Human Genome Research
NHGRI supports the development of resources and technologies that will accelerate genome research and its application to human health and genomic medicine. A critical part of the NHGRI mission continues to be the study of the ethical, legal and social implications (ELSI) of genome research. NHGRI also supports the training and career development of investigators and the dissemination of genome information to the public and to health professionals. The Small Business Innovation Research (SBIR) program is used to increase private sector commercialization of innovations derived from Federal research and development; to increase small business participation in Federal research and development; and to foster and encourage participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation. The Small Business Technology Transfer (STTR) program is used to foster scientific and technological innovation through cooperative research and development carried out between small business concerns and research institutions; to foster technology transfer between small business concerns and research institutions; to increase private sector commercialization of innovations derived from Federal research and development; and to foster and encourage participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation.
General information about this opportunity
Federal Agency/Office
National Institutes of Health, Department of Health and Human Services
Type(s) of Assistance Offered
B - Project Grants
Fiscal Year 2016 Encyclopedia of DNA Elements (ENCODE). After completing the full sequence of the human genome, scientists faced the challenge of understanding what that sequence means and how it contributes to health and disease. One approach NHGRI has taken to address this question is to support the Encyclopedia of DNA Elements (ENCODE) Project, which aims to identify the parts of the human genome sequence that are functional, that is, sequences that are thought to play a critical role in biological processes as measured by having some biochemical activity. Research laboratories participating in the ENCODE Project use a variety of methods to catalog the functional elements of the human genome. The resulting list of functional elements, which includes genes and regions that control the expression of genes, is presented as a resource that is freely available on the internet. This resource gives scientists a new set of tools to use while investigating biological phenomena and human disease. $30,000,000
Fiscal Year 2018 The ELSI Research Program funds research studies, training opportunities and workshops, and develops and supports research consortia and conferences in the following broad areas. Genomic Research - Projects in this area examine and address the issues that arise in the design and conduct of genomic research, particularly as it involves the production, analysis and broad sharing of individual genomic data that is frequently coupled with detailed health information. Genomic Health Care - Projects in this area explore how rapid advances in genomic technologies and the availability of increasing amounts of genomic information influence how health care is provided and how it affects the health of individuals, families and communities. Broader Societal Issues - Projects in this area examine the normative underpinnings of beliefs, practices and policies regarding genomic information and technologies, as well as the implications of genomics for how we conceptualize and understand such concepts as health, disease, and individual responsibility. Legal, Regulatory and Public Policy Issues - Projects in this area explore the effects of existing genomic research, health and public policies and regulations and provide data to inform the development of new policies and regulatory approaches. A more detailed description of these areas and a list of examples of possible research questions related to each are available on the ELSI Research Priorities website: http://www.genome.gov/27543732.
Fiscal Year 2017 ClinGen aims to build an authoritative central resource that defines the clinical relevance of genes and variants for use in precision medicine and research. To do so, ClinGen investigators are developing standard approaches for sharing genomic and phenotypic data provided by clinicians, researchers, and patients through centralized databases, such as ClinVar, and are working to standardize the clinical annotation and interpretation of genomic variants. Working groups are implementing evidence-based expert consensus methods to curate the clinical validity and medical actionability of genes and variants. Experts in the areas of cardiovascular disease, pharmacogenomics, hereditary (germline) cancer, somatic cancer, and inborn errors of metabolism have been brought together to assist in these curation efforts. ClinGen also aims to develop machine-learning algorithms to improve the throughput of variant interpretation and to improve understanding of variation in diverse populations as it relates to interpreting genetic test results. Lastly, ClinGen will disseminate the collective knowledge and resources for unrestricted use in the community and for use in EHR ecosystems.
Public Health Service Act, Sections 301, 461 and 487, as amended; Public Laws 78-410 and 99-158, 42 U.S.C. 241, as amended; 42 U.S.C. 285k; 42 U.S.C. 288; Small Business Research and Development Enhancement Act of 1992, Public Law 102-564.
Who is eligible to apply/benefit from this assistance?
