March 2007 The Organization requires review and approval by a representative of the Pharmacy and Therapeutics (P&T) Committee for any use of drugs, biologics, or complimentary and alternative medicines (CAMs) in a research protocol prior to final JHM IRB action on a protocol. This objective will be accomplished by ensuring that JHM IRBs 1, 2, 3, and 5 shall have a member who is also a member of the P&T Committee. When a P&T member for the JHM IRB must be absent from a meeting, a P&T member from another JHM IRB, or the Chair of the P&T Committee, may serve as a designated alternate and attend the meeting. In cases where a P&T IRB member or alternate cannot attend a convened meeting, the IRB will table applications that include drugs used in clinical investigation until the next meeting when the P&T IRB member can attend. JHM IRB X reviews research that qualifies as a minimal risk activity which may be reviewed through an expedited review process. JHM IRB X may review applications using a minimal risk application that includes a marketed drug only if it obtains a written consult from a P&T/IRB member from another JHM IRB. The P&T IRB members will provide information to the P&T Committees of the three Organization hospitals (JHH, JHBMC, and HCGH) to assure proper communication regarding drug research approved for conduct at the Hospitals. |
