About the KP Research Bank
The Kaiser Permanente (KP) Research Bank is the second largest biobank in the US. It provides an exceptional opportunity to enable research studies related to the prevention, diagnosis and treatment of disease. KP makes this core resource—including de-identified medical record information, a health survey and biospecimens—available to scientists who apply to use the information for genetic, epidemiological, and other scientific research.
KP is unique in that it is
- population-based, including up to 20-50% of each regional area’s insured population;
- large, consisting of over 12.5 million members; and
- has a well-characterized population, with more than 12 years of electronic medical records.
The KP Research Bank is structured both technically and operationally to provide the widest possible value to the genomics and translational research community. The opportunities for collaborative research are unparalleled.
The KP Research Bank’s mission is to create a core resource with high quality biospecimen and data collection to enable research in all areas with an emphasis on genomics and translational research with the goal of advancing knowledge for the prevention, diagnosis, treatment and management of disease that benefits our members and the community at large.
The goals of the KP Research Bank are to:
- Establish a resource for investigators both at Kaiser Permanente and external institutions to advance knowledge and understanding of factors involved in human health and disease.
- Enroll 400,000 volunteers.
- Conduct research in strict compliance with all legal requirements and ethical best practices.
- Protect the security and privacy of individuals who contribute data and biospecimens to the KP Research Bank resource in accordance with all applicable legal safeguards.
Institutional Review Board (IRB)
Similar to all research institutions, the KP Research Bank is required to have an Institutional Review Board (IRB). This governing body of physicians, scientists, and community representatives reviews and approves every study before it begins.
The goal of this Board is to minimize any risk to participants by making sure that the KP Research Bank, as well as collaborating organizations and research scientists, follow federal research regulations, guidelines, and ethical principles.
Researcher Application Process
- Register to the KP Research Bank Access Portal
- Submit your pre-application or preparatory to research data request
- Submit your application
- Get your project funded and IRB approved
- Set up use agreements with the KP Research Bank
- Return data to the KP Research Bank
- Inform KP Research Bank of publications
Access Review Committee and Review Criteria
The KP Research Bank Access Review Committee (ARC) reviews each research proposal.
The KP Research Bank strives for transparency in the review process. The table found here outlines the review criteria used to assess KP Research Bank pre-applications and applications. If you have questions about the review criteria or process, complete the form below.
Applications are subject to two stages of review: Pre-application review and application review.
- Pre-applications may be submitted at any time.
- Annual submission deadlines for applications are February 15th, April 15th, June 15th, August 15th, October 15th, and December 15th Applications will be reviewed by the ARC in the month following the deadline.
If you are interesting in conducting research with the KP Research Bank, but you have more questions, fill out and submit the form below.
Pre-application and Preparatory to Research Data Request
To submit a pre-application, please click on Apply to Use Resource to register for the KP Research Bank Access Portal. After doing so, you will receive a verification email in 1-2 business days with instructions for submitting your pre-application. If you have any questions, please contact the Access Administrator using the form below. For reference only, please see the pre-application linked below.
If your pre-application is approved, you will receive an email notification inviting you to submit an application through the KP Research Bank Access Portal.
To help determine study feasibility, KP researchers may submit a preparatory to research (PTR) data request. This can be submitted with or without a pre-application. Researchers external to KP may submit a PTR request with a pre-application. If requesting PTR data, complete and upload the “KPRB Preparatory to Research Attestation” linked below when completing your online submission.
- Pre-applications will be reviewed by the ARC within 2-4 weeks of submission, depending on whether assistance is required to identify a KP collaborator.
- If the pre-application is approved, the Access Administrator will notify and invite the investigator via email to submit an application.
The purpose of the pre-application is to:
- Outline the proposed research project, including requested biospecimens and/or data (1 page limit)
- Provide a brief lay summary of the proposed research project that can be understood by members of the public (200 word limit)
- Outline the credentials of the applicant
- Request KP collaborators if not already identified
Once your pre-application has been approved, you will be invited to submit an application through the KP Research Bank Access Portal. For reference only, please see the Application below.
Description of Our Collections
The KP Research Bank includes members aged 18 and over, from all KP regions, who volunteered to participate in the program.
The KP Research Bank is currently enrolling, consenting, and collecting blood specimens and other data on adult KP members aged 18 years and older who volunteer. Recruitment is done using e- mail, U.S. mail and in person communications at KP facilities.
To enable the broadest possible collaborative opportunities for the KP Research Bank, we collect biologic samples with a consent that specifies use in future research, and possible sharing of data with researchers outside KP. We collect whole blood through standard venipuncture at any KP clinical laboratory. Primary sample types stored are whole blood, DNA and serum.
Although a large general cohort will have many prevalent cases of common and rare diseases that are useful for case- control studies, the need for very large sample sizes is critical to determine their association with a trait or disease. The recent advent of lower cost and high throughput technologies such as next generation sequencing — such as with large gene panels, exome and whole genome sequencing — can identify rare variants.
