EXPIRED
Department of Health and Human Services
National Institutes of Health (NIH)
National Human Genome Research Institute (NHGRI)
Research and Development for Genome Reference Representations (GRR) (U01 Clinical Trial Not Allowed)
U01 Research Project Cooperative Agreements
New
None
RFA-HG-19-003
RFA-HG-19-002, U01 Research Project Cooperative Agreements
RFA-HG-19-004, U41 Biotechnology Resource Cooperative Agreements
93.172
The National Human Genome Research Institute (NHGRI) seeks to support research and development for a next-generation genome reference representation. This pan-genome model will be able to capture all human genome variation and support scalable analysis in a software framework that will set a robust foundation for open science. Projects will develop improved representations for computing on the information contained within the increasing numbers of diverse genome assemblies that will make up the human reference sequence going forwards. Further research and development is needed to refine and implement a practical and robust representation with software to demonstrate the ability of the reference to enable active use of population-scale variation. The pan-genome representation will need to demonstrate efficiency, scalability, computational speed, ease of use, foster adoption of the reference, and support analysis tool development by other contributors for a wide range of purposes. The FOA will fund multiple projects that will together help set benchmarks and standards in this domain. A primary requirement is to adhere to a high level of open science including open-source tools, standards, specifications, and robust software engineering to enable this core resource to be sustainable, widely integrated in the larger community and encourage outside contributions. Robust design is also expected to provide a foundation for independent efforts that may have enhanced privacy and security requirements.
January 30, 2019
March 2, 2019
March 2, 2019
April 2, 2019, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.
No late applications will be accepted for this Funding Opportunity Announcement
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not applicable
June 2019
October 2019
December 2019
April 3, 2019
Not Applicable
It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section
I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The National Human Genome Research Institute (NHGRI) seeks to support research and development for a next-generation genome reference representation as part of the Human Genome Reference Program (HGRP). When fully implemented, these representations should be able to contribute to a pan-genome model that strives to fully represent human genome variation and support scalable analysis in a software framework that has a robust foundation in open science. Projects will develop improved representations for computing on the information contained within the increasing numbers of diverse genome assemblies that will make up the human reference sequence. While the high-level concept of the pan-genome as a graph is well-established, further research and development is needed to refine and implement a practical representation and implementation to enable active use of population-scale variation. Software is needed that can demonstrate efficiency, scalability, computational speed, ease of use, and the ability to foster adoption of the reference and analysis tool development by other contributors for a wide range of purposes. The Genome Reference Representation (GRR) projects will work together to help set benchmarks and open standards to build the foundation for adoption, widespread use and population-scale analysis. A primary requirement is to adhere to a high level of open science including open-source tools, standards, specifications, and robust software engineering to enable the pangenome reference to be widely integrated in the larger community and to support outside contributions. Robust design is also expected to provide a foundation for independent efforts that may have enhanced privacy and security requirements.
Background
The current practice with large genomes, such as the human genome, is to use a standard reference as a scaffold to assemble new sequence data, given practical challenges with de novo assembly. Initiated during the International Human Genome Project, this scheme for the human genome reference has sustained and supported genomic research for more than a decade. The linear genome reference has been extended to include alternative pathways ( alt paths ) that are added to the standard reference sequence to show some variation. However, even extended versions of the current human reference sequence have proven to be an imperfect guide to the full range of variation in human populations, which has resulted in roadblocks for analysis.
The opportunity for improvement has developed in several areas. First, the current reference does not adequately represent human population genetic diversity given the limited range of haplotype and structural variation that can be included in the linear plus alt paths representation. This results in suboptimal ability to map short-read genome sequence data to the reference, in a way that is biased to favor the populations already represented in the reference. Second, it is recognized that the addition of many new individual sequences to the reference will require improvements to the ways that the information is represented, in order to ease computation and downstream use. Third, the community of users of the reference continues to expand and diversify, meaning that new informatics tools will need to be developed to make the reference easily usable for multiple communities. A solid foundation is needed to support and spur development of the diverse tools that will be needed for researchers and clinicians to take full advantage of population-scale variation.
