Pediatric Protocol Review Committee (PPRC)

The purpose of the Pediatric Protocol Review Committee is twofold: 1) to review the scientific validity of proposed studies in children, and 2) to ensure that appropriate and systematic measures to minimize risk to participating subjects are incorporated into the protocols; thereby, voting on and recommending a risk assessment to the Human Investigation Committee (HIC.)

For additional information regarding whether or not a protocol needs to go through the PPRC please email pprc.ycci.committees@yale.edu.

All protocols that include minors as research subjects that are submitted for review to the Yale IRB or approved by the HRPP for review by an external IRB are subject to PPRC review. Protocols are triaged by risk as defined by the 21 CFR part 50, Subpart D/45 CFR part 46, Subpart D by the HRPP Intake team. Protocols are additionally triaged by study authorship by the PPRC Regulatory Analyst.

Studies Authored by Principal investigator

Studies authored by a Yale Faculty Member or a Faculty Member at another academic medical institution will be assigned to review by a primary reviewer with expertise in the disease or field. If the protocol contains a statistical plan, a statistical reviewer will be assigned. If there are significant concerns during the review of the protocol, the reviewer may request that the submission is reviewed by the full PPRC board.

Minimal risk study types excluded from review include but are not limited to:

• Studies authored by Industry
• Studies that are conducted by an approved consortium
• Studies that have undergone NIH peer review
• Medical record reviews
• Banking Protocols
• Exempt research
• Surveys in minors
• Studies that are only for data collection purposes
• Interview studies
• Minimal risk imaging studies These studies will not be routed for PPRC review by the HRPP intake team. If the study is being reviewed by the Yale IRB and there are significant concerns during the course of review, the Yale IRB may request that the study is reviewed by the PPRC.

Studies Authored by Principal investigator

Studies authored by a Yale Faculty Member or a Faculty Member at another academic medical institution will be assigned to be reviewed by the Full PPRC Board. A primary reviewer with expertise in the disease or field and a statistical reviewer will be assigned to review the submission.

Studies Authored by Industry, Conducted by Approved Pediatric Consortium, or Undergone NIH Peer Review

Studies authored by Industry, conducted by an approved pediatric consortium, or undergone NIH Peer Review will be assigned to review by a primary reviewer with expertise in the disease or field. If the protocol contains a statistical plan, a statistical reviewer will be assigned. If there are significant concerns during the review of the protocol, the reviewer may request that the submission is reviewed by the full PPRC board.

Pediatric Cancer-Related Trials

Cancer-related trials that involve minors will be triaged to the Yale Cancer Center Protocol Review Committee (PRC) or PPRC by the Office of Quality Assurance and Training and PPRC Chair and/or Vice-Chair based upon appropriate expertise. Approval is only required from one of the aforementioned ancillary committees prior to IRB review.