Opportunity Information: Apply for RFA HG 12 008
Apply for RFA HG 12 008
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical Sequencing Exploratory Research Coordinating Center (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.172 Human Genome Research.
- This funding opportunity was created on Apr 20, 2012 and posted on Apr 20, 2012.
- Applicants must submit their applications by Jul 26, 2012. (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 $800,000.00 in funding.
- Eligible applicants include: Private institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Special district governments State governments County governments City or township governments Others (see text field entitled Additional Information on Eligibility for clarification) Small businesses Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The Clinical Sequencing Exploratory Research Coordinating Center (U01) funding opportunity (RFA-HG-12-008) is an NIH cooperative agreement designed to act as the central hub for coordination, support, and shared infrastructure across multiple NIH-funded research efforts focused on using genomic sequencing in real clinical care. Rather than funding a standalone sequencing study, this announcement funds a coordinating center whose main job is to help a network of already-funded projects work together efficiently, use consistent approaches where appropriate, and generate knowledge that is comparable and useful across sites. The coordinating center is intended to support investigators funded under the Clinical Sequencing Exploratory Research (CSER) program (referencing RFA-HG-10-017 and RFA-HG-12-009), which studies how genomic sequence data can be applied to patient care in active clinical settings. It also supports the Return of Results (RoR) Consortium, which brings together elements of CSER along with projects funded under the Ethical, Legal, and Social Implications (ELSI) program (RFA-HG-11-003 and RFA-HG-11-004), reflecting the reality that returning genomic findings to patients raises scientific, clinical, ethical, legal, and social questions that need coordinated study.
Because the mechanism is a cooperative agreement (U01), NIH expects substantial involvement with the awardee in shaping, guiding, and overseeing the work of the coordinating center. In practical terms, this structure is commonly used when NIH wants a funded group to run shared services for a multi-site program, convene working groups, harmonize data elements, and enable cross-project analyses, while keeping NIH program staff actively engaged in governance and progress monitoring. The coordinating center role implied by the announcement is to provide centralized project management and communications support for the CSER and RoR investigators, enabling collaboration across studies that may differ in patient populations, sequencing strategies, clinical workflows, and return-of-results models. The ultimate goal is to accelerate learning about how sequencing can be integrated into healthcare, and to make the evidence generated by these independent but related projects more coherent and broadly informative.
This opportunity falls under the NIH activity category of Health and is associated with CFDA 93.172 (Human Genome Research), indicating it is situated within NIH genome research priorities, including the translation of sequencing into clinical contexts. The award ceiling listed is $800,000, and there is no cost-sharing or matching requirement, which means applicants are not required to contribute non-federal funds as a condition of receiving the award. The announcement was posted and created on April 20, 2012, with an original and current closing date of July 26, 2012, and an archive date of August 26, 2012, indicating it was a time-limited competition tied to that program period.
Eligibility is broad and reflects NIH norms for institutional applicants. Eligible applicants include public and private institutions of higher education, nonprofit organizations (including those with and without 501(c)(3) status, other than universities), for-profit organizations (including small businesses and other for-profits), and a wide range of government entities such as state, county, city/township governments, special district governments, and certain housing authorities. The eligibility language also explicitly includes many mission-serving and community-based institutions and organizations, such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, and regional organizations, as well as eligible federal agencies. Tribal governments and tribal organizations are included, with distinctions between federally recognized tribal governments and other tribal entities. U.S. territories or possessions are also listed as eligible. At the same time, non-U.S. (foreign) institutions are not eligible to apply as the applicant organization, though non-U.S. components of U.S. organizations are allowed, and foreign components (as defined in NIH policy) are permitted. This structure is typical for NIH awards where the prime recipient must be a domestic entity, but international collaborations or activities can be incorporated when justified and consistent with NIH policy.
Conceptually, the coordinating center supported by this FOA is meant to strengthen the overall CSER and RoR ecosystem by creating shared processes and points of connection across otherwise independent projects. That often includes organizing consortium meetings and working groups, supporting collaborative protocol development or alignment, facilitating the sharing of tools and methods, promoting consistency in how key outcomes are measured, and enabling network-level dissemination of findings and best practices. Given the RoR and ELSI linkage, the coordinating center would be expected to help integrate clinical implementation questions with return-of-results challenges, such as patient preferences, consent models, communication strategies, clinical follow-up, provider education, privacy and data use considerations, and downstream outcomes once results are returned. In short, the grant is about building and running the coordination backbone for a multi-study program exploring real-world clinical sequencing and the responsible return of genomic information.
The sponsoring agency is the National Institutes of Health, and the full announcement was made available through the NIH Grants Guide. For technical issues accessing the electronic announcement, NIH provided the Office of Extramural Research (OER) webmaster contact (FBOWebmaster@OD.NIH.GOV), reflecting the announcement era when opportunities were commonly cross-posted and linked between NIH systems and federal opportunity portals.
Frequently Asked Questions (FAQs)
What is the Clinical Sequencing Exploratory Research Coordinating Center (U01) opportunity (RFA-HG-12-008)?
RFA-HG-12-008 is an NIH cooperative agreement (U01) that funds a coordinating center to serve as a central hub for coordination, support, and shared infrastructure across multiple NIH-funded research efforts using genomic sequencing in real clinical care settings.
