August 2010

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 substances (e.g., food additives, food derivatives, vitamins, minerals, extracts, etc.); or complementary and alternative medicines (CAMs).  This objective will be accomplished by ensuring that JHM IRBs 1, 2, 3, and 5 shall have 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 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 approved, unlicensed, or unapproved drugs; botanicals; biologics; other substances (e.g., food additives, food derivatives, vitamins, minerals, extracts, etc.);  or CAMs used in clinical investigations 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 that include marketed drugs only if it obtains a written approval from a P&T IRB member from another JHM IRB.  

The P&T IRB members will provide information to the P&T Committee of the Organization hospital on which they serve.