National Institutes of Health (NIH)
National Human Genome Research Institute (NHGRI)
The NHGRI Genomic Data Science Analysis, Visualization, and Informatics Lab-space (AnVIL) (U24)
U24 Resource-Related Research Projects – Cooperative Agreements
The scope of this FOA is to establish the NHGRI Genomic Data Science Analysis, Visualization, Informatics Lab-space ("AnVIL") in support of genomic research. The AnVIL aims to create an interoperable resource for the research community by co-locating data, storage and computing infrastructure with commonly used services and tools for analyzing and sharing data. The AnVIL will further advance research by leveraging a cloud-based infrastructure to facilitate genomic data access by the broad scientific community, integration and computing on and across large datasets generated by NHGRI programs, or programs funded by others in support of human genomics research. In particular, the AnVIL resource will provide genomic researchers with the following:
July 17, 2017
October 9, 2017
30 days prior to the application due date
November, 9, 2017), 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.
July 1, 2018
November 10, 2017
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.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
Section I. Funding Opportunity
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
Enabled by decreasing costs, generation of genomic sequence data has become a routine part of biomedical research and, increasingly, clinical applications. Such data are produced on many scales, ranging from individual patients to large population or common disease studies. However, the ability to store, transfer, and work with these data has not kept up, resulting in many challenges. For example, the ability of researchers to work effectively on these data requires access to high-performance computing and specialized expertise to use it. However, many researchers do not have the computing infrastructure nor the expertise in-house. Also, the growing scale of the sequencing data has forced researchers to download only subsets of the data to local file systems for analysis, which impede processes that lead to novel scientific discovery.
A cloud-based storage and computing resource can alleviate many of these challenges. A cloud-based data environment would allow users to upload and run their own analysis tools where the data is stored. Over time, such an environment will foster the development and use of cloud-optimized genomic data analysis workflows and visualization tools. In addition, cloud-based resources are more likely to be scalable to accommodate ever increasing amounts of data to be stored or to compute on. Fully realized, a cloud-based environment would reduce the need for users to download data to their local computing systems, potentially alleviate data security issues, and decrease network traffic.
This FOA seeks to fund NHGRI's Genomic Data Science Analysis, Visualization, and Informatics Lab-space (herein referred to as "AnVIL"). The AnVIL will use a cloud-based data storage and compute environment to address the challenges discussed above. The AnVIL will support genomic data sharing and analysis needs of basic and clinical genomic researchers in the broad scientific community, as well as those participating in NHGRI-sponsored consortia. The AnVIL will serve bio-informaticians and computational biologist users familiar with cloud or high-performance computing, and also researchers without extensive coding experience who want to use simpler tools and web interfaces for their genomic data analysis needs. AnVIL will also support the rapid release of data to the broad scientific community and will adhere to NIH requirements and policies regarding the security of these data.
The AnVIL should be a component of the emerging NIH Data Commons, and is expected to collaborate and integrate with other genomic data resources through the adoption of the FAIR (Findable, Accessible, Interoperable, Reusable) principles, as their specifications emerge from the scientific community. The NIH genomic data commons ecosystem may include, for example, the NCI Genomic Data Commons (GDC) and Cloud Pilots, which provide the cancer research community with data repositories that are unified in their ability to enable data sharing, integration, analysis and standardization of genomic and clinical data across cancer genomic studies; The NHLBI Trans-Omics for Precision Medicine (TOPMed) Program, which plans to build a data commons repository that collects WGS data, RNA-Seq, methylation, metabolomics, other “omics” and clinical outcomes data from NHLBI-funded studies, making the data available for analysis; The All of Us Research Program (AoU) of the Precision Medicine Initiative® (PMI) that includes a Data and Research Center which will store and curate AoU data in a cloud-environment and make the data accessible for researchers through a dedicated analysis platform.
Finally, a goal of this program is for the AnVIL resource to explore and address the challenges of transitioning from traditional centralized genomic data archives, to a distributed federated data commons system to facilitate genomic data access, sharing and computing at scale.
