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103.19 Organization Policy on Pharmacy and Therapeutics Committee and JHM IRB

August 2013

Prior to final JHM IRB action, the Organization requires review and approval by a representative of  a JHM Pharmacy and Therapeutics (P&T) Committee for any use in a research protocol of approved, unlicensed, or unapproved drugs, botanicals, biologics, other related substances (e.g., food additives, food derivatives, vitamins, minerals, extracts, etc.), or complementary and alternative medicines (CAMs).  

Each of the convened JHM IRBs has an IRB member who is also a member of a JHM P&T Committee.  When a P&T member for the JHM IRB must be absent from a meeting, a P&T IRB member from another JHM IRB or the Chair of a JHM P&T Committee may serve as a designated alternate and attend the meeting.  When a P&T IRB member or alternate cannot attend a convened meeting, the IRB will table or remove from its agenda studies which require P&T review and approval.  Such applications will be reviewed at a subsequent IRB meeting when a 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.  IRB X may review studies that involve the use of approved drugs only if it obtains a consultation from a P&T member from another JHM IRB.   

The P&T IRB members will provide relevant information concerning the IRBs’ reviews of such studies to the P&T Committee of the Organization hospital on which they serve.


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