Protecting human subjects focus of national FDA conference at UH

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, a

Contact: Lisa Merkl
University of Houston

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