Department of Health
and Human Services (HHS)
and Human Services (HHS)
National Institute on Aging (NIA)
Reissue of PAR-16-047
NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available
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August 23, 2019- Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137
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This Funding Opportunity Announcement (FOA) invites applications specific to infrastructure that will support the storage, analysis, and sharing of primary and secondary data for the genetics and genomics of Alzheimer's disease and Alzheimer's disease-related dementias (AD/ADRD).
February 6, 2020
April 25, 2020
Standard dates apply.
The first standard due date for this FOA is May 25, 2020.
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
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
Standard dates apply.
Standard dates apply.
Standard dates apply.
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.
This FOA invites applications for a competition to continue and to extend the scope of the NIA Genetics of Alzheimer's Disease Data Storage Site (NIAGADS).
NIAGADS was established in 2006 as a data storage site to act as a research resource for the NIA Alzheimer's Disease (AD) Genetics Initiative. NIAGADS archives, processes, and distributes genetic data and publicly displays results in accord with the Genomics of Alzheimer's Disease Sharing Policy. Data stored at NIAGADS include genetic, genomic, phenotypic, analytic, and other data relevant to genetic analysis, such as clinical and neuropathology data elements and related data provided by NIA-funded investigators in keeping with the NIAGADS Data Distribution Agreement. Genetic, expression, epigenomic, and related data are available at the level of specific genes. Following a review and approval process by a Data Access Committee, NIAGADS makes available to qualified investigators data from early- and late-onset AD/ADRD. Data types include those from genetic/genomic studies of AD, such as high-density genotyping and sequencing data, genomic data, extensive multi-layered phenotype data, and summary statistics from published genetic studies. The information technology employed serves to optimize the accessibility and usefulness of the information within the database. Ongoing outreach efforts are designed to maximize data sharing in order to enhance research in AD/ADRD. NIAGADS maintains an up-to-date listing of resources for researchers in the scientific community and has a flexible web-based data entry system using standardized common data elements for AD research studies that can be accessed by qualified investigators for a variety of basic science and clinical research studies.
The NIAGADS mission was broadened in 2012 when it was funded as a cooperative agreement simultaneously with the launch of the Alzheimer's Disease Sequencing Project (ADSP). NIAGADS supports ADSP production of genetic data and summary statistics from large numbers of genetically informative, phenotypically well-characterized families having multiple individuals affected with AD and from early- and late-onset AD/ADRD cases and controls. NIAGADS is fully engaged in providing infrastructure support for sequence data analysis and participates in key ADSP Work Groups to facilitate rapid data sharing. NIAGADS acts as the data coordinating center for ADSP-related data, including genome wide association studies (GWAS), whole genome sequence data (WGS), whole exome sequence data (WES), targeted genome sequencing data, phenotypic data, functional genomics data, and related primary and secondary analysis data. NIAGADS provides a genomics database and other bioinformatics infrastructure. NIAGADS receives input on operations from an external board of consultants.
This research resource provides a large data storage site of publicly available harmonized sequence, phenotypic, and annotation data, along with an integrated tool set for examining and comparing the genomes of affected and unaffected individuals, aligning sequence to genomes, and displaying and sharing users own annotation data. NIAGADS has the capacity for user authentication in keeping with NIH policy, operates using cloud-based services, is compliant with NIH-mandated data security policies, and is presently certified to operate at the Fed-Ramp moderate approval level. NIAGADS has the ability to accept and link to associated genetic and phenotypic data that are available in other AD/ADRD-related databases and to link with other NIH genetic research resources and genomic databases. NIAGADS works in tandem with other NIH science and technology research infrastructure to maximize the use of cloud environments and to streamline NIH data accessibility and use. NIAGADS also maintains a robust outreach effort.
NIAGADS acts as the data repository for the ADSP. An important aspect of NIAGADS function in the next five years is to continue to coordinate with the National Centralized Repository for Alzheimer's Disease and Related Dementias (NCRAD) and the National Alzheimer's Coordinating Center (NACC) and to provide infrastructural support for the NIA-funded ADSP Discovery, Discovery Extension, and the Follow-Up Study (FUS). In 2016, NIA funded the NIA Genomics Center for Alzheimer’s Disease (GCAD) U54 as part of the ADSP to facilitate and support quality control checking, data harmonization, and meta-analysis for all phases of ADSP activities. GCAD provides quality control checked and harmonized data to NIAGADS. NIAGADS, in turn, provides these data to the research community at large. Working in tandem, multiple entities interact in this effort, including the Alzheimer Disease Genetic Consortium (ADGC), the Collaboration on Alzheimer’s Disease Research (CADRE), the Cohorts for Heart and Aging Research in Genomic Epidemiology (CHARGE), the network of NIA-sponsored Alzheimer's Disease Centers (ADCs), the Alzheimer's Disease Neuroimaging Initiative (ADNI), and other multiple- and single-site studies that involve the collection and storage of data for genetic research on AD/ADRD. Other ongoing collaborations include those with the National Human Genome Research Institute (NHGRI)and other NIH Institutes and Centers (ICs). NIAGADS has developed working relationships with all of these entities. Future success depends on keeping the relationships together.
