Our Mission and Vision
To accelerate clinical research throughout the perinatal division and collaborating partners. Our vision is to create and sustain an accessible and useful platform for patient-centered research.
Resources provided by the OPRN include:
- OPRN Banked Biospecimens
- Data from OPRN Clinical Databases
- Research Coordinator Support for Prospective Clinical Investigations
- Biostatistical Support of Data Analyses
The OPRN repository includes a vast amount of maternal-paternal-child triad clinical data and biospecimens. These include the following samples at given time points within the duration of an infant’s hospital stay:
- Blood – Up to 30mLs or 2 tablespoons. Dried blood spots cards are also available.
- Buccal Swab – If a blood sample cannot be collected.
- Urine – Maximum amount obtained does not exceed 120mLs or 4 ounces.
- Breast Milk – If mother is breastfeeding, milk samples up to 5mLs or 1 teaspoon are collected.
The SRC oversees and ensures the scientific merit, priority, and progress of studies conducted within the OPRN or using OPRN resources.
All research proposals must first obtain approval by the NCH Institutional Review Board (IRB) before OPRN data, specimens, or data analytic resources will be provided. It is strongly suggested that applicants submit an IRB application before or at the same time as an application to the SRC.
The SRC is Responsible for:
Scientific and biostatistical peer review of submitted protocols. This comprehensive review will be performed on all new investigator-initiated and industry-sponsored research studies, as well as on any substantive amendments to established protocols. Review of approved study progress will occur every 12 months.
Review by the SRC
An SRC member designated to be the primary reviewer for the protocol will summarize and present the study to the SRC, suggest changes, if needed, as well as make a recommendation for consideration by the SRC.
The protocol will be discussed in open forum by all members and concludes with a call to vote by the SRC chair for:
- Approval - the study is approved as submitted.
- Approval with Clarifications - the protocol is approved if clarification(s) are submitted in writing to the satisfaction of the SRC chair.
- Disapproval – study issues outweigh the merit and safety of conducting the study
- Deferral – issues with the protocol would negatively impact the conduct of the study and must be addressed by the investigator. The investigator's written response will be brought before the convened SRC to reassess the study.
Committee independence and the avoidance of conflict of interest are maintained by excluding any SRC member with a direct interest in a proposal from participating in its review. The Committee has the authority to seek outside review of a protocol if none of the members has expertise in the protocol subject matter. The SRC chair will notify the investigator of the Committee's decision by email.
The SRC meets on the third Tuesday of every month to review and assign new proposals and requests. Proposals submitted prior to committee review will receive a response by the next cycle of meetings (i.e. submissions prior to January meeting will be determined by the February meeting).
- Scientific review committee (SRC)
- Academic advisory committee (AAC)
- Lead: Bernadette Chen, MD
- NAS subcommittee
- Lead: Kristen L. Benninger, MD
- ELBW subcommittee
- Lead: Leeann R. Pavlek, MD
- BPD subcommittee
- Lead: Matthew J. Kielt, MD
OPRN partners with:
- Baby Brain Optimization Project (BBOP)
- Maternal-Fetal Medicine
- Ohio Better Birth Outcomes
- Pediatric Surgery
Our methodological “tool-box” includes:
- Implemented web-based project management system to organize and streamline study start up and close out
- Statistical planning and analysis are available upon request for researchers and clinicians.
- Training program for trainees and junior faculty: Monthly journal club with statistical staff to review study staff design and statistical analysis across a broad range of academic scholarship (quality improvement, clinical trials, outcomes research)
Step 1 - Develop Study Plan: Write a Study Plan, which includes a full description of the proposed research study.
Step 2 - Contact AAC: Send an email to AAC with study plan to help finalize the study plan. This must be done before submitting the Determination of Research Request Form.
IRB Documentation: Research may begin once you receive an email from the IRB stating your research is exempt or receive an approval letter for your project.. This should be done by completing the Determination of Research Request Form on eIRB2. The email or IRB approval letter serves as IRB Documentation.
Step 3 - Submit Specimen Request Form: Complete the online form to initiate the specimen request process. The Study Plan MUST be included with your submission. Request can be submitted without IRB Documentation, but WILL NOT be approved until documentation is provided.
SRC Review: Approval will be granted based on feasibility (type, timeframe, and amount of specimens required) and overall scientific merit as determined by the Scientific Review Committee (SRC).
Data/Specimen Collection: Once approved by the SRC, the SRC works with the primary contact, as noted on the Proposal Form, to arrange collection and/or delivery of specimens and data.
OPRN AcknowledgementPublish Results: Publications resulting from studies supported by the OPRN should include the following acknowledgement:
This research was supported by the Ohio Perinatal Research Network (OPRN) at Nationwide Children’s Hospital. OPRN is supported by the Center for Perinatal Research at Nationwide Children’s Hospital. Funding is provided by the Abigail Wexner Research Institute at Nationwide Children’s Hospital. (AWDXXXX).
- Main campus
- St. Ann’s
- Riverside Methodist
- OSU Wexner Medical Center
- Mount Carmel East / West
- Doctor’s Dublin