On June 15, 2007, the University of Kentucky proudly became a fully accredited institution by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).  Prior to receiving full accreditation, the University of Kentucky had to revise various policies, procedures, IRB forms, and educational/guidance documents in response to AAHRPP recommendations.  As training and educational efforts to update appropriate parties progress, applicable IRB forms and educational/guidance documents are put into production.

The documents listed below have been updated and posted to the ORI web site.  Please be sure to use the revised versions from this point on.  If you have saved any of these documents to a personal space (computer, jump drive), please be sure to replace them.

Medical General Information Sheet (GIS) [Form A]
Nonmedical GIS [Form A]
Study Personnel List Template [Human Research Forms]
Medical Research Description [Form B]
Nonmedical Research Description [Form B]
Expedited Certification Form [Form A-1 - Med & Nonmed]
Summary of FDA Requirements For Investigators Who Are Also Considered Sponsors of New Drugs [Educational Materials, Regulations and Policy Guidance]
Summary of FDA Requirements For Investigators Who Are Also Considered Sponsors of New Devices [Educational Materials, Regulations and Policy Guidance]

The following new documents posted to the ORI web site can be found under the topic "Investigator Responsibilities" on the Educational Materials, Regulations and Policy Guidance web page.

Sponsor-Investigator Clinical Trials with FDA Regulated Products [PPT] 
Investigator Initiated Trial Questions  [PDF]