# Clinical Core

> **NIH NIH U19** · BENAROYA RESEARCH INST AT VIRGINIA MASON · 2022 · $326,266

## Abstract

SUMMARY/ABSTRACT
The Clinical Core will be responsible for patient recruitment, sample acquisition, clinical data collection, and
regulatory compliance for both of the research projects in the HIPC Center entitled “Systems immunology
profiling of respiratory viral infections in vulnerable populations”. The Clinical Core has three Specific Aims. In
Specific Aim 1, the Clinical Core will identify, recruit, and follow a pediatric cohort with asthma and an adult
cohort with rheumatoid arthritis before and after acute respiratory viral infection. In Specific Aim 2, the Clinical
Core will manage the acquisition, processing, and distribution of biologic specimens with associated clinical
information. In Specific Aim 3, the Clinical Core will ensure regulatory compliance and the protection of human
subjects. To accomplish these aims, the Clinical Core will leverage the existing infrastructure of the Childhood
Asthma in Urban Settings (CAUSE) Network and the Benaroya Research Institute at Virginia Mason (BRI). For
Research Project 1, the Clinical Core will recruit children with asthma, children with allergic sensitization, and
healthy children with no personal history of asthma or allergic sensitizations. For Research Project 2, the
Clinical Core will recruit adults with rheumatoid arthritis and healthy adults with no personal or family history of
autoimmune disease. The Clinical Core will also be responsible for longitudinal sampling of peripheral blood,
nasal swabs, and sputum collected at four in-patient clinic visits: baseline, during acute respiratory viral
infection (ARVI; 4-6 days post start of ARVI), 4 weeks post ARVI, and 12 months post baseline. Nasal swabs
will also be collected at home at the start and end of ARVI. The Clinical Core will also collect demographic and
clinical data using the HIPC clinical characterization template. Samples and linked clinical data will be tracked
in the BRI Sample Repository database where datasets can easily be queried for sample selection and
provided to research scientists for samples upon unblinding, or to the Data Management & Analysis Core for
bioinformatics analysis. The Clinical Core will also be responsible for sample processing as well as sample
distribution to each of the Research Projects, the Genomics Core, and the Adaptive Phenotyping Core. The
Clinical Core will ensure regulatory compliance and the protection of human subjects by developing and
managing registry and study documents including clinical protocols, IRB applications, and informed consent
forms. Thus, the Clinical Core has an essential role in ensuring the HIPC Center achieves its scientific
objectives.

## Key facts

- **NIH application ID:** 10420945
- **Project number:** 1U19AI167891-01
- **Recipient organization:** BENAROYA RESEARCH INST AT VIRGINIA MASON
- **Principal Investigator:** Jane Hoyt Buckner
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $326,266
- **Award type:** 1
- **Project period:** 2022-03-29 → 2027-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10420945

## Citation

> US National Institutes of Health, RePORTER application 10420945, Clinical Core (1U19AI167891-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10420945. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*