Is this grant intended to fund a standalone genomic sequencing research study?
No. This funding opportunity is specifically for a coordinating center, not a standalone sequencing study. The main purpose is to help a network of already-funded projects collaborate effectively, align approaches where appropriate, and generate comparable and useful knowledge across sites.
What programs and projects does the coordinating center support?
The coordinating center is intended to support investigators funded under the Clinical Sequencing Exploratory Research (CSER) program (referencing RFA-HG-10-017 and RFA-HG-12-009). It also supports the Return of Results (RoR) Consortium, which brings together elements of CSER along with projects funded under the Ethical, Legal, and Social Implications (ELSI) program (RFA-HG-11-003 and RFA-HG-11-004).
What is the CSER program focused on?
CSER studies how genomic sequence data can be applied to patient care in active clinical settings, with the goal of learning how sequencing can be integrated into healthcare.
What is the Return of Results (RoR) Consortium and why is it included?
The RoR Consortium focuses on issues involved in returning genomic findings to patients. It is included because returning genomic results raises scientific, clinical, ethical, legal, and social questions that benefit from coordinated study across projects and disciplines.
What does it mean that this is a cooperative agreement (U01)?
A U01 is a cooperative agreement mechanism where NIH expects substantial involvement with the awardee in shaping, guiding, and overseeing the work. This is commonly used when NIH wants a funded group to run shared services for a multi-site program, convene working groups, harmonize data elements, and enable cross-project analyses, while NIH program staff remain actively engaged in governance and progress monitoring.
What kinds of activities is the coordinating center expected to perform?
Based on the opportunity description, the coordinating center is expected to provide centralized project management and communications support for CSER and RoR investigators and enable collaboration across studies that may differ in patient populations, sequencing strategies, clinical workflows, and return-of-results models. The coordinating center role also includes building shared processes and points of connection across otherwise independent projects.
Does the opportunity describe specific coordination functions the center may carry out?
Yes. The description indicates the coordinating center may organize consortium meetings and working groups, support collaborative protocol development or alignment, facilitate sharing of tools and methods, promote consistency in how key outcomes are measured, and enable network-level dissemination of findings and best practices.
How does this opportunity connect clinical implementation questions with ELSI issues?
The coordinating center is expected to help integrate clinical implementation questions with return-of-results challenges. The description highlights areas such as patient preferences, consent models, communication strategies, clinical follow-up, provider education, privacy and data use considerations, and downstream outcomes once results are returned.
What is the overall goal of funding a coordinating center for clinical sequencing research?
The goal is to accelerate learning about how sequencing can be integrated into healthcare and to make the evidence generated by independent but related projects more coherent, comparable, and broadly informative across sites.
Which NIH category and CFDA number are associated with this opportunity?
This opportunity falls under the NIH activity category of Health and is associated with CFDA 93.172 (Human Genome Research).
What is the maximum award amount listed for this opportunity?
The award ceiling listed is $800,000.
Is cost-sharing or matching required?
No. The opportunity states there is no cost-sharing or matching requirement, meaning applicants are not required to contribute non-federal funds as a condition of receiving the award.
When was this funding opportunity posted, and what were the key dates?
The announcement was posted and created on April 20, 2012. The original and current closing date was July 26, 2012, and the archive date was August 26, 2012, indicating it was a time-limited competition tied to that program period.
Who is the sponsoring agency?
The sponsoring agency is the National Institutes of Health (NIH), and the full announcement was made available through the NIH Grants Guide.
What organizations are eligible to apply?
Eligibility is broad and includes public and private institutions of higher education; nonprofit organizations (including those with and without 501(c)(3) status, other than universities); for-profit organizations (including small businesses and other for-profits); and a wide range of government entities such as state, county, and city/township governments, special district governments, and certain housing authorities.
Are community-based, mission-serving, and minority-serving institutions eligible?
Yes. The eligibility language explicitly includes Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, and regional organizations.
Are tribal governments and tribal organizations eligible?
Yes. Tribal governments and tribal organizations are included, with distinctions made between federally recognized tribal governments and other tribal entities.
Are U.S. territories or possessions eligible to apply?
Yes. U.S. territories or possessions are listed as eligible.
Can a non-U.S. (foreign) institution apply as the main applicant?
No. Non-U.S. (foreign) institutions are not eligible to apply as the applicant organization under this opportunity.
Are foreign components or non-U.S. components allowed in any form?
Yes. Non-U.S. components of U.S. organizations are allowed, and foreign components (as defined in NIH policy) are permitted.
Why does NIH use a coordinating center model for this kind of program?
The coordinating center model supports shared services and infrastructure for a network of projects, helps convene investigators, harmonizes data elements and approaches where appropriate, and enables cross-project analyses and dissemination. This structure is especially relevant when multiple studies differ in design and context but need a coherent way to compare results and learn collectively.
What should applicants understand about NIH involvement during the project?
Because it is a cooperative agreement (U01), NIH program staff are expected to be actively engaged in governance and progress monitoring, with substantial involvement in shaping, guiding, and overseeing the coordinating center's work.
Who should be contacted for technical issues accessing the electronic announcement?
For technical issues accessing the electronic announcement, NIH provided the Office of Extramural Research (OER) webmaster contact: FBOWebmaster@OD.NIH.GOV.
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