Publications based on research using the PaTH Network should cite the PCORI PaTH Contract: “This work is (partially) supported through the Patient-Centered Outcomes Research Institute Program Award (PCORI CDRN #1306-04912).”
Publications based on research reviewed by the PaTH Network Protocol Review Committee (PNPRC) should state the following: “This study underwent review by the PaTH Network Protocol Review Committee (PNPRC). The PNPRC was established to ensure input from each institution prior to review by the central IRB at Johns Hopkins University. The PNPRC has representation from at least one local IRB official and one patient representative from each PaTH institution.”
The lead author who is planning to prepare an abstract or manuscript using the PaTH Clinical Data Research Network in any way needs to record their publications and/or presentations within 30 days of acceptance. Articles that are rejected must also be reported. This requirement includes studies that have received additional funding outside of the PaTH Clinical Data Research Network but still use the PaTH infrastructure.
PCORI mandates that “To the extent Recipient desires to submit, publish, or distribute any publication arising from the CDRN (?) Project, Recipient shall inform PCORI and PCORI shall be provided with the opportunity to review and comment on the draft article or manuscript prior to its submission for publication or distribution. PCORI shall provide comments to Recipient not later than fourteen (14) days after the provision of the draft to PCORI."
The PaTH Network Protocol Review Committee (PNPRC) is charged by the PaTH Executive Committee to review all investigational protocols that will use the PaTH network prior to submission to the overseeing Institutional Review Board (IRB).
The PNPRC reviews research study applications prior to a formal IRB submission in order to provide a forum for more comprehensive input from patient partners, identify concerns an IRB committee might have, and attempt to create consistency about how IRBs would address the concerns. The PNPRC provides feedback to investigators regarding the investigational protocol and offers recommendations to the PaTH IRB of record. The overseeing IRB shall have ultimate authority to review and approve protocols.
The PNPRC is comprised of one IRB professional and one patient or community stakeholder from each PaTH Network site. The PaTH Network site Principal Investigator will nominate representatives to participate in the PNPRC. These representatives will possess appropriate experience, authority, and knowledge to assist in growing PaTH. The PNPRC is chaired by one of the network site IRB professionals. The chair is designated by the Executive Committee and can vary based on the lead IRB site for a particular protocol.