The impetus for the HGRP, of which this FOA will fund a component, was a community webinar aimed at providing NHGRI with advice about future needs for the human genome reference. An Executive Summary for the webinar is available.
Research Objectives
There is a growing consensus on the need for a pan-genome reference that faithfully and usefully represents sequences from diverse haplotypes and populations and that can be integrated into well-engineered computational frameworks for scalable, reproducible analysis. There is a large body of prior art in graph methods from mathematics, algorithms, and computational optimization, and significant use of these methods in genomics applications. A full graph representation of the pangenome may provide better ways to understand haplotype diversity and complex variation such as structural variation, copy number variation, and repetitive sequences as well as support efficient genome data management by compressing out redundancy in population-based sequences. However, other next-generation representations other than graphs may also emerge that can meet challenges in scalability, utility, and computational efficiency, and high-value representation of the biological information.
Further research and development is needed to refine and implement a practical representation for the pan-genome that can be deployed with well-constructed software to enable active use and provide the foundation for next-generation human genomics at population-scale. The pan-genome represents a paradigm shift in genomics representation and analysis and may be poised to take advantage of advances in computation that are rapidly becoming available across many domains. The pangenome representation must support and enhance the ability of developers to produce well-engineered software that can promote the utility and adoption of the reference and build the fundamental underpinnings for success of outside efforts for a wide range of purposes. These independent efforts (outside of HGRP) may include the development of analysis tools that make use of the pangenome, visualization tools to democratize access, and establishment of independent pan-genome nodes to represent particular populations with special characteristics. These should remain interoperable to allow as much data sharing as possible in a federation but may also meter information release for sensitive data or to meet legal requirements internationally. Forward-looking design, implementation, testing and validation using robust engineering, open science principles and an outward-looking community focus will be essential to meeting these goals.
Applicants should anticipate that they will be working collaboratively with the NHGRI HGRP as a whole, of which this FOA is a component, as well as with other GRR projects funded as cooperative agreements by this opportunity. These interactions may include aspects of the human genome reference that is shared through the Human Genome Reference Center (HGRC), interacting with downstream user tool development efforts, and helping to assess the quality of the pan-genome reference that is provided.
The projects are intended to foster an emerging standard and prototype for the next-generation pan-genome reference. Models and software developed by this effort may ultimately be candidates for adoption within the HGRC. The GRR projects are meant to seed an open-source model that will encourage and integrate valuable contribution from outside participants and ultimately stimulate community-based tool development for many purposes in genomics, epigenomics, function, and clinical research. Successful efforts will model and help build the foundation to be "sustainable by design" by taking into account and integrating multiple factors that enable efficiency and community engagement. Given the limited funds that can be allocated at this early, exploratory stage, GRR projects are expected to adopt a pragmatic approach. Projects should advance a pangenome reference representation and demonstrate its properties with implementation, prototypes, validation, and testing to measure the feasibility and suitability of the model from multiple dimensions, such as low-level infrastructure performance and as a foundation to enable outside groups to use the software. This FOA is considered an opportunity to develop, engage, and demonstrate the model for a robust solution, taking into account multiple scientific, technical, engineering, organizational, and social factors that promote good design and help standards and development efforts succeed in periods of change.
Projects should be responsive to emerging standards in the broader community, such as the Global Alliance for Genomics and Health (GA4GH) and other relevant efforts. In general, GRR projects are expected to adhere to a high level of open science in design, open-source tools, standards, specifications, documentation, and robust software engineering practices to enable ultimately this core resource to be easily adopted, widely integrated in the larger community and to encourage and support outside contributions. This includes attention to documentation, open software license, distribution mechanism, and robust software development practices that are ultimately more efficient.
The HGRP is expected to use samples that are consented for unrestricted access data within current NIH policy (http://gds.nih.gov/). However, privacy by design strategies, where feasible, would be in scope for these awards. In general, design choices and implementations should consider as a factor the impact on the ability of independent groups (outside the HGRP) to embed and layer protections as needed, making information release a tunable dial, ranging from fully open to tightly controlled for data from sensitive populations.