Applicant Eligibility
Research Projects: Awards can be made to any public or private, for-profit or nonprofit university, college, hospital, laboratory, or other institution, including State and local units of government, qualifying small businesses (through the Small Business Innovation Research/STTR Programs, and to individuals. SBIR grants can be awarded only to domestic small businesses (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed, and have no more than 500 employees). Primary employment (more than one- half time) of the principal investigator must be with the small business at the time of award and during the conduct of the proposed project. In both Phase I and Phase II, the research must be performed in the U.S. or its territories. To be eligible for funding, an SBIR grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council. STTR grants can be awarded only to domestic small business concerns (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed and have no more than 500 employees) which "partner" with a research institution in cooperative research and development. At least 40 percent of the project is to be performed by the small business concern and at least 30 percent by the research institution. In both Phase I and Phase II, the research must be performed in the U.S. and its possessions. Applicants to the Small Business Innovation Research/STTR Programs must meet special requirements for small businesses, as defined by the Small Business Administration. Non-federal public and private domestic organizations may apply for an Institutional National Research Service Award. Individual National Research Service awardees must be nominated and sponsored by a public or nonprofit private institution having staff and facilities appropriate to the proposed research training program. All awardees must be citizens or have been admitted to the United States for permanent residence. Predoctoral awardees must have completed the baccalaureate degree, and postdoctoral awardees must have a professional or scientific degree (M.D., Ph.D., D.O., D.V.M., Sc.D., E.Eng., or equivalent domestic or foreign degree). To be eligible for funding for any award, an application must be reviewed for scientific merit by a scientific review group and for program relevance by a national advisory council.
Beneficiary Eligibility
Any nonprofit or for-profit organization, company, or institution engaged in biomedical research can apply for research support.
Credentials/Documentation
Each applicant for a research project must present a research plan and furnish evidence that scientific competence, facilities, equipment, and supplies are appropriate to carry out the plan. The applicant must have the expertise to carry out the project. Applications must submit an electronic grant application form SF424 which can be accessed from the funding opportunity announcement. For applicants for National Research Service Awards, the academic record, research experience, citizenship, institutional sponsorship, and the proposed area and plan of training must be included in the application. The applicant institution must show the objectives, methodology, and resources for the research training program, the qualifications and experience of directing staff, the criteria to be used in selecting individuals for the award, and a detailed budget and justification for the grant funds requested. For-profit organizations, costs are determined in accordance with 48 CFR. For other grantees, costs will be determined in accordance with HHS Regulation 45 CFR 75. For SBIR and STTR grants, applicant organization (small business concern) must present in a research plan an idea that has potential for commercialization and furnish evidence that scientific competence, experimental methods, facilities, equipment, and funds requested are appropriate to carry out the plan. SF424 applications are used for SBIR and STTR programs. SBIR and STTR applicant organizations must comply with the SBA's definition of a small business. In order to be eligible for a NRSA award, the individual must be a US citizen or permanent resident of the US.
What is the process for applying and being award this assistance?
Pre-Application Procedure
Preapplication coordination is not applicable.
2 CFR 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards applies to this program. Only application submitted in response to a funding opportunity announcement will be accepted.The standard application forms, as furnished in the Funding Opportunity Announcements at www.grants.gov, must be used for this program. This program is subject to the provisions of 45 CFR 75. The SBIR and STTR Solicitations may be obtained electronically through the NIH "Small business Funding Opportunities" homepage at: https://sbir.nih.gov/
Award Procedure
All applications must respond to a funding opportunity announcement, must be reviewed for scientific merit by an appropriate initial review group, and must be considered by the National Advisory Council for Human Genome Research (NACHGR) for program relevance. Individual NRSA applications are not reviewed by council. All scored applications compete for available funds on the basis of scientific merit and program emphasis, and availability of funds. Applications in response to a Request for Applications have council approved set aside funds, but awards are based primarily on the quality of the applications. Awards are issued throughout the year. All applications receiving a impact score ranging from the best (10) to worst (90) compete for the available funds on the basis of scientific and technical merit (SBIR/STTR applications must also demonstrate the potential for commercial application for SBIR/STTR applications), program relevance, and program balance among the areas of research. However, in reality, applications with impact scores of 30 or greater are rarely considered for funding.
October 5, 2017 to October 5, 2020 Receipt dates for applications can be found at this URL: https://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/due-dates.htm. Requests for Applications and Program Announcements for Special Review or Set Aside are not submitted on standard due dates. The submission dates of these funding opportunity announcements can be found at: https://grants.nih.gov/funding/searchguide/index.html#/.
Approval/Disapproval Decision Time
A description of the NIH Peer Review Appeal procedures is available on the NIH home page https://nexus.od.nih.gov/all/2011/04/27/the-right-step-for-filing-an-appeal/.
How are proposals selected?
The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed project; and (5) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific and technical merit of the proposed approach for achieving the Phase II objectives; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation, originality, or societal importance of the proposed research; (5) the potential of the proposed research for commercial application; (6) the reasonableness of the budget request for the work proposed; (7) the adequacy and suitability of the facilities and research environment; and (8) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment.
