Core B - Human Subjects Core

NIH RePORTER · NIH · P01 · $409,165 · view on reporter.nih.gov ↗

Abstract

Summary / Abstract The Human Subjects Core will provide a core resource for the recruitment of human participants for clinical studies that support the aims of the projects. Recruiting human subjects for mechanism-oriented clinical research protocols requires well-developed systems to ensure successful subject recruitment and the collection of high quality biospecimens from well-characterized human subjects. The Core will serve all projects, and it will provide strong resources for the safe conduct of human-based research. The clinical studies conducted by the core involve complicated protocols that include virtual navigational bronchoscopy. The infrastructure required to support this kind of human research is complex and challenging and the core provides experienced and highly trained personnel to meet this challenge. Therefore, the first aim of the core is to provide a human subjects core for PPG investigators with strong personnel resources and effective participant recruitment systems to ensure the safe conduct of the protocols, compliance with regulatory requirements, and timely recruitment. The second aim of the core is to enroll human participants in two clinical studies to support the three PPG projects: (i) “Study Of Focal Airway disease in Asthma using Image Guided Bronchoscopy” - “SOFA study”; this study is notable for its use of virtual navigational bronchoscopy to allow directed collection of airway biospecimens from mucus plugged airways and control airways (patent airways); (ii) “Tissue Immune interaction in nasal Polyposis - “TIP study”. The TIP study is notable for its collection of nasal polyp tissue and sinus mucus samples. Both studies will provide high quality biospecimens from either lower airway (SOFA study) or upper airway (TIP study) type 2 niches.

Key facts

NIH application ID
10226874
Project number
5P01HL107202-08
Recipient
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
Principal Investigator
John V Fahy
Activity code
P01
Funding institute
NIH
Fiscal year
2021
Award amount
$409,165
Award type
5
Project period
2012-08-15 → 2024-07-31