- This event has passed.
Deadline for Internal Proposals: NIH Childhood Asthma in Urban Settings – Clinical Research Centers (U01)
April 6, 2020 @ 11:30 pm
Limited Submissions: Internal Call for Proposals
National Institute of Health
Childhood Asthma in Urban Settings -Clinical Research Centers (U01 Clinical Trial Optional)
UNC Internal deadline: 11:59PM, Monday, April 6, 2020
Key Dates
UNC Internal Deadline: 11:59PM, Monday, April 6, 2020
LOI Due Date: 30 days prior to application deadline
NIH Application Deadline: June 19, 2020
Important Information
- Number of Applications per Institution: Only one application per institution is allowed.
To Apply
Submit the following (in ONE .pdf) to the Office of Research Development limited submissions inbox Limited_Submissions@unc.edu by 11:59PM, Tuesday, March 3, 2020.
- PI/Proposed team member’s CV/NIH Biosketch (five-page maximum)
- Project Summary (two-page maximum)
- List of potential/committed collaborators (internal and external to UNC)
- Names of three internal (to UNC) experts who could speak knowledgeably about the candidate’s research and who could potentially serve on an internal review panel.
- Please do not include the names of faculty named on the project, chairs, deans, directors, direct reports, or others who have a conflict of interest.
- Please notify all potential internal reviewers before submitting the pre-proposal packet to ORD.
Program Overview
Background: NIAID has a long-standing interest in understanding and reducing the disproportionate burden of asthma among children living in low-income urban communities and has funded research initiatives towards this goal over the previous 3 decades. Previous NIAID-sponsored asthma-related initiatives include: a) the National Cooperative Inner City Asthma Study (NCICAS, 1991-1995) which identified cockroach as a major allergen for urban residents with asthma and demonstrated the effectiveness of an Asthma Counselor intervention; b) the Inner City Asthma Study (ICAS, 1996-2001), which demonstrated the effectiveness of an environmental intervention aimed at reducing allergen exposure among inner-city children; c) the Inner City Asthma Consortium I (ICAC I, 2002-2008), which conducted clinical trials evaluating the biomarker exhaled nitric oxide as a guide for asthma therapy, the use of omalizumab therapy for inner-city children with asthma and established URECA, a birth cohort; d) the Inner City Asthma Consortium II (ICAC II, 2008-2014), which conducted a large asthma phenotyping study, a clinical trial evaluating the use of omalizumab for fall exacerbations, and conducted safety and biomarker trials of cockroach immunotherapy. The current Inner-City Asthma Consortium III (ICAC III, 2014-2021) consists of 10 clinical sites and 6 mechanistic sites. The ongoing ICAC III has completed a clinical study determining the transcriptomic signature of asthma exacerbations and is conducting a clinical trial evaluating the effectiveness of mepolizumab among exacerbation prone children with asthma and a trial of cockroach subcutaneous immunotherapy for asthma.
Objectives and Scope: The CAUSE Clinical Research Network will conduct observational studies and clinical trials to further improve our understanding of asthma and to develop effective interventions and asthma prevention approaches tailored to children of low-income families living in urban communities.
Research supported by this FOA will involve a) children of families living in census tracts within US Office of Management and Budget-defined Metropolitan Statistical Areas (MSAs) where ≥10% of families have income below the poverty level and b) children of families who have publicly-funded health insurance, but live in MSA census tracts where <10% of families have income below the poverty level.
Specifically, research areas to be pursued in center-specific projects by the CAUSE-CRC investigators may include, but are not limited to:
-
- Mechanisms of immune tolerance to allergens
- Understanding the role of early environmental exposures in the pathogenesis of asthma
- The role of the respiratory epithelium in asthma
- Investigations into the pathogenesis and mechanisms of non-atopic asthma
- Development or early-stage evaluation of allergen immunotherapy or other immunomodulatory modalities to mitigate and/or prevent the effects of relevant allergens on asthma
Other areas of interest include studies that fall under the general objective of elucidating the pathogenesis of asthma or improving the management of asthma in children living in low-income, urban communities and focus on the immune system.
Specific Review Criteria
Significance: Does the application provide overall convincing evidence that the proposed CAUSE-CRC will be a valuable component of the CAUSE clinical research network by providing a strong clinical research site for the conduct of the CAUSE network-wide clinical trials and studies and through its own proposed center-specific studies?
Investigator(s): Do the PD(s)/PI(s) have documented experience of working collaboratively in multi-center clinical trials and/or studies? Do the PD(s)/PI(s) have experience conducting clinical research that involves children with asthma from low-income, urban communities? Are junior faculty members included in key roles in the proposed research projects?
Approach: CRC Clinical Research Functions: Do the staff have appropriate and adequate qualifications, training and expertise in the field of asthma research? Does the application present adequate plans for professional development for CAUSE-CRC investigators and staff in accordance with Federal regulatory requirements, Good Clinical Practice (GCP) guidelines and International Conference on Harmonization (IHC) standards? Does the application describe a cohesive structure and range of services to support asthma clinical research projects under the CAUSE clinical research network? Does the application indicate capacity and readiness to conduct CAUSE network-wide clinical research projects in an expeditious manner? Does the proposed CRC offer unique characteristics that will contribute to the CAUSE, such as unique recruitment capabilities and approaches for pediatric patients? Is the number of low-income, urban pediatric patients with asthma seen per year in clinics within the applicant’s institution adequate to support the CRC’s role in conducting the CAUSE network-wide and the center-specific projects? Does the application offer satisfactory approaches to recruitment of difficult-to-enroll groups, such as minorities and infants, if required? Is there an IRB-approved, active protocol that allows recruitment and clinical characterization of pediatric patients with asthma, as well as healthy volunteers?
CRC-Specific Research Projects: Are the center-specific research project plans realistic and capable of completion within the period of the award? Is each of the proposed center-specific projects adequately justified and supported by preliminary data and/or previously published research? Is the experimental design of each center-specific project appropriate in terms of outcomes, study population and eligibility criteria, study arms (appropriate controls), study visit schedule and primary evaluations, study duration and study timeline? For proposed center-specific mechanistic studies, has a clear rationale justifying the need for each study been presented and has adequate evidence been provided demonstrating the robustness and feasibility of proposed laboratory tests/capabilities? Does each center-specific project include an appropriate management plan describing the personnel involved in conducting the research, data entry and management, processing and handling of biosamples, and, if applicable, in handling investigational products? For proposed biosamples in each center-specific project, is there a description of the source and quantity to be obtained, and have potential safety and ethical issues in obtaining such samples (for example, blood drawing volume limitations) been addressed? If the use of an investigational drug is proposed in one or more of the center-specific projects, has the applicant included clear evidence of commitment by the manufacturer? If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Environment: CRC-Specific Research Projects- Does the application include acceptable evidence for the capabilities of the research laboratories to be used in center-specific projects? If applicable, does the application include suitable evidence for the availability and capabilities of investigational pharmacy services?
Please visit the full solicitation for specific review criteria.
Eligibility
- Only one application per institution.
- Eligible Individuals (Program Director/Principal Investigator): Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
Award Information
Award Budget: $300,000
Award Project Period: The proposed project period must be 7 years.
Additional Information
Full Solicitation: https://grants.nih.gov/grants/guide/rfa-files/RFA-AI-19-073.html
For additional information, please contact the Limited Submissions Team with questions at Limited_Submissions@unc.edu.
Limited Submissions Team
Office of Research Development
University of North Carolina at Chapel Hill
308 Bynum Hall
Chapel Hill, NC 27599
(919) 962-7503