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2007 OHRP
Research Community Forum
Overview
A one day Research Community Forum will be co-sponsored by the Florida Hospital and the Office for Human Research Protections for all persons interested in biomedical and social/behavioral human subject research on Monday, February 26, 2007 at the Ivanhoe Plaza Hotel in downtown Orlando, Florida. Additional co-sponsors are the Orlando Regional Healthcare System, the University of Central Florida Hospital, the AH [spell out name], and the SCRC [spell out name]. The forum is entitled:
“Challenges of Protecting Human Subjects in Research: 7 Years into the Millennium”
Forum Highlights
Keynote Address: “Challenges: Natural and Man Made”
- John Agwunobi, M.D., Assistant Secretary of Health (ASH), U.S. Department of Health and Human Services
Federal Updates
- Bernard A. Schwetz, D.V.M., Ph.D., Office for Human Research Protections
- Chris B. Pascal, J.D., Director, Office of Research Integrity
- David A. Lepay, M.D., Ph.D., U.S. Food and Drug Administration
Special Panel: “Protecting Research Patients During a Disaster”
- Joe Breault, Oschner Health System, New Orleans, LA
- FDA Rep
- OHRP Rep
Special Panel: “Handling Conflict: It Isn’t Just the Money”
Special Panel: “Informed Consent: 5 pages or 15 pages ?
English or Foreign Language ?
Special Panel: “Update on Adverse Event reporting and Safety Reports:
What Do Investigators and Institutions Want?”
12 Breakout Sessions Include:
- Florida Law vs. Federal Law in Research [wards of the state, advocates, & legally authorized representatives]
- Vulnerable Populations
- Device Advice
- Drug Studies [ emergency use & treatment]
- Social/Behavioral Studies
- Federal Grants
- OHRP Review & New Guidance
- SOPs for Handling Research in a Disaster
- FDA Audits
- Ramifications of Misconduct
- HIPAA
- TBD
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