Clinical Sequencing Evidence-Generating Research (CSER2) - Clinical Sites (U01) | Apply Online

Frequently Asked Questions (FAQs)

What is the Clinical Sequencing Evidence-Generating Research (CSER2) - Clinical Sites (U01) opportunity?

CSER2 - Clinical Sites (U01) (RFA-HG-16-010) is a National Institutes of Health (NIH) cooperative agreement funding opportunity intended to support clinical research sites that can test and evaluate how genome sequencing performs in routine, real-world healthcare settings.

Which federal agency is offering this grant?

This is a discretionary funding opportunity under the U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH). The agency listing provided is HHS-NIH11.

What is the main purpose of funding clinical sites through CSER2?

The program is designed to build a group of clinical sites that reflect a broad range of real-world care environments and serve patients who are diverse both ancestrally and socioeconomically, across many different clinical conditions. The central focus is generating practical evidence that can guide clinical decision-making and health system implementation of genome sequencing.

Is this program focused only on laboratory sequencing work?

No. CSER2 is explicitly centered on evidence-generation in healthcare practice, not sequencing as a stand-alone laboratory activity. The expectation is that clinical sites will study how sequencing results are used (or not used) in everyday care and what impact that has on decisions and outcomes.

What does "clinical utility" mean in the context of this FOA?

In this funding opportunity, clinical utility refers to whether and how genome sequencing changes patient care in meaningful ways. Examples described include improving diagnosis, influencing treatment choices, altering care pathways, affecting outcomes, or reducing unnecessary testing. Awardees are expected to define, generate, and analyze evidence about these kinds of real clinical impacts.

What kinds of evidence are awardees expected to produce?

Awardees are expected to go beyond reporting sequencing results. The program emphasizes producing evidence that helps clinicians, health systems, and policymakers understand the real clinical value of genome sequencing in specific contexts, including whether it changes care and how it affects downstream decisions and utilization.

What is meant by "implementation research" in this opportunity?

Implementation research here focuses on human and organizational factors that determine whether clinical genome sequencing is used effectively. This includes studying the interactions among patients, family members, healthcare practitioners, and clinical laboratories, because those relationships shape how results are ordered, communicated, understood, trusted, and acted upon.

What patient- and provider-facing issues are specifically highlighted?

The FOA highlights practical issues such as informed consent, patient preferences, result disclosure, provider education and readiness, clinical workflow integration, and coordination between laboratories and clinicians for variant interpretation and reporting.

Does the FOA address electronic health records (EHR) and data integration?

Yes. A major emphasis is on real-world data challenges related to connecting genomic information with clinical records and healthcare utilization data. Funded sites are expected to identify and address barriers to integrating genomic data with electronic health records and other health system data sources so outcomes, utilization patterns, and downstream clinical decisions can be analyzed at scale.

Why does the program emphasize integrating genomic data with clinical and utilization data?

The broader intent described is to help build a shared evidence base that supports more consistent and data-driven clinical decision-making around genome sequencing across institutions. Linking genomic data to clinical records and utilization data is presented as a practical requirement to evaluate real-world impact.

How does CSER2 incorporate equity and inclusion requirements?

Equity and inclusion are explicitly built into the program requirements. Applicants to this FOA are expected to recruit at least 25 patients from groups that are racial or ethnic minority populations, underserved populations, or populations that experience poorer medical outcomes.

Is there a different recruitment expectation mentioned for a related announcement?

Yes. The text notes a higher recruitment expectation in a companion funding announcement (RFA-HG-16-011), where applicants are expected to recruit a minimum of 60 patients from racial or ethnic minority populations, underserved populations, or populations that experience poorer medical outcomes. This is described to underscore the program structure aimed at ensuring evidence is not limited to historically overrepresented populations.

What type of NIH funding mechanism is used?

The opportunity uses a U01 cooperative agreement mechanism. A U01 typically involves substantial NIH programmatic involvement compared with standard research grants, as indicated in the description.

What is the activity category for this opportunity?

The opportunity is listed under the Education and Health activity category.

What CFDA numbers are associated with this opportunity?

The opportunity lists CFDA numbers 93.172 and 93.399.

Who is eligible to apply for this grant opportunity?

Eligibility is broad and includes multiple levels of government, public and private institutions of higher education, nonprofit organizations (both 501(c)(3) and non-501(c)(3)), for-profit organizations (including small businesses), tribal governments and tribal organizations, and other entities as described in the full eligibility language.

What kinds of clinical sites is NIH trying to fund through this FOA?

NIH intends to fund clinical research sites that can deliver genome sequencing in real care settings while also rigorously evaluating its clinical impact. Collectively, the sites are intended to reflect a wide range of real-world care environments and patient populations that are ancestrally and socioeconomically diverse across many clinical conditions.

What is the award ceiling listed for this opportunity?

The award ceiling is listed as $2,000,000.

When was this opportunity posted, and what is the application closing date?

The opportunity was posted and created on May 6, 2016. The application closing date is September 7, 2016.

How does this program aim to influence clinical decision-making?

The program aims to generate practical, real-world evidence about when genome sequencing is clinically useful and how it can be implemented effectively in health systems. This evidence is intended to inform clinicians, health systems, and policymakers about when and how sequencing should be used to support consistent, data-driven decisions.

What downstream impacts of sequencing are specifically called out as areas of interest?

The description highlights impacts such as improving diagnosis, influencing treatment choices, altering care pathways, affecting outcomes, and reducing unnecessary testing. It also emphasizes examining downstream clinical decisions and healthcare utilization patterns by linking genomic and health system data.