The scope of this FOA is to establish the NHGRI Genomic Data Science Analysis, Visualization, Informatics Lab-space in support of genomic research. The AnVIL aims to create an interoperable resource for the research community by co-locating data, storage and computing infrastructure with commonly used services and tools for analyzing and sharing data. The AnVIL will further advance research by leveraging a cloud-based infrastructure to facilitate genomic data access by the broad scientific community, integration and computing on and across large datasets generated by NHGRI programs, or programs funded by others, in support of human genomics research.
The AnVIL resource is expected to include, but is not limited to, the following key elements:
The AnVIL should provide users with a cloud-based infrastructure and software platform that is scalable with respect to storage and computing capacity, available on demand by users, and elastic with the provisioning and de-provisioning of cloud resources in an automatic manner. The infrastructure should provide a storage system for diverse data access types, including for frequent data usage and high performance computing applications, as well as for less frequent usage and long term archiving. Additionally, the AnVIL should be able to accommodate growth in storage, computing, and network traffic needs over the funding period.
Should the need arise due to economical or technical convenience to the Government, the software platform on top of the cloud infrastructure should be able to be redeployed with limited new development effort on more than one commercial or private cloud service provider.
The infrastructure should also host a data management system that supports the general operations of the resource, including user accounts information, query, retrieval, access control, and a catalog of hosted datasets with key descriptors (e.g. sample size, inclusion/exclusion criteria, data use limitations, cohort demographics, data types collected, sample collection protocols, data quality), billing information, reports on usage metrics, configuration parameters for centralized analysis workflows, etc.
The AnVIL should provide a shared analysis and computing environment where individual researchers and research consortia can upload their datasets and perform analyses on their own data, or in combination with other data hosted by the AnVIL. Researchers could either use their own analysis tools or tools made available by the AnVIL. The AnVIL platform should allow users to develop, optimize, deploy, share, and reuse statistical, visualization and other types of genomic applications and analysis workflows on-demand. The AnVIL should also be able to identify and run computational analysis pipelines to generate processed datasets of broad interest to the community, such as variant calling pipelines to harmonize variant calls on datasets from various NHGRI and NIH genotyping and genome sequencing studies, or RNA-Seq pipelines to map sequence reads from multiple expression studies to the same human reference genome.
The AnVIL should be able to provide a collaborative environment for NHGRI-funded consortia where datasets and analysis workflows can be shared within the consortium, and be prepared for public release to the broad scientific community through AnVIL interfaces. In some cases, the AnVIL could interact and exchange data with consortia’s data coordination centers. In other cases, the AnVIL may directly serve as the data coordination center for NHGRI consortia, uploading data directly from consortium members and satisfying other data management needs. The establishment of consortium member accounts and their access privileges to the data and computing resources of the consortium will be coordinated with the NHGRI program officials responsible for the consortium.
The AnVIL should include a web-based portal and programmatic user interfaces. These interfaces should provide administrative, training, technical, pricing, and general information about the resource. Through these interfaces, users should be able to understand not only the overall purpose and capabilities of the AnVIL, but also how to access datasets, study-related documentation, and training materials. The portal should accept and process requests for accounts, data access, and user support.
The AnVIL should participate and contribute to the establishment of a federated genomic data commons ecosystem that may include other data commons established within and outside the NIH (e.g., the NCI Genomic Data Commons or the All of Us data resource). Adherence to FAIR requirements established by the scientific community is expected. The AnVIL is expected to implement FAIR principles in the federated ecosystem by adopting, for example, agreed upon data indexing approaches, deploying reusable and portable analysis workflows that work seamlessly on datasets distributed across cloud service providers and the federated ecosystem, standardizing metadata and applying common ontologies, and adopting common application programming interfaces (API) for sharing appropriate data and tools. The web portal and other user interfaces should also be designed to facilitate interoperability with other public genomic resources following FAIR principles.
The performance and cost competitiveness of the cloud services offered by the AnVIL will need to be carefully monitored and methods to estimate and monitor costs should be developed. Technical approaches and software solutions to reduce costs should be actively pursued. The usage of the datasets and analysis resources provided by the AnVIL should also be monitored to inform decisions about archiving.
