Public Affairs Highlights at EB2004

Human Research Protections 1a: How to Navigate Human Research Protection Regulations
Saturday, April 17, 9:00 - 11:00 am, Room 101

This workshop will provide an introduction to principles of bioethics and current U.S. federal regulations for protecting human subjects involved in research. The workshop will describe a comprehensive program of protections that an institution can provide to effectively protect human subjects and simultaneously conduct good scientific research. Emphasis will be on the roles of Institutional Review Boards (IRBs) and investigators in protecting research subjects and will include a c omparison of the “Common Rule” with HIPAA concerning the use of human biological materials. There is no charge for this session, but seating is limited so you must register to attend. Contact: Tara Zeitner

This presentation moves beyond the basics of IACUC to address issues that may require special attention from the IACUC. Including the role of IACUC as facilitator or research, conducting semi-annual program review and facility inspection, protocol approval monitoring and more. Participants will be able to pose questions to representatives of USDA, OLAW, and AAALAC. There is no charge for this session, but seating is limited so pre-registration is encouraged. Contact: Alice Ra'anan

The goal of this symposium is to familiarize scientists with how the media works. The ever expanding interest in scientific news is an opportunity to assist in public understanding of and public support for biomedical research. Helping scientists to take advantage of these opportunities is the aim of this symposium. A panel of three journalists will offer their insight into what makes science news and the best practices for getting scientific research covered. Contact: Stacy Brooks

The New CSR Review Process: An NIH Review
Sunday, April 18, 1:00 - 2:30 pm, Room 147A

This session will present an overview of the changes to Initial Review Groups at NIH's Center for Scientific Review that are being implemented as a result of the recommendations of the Panel on Scientific Boundaries of Review.

Scientific and Regulatory Challenges Involving Dietary Supplements and Botanical Products
Monday, April 19, 12:30 - 2:00 pm, Room 143AB
Confirmed Speakers:
Marc McClellan, Commissioner, Food and Drug Administration
Paul Coates, Director, Office of Dietary Supplements, NIH
Stephen Straus, Director, National Center for Complementary & Alternative Medicine, NIH.

Topics to be addressed include: how to promote a stronger scientific foundation at the FDA and the need to promote better health through better research; how new collaborations with NIH will help to improve our understanding of the underlying mechanisms of action and help to improve safety and efficacy of these products; research opportunities for the extramural community; and regulatory perspectives on the Dietary Supplement Health & Education Act of 1994 (DSHEA).

Will You Still Fund Me Tomorrow? The Deficit, Biodefense, and the NIH Roadmap
Monday, April 19, 3:00 – 4:30 pm, Room 207B
Featured speakers:
Dr. Elias Zerhouni, Director, National Institutes of Health
Dr. Allen Spiegel, Director, National Institute of Diabetes & Digestive & Kidney Diseases

Join Elias Zerhouni, M.D., NIH Director and Allen Spiegel, M.D., Director of the National Institute of Diabetes & Digestive & Kidney Diseases in a panel discussion to address how a radically changing environment will impact NIH grantees in the coming years. Drs. Zerhouni and Spiegel will discuss the prospects for NIH funding in light of increasing federal budget deficits, the need for biodefense spending, and the NIH Roadmap. They will also address how the roadmap initiatives will complement or compete with investigator-initiated research and how the various institutes and centers will implement and plan for future Roadmap projects.
Attendees will have ample time to direct questions to the NIH leadership.
Sponsored by: AAA, AAI, APS, ASIP, ASNS, and ASPET

Sustaining Integrative & Organ Systems Sciences: Problems, Opportunities, Solutions
Tuesday, April 20, 12:30 – 2:00 pm, Room 143C
Confirmed Speakers: Other speakers to be announced
Jerry Buccafusco, Medical College of Georgia
Gerald Schaefer, Wil Research Laboratories, Inc.
Steve Zeisel, University of North Carolina
Irv Zucker, University of Nebraska
Stanley J. Wiegand, Regeneron Pharmaceuticals, Inc. .

The advent of molecular biology has produced a vast wealth of information on human health and disease. However, there has been a diminishment in the number and ability of trained investigators – and students pursuing training and research – in the integrative and organ systems sciences. Science cannot effectively study disease or treatments for a disease simply by using isolated molecules, cells, or organs. Speakers will give their perspectives on the challenges and opportunities for enhancing the integrative & organ systems sciences by addressing its impact on both academic and industrial concerns.