How may assistance be used?
The research project grant is awarded to an eligible institution in the name of a principal investigator for a discrete project or group of related projects representing the investigator's interest and competence. Funds may be used for salaries and wages, equipment, supplies, travel and other costs required to carry out the research project. National Research Service Awards are made directly to individuals for research training in disciplines supporting the research areas. In addition, grants may be made to institutions to enable them to select individuals for National Research Service Awards. Each individual who receives a National Research Service Award is responsible for certain service and payback provisions. Small Business Innovation Research (SBIR) Program: SBIR Phase I grants (of approximately 6 months' duration) are to establish the technical merit and feasibility of a proposed research effort that may lead to a commercial product or process. Phase II grants are for the continuation of research initiated in Phase I and which are likely to result in commercial products or processes. Only Phase I awardees are eligible to apply for Phase II support. STTR Phase I grants (normally of 1-year duration) are to determine the scientific, technical, and commercial merit and feasibility of the proposed cooperative effort that has potential for commercial application. Phase II funding is based on results of research initiated in Phase I and scientific and technical merit and commercial potential of Phase II application. Responsibilities of grantees and restrictions on use of funds are set forth in the Public Health Service policy statement on grants for research projects, which is available on request from the Division of Extramural Outreach and Information Resources, Office of Extramural Research, National Institutes of Health (NIH), 6701 Rockledge Drive, Room 6207, MSC 7910, Bethesda, MD 20892-7910. Telephone: (301) 435-0714. Fax (301) 480- 0525. E-mail: asknih.od.nih.gov.
What are the requirements after being awarded this opportunity?
Performance Reports: Program Directors review the reports and contact the PIs for a verbal discussion that expands upon the written report. If problems are noted, the program director will note this in the report and talk with the PI about what can be done to ensure progress is satisfactory. For more complex grants, the Program Director may request the PI to provide more frequent accounting of progress and/or teleconferences. The Grants Management Specialist/Officer reviews applications for the appropriateness of the budget requested.
Expenditures and other financial records must be retained for 3 years from the day on which the grantee submits the last expenditure report for the report period.
Other Assistance Considerations
Formula and Matching Requirements
Statutory formula is not applicable to this assistance listing.
Matching requirements are not applicable to this assistance listing.
MOE requirements are not applicable to this assistance listing.
Length and Time Phasing of Assistance
Research and program projects are awarded for 2-5 years. Institutional training grants are awarded for 5 years. Individual fellowships and career development awards are from 2-5 years. For SBIR and STTR applications, normally Phase I awards are for 6 months and Phase II awards are or 2 years. Method of awarding/releasing assistance: Letter.
Who do I contact about this opportunity?
Regional or Local Office
None/Not specified.
Bettie J. Graham, Ph.D
6700B Rockledge Drive
Bethesda, MD 20892 USA
grahambj@exchange.nih.gov
http://www.genome.gov/
Account Identification
75-0891-0-1-552
(Project Grants) FY 18$267,065,177.00; FY 19 est $275,654,000.00; FY 20 est $231,164,999.00; FY 16$377,186,406.00; FY 17 est $389,196,000.00; - RPGs: FY16 actual $244,685,229; FY17 est. $254,965,000; FY18 est. $196,855,000 Centers: FY16 actual $84,713,418; FY17 est. $74,459,000; FY18 est. $45,284,000 NRSAs: FY16 actual $ 7,751,441; FY17 est. $8,575,000; FY18 est. $7,271,000 SBIR/STTR Grants: FY 16 actual $13,009,935; FY 17 est. $14,168,000; FY18 est. $10,679,000 Other Grants: FY16 actual $11,334,338; FY17 est. $18,083,000; FY18 est. $13,964,000 R&D FY16 actual $15,692,045; FY17 est. $18,946,000; FY18 est. $13,900,000 (Project Grants (for specified projects)) FY 18$59,635,045.00; FY 19 est $58,436,999.00; FY 20 est $52,963,000.00; - (Project Grants (Fellowships)) FY 18$9,306,470.00; FY 19 est $10,314,999.00; FY 20 est $8,632,000.00; -
Range and Average of Financial Assistance
For Research project grants the range is from $26,000 - $19,996,553.
Regulations, Guidelines and Literature
42 CFR 52; 42 CFR 66; 45 CFR 74; 45 CFR 92; NIH Extramural Programs brochure and other miscellaneous program literature are available from Headquarters Office. Grants will be available under the authority of and administered in accordance with the PHS Grants Policy Statement and Federal regulations at 42 CFR 52 and 42 U.S.C. 241; Omnibus Solicitation of the Public Health Service for Small Business Innovation Research (SBIR) Grant and Cooperative Agreement Applications. Omnibus Solicitation of the National Institutes of Health for Small Business Technology Transfer (STTR) Grant applications.