To promote responsible usage of the AnVIL and its cloud-based resources, NHGRI expects outside users to be responsible for costs related to computing, storing and downloading their own data. Users should be given tools to estimate their costs. A billing system for the use of the cloud’s storage and computing infrastructure should be developed, implemented, and updated as users’ needs change. The billing model should be established in consultation with the NHGRI staff and the External Advisory Committee (see below).
The AnVIL should store and make available to the broad research community both unrestricted and controlled access data and associated metadata, including individual-level phenotypic information and genomic data. The AnVIL will host datasets that are expected to have, or already have, broad utility to the genomic research community, such as those from the 1000 Genomes, The Electronic Medical Records and Genomics (eMERGE) Network, The Genotype-Tissue Expression Project (GTEx), and The Encyclopedia of DNA Elements (ENCODE) projects. Data from the NHGRI Centers for Common Disease Genomics and the Centers for Mendelian Genomics programs, and potentially from other NIH programs, are expected to be shared with the community via the AnVIL. The datasets hosted by the AnVIL, and their online or archival storage status, will change as genomic research priorities change. The Data Steering Committee (see below) with input from the NHGRI staff will prioritize the datasets to be hosted and made accessible to the broad scientific community, the specific data types included, the storage and archival status, and formats utilized.
To provide harmonization of metadata and phenotype classification and facilitate cross-study comparison among the datasets hosted by the resource, commonly used controlled vocabularies, standards and ontologies (such as the PhenX Toolkit, the NIH Common Data Elements, the Human Phenotype Ontology, and OMIM terms) should be adopted and applied to the datasets’ metadata. In addition, the management staff of the AnVIL will need to work closely with owners of data sets being deposited into the AnVIL to ensure appropriate harmonization efforts have been performed.
Data security encompasses confidentiality, data integrity, and availability. While all three elements are important for the AnVIL, maintaining confidentiality of controlled access data is a particularly high priority. Confidentiality includes managing data access to maintain data security, and make data accessible to authorized users only for authorized purposes. Data security protection and proper stewardship of human genomic, phenotypic and other sensitive information stored and distributed by the AnVIL is of the utmost importance. The Notice for Use of Cloud Computing Services for Storage and Analysis of Controlled-Access Data Subject to the NIH Genomic Data Sharing (GDS) Policy (Ref: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-086.html) allows investigators to perform genomic analyses on a cloud platform. The NIH security best practices and provisions (https://www.ncbi.nlm.nih.gov/projects/gap/pdf/dbgap_2b_security_procedures.pdf) should be implemented to protect the privacy and confidentiality of research participants, and prevent unauthorized access to data. The resource is also expected to develop policies and procedures for notifying NHGRI, and managing, and mediating any loss of data or compromise of data confidentiality.
The AnVIL should conduct regular audits of its data security and protection processes, which should be validated by third party independent assessments. The Precision Medicine Initiative's Data Security Principles Implementation Guide provides an example for auditing and data security protection processes https://www.healthit.gov/sites/default/files/pmi_security_ig_v16-clean.pdf
The AnVIL will need to establish and maintain a user authentication system to allow secure access to the data and computing services of the AnVIL by individual researchers and groups of users with different access privileges. The user authentication system developed for the AnVIL should also be interoperable with established NIH authentication systems, such as the eRA Commons, for approved users of NIH data resources. Also, current NIH processes that authorize access to controlled access data through the NIH Data Access Committees should be supported.
The AnVIL is also expected to develop and implement streamlined technical and administrative processes to review and authorize controlled-access data requests, while taking into account the data use limitations of the studies hosted by the AnVIL. In addition, guidelines for the download of data from the AnVIL, including data derived from computational analyses of AnVIL’s datasets performed by the users, should be developed and implemented to address any privacy concerns associated with the download of individual level data. These activities should be pursued in consultation with NHGRI staff (including the NHGRI Data Access Committee), the Data Steering Committee and External Advisory Committee (see below).
The AnVIL should serve a diverse set of users with various levels of expertise in analysis of large genomic data sets using cloud-based resources and data security protection. Various training approaches should be developed for experienced and inexperienced users, including for example online videos, webinars, in person hackathons, and training workshops.
The AnVIL should systematically solicit and address users’ feedback about the interfaces, the datasets to be included within the resource, the training available, and the general operations of the resource, to improve the quality of the AnVIL’s services and inform development priorities.
