Perinatal Research Advisory and Facilitation Process
Pregnant individuals, their fetuses and newborn infants, especially preterm infants in neonatal intensive care units, represent a unique and limited population of families who would like to participate in clinical research. There is considerable potential for competition among studies that begin at these unique stages of the life cycle, which is a burden to studies recruiting from these limited subject populations.
We have a Perinatal Research Advisory and Facilitation Committee to assist investigators whose studies involve:
- Recruitment of pregnant patients at UCHealth or Children’s Hospital
- Recruitment of patients in the postpartum period (up to 12 weeks postpartum)
- Infants <60 days of age admitted to an inpatient unit at UCHealth or Children’s Hospital
- Collection of placenta, umbilical cord or cord blood samples
Vision
All pregnant patients and families with a neonate receiving care through UCH and/or CHCO will have an opportunity to participate in research.
All pregnant patients and families with a neonate will be approached about research in a way that is coordinated, respectful, and integrated into a high-quality care experience at UCH and/or CHCO.
All perinatal investigators on the AMC will conduct high-caliber translational science in a collaborative, coordinated, and mutually respectful manner.
Process
How to apply for review by PRAFC: All potential perinatal research projects must be reviewed by the Committee prior to the initiation of any study. Upon completing protocol submission in the Human Subjects Research (HSR) portal and indicating that your protocol meets one of the above requirements, the PRAFC questionnaire and review process will automatically be initiated. If a protocol is already reviewed by SARC, the review by PRAFC will be incorporated into the SARC process. Other studies that do not require SARC review will be reviewed by PRAFC through an expedited e-review process.
Primary Goals of the Facilitation Process
Determine the feasibility of the proposed research
Identify overlap with existing studies
Foster collaboration among overlapping research investigators
Establish priorities for protocols
Assure that investigators are fully aware of existing data and biobank resources already available
When necessary, direct investigators to alternative resources and/or research sites
For additional questions, please contact Jocelyn Phipers