In the next five years NIAGADS should continue to work toward:
NIAGADS should continue to develop procedures to identify and code data that should be preserved for long-term research community availability; likewise, NIAGADS should provide infrastructure for the long-term preservation and stewardship of those research products. NIAGADS should continue developing and sustaining the infrastructure necessary for long-term stewardship of NIA-funded legacy data related to the genetics and genomics of AD/ADRD.
NIAGADS should continue working internationally and should be enabled to interact with collaborators that cross disciplinary boundaries. NIAGADS should seek to ensure that their research products are made available according to the FAIR principles to ensure that data are findable, accessible, interoperable, and reusable, while operating under NIH policy on genomic data sharing. NIAGADS should provide access to metadata and landing pages for discoverability and should support researchers with documentation guidance, citation support, and data curation. NIAGADS should consider options for working with a Global Unique Identifier (GUID) to provide subject identification that allows researchers to share data specific to a study participant without exposing personally identifiable information (PII). NIAGADS will distribute data to qualified investigators for use in research studies following government guidelines and regulations.
NIAGADS should continue providing milestone-driven overall ADSP project management activities through the Dashboard or a similar mechanism to support ADSP investigator goals. The database should have the ability to receive and organize previously collected and new genetic, genomic, and phenotypic data. It should devise plans for working with a range of stakeholders, including government, academic scientists, industry, and data-management experts. Ongoing and new collaborative interactions should be supported, including those with NACC, NCRAD, the Alzheimer's Disease Neuroimaging Initiative (ADNI), and the Accelerating Medicines Partnership (AMP) Sage Bionetworks (SAGE). In addition, interactions with AnVil (RFA-HG-17-011); NHLBI’s Data Storage, Toolspace, Access, and analytics for biG-data Empowerment (DataSTAGE); and the NIH Science and Technology Research Infrastructure for Discovery, Experimentation, and Sustainability (STRIDES) Initiative should be considered in order to parallelize activities across NIH. The database should be enabled for cellular network/pathway analysis and data visualization, with the ability to interface with external databases to enable linking of genetic/genomic data for rapid discovery of therapeutic approaches for AD. This will require coordination of the receipt, processing, storage, annotation, analysis, and distribution of data from a variety of projects and the ability to link clinical data with various forms of genetic and genomic data. This will also require the skills and flexibility to apply cutting-edge science to the development and use of new data analysis protocols and quality assurance/control measures.
Community outreach and a user-friendly, query-based website are essential components of the overall activity of the database. In the next five years, the database should expand its user base to other complex neurological diseases and stakeholders. This may mean including genetic counsellors, clinicians, and neuroscientists in basic and clinical research as potential users by providing scientific expertise. Projects supported by NIAGADS will include both academic and industry-based research. Data sharing, effective workflow management, and protocol standardization are expected to play a significant role in the success of these activities as an AD/ADRD research resource.
New NIA Initiatives
In the next five-year funding period, it is expected that NIAGADS will expand its scope to ensure that the database will have a central data repository that will meet the needs of the growing AD Genetics Initiative. Emphasis should be on facilitating the analysis of deep endophenotypic data. NIAGADS should be a state-of-the-art central data repository for data (genetic, genomic, annotation, analysis, statistical, and phenotypic) collected by other NIA-funded studies with the capability to work in the cloud environment. The NIA AD Genetics Initiative has recently expanded to include three new major components that require robust augmentation of database infrastructure: phenotypic data harmonization, alternative approaches to analyzing ADSP genetic data through machine learning and related approaches, and functional genomics.
