The research protocol and supporting documents may be submitted simultaneously to the UVM Institutional Review Board (IRB) for review, however, a study cannot be activated and participants may not be enrolled until both the IRB and PRMC approve it. Please note, the PRMC requires a full protocol that has been written according to ICH GCP Guidelines and will not accept an IRB Protocol Summary Template Document. However, the UVM IRB will accept this full protocol document in lieu of their IRB Protocol Summary Template Document to reduce duplication efforts.
New research studies must be submitted to the PRMC via e-mail to PRMC@med.uvm.edu. All submissions must be accompanied by a Protocol Submission Form (PSF) signed by the study PI and the Transdisciplinary Team (TDT) form completed and signed by the study specific disease team leader. The PRMC Coordinator will assign new studies to specific PRMC members to review at least two weeks prior to the PRMC meeting. Each study is assigned to two members (a primary and secondary reviewer with relevant expertise) as well as PRMC representatives from appropriate complementary specialties, such as biostatistics, clinical research, and/or pharmacy. Prior to the monthly PRMC meeting, each assigned reviewer completes the PRMC Reviewer Assessment Form to document their review of the protocol. This form includes items such as scientific rationale and literature review, clarity of goals, appropriateness of study design, and adequacy of patient population, based on the recommendation from the TDT. For treatment trials only, the reviewers will also assess the study’s innovation and potential clinical impact. Should a reviewer have questions during the review of the study, they may contact the PI for clarification. The reviewers then discuss the proposed research study during the scheduled PRMC meeting with at least a quorum of the committee present.
The PRMC meets once a month (the second Tuesday of the month) with meetings timed to occur the week prior to the UVM IRB meeting (third Wednesday of the month). Each research study is presented by the assigned reviewers and discussed by the full committee, followed by a committee vote. Based upon reviewer comments and those of other members, one of the following recommendations is made: approved, approved, pending clarification (no revisions required), approved, pending minor revisions to the protocol, tabled until further clarifications/revisions to the protocol are provided or disapproved.
After the meeting minutes have been transcribed and finalized, the PI will be notified in writing of the committee’s action and, if applicable, member comments. If a study is either approved or disapproved by committee vote, no response or further action from the PI is necessary. If a study is approved, pending clarification (no revisions required) by committee vote, the study responses will receive an administrative review and approval. If a study is approved, pending minor revisions to the protocol, by committee vote, the study responses will most likely receive an administrative review and approval. If substantial changes are made that affect the science of the study, the response and study revisions will be placed on the next full board agenda for review. If a study is tabled until further clarifications/revisions to the protocol are provided, a written response from the PI is expected and the response and study revisions will be placed on the next PRMC agenda. If no response is received within 90 days of receipt of the PRMC memo, the PI will receive a reminder from the PRMC that their response is still outstanding. Should an investigator fail to respond within 120 days, the PRMC may withdraw the study from consideration.
Minutes of each PRMC meeting are reviewed and approved at the next committee meeting and are distributed to PRMC members, the IRB, and to the Cancer Center Director.