Help, Research Administration:

our hospital has reorganized to a "health system" approach where quality
improvement (QI) and quality assurance (QA) studies will become essential in
preparing a hospital "report card" as related to services and quality of care,
etc.  In essence, we are catagorizing QA/QI studies as those that entail
collecting patient data to keep track of procedures, quality of life, etc.
reporting these data on an organizational level, and possibly changing
the aspects of how things are done (fully understanding that interventions,
etc. to be made involving patients would need to go through the IRB).

our IRB is being asked to help administrators and health improvement
researchers define what constitutes QA & QI studies and to help prepare
guidelines in regards to the protection of human subjects when these
organizational studies are being conducted.

i need to find out if anyone, especially in a hospital environment, is
confronting similar situations, and if you have any standard
 definitions and or policies concerning QA/QI studies in regards to IRB
issues.

please respond to me directly or to the group.

Scott Miller Grants/IACUC Coordinator Charleston Area Medical Center

khan!xxxxxx@camcare.attmail.com