Phenotypic Data Harmonization
The ADSP FUS expects ~28,000 whole genomes from ethnically diverse populations to be ready for analysis in 2020-2021. By 2023 the total number of ADSP subjects with WGS is expected to be ~50,000, including multi-ethnic cohorts from global regions such as Central and South America and Asia. NIA has supported the development of several epidemiologic cohorts that have genetic data and omic data. There are massive amounts of clinical and phenotypic data available on these subjects. To ensure the value of the analysis of the genetic/genomic data, harmonization of the phenotypic data must be done. Thus, NIA has an urgent need to develop fast and efficient approaches to data harmonization to drive the field toward therapeutic target discovery. The NIA National Advisory Council on Aging (NACA) has supported the policy that the infrastructure for this effort be provided by NIAGADS. It is expected that NIAGADs will develop and maintain appropriate infrastructure support for this effort.
Machine Learning and Related Analytical Approaches for ADSP Genetic Data
NIA PAR-19-269 invites applications that propose Artificial Intelligence (AI), Machine Learning (ML), and/or Deep Learning (DL) approaches that lead to the identification of gene mutations/variants that cause or contribute to the risk of or protection against the development of AD/ADRD via analysis of a variety of genetic, genomic, and biomarker data that are being made available to the research community through NIAGADS. Under this FOA, a large amount of existing GWAS, whole genome, whole exome, genomic, endophenotypic, clinical, and epidemiological data from ethnically diverse affected and unaffected individuals will be harmonized and analyzed using cognitive systems analytical approaches. Final outcome data and support documents resulting from this study will be shared with the research community through NIAGADS. It is expected that NIAGADs will develop and maintain appropriate infrastructure support for this effort.
Functional Genomics
The ADSP has identified more than 50 unique genetic variants, including single-nucleotide variations, rare copy-number, and structural variations, most of which reside in the inter- and intragenic regions that may affect gene expression rather than protein sequence. Determining the functions of ADSP-identified coding and non-coding genomic elements, transcription factors, and non-coding RNAs will increase the understanding of AD/ADRD endophenotypes and facilitate the transition of genetics from gene discovery to a deeper mechanistic understanding of the genetic etiology of AD/ADRD. NIA expects the ADSP and other researchers to generate comprehensive maps of genome and epigenome annotations with AD/ADRD-associated functional genomic elements to establish a fundamental research resource to be made quickly available to the community. This will enable genetically driven investigation of disease heterogeneity and mechanisms, leading to improved understanding of the genetic architecture of AD/ADRD. As with all facets of the ADSP, NIAGADS will support rapid and broad sharing of outcome data. NIAGADS will support the AD/ADRD functional genomics portfolio and incorporate these annotation data as part of the genome browser effort to increase the potential to identify therapeutic targets for this disease. NIAGADS will serve as a bridge to facilitate the transition of genetic discoveries for the development of potential new targets for medical diagnostics and therapeutics. It is expected that NIAGADs will develop and maintain appropriate infrastructure support for this effort in the long term.
Summary
In summary, this FOA addresses NIA's vital need for a central database for the storage and exchange of AD genetics and related data. NIA is committed to facilitating the collection and sharing of data related to research in the area of the genetics of AD. NIAGADS is a critical facet of the NIA Alzheimer's Disease Genetics Initiative that effectively leverages the investments already made related to the etiology of AD/ADRD. Applications considered for funding should effectively leverage the investments already made related to investigation of the root causes of the disease. The research resource should provide a large database of publicly available sequence and annotation data, along with an integrated tool set for examining and comparing the genomes of affected and unaffected individuals, aligning sequence to genomes, and displaying and sharing users own annotation data. Besides data storage, data processing, and data sharing, the database should provide optimally effective mechanisms for data distribution. In addition to efforts already under way, NIAGADS will support three new components of the AD/ADRD Genetics Initiative: ADSP phenotypic data harmonization, machine learning and related approaches to the analysis of AD/ADRD genetic and genomic data, and functional genomics. NIAGADS will facilitate and support the harmonization and analysis of large-scale phenotypic data for the next phase of ADSP activities. The effort will serve as a means to better understand endophenotypes of AD/ADRD that may accelerate the discovery of therapeutic targets for the disease. It is anticipated that these data will become a long-lived legacy data set that will be perpetually curated. NIAGADS will act as a central hub for the machine learning effort in order to avoid redundancy in existing infrastructure. Functional genomics data will be a new and integral component of the data sets that will be managed by the database. Investigators will coordinate milestone-driven efforts through NIAGADS to generate data that are consistent in presentation to the research community and to integrate data and related data files necessary for their research.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
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The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
The maximum project period is five years.
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
For-Profit Organizations
Governments
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 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.
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.
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.
