Overview of Human Subjects Research and the IRB
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Overview of Human Subjects Research and the IRB
Research Enterprise's Closed
History of Human Subjects Protection
History of Human Subjects Protection (con't)
The "Common" Rule
Vulnerable Populations
Administrative Oversight of Human Research
What is a "Human" Subject?
What is Research??
Examples of Research
Research Involving Human Biological Materials
History
Where are they?
Ethical Issues Considered by the National Bioethics Advisory Commission
Ethical Issues, cont'd
National Bioethics Advisory Commission
Categories of human biological materials
Categories, cont'd
Categories, cont'd
Categories, cont'd
NBAC recommendations
NBAC Recommendations
Ownership of tissues
Summary
Multiple Project Assurance (MPA)
UF IRB Administrative Structure
Role of the IRB
Methods of Review
What is Minimal Risk?
Requirements for IRB Submission
Dilbert
Potential Outcomes from a Full Board IRB Meeting
Informed Consent
Informed Consent - Components
Informed Consent
Informed Consent
Informed Consent
Informed Consent
Medical Device Approvals
IRB Role with Medical Devices
Investigator Responsibilities for Human Subject Research
New DHHS Educational Requirements
New DHHS Educational Requirements
Education on the Horizon
Data Safety Monitoring Committees (DSMC)
Adverse Events
New DHHS Grant Review Requirement
Top Reasons for Tabling Protocols
Complaints from Investigators
Breaking the Rules
Related Committees
R-99 Accounts
Inpatient Studies
Ask, before you act!
Thank You!
Author: R. Peter Iafrate, Pharm.D. / iafrate@shands.ufl.edu
Version: Produced by the Office of Medical Informatics
Copyright: 2000 by the University of Florida
Location: http://medinfo.ufl.edu/other/irb/index.html
Created: December 8, 2000
Modified: June 18, 2001