GRR projects where feasible should indicate how software to construct and analyze a pan-genome reference can be installed by outside groups who may be working with data from sensitive populations. The ability to foster a federation of pan-genome resources that are interoperable could be part of a sustainability model that also overcomes barriers to data sharing by sharing as much as possible while formally protecting privacy. For example, more sensitive nodes might still exchange limited data through GA4GH Beacons or similar strategies. Other nodes may find lightweight protection to be sufficient to join a sharing ecosystem that may extend across international boundaries.
In a similar way, "visualization by design" strategies where feasible are encouraged. It is expected that design and implementation choices will take into account the ability of independent groups (outside the HGRP) to develop analysis and visualization tools that utilize the new reference representation. Visualization tools are often added as an afterthought, but the ability to construct the most effective strategies can be sensitive to underlying design choices that are made early in software development. Making the pangenome reference as useful to as many researchers and clinicians as possible is an important goal, which is expected to leverage user-friendly interfaces and visualizations. Similarly, projects should address where backwards compatibility can be feasible as a means to foster a smooth transition in the community, while maintaining a forward-looking perspective.
Informational Webinar: Prospective applicants are strongly encouraged to attend an informational webinar with NIH staff on March 8, 2019. Applicants should refer to https://www.genome.gov/27572476/human-genome-reference-program-webinar/
All applicants are strongly encouraged to contact NIH Staff (see Agency Contacts) to discuss the alignment of their proposed work with the goals of this FOA.
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
New
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Not Allowed: Only accepting applications that do not propose clinical trials
Need help determining whether you are doing a clinical trial?
NHGRI intends to commit $1.25 M in FY 2020 to fund 2-4 awards.
The scope of the proposed project should determine the project period. The maximum project period is three years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
o Hispanic-serving Institutions
o Historically Black Colleges and Universities (HBCUs)
o Tribally Controlled Colleges and Universities (TCCUs)
o Alaska Native and Native Hawaiian Serving Institutions
o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Other
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.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Heidi Sofia, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-480-3424
Email: Heidi.Sofia@nih.gov
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
The research plan should explain how the proposed work will advance a model for the genome reference representation for the pan-genome and develop software to help establish the foundation for its use at population scale.
The research plan should describe how the team will collaborate with other components of the HGRP such as the HGRC, HGRQ, as well as other GRR projects, and a plan for how they will be responsive to emerging standards in the broader community.
The application should provide a robust software plan with metrics and milestones that test the properties and suitability of the representation, validate the implementation, and build the foundation for sustainable, active use of the pan-genome reference in analysis of population scale variation.
The research plan should describe how the software implementation uses best practices to test and validate the suitability of the model. Applications should address how the representation and implementation can be scalable, sharable, transferable, and interoperable in an open-access and open science paradigm.
Applicants should describe how the design provides value to the biological and clinical research communities and enables independent groups (outside of HGRP) to develop (1) analysis tools for diverse genomics, epigenomics, and functional use cases, (2) robust visualization tools and user-friendly interfaces to democratize access, (3) independent nodes for a federation of interoperable references, (4) ways to measure and control information release as needed depending on the sensitivity of the data as a strategy to achieve as much interoperable data sharing as possible and (5) backwards compatibility where feasible.
The research plan should address considerations of "sustainability by design" including how it fosters an open source resource to encourage outside contributors, and addresses scientific, technical, engineering, organizational, and social factors that promote adoption to help ensure standards and development efforts succeed in periods of transition.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
In order to expedite review, applicants are requested to notify the NHGRI Referral Office by email at bettie_graham@nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Only the review criteria described below will be considered in the review process.
Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
The GRR projects are expected to perform essential research and development and work openly and collaboratively to set the foundation for a pan-genome reference representation and software implementation. This goal is innovative in itself. Innovation in the GRR projects can be measured by the pragmatic likelihood for success based on the overall integrated plan, which may combine scientific, technical, engineering, social organization, and community-focused strategies.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Does the application have high potential to advance a next-generation genome reference representation for the pan-genome as a shared, community resource?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Do the individual participants have experience and successful track records in collaborations, consortium contributions, and community-based projects?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Does the application show creative and forward-looking use of limited resources in an integrated, practical, and pragmatic plan that is likely to advance the consortium goals?
Is there innovation in scientific, technical, engineering, social organization, data and software sharing, outreach and engagement, or other categories that should be highlighted as a positive factor in contributing to the likelihood of success of the pan-genome reference?
Does the overall plan combine novel and practical elements in a pragmatic way as to enhance the overall likelihood of success?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
Does the application advance a genome reference representation that is likely to support the demands of a pan-genome reference at population-scale?
Does the application describe a collaboration plan with other components of the HGRP, other GRR projects, and how the project will engage with developing standards in the community?
Is there a robust software plan with metrics and milestones that test the properties of the representation, validate the implementation, and build the foundation for sustainable, active use of the pan-genome reference in analysis of population scale variation?
Are scientific criteria such as validity of representation and technical criteria such as scalability, efficiency, and computational speed addressed?
Does the application describe design and implementation plans that are likely to enhance the ability of independent groups (outside of HGRP) to build analysis tools, generate visualizations, democratize access, allow deployment in a federation, and encourage data sharing by providing tunable, provable privacy protection and control of information release?
Is an integrated approach based on open source and open science presented that is likely to promote adoption in the community?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address
1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Not applicable
Not applicable
Not applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Human Genome Research Institute, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council for Human Genome Research. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and
not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH
grant administration policies.
The administrative and funding instrument used for this program will be the
cooperative agreement, an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIH programmatic
involvement with the awardees is anticipated during the performance of the activities.
Under the cooperative agreement, the NIH purpose is to support and stimulate
the recipients' activities by involvement in and otherwise working jointly with
the award recipients in a partnership role; it is not to assume direction,
prime responsibility, or a dominant role in the activities. Consistent with
this concept, the dominant role and prime responsibility resides with the
awardees for the project as a whole, although specific tasks and activities may
be shared among the awardees and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
Areas of Joint Responsibility include:
Participation in the Steering Committee. A Steering Committee (or similar
coordinating unit for the program) will serve as the main governing board of
the HGRP. The Steering Committee membership will include the NHGRI Project
Scientist(s) and the P.I. of each awarded cooperative agreement. Additional
members may be added by action of the Steering Committee. Other NIH or
government staff may attend the Steering Committee meetings, if their expertise
is required for specific discussions. Each full member (limited to one person
per award center, in the case of multiple PI's per center) will have one vote,
except for NHGRI Project Scientist(s) who will have one collective vote.
Awardee members of the Steering Committee will be required to accept and
implement policies approved by the Steering Committee.
To address particular issues, the Steering Committee may establish Working Groups as needed, which will include representatives from the program, the NIH, and possibly other experts.
The Steering Committee will:
An External Scientific Panel (ESP) will be established by NHGRI, and will be responsible for reviewing and evaluating the progress of members of the HGRP toward meeting their individual and collective goals. The ESP will be composed of three to five senior scientists with relevant expertise who are not PIs of a cooperative agreement involved in the HGRP. The membership of the ESP may be enlarged permanently, or on an ad hoc basis, as needed. The ESP will meet at least once a year. During part of this meeting there will be a joint meeting with the Steering Committee to allow the ESP members to interact directly with the awardees. The ESP will make recommendations regarding progress of the HGRP and present advice about changes, if any, which may be necessary.
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help
Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information
(Questions regarding application instructions, application processes, and NIH
grant resources)
Email: GrantsInfo@nih.gov (preferred
method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support (Questions regarding
Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Heidi Sofia, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-480-3424
Email: Heidi.Sofia@nih.gov
Rudy Pozzatti, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-8739
Email: pozzattr@exchange.nih.gov
Deanna Ingersoll
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-7858
Email: Deanna.Ingersoll@nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.