What is PeriBank?
PeriBank is our proprietary name we have generated for our universal combinatorial obstetrical database and biospecimen repository. This is a coded and de-identified database, meaning that the identity of subjects enrolled in PeriBank cannot be shared or discovered and is kept secure.
What is collected?
- Information: Database information pertaining to the pregnancy, the delivery, and the postnatal course will be collected from every delivery occurring at BTH and the Pavilion for Women, currently comprising roughly 8000 deliveries per year. This information is extracted by research coordinators from patient charts and from direct patient query. If you would like to learn more about PeriBank, email Jia Chen at firstname.lastname@example.org.
- Specimens: Placenta, cord blood, maternal blood, and paternal blood is attempted to be collected on every delivery.
When is it collected?
Subjects are enrolled at the time they present to labor and delivery, or immediately after delivery if they precipitously or emergently deliver. Our IRB approval allows us to set aside specimens in such situations until the subject is enrolled or declines enrollment.
What is the index identifier?
The data and biospecimens will be indexed by the maternal subject identification, with query capacity for any and all maternal, paternal, neonatal, and other features.
How are the data and specimens queried?
Ultimately, we are able to query all aspects of the database for identification of samples, or can query data for quality or outcomes based research.
Retrieving sample cohorts for research: For example, say we wish to pull placental samples from all women who had:
- delivered at 26 to 28 weeks,
- smoked, and
- had a history of preeclampsia in a prior pregnancy.
We then needed as controls both smokers and non smokers without preeclampsia, but whom delivered at 26 to 28 weeks and had a history of preeclampsia in a prior pregnancy. A third nested control cohort would need to be term deliveries among non-smokers but with preeclampsia. Finally, we may also need to query for all placental specimens in the repository who also have a sibling in the repository. Because we have built PeriBank as both a database and linked specimen repository, we are able to query and pull these samples with relative ease and expediency.
Mining data for quality initiatives and research: For example, say we wish to query estimated blood loss as defined by change in hemoglobin of >3 g/dL in all subjects who underwent delivery at BTGH, and stratify by mode of delivery and presence or absence of preeclampsia. Because we have gathered data on laboratory peak and nadir values, we can query the database for a delta in the hemoglobin, alongside additional maternal or neonatal comorbidities.
What are the unique key features of PeriBank both now and in the future?
- The capability to track specimens for more than one protocol
- Specimen collection can be broken down by participating facility (BTGH, PfW), specimen type (blood, placenta, maternal or paternal blood), and availability (previously extracted for another protocol)
- Capability to upload attachments that are tied to the specimen (ex. Pathology report, Consent form)
- Can be used as a tool for tracking patient consent, protocol registration and protocol withdrawal
- Uses barcode printing and scanning to log and check-out specimens, and to locate within the freezers
- Capability to record specimen annotations according to a researcher’s individual needs
- Web-Based: users can have different levels of access within the system.
- Simple and flexible specimen searching and ad hoc reporting
- System is compatible with appropriate guidelines, regulations and standards such as HIPAA, Common Rule, and OBBR j. Capability to run specialized reports from the system
- Capability to coordinate and manage clinical trials (future need)
- Capability to be linked to our database, as well as VON (Vermont Oxford Network, the voluntary database of over 900 NICU worldwide) the neo database (SQL, OVID capacity)
- Uses standard data elements to maintain integrity and quality of data
- Capability to integrate key hospital and laboratory systems that can be used to automatically populate registries
Is there anything I cannot do with PeriBank?
PeriBank is designed for both data-driven and translational research. On the translational research front, all types of “omics” research is possible (from genomics-based DNA sequencing or SNP/CNV studies, to RNA sequencing and transcriptomics, to proteomics, metabolomics, and metagenomics). We do not allow samples to be sold to third parties, and generally recontacting subjects is not approved. As with all human subjects research, use requires IRB approval for the specific research question being asked—PeriBank sets the stage for this by having the data and specimens approved for broad future use, stored, and available.
What are the steps I need to take to use PeriBank?
PeriBank is a resource built jointly by the Departments of Pathology and Obstetrics & Gynecology and with the support of Texas Children’s Hospital, and designed to be used by faculty, students, residents, and fellows at Baylor College of Medicine, Texas Children’s Hospital, and our collaborators. We have attempted to make it easy and accessible. It is our goal that that “bank” will have daily deposits and withdrawals and will be a resource to improve the health of women and children.
There are three basic steps:
- Obtain permission: This is a two step process. First, permission is requested from the PeriBank Governance Board by filling out a one-page sheet. After permission is obtained, you may apply for IRB approval through Baylor College of Medicine (or your IRB of record). Because all subjects have already consented, this will not require subject consent and in many cases the IRB may be expedited. You may also have to complete a Data Use Agreement or Material Transfers Agreement, and we can help guide that process.
- Access PeriBank: Contact Jia Chen (PeriBank lead coordinator, OB GYN) to undergo a brief (<30 minute) training session (email@example.com) and obtain approved access. For studies which will utilize specimens, Jia will work with her counterpart in Pathology to pull the specimens which have been requested and approved for use. In addition, Jia is available to assist in downloading the data and importing to a variety of files for analysis, including xls and access.
- Conduct research: Once the data is downloaded and the specimens are pulled, they are ready to use in the manner you described and was allowed in your IRB. Following completion of specimen use, remaining material may be returned to PeriBank and will be annotated as to quantity, quality, and form (for example, extracted DNA) and which PI used under which designated IRB. This will additionally enable future investigators to query for already extracted materials, such as proteins or DNA or RNA.