NHLBI TOPMed: Omics Phenotypes of Heart, Lung, and Blood Disorders (X01 - Clinical Trial Not Allowed) | PAR 19 048

Frequently Asked Questions (FAQs): NHLBI TOPMed - Omics Phenotypes of Heart, Lung, and Blood Disorders (PAR-19-048)

What is the NHLBI TOPMed: Omics Phenotypes of Heart, Lung, and Blood Disorders opportunity (PAR-19-048)?

This is a National Institutes of Health (NIH) funding announcement from the National Heart, Lung, and Blood Institute (NHLBI) designed to help researchers generate large-scale omics datasets (such as whole genome sequencing and other high-throughput assays) tied to well-characterized heart, lung, and blood disorders. The goal is to create standardized, high-quality omics and phenotype data that can accelerate discovery for the broader research community.

What is the main purpose of this program?

The core purpose is to enable well-phenotyped cohorts to use NIH-supported omics infrastructure to uncover genetic contributors and molecular signatures linked to common, complex diseases affecting the heart, lungs, and blood. The emphasis is on producing datasets that support downstream analyses, including identifying variants, pathways, biomarkers, and disease subtypes.

What kinds of diseases or conditions are in scope?

The opportunity focuses on common, complex disorders affecting the heart, lungs, and blood. The program expects phenotypes relevant to these conditions to be well-curated and clearly defined so that omics measurements can be meaningfully linked to disease traits, outcomes, risk factors, severity, progression, and subtypes.

What does "omics" mean in this opportunity?

In this context, "omics" refers to large-scale molecular profiling, including whole genome sequencing and potentially other high-throughput assays supported through NIH omics capacity. The specific assays can include genomics and other molecular profiling approaches, depending on what NIH infrastructure is accessed for the project.

Does this opportunity fund the creation of new laboratory capacity?

No. The program is designed to use existing NIH-funded omics resources rather than paying to build new lab capacity. The central benefit is access to NIH-supported omics infrastructure to generate standardized datasets.

What is the award mechanism, and what does it mean for applicants?

This is an X01 mechanism. It provides no direct funding to applicants. Instead, it provides access to NIH-funded omics capacity (for example, sequencing or other assays). Applicants should plan to support all project components not covered by the NIH-provided omics services.

If there is no direct funding, what does the award actually provide?

The primary benefit is access to NIH-supported omics capacity to perform whole genome sequencing or other high-throughput assays. In practice, it functions more like a resource-access or services mechanism than a traditional grant that pays for staff, supplies, or research operations.

What parts of the project are applicants expected to support themselves?

Applicants are expected to support the work not covered by NIH-provided omics capacity, such as cohort management, sample collection and processing logistics, phenotype harmonization, regulatory compliance, and coordination needed to deliver high-quality samples and data.

What are the expectations for biospecimens?

Successful applicants are expected to contribute biospecimens suitable for whole genome sequencing or other omics assays. The biospecimens must be paired with strong phenotype information relevant to heart, lung, and blood conditions.

Why is phenotype quality emphasized so strongly?

The scientific value of omics data depends heavily on the quality and depth of clinical and epidemiologic characterization. The program prioritizes datasets where molecular measurements can be connected to clearly defined traits, outcomes, and risk factors, enabling robust genetic and molecular association analyses.

How will data sharing work under this opportunity?

There is a strong commitment to data sharing. Resulting omics data and associated phenotypic information will be deposited into a public data repository such as dbGaP, making the dataset broadly available for secondary research by the wider scientific community.

What is dbGaP, and why is it mentioned?

dbGaP is named as an example of a public data repository where generated omics and phenotype data will be deposited. Its inclusion highlights that public deposition and broad reuse are built into the program design.

What should applicants consider regarding consent and data governance?

Applicants should expect that consent, data governance, and any data-use limitations must align with broad data sharing and NIH expectations, because public deposition of the resulting data is a central feature of the program.

Who can apply for this opportunity?

Eligibility is broad and includes many organization types that can assemble valuable cohorts and biospecimen resources. Eligible applicants include various levels of government (state, county, city/township, special district), independent school districts, public and private institutions of higher education, tribal governments and tribal organizations, public housing authorities/Indian housing authorities, nonprofits (with or without 501(c)(3), other than institutions of higher education), for-profit organizations (other than small businesses), small businesses, and other organizations.

Are minority-serving institutions and community-based organizations eligible?

Yes. The eligibility list explicitly includes groups such as HBCUs, Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISISs). It also calls out faith-based or community-based organizations as eligible.

Are U.S. territories, federal agencies, regional organizations, or foreign organizations eligible?

Yes. The opportunity includes eligibility for eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations).

Which NIH institute sponsors this opportunity?

The sponsoring agency is the National Institutes of Health (NIH), with the National Heart, Lung, and Blood Institute (NHLBI) as the relevant institute for this announcement.

What is the activity area and how is this opportunity categorized?

It is categorized as a discretionary grant opportunity under NIH, with health as the activity area.

What CFDA numbers are associated with this opportunity?

The opportunity is associated with CFDA numbers 93.233, 93.837, 93.838, and 93.839.

Is a clinical trial allowed under this announcement?

No. The opportunity is labeled "Clinical Trial Not Allowed," meaning applications should not propose a clinical trial as part of the work under this mechanism. The scope is oriented toward generating omics and phenotype datasets for observational, genetic, and molecular association research rather than testing interventions.

What is the timeframe shown for this specific announcement?

The source information lists an original posting date of 2018-11-01 and an original closing date of 2019-10-18, indicating that this specific announcement had a defined submission window during that period.

Why does the program emphasize broad reuse of the resulting datasets?

The structure is intended to maximize return on investment by enabling many investigators to reuse the data for replication studies, meta-analyses, method development, and new hypothesis testing. Public deposition supports broader scientific value beyond the original cohort team.

What is the expected end product from projects supported by this mechanism?

The expected outputs are standardized, high-quality omics datasets (such as whole genome sequence data and potentially other high-throughput assay data) linked to well-curated phenotype information for heart, lung, and blood disorders, with deposition into a public repository such as dbGaP.