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:
Marilyn Miller, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9350
Fax: 301- 494-1494
Email: millerm@nia.nih.gov
It is expected that PD(s)/PI(s) and other personnel will have appropriate experience and training for management of large-scale databases, with expertise in archiving, processing, and distributing genetic and phenotypic data and publicly displaying data. The PD(s)/PI(s) should be facile in curation of large data sets, including genetic, genomic, and phenotypic data relevant to genetic analysis, such as clinical and neuropathology data elements and related data provided by NIA-funded investigators. The PD(s)/PI(s) should have demonstrated experience and an ongoing record of accomplishments in effectively managing a cloud-based secure database in order to discover risk and protective genetics factors for AD. The PD(s)/PI(s) should demonstrate significant experience with coordinating collaborative (basic or clinical) research. If the application is multi-PD/PI, investigators should have complementary and integrated expertise and skills in order to provide appropriate leadership, governance, plans for conflict resolution, and organizational structure applicable to the database. The applicant should have experience overseeing selection and management of sub awards, if needed. The PD(s)/PI(s) should provide a plan to form an executive committee that oversees the work and that ensures that the AD community is well served by the genetics and genomics database.
All instructions in the SF424 (R&R) Application Guide must be followed.
Research Strategy
Explain how the proposed data storage site will be response to the need to serve as an interface between the ADSP, the AD/ADRD research community, the NIA Genome Center for Alzheimer's Disease, and other related ADSP infrastructure. Explain how the proposed data storage site will be responsive and flexible to the evolving needs in the AD research community, including its ongoing collaborations and existing interactions with stakeholders on data harmonization, machine learning and related efforts, and functional genomics.
The following modifications also apply:
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.
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.
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, NIH. Applications that are incomplete or non-compliant will not be reviewed.
Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.
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.
Does the proposed data storage site address the needs of the research programs that it will serve? Is the scope of activities proposed for the data storage site appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research programs?
How responsive and flexible is the proposed data storage site likely to be to evolving needs in the AD research community, including its ongoing collaborations and existing interactions with stakeholders on data harmonization, machine learning and related efforts, and functional genomics? How responsive is the proposed data storage site to the need to serve as an interface between the ADSP, the AD/ADRD research community, the NIA Genome Center for Alzheimer's Disease, and other related ADSP infrastructure?
Are the PD(s)/PI(s) and other personnel well suited to their roles in the data storage site? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing a database in order to discover risk and protective genetic factors for AD? Do the investigators demonstrate significant experience with coordinating collaborative basic or clinical research? If the application is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the data storage site? Does the applicant have experience overseeing selection and management of subawards, if needed?
Do the PD(s)/PI(s) and other personnel have appropriate experience and training for management of large-scale databases, with expertise in archiving, processing, and distributing genetic and phenotypic data for AD/ADRD and publicly displaying data? Are the PD(s)/PI(s) facile in curation of large data sets, including genetic, genomic, and phenotypic data relevant to genetic analysis, such as clinical and neuropathology data elements and related data? Do the PD(s)/PI(s) provide a plan to form an executive committee that oversees the work and that ensures that the AD community is well served by the genetics and genomics database?
Does the application propose novel organizational conceptss, management strategies, or instrumentation in coordinating the research programs that the data storage site will serve? Are the concepts, strategies, or instrumentation novel to AD genetics or genomics research or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed?
Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research programs the data storage site will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the programs, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the programs are in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the programs? Are an appropriate plan for work flow and a well-established timeline proposed?
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 institutional environment in which the data storage site will operate contribute to the probability of success in facilitating the research programs it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the data storage site proposed? Will the data storage site benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?
For research that involves human subjects but does not involve one of thecategories 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.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
For Renewals, the committee will consider the progress made in the last funding period.
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
Not Applicable
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 NIA, 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.
Information regarding the disposition of applications is available 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.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
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.
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.
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.htmlhttps://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.htmlor 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.
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:
The PD(s)/PI(s) will have primary authority and responsibility to define objectives, approaches, and analysis protocols; data analyses and interpretation; follow-up analyses; and quality control. The PD(s)/PI(s) will work directly with leadership and staff at NIA and other NIH Institutes and Centers and will work collaboratively with the Genome Center for Alzheimer’s Disease (GCAD) and members of various consortia and NIA-funded infrastructure, including the NIA Alzheimer's Disease Genetics Consortium (ADGC), the National Alzheimer's Coordinating Center (NACC), the National Centralized Repository for Alzheimer's Disease and Related Dementias (NCRAD), the Alzheimer's Disease Centers (ADCs), the Alzheimer's Disease Genetics Consortium (ADGC), the Collaboration on Alzheimer’s Disease Research (CADRE), the Cohorts for Heart and Aging Research in Genomic Epidemiology (CHARGE) Consortium, the Alzheimer's Disease Neuroimaging Initiative (ADNI), the Alzheimer's Disease Sequencing Project (ADSP), the Accelerating Medicines Partnership (AMP-AD), and other NIA-funded investigators. NIA-funded study sites will transfer genetic and phenotypic data to NIAGADS for sharing with the research community.
