15. FDA Regulated Research

15 FDA Regulated Research

15 FDA Regulated Research 

It is the policy of the CUHS to enter into Institutional Authorization Agreements with hospitals or other institutions that have appropriate federalwide assurances and IRBs with medical, scientific and local expertise to carry out the review of applications for research governed by FDA regulations. In certain cases, such as a study that combines investigational drug or device use with significant research elements that are not FDA regulated (psychological testing, for example) the CUHS may arrange for review by an IRB qualified to review FDA-regulated research, and continue to oversee the study as well.