Opportunity Information: Apply for RFA HG 16 011
Apply for RFA HG 16 011
- The HHS-NIH11 in the education, health sector is offering a public funding opportunity titled "Clinical Sequencing Evidence-Generating Research (CSER2) - Clinical Sites with Enhanced Diversity (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.172, 93.307, 93.399,.
- This funding opportunity was created on May 06, 2016 and posted on May 06, 2016.
- Applicants must submit their applications by Sep 07, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $2,500,000.00 in funding.
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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Opportunity Summary:
Clinical Sequencing Evidence-Generating Research (CSER2) - Clinical Sites with Enhanced Diversity (U01) is an NIH cooperative agreement funding opportunity (RFA HG 16 011) designed to build real-world evidence about how genome sequencing should be used in everyday clinical care, especially in settings that serve patients from ancestrally and socioeconomically diverse backgrounds. The program aims to create and support a set of clinical sites that, taken together, represent a wide range of healthcare environments (for example, different types of hospitals and clinics, different patient populations, and different clinical indications). A central emphasis is ensuring the research includes groups that have historically been underrepresented in genomic research and that often experience worse health outcomes due to structural, social, and access-related factors.
The scientific and practical goals are threefold. First, funded sites are expected to define, generate, and analyze evidence about the clinical utility of genome sequencing. In practice, this means moving beyond whether sequencing can technically produce a result and focusing on whether it improves care: does it change diagnosis, influence treatment choices, guide prevention, clarify prognosis, or reduce unnecessary testing, and under what circumstances. Second, the opportunity explicitly calls for studying the human and organizational interactions that shape implementation, including how patients and family members understand and use results, how clinicians incorporate genomic findings into care decisions, and how clinical laboratories communicate, validate, and report results in ways that are usable in a busy healthcare setting. Third, it targets the operational barriers that arise when trying to connect genomic data with clinical records and healthcare utilization data inside a health system, with the intent of building an evidence base that supports better clinical decision-making over time. That includes challenges such as data interoperability, governance and consent, workflow integration, privacy and security considerations, and aligning data capture with routine care processes.
A defining feature of this FOA is the enhanced diversity recruitment expectation. Applicants are expected to recruit at least 60 patients who come from racial or ethnic minority populations, underserved populations, or populations that experience poorer medical outcomes. This requirement is notably higher than the recruitment expectation in the companion announcement (RFA HG-16-010), which sets a minimum of 25 such patients. The increased threshold signals that this particular funding track is specifically intended to strengthen evidence about genome sequencing in populations and care settings where evidence gaps are often largest, and where implementation hurdles may differ due to differences in access, trust, language, resources, and care pathways.
Administratively, the award mechanism is a U01 cooperative agreement, meaning NIH is expected to have substantial involvement in the project beyond standard grant oversight. The sponsoring agency is within HHS/NIH (listed as HHS-NIH11), and the funding activity category is Education and Health, with CFDA numbers 93.172, 93.307, and 93.399. The opportunity is open to a broad set of eligible applicants, including state, county, and local governments; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities; nonprofit organizations (both 501(c)(3) and non-501(c)(3)); for-profit organizations (other than small businesses); small businesses; and other entities as specified in the eligibility clarification text. The award ceiling is listed at $2,500,000. The FOA was created and posted on May 6, 2016, with an application closing date of September 7, 2016.
Overall, this opportunity funds clinical research sites that can both deliver genomic sequencing in real healthcare environments and rigorously study what happens when sequencing is introduced into care for diverse patient groups. The intent is to produce actionable evidence about benefits, limitations, and best practices, while also confronting the practical realities of integrating genomic information with clinical and utilization data so that health systems can make better, evidence-based decisions at the point of care.
Frequently Asked Questions (FAQs)
What is the Clinical Sequencing Evidence-Generating Research (CSER2) - Clinical Sites with Enhanced Diversity (U01) opportunity?
This opportunity is an NIH cooperative agreement funding program (RFA HG 16 011) intended to support clinical research sites that generate real-world evidence about how genome sequencing should be used in everyday clinical care, with a strong focus on care settings serving ancestrally and socioeconomically diverse patient populations.
What is the main purpose of this funding opportunity?
The purpose is to build evidence about the clinical utility and practical implementation of genome sequencing in routine healthcare, particularly in environments where patients have historically been underrepresented in genomic research and may face structural, social, and access-related barriers that can affect health outcomes.
What does "clinical utility" mean in the context of this program?