The NIA Genetics of Alzheimer's Disease Data Storage Site (NIAGADS) Program Director(s), in consultation with the NIA Project Scientist, will establish a board of external consultants to provide guidance on analytical methods and advances in methodology appropriate for use in this context. Consultants will be selected as individuals who are not involved in AD genetics research but who could advise the awardees with an emphasis on analytical methods.
The PD(s)/PI(s) and key NIAGADS personnel and selected awardees of the ADSP, in consultation with the NIA Project Scientist, will form an Executive Committee. The Executive Committee will hold meetings and conference calls to facilitate development and implementation of common measures and practices. The Executive Committee will define the rules regarding access to, and publication of, findings from analyses of common data.
Existing Data Access Committees and a Data Use Committee, selected by the NIA Project Scientist in collaboration with the awardees of the cooperative agreement, will continue to act in a decision-making capacity regarding use of the data that are stored at the data storage site, data that are provided to the data storage site, and review of ADSP applications. Institutions providing data will retain custody of, and primary rights to, the site-specific data developed under their individual awards, in keeping with Institutional Review Board approval, and subject to Government rights of access, consistent with current HHS, PHS, and NIH policies.
The Program Director of the data storage site will work collaboratively with other investigators to develop milestone-driven study analysis design, collect appropriate data, and perform analyses for the AD genetics community as approved by the Executive Committee in consultation with the NIA Project Scientist.
The PD(s)/PI(s) will administer the establishment, operation, and quality control of genotypic and phenotypic data, including the development of procedures for assuring data quality control and procedures for transfer of data generated by NIH-funded investigators into the database. The PD(s)/PI(s) are responsible for working cooperatively with study sites and sponsoring organizations and for overseeing the implementation of, and adherence to, common protocols, as well as assuring quality control of the data collected. In addition to organizing and attending regular meetings, the PD(s)/PI(s) will be expected to maintain close communications with the NIA Project Scientist and, where appropriate, the Program Directors of the ADSP and the NIA Coordinating Center for Genetics and Genomics of Alzheimer's Disease. The PD(s)/PI(s) will ensure that ADSP data are made available immediately upon deposition into the data storage site.
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
The designated NIA Project Scientist will have scientific involvement during conduct of this activity, through technical assistance, advice, and coordination. The NIA Project Scientist will monitor the deposition of data into the data storage site to ensure that NIA-funded investigators have appropriately deposited data and have properly acknowledged the use of the data storage site in the publication of their work. The NIA Project Scientist will review protocols for workflow and data sharing before they can be implemented. The NIA Project Scientist will be a non-voting "ex officio" member of the Executive Committee and all key subcommittees.
Additionally, the NIA Program Official will be responsible for normal program stewardship, including assessing the progress toward the accomplishment of specified milestones and for recommending release of additional funds to the project, and will be named in the award notice.
Areas of Joint Responsibility include:
For areas of joint responsibility, an Executive Committee including Program Director(s) of the data storage site, selected Program Director(s) from the ADSP, the NIA Coordinating Center for Genetics and Genomics of Alzheimer's Disease, and the NIA Project Scientist should be formed. The Executive Committee will serve as the main decision-making body for the shared aspects of the study and will devise common protocols related to data sharing among collaborators, stakeholders, and the AD research community. Appropriate data storage site staff may attend the Executive Committee Meetings as needed. Members of the Executive Committee for the data storage site will contribute to the effort by accessing and assessing appropriate genetic and phenotype data and providing expertise in the analysis of genetics data from specific AD cohorts. The Executive Committee will meet bi-monthly or as needed. An external board of consultants will advise the PD(s)/PI(s) on analytical approaches; phases of the award will proceed only after review of the common protocols and approval by the Executive Committee and acceptance by NIA.
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 composed of three members 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.
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 agreementsare 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.
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Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9666
Email: ramesh.vemuri@nih.gov
Jillian Morris
National Institute on Aging (NIA)
Telephone: 301-496-1473
Email: morrisjil@mail.nih.gov
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