October 26, 2021
PA-20-183 NIH Research Project Grant (Parent R01 Clinical Trial Required)
PA-20-185 NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
National Heart, Lung, and Blood Institute (NHLBI)
The purpose of this Notice of Special Interest (NOSI) is to stimulate research and advancement of methodologies in data science in heart, lung, blood, or sleep (HLBS) biomedical research, and ultimately translate new insights into decision-making to improve health.
Background
The adoption of data science has accelerated into several industries, including healthcare and biomedical research. The rise of artificial intelligence (AI) and machine learning (ML) have enabled the advent of relevant solutions to health issues that help train computer systems for auto-tuning and finding insights faster and more accurately. Thus, the rapidly changing landscape in technology, dynamic data sources and data types, manual and labor-intensive analytics, technology silos in healthcare services, and accuracy in interpretation and translational insights have become major challenges to understand and discover complex mechanisms of human health and disease. Numerous challenges of biomedical research exist in data science from data ascertainment, data processing, model building, outcome assessment to solution deployment with ethical considerations. Examples of issues and challenges include, but are not limited to:
The overarching goal of this NOSI is to enhance robustness, explainability, feasibility, usability, and workforce development to accelerate discovery at all phases of HLBS research. With NHLBI’s continuing support, the reissue of this NOSI seeks to attract the emerging data science workforce into biomedical research interests from all levels of education and career stages to open new frontiers in HLBS research.
Research Objectives
The objectives of this Notice are to: (1) stimulate the advancement of novel data science methodologies for gaining new insights; (2) enable innovative engineering solutions for better and faster data analytics; and (3) communicate research outputs through open-science platforms. The scope of the scientific issues and challenges must be of relevance to the NHLBI’s mission and aligned with the NHLBI Strategic Vision.
The innovative methodologies of data science may focus on either single or multiple algorithms in AI and ML. Study designs may be in basic, pre-clinical, clinical, clinical implementation, and public health, or a combination of these phases. The sources of data may come from any study design phase or from real-world data/real-world evidence, such as electronic medical/health record systems (EMR/EHR), product and disease registries, mobile devices, Internet of Things (IOTs), social media, geospatial environments, etc. A complementary, multi-disciplinary, Multi-Principal Investigators (MPIs) approach is encouraged to address the Critical Challenges/Compelling Questions of the NHLBI’s Strategic Vision, NIH Publication 16-HL-6150.
Sharing of resources and effective communication of outputs to the broader scientific community is an essential element of applications. Research plans that actively adhere to open-science and FAIR (Findable, Accessible, Interoperable, and Reusable) principles would be of greatest interest to NHLBI. Research outputs may include but not be limited to open-source, reusable, high-quality metadata; smart tools; algorithms; documentation; supplemental materials; presentations at conferences or publications containing guidelines with examples, tutorials, and source code.
For the integrative omics analysis of NHLBI TOPMed data, please check NOT-HL-21-017.
Application and Submission Information
Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement.
NOTE: For this NOSI, NHLBI will only accept applications in response to PA-20-183 and PA-20-185. For PA-20-183, only mechanistic clinical trials will be accepted in accordance with NOT-HL-19-690. Applicants wishing to propose non-mechanistic clinical trials may consider applying to one of the NHLBI clinical trial mechanisms described at https://www.nhlbi.nih.gov/grants-and-training/clinical-trial-development-continuum. Non-mechanistic clinical trials submitted in response to this NOSI via PA-20-183 will be withdrawn.
All instructions in the SF424 (R&R) Application Guide and the FOAs used for submission must be followed, with the following additions:
Potential applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must consult NHLBI program staff and submit a letter of request to the NHLBI prior to submitting any applications, and follow the procedures of the NHLBI implementation of the NIH Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.
Investigators planning to submit an application in response to this NOSI are strongly encouraged to contact and discuss their proposed research/aims with an NHLBI program officer listed on this NOSI well in advance of the grant receipt date.
Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.
John Haller, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Email: [email protected]