Examples of Funded Projects
Fiscal Year 2016 Centers for Common Disease Genomics. The National Human Genome Research Institute (NHGRI) seeks to fund a collaborative large-scale genome sequencing effort to comprehensively identify rare risk and protective variants contributing to multiple common disease phenotypes. This initiative will explore a range of diseases with the ultimate goal of undertaking variant discovery for enough different examples of disease architectures and study designs to better understand the general principles of genomic architecture underlying common, complex inherited diseases; understand how best to design rare variant studies for common disease; and develop resources, informatics tools, and innovative approaches and technologies for multiple disease research communities and the wider biomedical research community. NHGRI plans to make 2-5 awards in FY16.
Fiscal Year 2017 The Genomics of Gene Regulation (GGR) projects will use genomic data and technologies to understand how genetic regulatory systems are assembled and how genetic regulatory systems function to determine biological processes at a mechanistic level. GGR projects are designed to advance genomic science towards the long-term goal of NHGRI research in this area, which is to be able to predict, from reading DNA sequence, when and at what level a gene is expressed, in the context of a particular cell fate/state. Understanding gene regulatory networks could facilitate interpreting the phenotypic consequences (e.g. disease) of genetic variation, particularly in non-coding regions of the genome. This is a highly significant problem, as the vast majority of disease-associated variants found using GWAS lie outside of protein-coding sequences. Many of these disease associations map to ENCODE-annotated regions, thus highlighting the importance of these ENCODE annotations. While genomic annotations are important, they are not sufficient to understand dynamic biological processes. GGR is one path to bring together modeling methods with catalogs of genomic data to understand what elements are controlling what genes, in what cell types. The ability to make accurate predictions from gene regulatory networks could support genomic medicine and precision medicine, by providing us one more tool to understand the consequences of genetic variation. As set out in the RFA, individual projects collect genomic data on gene expression, as well as surrogate markers of regulatory elements, in different cell fates or cell states. They use the gene expression and functional element data to construct gene regulatory network models, taking advantage of the dynamics of the system as the cells transition from one physiologic fate or state to another. These models will describe the biological role of the identified functional elements and how they interact to form a genetic regulatory circuit. The predictions of the initial model would then be tested experimentally by appropriate assays, for instance by perturbing (by genetic or environmental means) identified key regulators and comparing the measured biological response to the predicted response. Analysis of the outcomes of these experiments would be used to refine and further develop the model in an iterative process of modeling, prediction, and experimentation. It is hoped that this approach will lead to a detailed understanding of the individual genetic regulatory circuits under study. It is further hoped that by investigating several genetic regulatory circuits this way and organizing the projects in a collaborative research network, the GGR investigators will form an interactive group, accelerating discovery through the sharing of technical and biological insights gained during the course of the project. These interactions will be important in learning the features that are generalizable and the features that are unique, because the individual projects will be using different approaches and biological systems.
Fiscal Year 2018 ClinGen is building an authoritative central resource that defines the clinical relevance of genes and variants for use in medicine and research. To do so, ClinGen investigators are developing standard approaches for sharing genomic and phenotypic data provided by clinicians, researchers, and patients through centralized databases, such as ClinVar, and are working to standardize the clinical annotation and interpretation of genomic variants. Working groups are implementing evidence-based expert consensus methods to curate the clinical validity and medical actionability of genes and variants. Experts in the areas of cardiovascular disease, hereditary (germline) cancer, somatic cancer, pediatric neurology, hearing loss, inborn errors of metabolism among others have been brought together to assist in these curation efforts. ClinGen is also developing tools to improve the throughput of variant interpretation and to improve understanding of variation in diverse populations as it relates to interpreting genetic test results. Lastly, ClinGen will disseminate the collective knowledge and resources for unrestricted use in the community through the website (www.clinicalgenomeresource.org). Important Collaborations: • NICHD developed a three-year U24 funding opportunity (FY17-FY20) to support three curation committees to implement ClinGen frameworks into priority diseases and conditions for their institute (RFA-HD-17-001) • The American Society of Hematology (ASH) plans to support two curation committees in malignant hematology and platelet disorders. • The FDA is collaborating with ClinGen to identify novel opportunities for using high-quality public databases of clinically relevant variants to streamline review and approval of NGS-based in vitro diagnostics. The criteria for such databases are outlined in the draft guidance, "Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics."
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