Opportunity Information: Apply for RFA HG 12 009
Apply for RFA HG 12 009
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Clinical Sequencing Exploratory Research (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 93.279 Drug Abuse and Addiction Research Programs.
- 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.)
- The funding agency has allocated a total of $5,700,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $1,500,000.00 in funding.
- Eligible applicants include: City or township governments For profit organizations other than small businesses Others (see text field entitled Additional Information on Eligibility for clarification) State governments Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts County governments Special district governments Public and State controlled institutions of higher education Small businesses Native American tribal governments (Federally recognized) 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.
- 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 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 (U01) opportunity, offered by the National Human Genome Research Institute (NHGRI) together with the National Institute on Drug Abuse (NIDA) under Funding Opportunity Number RFA-HG-12-009, supported early, real-world studies on how genomic sequencing could be used directly in patient care. The core idea was to move beyond theoretical discussions and pilot sequencing projects and instead test, inside active clinical settings, what it actually takes to generate genomic sequence data, interpret it in a medically meaningful way, deliver it to clinicians in a form they can use, and communicate results to patients responsibly. The announcement recognized two converging trends: rapidly expanding knowledge about how genetic variation influences disease risk and treatment response, and major advances in sequencing technology that made broad genomic sequencing far more feasible in terms of cost and technical capacity. Because of that, NIH sought applications that would tackle the practical and scientific barriers to integrating sequencing into routine clinical workflows.
Projects responding to this FOA were expected to address critical end-to-end questions across the clinical sequencing pipeline. That included the generation of sequence data (for example, approaches to sequencing in a clinical context, quality standards, and handling of large-scale genomic outputs), interpretation and translation (how to decide which variants matter, how to classify findings, and how to turn complex genomic information into clear clinical statements), and delivery to the physician (how to present results in ways that fit clinical decision-making, potentially including reporting formats, clinical decision support concepts, and integration with existing care processes). A major emphasis was also placed on patient communication, meaning applicants needed to consider how genomic information would be explained, what kinds of results should be returned, and how uncertainty, secondary or incidental findings, and evolving interpretations would be handled over time.
A distinctive feature of the program was its explicit requirement to examine the ethical, legal, and psychosocial issues (often referred to as ELSI) that come with bringing broad genomic data into the clinic. In practice, this could involve questions such as informed consent for sequencing that may reveal unexpected health risks, privacy and confidentiality challenges, implications for family members, potential stigma or discrimination concerns, and the psychological impact on patients who receive complex or probabilistic risk information. The FOA signaled that technical success alone was not enough; funded projects needed to explore how clinical sequencing affects patients, providers, and health systems, and what safeguards, policies, or best practices might be necessary.
From an administrative standpoint, this was a discretionary funding opportunity using the Cooperative Agreement mechanism (U01), which generally indicates substantial NIH program involvement compared to standard research project grants. The funding activity categories listed were Education and Health, and the program was associated with CFDA numbers 93.172 (Human Genome Research) and 93.279 (Drug Abuse and Addiction Research Programs). The estimated total funding available was $5.7 million, with an award ceiling of $1.5 million per award, and there was no cost-sharing or matching requirement. The opportunity was posted on April 20, 2012, with an application due date (original and final) of July 26, 2012, and it was archived on August 26, 2012.
Eligibility was broad and included many types of domestic U.S. organizations and governments, such as state, county, city, township, special district governments, public housing authorities, independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, nonprofits (including both 501(c)(3) and non-501(c)(3) entities), small businesses, and for-profit organizations other than small businesses. It also allowed participation from tribal governments and tribal organizations, and specifically noted eligibility for a range of mission-focused institutions and community organizations, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, and tribally controlled colleges and universities (TCCUs). Importantly, non-U.S. entities (foreign institutions) were eligible to apply, non-U.S. components of U.S. organizations were eligible, and foreign components as defined by NIH policy were allowed, which reflects the international relevance of genomic medicine and the value of diverse clinical settings and populations.
Overall, this FOA was designed to fund exploratory, clinic-embedded research that would surface the real operational, interpretive, and human challenges of using genomic sequencing as part of health care. Rather than focusing only on sequencing technology itself, it targeted the full translation pathway: how raw sequence becomes a clinical report, how clinicians and patients understand and act on it, and what ethical and psychosocial considerations must be addressed for genomic medicine to be used safely, effectively, and responsibly.
Frequently Asked Questions (FAQs): Clinical Sequencing Exploratory Research (U01)
What is the name of this funding opportunity?
The opportunity is titled Clinical Sequencing Exploratory Research (U01).
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA-HG-12-009.
Which NIH institutes are offering this opportunity?
This FOA was offered by the National Human Genome Research Institute (NHGRI) together with the National Institute on Drug Abuse (NIDA).
What is the main purpose of this FOA?
The purpose was to support early, real-world studies that test how genomic sequencing can be used directly in patient care. The emphasis was on moving beyond theoretical discussions and stand-alone pilot sequencing efforts to study what it takes to generate, interpret, deliver, and responsibly communicate sequencing results within active clinical settings.
What kinds of studies was NIH trying to move beyond?
The FOA specifically aimed to move beyond theoretical discussions and pilot sequencing projects by funding clinic-embedded research that tests sequencing in real clinical workflows.
Why was this opportunity created (what trends did it respond to)?
The announcement highlighted two converging trends: (1) rapidly expanding knowledge of how genetic variation influences disease risk and treatment response, and (2) major advances in sequencing technology that made broad genomic sequencing more feasible in terms of cost and technical capacity.