Over the funding period of the AnVIL award, new scientific and technology advances for supporting genomic data sharing, access and computing in a federated data ecosystem may emerge. The AnVIL should aim to identify, evaluate, and incorporate new data science approaches and information technologies that improve the usage, quality, and cost effectiveness of the resource. Examples include, but are not limited to, the optimization of analysis tools and workflows for cloud platforms, the adoption of new data compression methods to reduce storage costs, tools to improve data security and protection of research participant data, and the development of tools for the parallel deployment of analysis workflows on a federated genomic data commons ecosystem.
AnVIL resource leadership and management: The leadership and management structure should be commensurate to the complexity of the project. The project management structure should ensure the efficient planning, initiation, implementation and timely completion of all activities as well as day to day oversight of the activities. Specific timelines and milestones should be developed and updated as needed, in collaboration with NHGRI staff and members of the Data Steering Committee and External Advisory Committee (see below). Metrics to assess the utilization of the resource and its impact on the genomic research community should also be developed.
The project management should involve frequent interactions and communications with NHGRI staff, including hosting site visits, and preparing additional reports as requested by NHGRI staff.
Data Steering Committee (DSC): The DSC will be established as a non-governing entity that includes PDs/PIs from each NHGRI extramural program that utilizes the AnVIL resources, the associated NIH Project Scientist(s), and the PD/PI of the AnVIL. Clinical research study participants should also be included for community representation, as well as individuals with expertise in policy development and ethical, legal or social implications (ELSI) issues. The DSC will provide recommendations for uniform data use procedures and policies across the programs and to ensure robust participant protection practices for data access and management. The DSC will also develop proposals to ensure that the AnVIL and its users consistently adhere to NIH policies and best practices. The DSC will develop criteria and assist in prioritizing datasets to be hosted and made accessible to the broad scientific community, their specific data types, their storage and archival status, and formats. NHGRI will appoint the DSC members.
External Advisory Committee (EAC): The EAC will be established to provide advice to the NHGRI and assess, on a regular basis, the AnVIL’s operations, scientific progress, guidelines to streamline data access, oversight of ethics concerns and participant protection practices, adoption of new technology solutions, cost-effective use of cloud resources, and interoperability with other data resources. The EAC members should have expertise in a broad range of topics that are relevant to genomic research, including genomic technologies, computational genomics and data science, cloud computing, data management, data sharing concerns (such as participant protection issues), and other ELSI issues. NHGRI will appoint the EAC members.
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.
The OER Glossary and the SF424 (R&R) Application Guide provide etails on these application types.
NHGRI intends to commit up to $5M in total costs in FY 2018 to fund one award. Future year amounts will depend on annual appropriations.
Application budgets should reflect the actual needs of the proposed project.
The total project period for this FOA is 5 years (FY18 through FY22).
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to 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:
Nonprofits Other Than Institutions of Higher Education
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
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:
Buttons to access the online ASSIST system or to download application forms 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, including Supplemental Grant Application Instructions 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.
For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.
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 no later than 30 days before the application due date to:
Ken Wiley, Jr. Ph.D.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed. For this specific FOA, the Research Strategy section is limited to 30 pages.
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. Provide a description of the experience of Senior/Key Personnel in similar activities.
All instructions in the SF424 (R&R) Application Guide must be followed. Costs for the procurement of cloud services should be clearly identified and detailed justification should be provided.
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:
Applicants should follow the general format of the form SF424 Application Guide (i.e., Significance, Innovation, Approach, Preliminary studies) while addressing all the scientific and foundational objectives described in the Purpose and Objectives section above.
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.
The Purpose and Objectives section above should be read carefully and for each element in that section applicants should provide the following:
Additional information applicants should provide for some specific elements is described below.
Cloud-based infrastructure and platform: This should include the technologies the applicants will use and measures they will take to enable deployment of third-party tools to the AnVIL. The portability of the proposed software platform to multiple cloud service providers should also be discussed.
Shared analysis and computing environment: Applicants should address how both individual and consortium users will be able to share data and analysis tools or workflows.
Participation in a federated genomic data commons ecosystem: Applicants should describe their plans to participate and provide leadership for collaborative activities and interoperability approaches to use in the emerging federated genomic data commons ecosystem.