In this program, clinical utility goes beyond whether sequencing can produce a technical result. It focuses on whether sequencing improves care in real clinical settings, such as whether it changes diagnosis, influences treatment choices, guides prevention, clarifies prognosis, or reduces unnecessary testing, and under what circumstances those benefits occur.
What types of clinical environments are expected to be represented by funded sites?
The program aims to support a set of sites that collectively represent a wide range of healthcare environments. Examples mentioned include different types of hospitals and clinics, different patient populations, and different clinical indications, so that findings reflect diverse real-world care contexts.
What is the "enhanced diversity" expectation?
A defining feature of this funding track is an enhanced diversity recruitment expectation. Applicants are expected to recruit at least 60 patients from racial or ethnic minority populations, underserved populations, or populations that experience poorer medical outcomes.
How does the recruitment expectation differ from the companion announcement?
This track requires recruitment of at least 60 patients meeting the diversity/underserved criteria, which is higher than the minimum in the companion announcement (RFA HG-16-010), which sets a minimum of 25 such patients. The higher threshold signals that this track is specifically meant to strengthen evidence where gaps are often largest.
Why does the FOA emphasize underrepresented and underserved populations?
The FOA emphasizes these groups because they have historically been underrepresented in genomic research and often experience worse health outcomes due to structural, social, and access-related factors. The goal is to ensure evidence about genome sequencing is relevant and actionable for the settings and populations where implementation challenges and evidence gaps may be greatest.
What are the three main scientific and practical goals of the program?
The goals are: (1) define, generate, and analyze evidence about the clinical utility of genome sequencing; (2) study the human and organizational interactions that shape implementation in real healthcare settings; and (3) address operational barriers to connecting genomic data with clinical records and healthcare utilization data within a health system.
What kinds of implementation factors does the FOA call for studying?
The FOA explicitly calls for studying how patients and family members understand and use results, how clinicians incorporate genomic findings into care decisions, and how clinical laboratories communicate, validate, and report results in ways that are usable in busy healthcare settings.
What operational and data-related challenges are included in the scope?
The FOA targets barriers involved in linking genomic data with clinical records and healthcare utilization data inside a health system. Examples listed include data interoperability, governance and consent, workflow integration, privacy and security considerations, and aligning data capture with routine care processes.
What is the award mechanism, and what does it imply for NIH involvement?
The award mechanism is a U01 cooperative agreement. This implies NIH is expected to have substantial involvement in the project beyond standard grant oversight, reflecting a more collaborative relationship between NIH and the funded sites.
Which federal agency sponsors this opportunity?
The sponsoring agency is within HHS/NIH (listed as HHS-NIH11).
What is the funding activity category for this opportunity?
The funding activity category is listed as Education and Health.
What CFDA numbers are associated with this opportunity?
The CFDA numbers listed for this opportunity are 93.172, 93.307, and 93.399.
Who is eligible to apply?
The opportunity is open to a broad set of eligible applicants, including: state, county, and local governments; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities; nonprofit organizations (both 501(c)(3) and non-501(c)(3)); for-profit organizations (other than small businesses); small businesses; and other entities as specified in the eligibility clarification text.
What is the maximum award amount (award ceiling)?
The award ceiling is listed as $2,500,000.
When was the FOA created and posted?
The FOA was created and posted on May 6, 2016.
What was the application closing date?
The application closing date was September 7, 2016.
What types of research outputs is the program trying to produce?
The intent is to produce actionable evidence about the benefits, limitations, and best practices for using genome sequencing in clinical care, while also addressing the practical realities of integrating genomic information with clinical and utilization data to support evidence-based decision-making at the point of care over time.
What does it mean that this opportunity funds "clinical sites"?
Based on the description provided, funded projects are expected to operate in real healthcare environments where genome sequencing can be delivered as part of clinical care, and where the site can rigorously study what happens when sequencing is introduced into routine workflows for diverse patient groups.
What kinds of patient-level outcomes or impacts are implied by the FOA's focus?
The FOA highlights impacts such as changes in diagnosis, treatment decisions, prevention strategies, prognosis clarification, and reductions in unnecessary testing, as well as how patients and families understand and use sequencing results in real-world care.
What kinds of health system outcomes or impacts are implied by the FOA's focus?
The FOA emphasizes evidence and infrastructure that support better clinical decision-making over time, including addressing interoperability and workflow challenges so genomic data can be meaningfully connected to clinical records and utilization data within health systems.
What is the official identifier for this funding opportunity?
The opportunity is identified as RFA HG 16 011 and is titled "Clinical Sequencing Evidence-Generating Research (CSER2) - Clinical Sites with Enhanced Diversity (U01)."
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