Professor of Pediatrics (Critical Care); Director of Trainee Research, Pediatrics; Chair, Pediatric Protocol Review Committee, Human Investigations Committee; Principal Investigator, Pathobiology, Epidemiology and Interventions against Thrombotic and Hemostatic Outcomes (PEITHO) Program, Pediatrics; Visiting Professor of Pediatrics (University of the Philippines College of Medicine)
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.
Review Criteria
All protocols that include minors as research subjects that are submitted for review to the Yale IRB or approved by the Yale 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 and 45 CFR Part 46, Subpart D by the HRPP Intake Team. Protocols are further triaged by study authorship by the Office of Quality Assurance and Monitoring PPRC Regulatory Analyst.
Minimal Risk Studies
Studies Authored by Principal Investigator
Minimal risk studies authored by a Yale Faculty Member, student or staff or a Faculty Member at another academic medical institution or research center will be assigned for review by a primary reviewer with expertise in the disease or field. The statistician does not review the statistical plan for minimal risk studies unless requested by the expert reviewer. If there are significant concerns during the review of the protocol, the reviewer(s) may request that the submission be reviewed by the full PPRC board at a convened meeting.
Minimal risk study types excluded from PPRC review include but are not limited to:
- Studies authored by Industry
- Studies that are conducted by an approved consortium
- Studies that have undergone National Institutes of Health (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 minimal risk 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 review, the Yale IRB may request that the study is reviewed by the PPRC at a convened meeting.
Greater than Minimal Risk
Studies Authored by Principal Investigator
Greater than minimal risk studies authored by a Yale Faculty Member, student or staff or a Faculty Member at another academic medical institution or research center will be scheduled for review by the PPRC Board at a convened meeting. 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 an Approved Pediatric Consortium, or Have Undergone NIH Peer Review
Studies authored by Industry, conducted by an approved pediatric consortium, or that have undergone NIH Peer Review will be assigned for 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 at the request of the expert reviewer. If there are significant concerns during the review of the protocol, the reviewer may request that the submission be reviewed by the full PPRC board at a convened meeting.
Pediatric Cancer-Related Trials
Cancer-related trials that involve minors will be triaged to the Yale Cancer Center Protocol Review Committee (PRC) by the Yale HRPP.
2024 PPRC Meeting Schedule and Related Deadlines
Committee Chairs
Associate Research Scientist; Co-chair Pediatric Protocol Review Committee, Yale Center for Clinical Investigation (YCCI); Member of the FAC executive committee, Yale School of Medicine; Faculty At Large, Educational Policy and Curriculum Committee Members
Dr. Landeros-Weisenberger graduated medicine from La Salle University in Mexico City, Mexico; and did her training in Psychiatry at the Hospital Espanol and the Universidad Nacional Autonoma de Mexico (UNAM) in the same city. After graduating, she came to Yale University through the American Psychiatric Association (APA) Minority Training grant (PMRTP) to do her research fellowship under the mentorship of Dr. James F. Leckman at the Yale Child Study Center; focusing on novel evidence-based psychotherapeutic interventions for mental disorders cross the lifespan. She has expertise in assessment of mood disorders, Tourette syndrome, obsessive compulsive disorder, trichotillomania and anxiety disorders, among others. She also has expertise conducting and implementing clinical trials in these same conditions both with industry and NIH. She enjoys teaching medical students in these disorders and training them in evidence-based techniques. She currently serves as a Co-chair of the Pediatric Protocol Review Committee (PPRC) and is a member of the executive committee for the dean's Faculty Advisory Council (FAC)and is a member of the Associate Research Scientist (ARS) and DEI subcommittees. She is a member of the Yale Human Investigation Committee 4-B and an elected voting member for the EPCC. She is a mother of three and is constantly searching for the ever-elusive work-life balance.