the private sector while conducting research involving human subjects.

Open to both graduate and undergraduate students, the conference will provide students with a forum to mingle with principal investigators, research staff and coordinators, those involved in institutional review boards, institutional officials, pharmaceutical research personnel and medical personnel with an interest in human subjects protection.

Key figures, offering a wide range of perspectives from the federal government, private industry and academia, will give presentations on topics such as the use of unapproved devices, bioterrorism, space research, FDA monitoring and sanctions and new issues arising with the developing field of bionanotechnology. Among the speakers will be top Texas Medical Center representatives and faculty from UH, The University of Texas Health Science Center, Baylor College of Medicine, Christus Health and M.D. Anderson Cancer Center, as well as CEO’s from MicroMed Technology, Pharma Frontiers and BioHouston. Notable presenters and panelists include OHRP Director Bernard A. Schwetz, D.V.M, David A. Lepay, M.D., senior adviser for clinical science at the FDA and Charles F. Sawin, the chief NASA scientist and leader of the International Space Station 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.

For additional conference 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.

About the UH College of Pharmacy
For more than 50 years, the University of Houston College of Pharmacy has shaped aspiring pharmacists, scientists and teachers. The college offers a Pharm. D. degree, a master’s in pharmacy administration, a Ph.D. in pharmaceutics or pharmacology and combined Pharm.D./Ph.D. degrees. Accredited by the American Council on Pharmaceutical Education, it is one of nearly 90 pharmacy colleges in the United States, with more than 45 basic science and clinical faculty, nearly 610 adjunct faculty and preceptors and 900 current pre-pharmacy and professional students. The college has facilities both on the UH campus and in the Texas Medical Center. At TMC, students have the opportunity to train with physicians, medical students and members of UH clinical faculty. In addition to faculty and staff offices, TMC also houses research laboratories, classrooms and the Contemporary Pharmacy Practice Laboratory.

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