Cloud services cost control: Applicants should propose a billing model and describe how it would be implemented technically.
Genomic datasets: Applicants should propose an initial set of unrestricted and controlled access datasets generated by NHGRI programs to be hosted and made available to the genomic research community. Provide a description of their formats, data types, quality and data usage limitation, estimated cloud costs and any other relevant information that explains the importance of these datasets for genomic research. Note: One of the responsibilities of the Data Steering Committee is to prioritize the datasets to be hosted and made accessible to the broad scientific community. Since the DSC will be established after the award, the AnVIL awardee in collaboration with NHGRI staff will select the datasets that initially populate the resource, their access level and other relevant features, based on the comments of the application’s reviewers.
Data access and data security: Applicants should describe any security certifications they believe to be necessary to ensure the protection and proper stewardship of sensitive information, and describe how they will achieve and maintain them over the award period.
Applicants should propose a streamlined technical and administrative authorization process for the broad scientific community to access unrestricted and controlled access data hosted in the AnVIL that is consistent with NIH policy principles for genomic data sharing.
Governance structure: Applicants should clearly describe the division of responsibilities for the whole project. The Governance structure should also describe how the PD(s)/PI(s) will manage the proposed resource, coordinate the day-to-day activities and support achievement of the proposed goals and milestones, plans for conflicts resolutions, as well as the provisioning of data for research use.
Metrics to assess the utilization of the resource and its impact on the genomic research community should be described.
Applicants should describe how they plan to interact with the EAC and DSC and organize their meetings. In describing previous experience with similar committees, applicants should discuss how advice was incorporated into a project and how this contributed to a project’s outcome. Since NHGRI will appoint the EAC and DSC members after the award, to avoid conflicts with potential reviewers, applicants should not name or contact any proposed EAC and DSC members.
Data/software transition plan: Applicants should provide a transition plan for transferring the AnVIL-associated data and software generated or otherwise made available during the award period in the event of the AnVIL being transferred to another grantee or to the Government. Refer to the "Data/software ownership and transition to another grantee" section under the Cooperative Agreement Terms and Conditions of Award below.
Other elements: Applicants are encouraged to include in the application additional topics or features that may improve the quality and effectiveness of the services provided by the AnVIL resource.
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.
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
All instructions in the SF424 (R&R) Application Guide must be followed.
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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.
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 firstname.lastname@example.org when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application in the email.
Applicants are required to follow the instructions for post-submission materials, as described in the policy.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
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 proposed resource address the needs of genomic research ? Is the scope of activities proposed for the resource appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the genomic research community?
Are the PD(s)/PI(s) and other personnel well suited to their roles in the resource? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing data science and genomic research? Do the investigators demonstrate significant experience with coordinating collaborative basic and clinical research? Does the proposed personnel include expertise in human subjects research? If the resource is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance and organizational structure and plans for conflict resolution appropriate for the resource? Does the applicant have experience overseeing selection and management of subawards, if needed?
How adequate is the proposed governance structure, including its timelines and milestones? Is the leadership structure appropriate for this resource project, including the level of effort of key personnel? Is the project schedule reasonable and well thought out? Is the plan for interacting and soliciting input from the EAC and DSC appropriate?
Does this application propose novel technical approaches and administrative solutions to support the needs of the genomic research community? Are the concepts and strategies novel and applicable in a broad sense? Are the plans for incorporating new scientific and technology advances to support efficient and cost effective genomic data sharing, access and computing adequate? Are the plans for safe-guarding sensitive study participant data appropriate and scalable?
Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the genomic research community? Are potential problems, alternative strategies, and benchmarks for success presented? Does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the resource? Is an appropriate plan for work-flow, and are well-established timelines and milestones, proposed?
Does the proposed cloud-based infrastructure and software platform meet the goal to facilitate genomic data access, integration and computing on large genomic data sets, with the highest standard for data security? Is the proposed software platform deployable on multiple cloud platforms?
Are the plans for safe-guarding sensitive study participant data adequate? Are the plans for ensuring and maintaining data access, data security, including audits of the data security processes, adequate? Are the proposed plans for user authentication and authorization appropriate?
