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103.19 Organization Policy on Pharmacy and Therapeutics Committee and JHM IRB
P&T Review of IRB applications
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 (a P&T IRB Liaison.) When a P&T IRB Liaison for the JHM IRB must be absent from a meeting, a P&T IRB Liaison 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 Liaison 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 Liaison 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 FDA approved drugs only if it obtains a consultation from a P&T IRB Liaison from another JHM IRB.
The P&T IRB Liaisons will provide relevant information concerning the IRBs’ reviews of appropriate studies to the P&T Committee of the Organization hospital on which they serve.
The review process conducted by the P&T IRB Liaison must include review of issues related to the following:
(a) drug safety [including a review of any REMS or black box warnings] ;
(b) drug management;
(c) study design;
(d) IND status;
(e) IDDS review for INDs, and for drugs requested by the P&T representative
(f) informed consent documents; and
(g) any other relevant material.
The IRB will be responsible for reviewing [in accord with the Organization policy 103.6(b),] unanticipated problems involving risk, which may include adverse drug events that occur during a clinical investigation.
Selection Process and Qualifications of the P&T/IDS IRB member on a JHM IRB
P&T Committee members, selected to serve as the P&T IRB Liaison shall be appointed by the Institutional Official in accord with Organization Policy No. 107.1. The Institutional Official shall consult with the Chair of the site-specific P&T Committee to identify individuals who may be appointed as a P&T IRB Liaison IRB member, but IO has the final appointment authority.
Selection of candidates for P&T IRB Liaison shall include in the evaluation:
- expertise in the concepts of pharmacology and study design (as may be indicated by the attainment of relevant academic degrees or by specific training); or clinical investigation experience; or at least two years of IDS activity:
- commitment to attendance at 80% or more of convened IRB meetings; and
- demonstrated ability to effectively communicate and to think clearly regarding medication-related issues.
P&T IRB Liaison Approval of Studies Involving Devices
Device studies that do not contain a drug do not require review and approval by the P&T IRB liaison.
In cases where a device study includes a drug, the study must be approved per above. In such cases of review of a device study that includes a drug, the P&T IRB liaison will base approval on the appropriateness of use involving the drug(s) and not on the use of the device per se.
Appointment Process for P&T IRB Liaison on the Johns Hopkins School of Public Health IRB
IRBs of Johns Hopkins School of Public Health (JHSPH) that review research involving a drug should have a P&T member appointed in accord with BSPH policy and in consultation with the Chair of the JHH P&T Committee. JHSPH policy will determine requirements for P&T IRB liaison review
Reports of the P&T IRB Member to the P&T Committee
The P&T IRB liaisons are fully accountable and responsible to their respective organization P&T Committees. An appropriate mechanism for reporting liaison activities to the P&T Committee must be established by each P&T Committee.