What practical barriers was NIH looking for applicants to address?
NIH sought applications that would tackle the practical and scientific barriers to integrating sequencing into routine clinical workflows, including generating sequence data, interpreting findings for medical use, delivering results to clinicians effectively, and communicating results to patients responsibly.
What parts of the clinical sequencing pipeline were projects expected to cover?
Projects were expected to address end-to-end questions across the pipeline, including:
- Generation of sequence data (sequencing approaches in clinical contexts, quality standards, handling large-scale genomic outputs)
- Interpretation and translation (deciding which variants matter, classifying findings, turning complex results into clear clinical statements)
- Delivery to physicians (reporting formats, clinical decision support concepts, and integration into care processes)
- Patient communication (how results are explained and returned, handling uncertainty, secondary/incidental findings, and evolving interpretations over time)
What did the FOA mean by “generation of sequence data” in a clinical setting?
Based on the FOA description, this included clinical-context sequencing approaches, establishing or applying quality standards, and dealing with the operational realities of producing and managing large-scale genomic outputs in care environments.
What issues were included under interpretation and translation of sequencing results?
The FOA highlighted challenges such as determining which variants matter, how to classify findings, and how to convert complex genomic information into clear, medically meaningful clinical statements.
What did “delivery to the physician” involve?
Delivery focused on presenting sequencing results in a way that supports clinical decision-making. The FOA pointed to possible elements like reporting formats, clinical decision support concepts, and integration with existing care processes.
How important was patient communication in this FOA?
Patient communication was a major emphasis. Applicants were expected to address how genomic information would be explained to patients, what results would be returned, and how to manage uncertainty, incidental/secondary findings, and changing interpretations over time.
Did the FOA require projects to address incidental or secondary findings?
Yes. The FOA explicitly called out the need to consider how secondary or incidental findings would be handled and communicated, including how uncertainty and evolving interpretation would be managed over time.
What are ELSI issues, and were they required in this program?
ELSI refers to ethical, legal, and psychosocial issues. A distinctive feature of this program was an explicit requirement to examine ELSI concerns that come with using broad genomic data in clinical care. The FOA signaled that technical performance alone was not sufficient.
What examples of ELSI topics did the FOA highlight?
The FOA provided examples including:
- Informed consent for sequencing that may reveal unexpected risks
- Privacy and confidentiality challenges
- Implications for family members
- Potential stigma or discrimination concerns
- The psychological impact of receiving complex or probabilistic risk information
Was technical success alone considered sufficient for funded projects?
No. The FOA emphasized that projects needed to explore how clinical sequencing affects patients, providers, and health systems, and to consider what safeguards, policies, or best practices might be needed for responsible use.
What award mechanism was used for this opportunity?
This was a Cooperative Agreement (U01) funding mechanism.
What does it mean that this was a Cooperative Agreement (U01)?
The FOA indicated that a U01 generally involves substantial NIH program involvement compared to standard research project grants.
What funding activity categories were listed?
The funding activity categories listed were Education and Health.
What CFDA numbers were associated with this program?
The FOA was associated with CFDA numbers 93.172 (Human Genome Research) and 93.279 (Drug Abuse and Addiction Research Programs).
How much total funding was estimated to be available?
The FOA listed an estimated total funding amount of $5.7 million.
What was the maximum award amount (award ceiling)?
The award ceiling was $1.5 million per award.
Was cost sharing or matching required?
No. The FOA stated there was no cost-sharing or matching requirement.
When was this opportunity posted?
The FOA was posted on April 20, 2012.
What was the application due date?
The application due date (original and final) was July 26, 2012.
Is this funding opportunity still open?
No. The FOA was archived on August 26, 2012.
What types of U.S. organizations were eligible to apply?
Eligibility included a wide range of domestic U.S. entities, such as state, county, city, township, and special district governments; public housing authorities; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits (both 501(c)(3) and non-501(c)(3)); small businesses; and for-profit organizations other than small businesses.
Were tribal governments and tribal organizations eligible?
Yes. The FOA allowed participation from tribal governments and tribal organizations.
Did the FOA specifically mention eligibility for certain mission-focused or community-based institutions?
Yes. The FOA specifically noted eligibility for organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, and tribally controlled colleges and universities (TCCUs), among others.
Could non-U.S. (foreign) organizations apply?
Yes. The FOA stated that non-U.S. entities (foreign institutions) were eligible to apply.
Could non-U.S. components of U.S. organizations participate?
Yes. The FOA stated that non-U.S. components of U.S. organizations were eligible.
Were foreign components allowed under NIH policy?
Yes. The FOA allowed foreign components as defined by NIH policy.
What kind of research setting was this FOA focused on?
This FOA was focused on research conducted inside active clinical settings, where sequencing could be tested as part of real patient care workflows.
Was the FOA focused only on sequencing technology development?
No. While it recognized advances in sequencing technology, the FOA targeted the full translation pathway: turning raw sequence data into clinical reports, ensuring clinicians can use the information, supporting responsible patient communication, and addressing ethical and psychosocial considerations.
What outcomes or insights was this program intended to surface?
The FOA was designed to surface real operational, interpretive, and human challenges of using genomic sequencing in health care, including what it takes to integrate sequencing into routine clinical workflows safely, effectively, and responsibly.
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Previous opportunity: Clinical Sequencing Exploratory Research Coordinating Center (U01)
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