Some participants in the KPRB general cohort were initially enrolled through the Research Program on Genes, Environment and Health (RPGEH) in Northern and Southern California. These participants provided a saliva sample in a whole-saliva collection kit (OrageneTM DNA collection kit, DNA Genotek, Inc., Ottawa, Ontario, Canada). In 2011, RPGEH transitioned from collection of saliva to the collection of blood specimens from participants. 103,000 of these subjects have available Affymetrics Axiom array data, a subset of which is available on the dbGaP website here.
Exposures during the prenatal period have lasting effects on maternal and child health outcomes. To better understand the effects of the in utero environment on women’s and children’s short- and long-term health, we have developed a large representative pregnancy cohort with comprehensive information on a broad range of environmental influences and the ability to link to prenatal, child and maternal health outcomes. The Kaiser Permanente Research Bank pregnancy cohort was established in 2010 to create a resource for conducting research to better understand factors influencing women’s and children’s health. Based in Kaiser Permanente’s Northern California region, with recruitment integrated into routine prenatal care, the KPRB pregnancy cohort currently contains approximately 25,000 unique pregnancies linked to EHR and survey data. The cohort represents the racial and ethnic diversity and pregnancy outcomes of female members in Kaiser Permanente Northern California.
An estimated 15.5 million cancer survivors live in the United States, and that number is expected to grow to over 20 million by 2026 (www.cancercontrol.cancer.gov/ocs). The need to identify ways to reduce the burden of cancer, through improved and targeted therapies, and symptom control remains an urgent element of the nation’s health research agenda. The purpose of the Cancer Cohort is to facilitate high-impact, population research focused on understanding the contribution of genetics and life-style factors in improving cancer treatment and outcomes, reducing co-morbidities, and maximizing quality of life. We plan to enroll 30,000 adult Kaiser Permanente members with newly diagnosed cancer using a rapid case ascertainment system that identifies patients within days of their diagnosis.
Demographic and clinical data on cohort members
2007-present: A comprehensive lifestyle and behavior survey is conducted at the time of consent to participation in the General Cohort, Cancer Cohort, and Pregnancy Cohort. Variables include self- and family history of the occurrence of about 35 conditions and diseases; behavioral factors, including diet, physical activity, smoking, and alcohol consumption; reproductive history for women; and urinary and reproductive health for men. This survey captures data not readily found in the medical record and will provide important information that can be associated with the molecular and biomarker information collected via the samples.
Data from electronic medical records and other health plan databases are also available for cohort members. Databases are standardized across the KP regions and include enrollment, demographics, procedures, diagnoses, medical encounters, pharmacy, vital signs, and census variables.
Approved studies may use the clinical and survey data, with or without the biologic specimens. Requests to use only KP clinical data will be redirected.
The KPRB maintains its own Research Biorepository that occupies over 5,000 square feet with state-of-the-art laboratory equipment. The KPRB Biorepository is staffed with dedicated research laboratory personnel who are responsible for maintaining the laboratory space and stored samples, processing and storing samples, performing quantity control, and retrieving sample aliquots for studies.
The following biospecimen types are available for research use: serum, EDTA plasma, DNA extracted from saliva, and DNA extracted from whole blood or buffy coat.
Blood and serum specimens are deidentified and aliquoted into 2D barcoded storage vials using robotic liquid handlers (Tecan EVO 150, Fluent 780). ThermoFisher Orbitor robot with integrated Kingfisher instruments is used for DNA extraction. DNA quantity is measured by Infinity M200, M-NANO multimode detectors or Qubit fluorometers. Normalized DNA specimens are aliquoted using Tecan EVO 200 robot in standard 96 well PCR plates or Micronic tubes for distribution.
Storage equipment includes an RTS A4 temperature and humidity controlled robotic ambient storage unit for archiving DNA stored using Biomatrica (DNA storage stabilizer); a walk-in ultra-low freezer with 2,552 cubic feet of usable storage for approximately 5,000,000 cryotubes, three upright ultra-low Thermo Fisher freezers, two -20 o C freezers and refrigerators. All cold chain and ambient storage equipment have audible/visual alarms, 24-7 Isensix monitoring system. All critical equipment is backed up with diesel power generators and uninterrupted power source (UPS). The walk-in ultra-low freezer unit is equipped with an independent liquid nitrogen back up system.
A customized 3rd party Laboratory Information Management System (LIMS) tracks specimens at each step and is linkable to KPRB operations and clinical information databases.
The KPRB Biorepository adheres to industry best practices for processing, long term storage, retrieval, and distribution of specimens. The KPRB Quality Management system is certified by TUV USA to ISO: 9001-2015. The KPRB also maintains an accreditation with the College of American Pathologists (CAP).