Are the proposed plans for providing training, outreach and soliciting users’ feedback from the research community adequate?
Is the plan for collaborative activities and interoperability approaches to use in a federated genomic data commons ecosystem adequate?
Are the proposed initial datasets to be hosted and made available by the resource of broad utility to the genomic research community and adequate?
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 children, justified in terms of the scientific goals and research strategy proposed?
Will the institutional environment in which the resource will operate contribute to the probability of success in serving the genomic research community? Are the institutional support, equipment and other physical resources available to the investigators adequate for the resource proposed? Will the resource benefit from unique features of the institutional environment, and infrastructure?
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.
Are the proposed cost control and tracking methods adequate? Is the proposed user billing model appropriate?
Are the proposed metrics to assess the utilization of the resource and its impact on the genomic research community adequate?
For research that involves human subjects but does not involve one of the six 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 six 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 children 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.
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 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 appropriate national Advisory Council or Board. 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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.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.
If you wish to add special terms and conditions of award, insert a comment for OEP to add.
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:
Data/software ownership and transition to another grantee:
The AnVIL will host genomic data, phenotype and other metadata generated by NHGRI programs and other initiatives, and the AnVIL awardee is responsible for the proper stewardship and security of all data. A fundamental objective of this cooperative agreement is to ensure that the valuable data and software resources provided by the AnVIL remain available without interruption to the research community if awardee withdraws or otherwise can no longer manage the resource or the award is terminated by the NIH.
Consistent with 45 C.F.R. 75.322, the awardee will own the data generated and software developed by the awardee, and it will be able to continue to use these data and software upon expiration or termination of the award. NIH will have unrestricted cost-free access and use of the data and software generated by the awardee, including the right to transfer said data and/or software to other NIH-funded and/or managed resource projects, at the NIH's sole reasonable discretion upon termination or expiration of this cooperative agreement.
Ownership of the data and software hosted or uploaded on the AnVIL platform remain with the data and software providers. The AnVIL has no possessor rights of the data and software provided or generated by its users, who will retain ownership and control of their own resources.
Open Source Technology: Capabilities and software built as part of the NHGRI Genomic Data Science AnVIL must be delivered under an open source model. Organizations may propose to use proprietary platforms, so long as the requirements for data transparency and interoperability are maintained.
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
The Project Scientist and the Program Official will have two separate roles for this award. Both will be a scientist of the NHGRI staff and have substantial scientific and programmatic involvement during the conduct of this activity through technical assistance, advice, and coordination. However, the role of NIH staff will be to facilitate and not to direct the activities. It is anticipated that decisions in all activities will be reached by consensus and that NIH staff will be given the opportunity to offer input to this process. The NHGRI Project Scientist and Program Official will participate as voting members of the AnVIL Data Steering Committee (DSC) and External Advisory Committee (EAC). The Project Scientist and Program Official will have the following substantial involvement:
Areas of Joint Responsibility include:
Due to the complexity regarding the infrastructure and services provided by the AnVIL, a close, and collaborative, interaction among PIs/PDs, and NHGRI staff will be required. An example of such interaction is promoting the availability of the data and related resources developed in the course of this service to the scientific community at large. Another area of joint responsibility is that the NHGRI and the PIs/PDs will work with and provide information to the DSC and EAC.
The PIs/PDs are encouraged to generate publications regarding the AnVIL infrastructure and services.
For datasets in the AnVIL that have not been publicly released, the PIs/PDs will need to get approval in writing from the data owners before using the data.
For controlled-access datasets in the AnVIL, the PIs/PDs will need to go through the proper controlled access authorization process.
Any disagreements that may arise in scientific or programmatic matters between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened, including a designee of the AnVIL EAC, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of NIH and AnVIL EAC cannot reach an agreement on the third member, the third 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.
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
registration, submitting and tracking an application, documenting system
problems that threaten submission by the due date, 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)
(Questions regarding application instructions and process, finding NIH grant
Email: GrantsInfo@nih.gov (preferred method of contact)
Kenneth Wiley, Jr.
National Human Genome Research Institute
Valentina Di Francesco
National Human Genome Research Institute
National Human Genome Research Institute
National Human Genome Research Institute
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.
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