IMPROVING HUMAN SUBJECTS PROTECTION

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The partners in this consortium application (Boston University and Boston Medical Center) have a rich tradition in clinical research. We are the major healthcare provider for Boston's ethnically-diverse, medically-underserved population, and much of the human research that we do focuses on problems that are particularly important to these under-served patient groups. Human research is a very important portion of our total research enterprise: in 2001,42% of new research grants awarded and 55% of the funding awarded had a human research component. Human research is also growing at a rate of greater than 10% per year. This growth has strained our current systems for educating investigators about the safe and ethical conduct of human research and has placed an enormous burden on our IRB committees. We propose to use the funds from this RFA to support three broad categories of improvements: 1.) Research education programs (including an on-line monthly clinical research bulletin and quiz; a HIPAA consultant to assist us in re-engineering our clinical research activities in a way that is consistent with HIPAA's new privacy rule; an "IRB Internship" for our clinical research trainees; improvements in the educational value of our IRB website; and videotapes of the informed consent process and IRB committees in action). 2.) Improvements in IRB infrastructure (both IRB management software and upgrades of the IRB computers and other hardware). 3.) Several pilot projects aimed at improving clinical research education and IRB function. All of these initiatives are designed so that the support from this RFA will have lasting value and will benefit both members of the consortium (Boston University and Boston Medical Center).