National Institute of Mental Health (NIMH)
Reissue of RFA-MH-18-100
Through this Funding Opportunity Announcement (FOA), the National Institute of Mental Health (NIMH) seeks applications to develop, sustain, enhance, and enrich a centralized national biorepository for genetic studies of psychiatric disorders to facilitate and accelerate the scientific understanding of the genetic risk architecture underlying mental disorders. This effort is expected to involve a functionally integrated, multi-disciplinary team that will provide for open sharing of biosamples and data resources through a single, centralized, national resource to advance basic and translational research in the genetics of mental disorders.
June 10, 2019
July 16, 2019
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.
It is critical that applicants follow the instructions in 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 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.
Identification of genetic and environmental contributions to the etiology of brain disorders remain a public health challenge. While recent technological advances offer promise in understanding the genetic etiology and mechanistic basis of mental disorders, realizing this potential requires the free and open sharing of genetic material, genetic and phenotypic data, and genetic analyses among researchers. This is especially true for mental disorders and other complex diseases, for which gene effect sizes are frequently modest and the integration of samples/data into a common analytical framework is often critical to achieve sample sizes that have adequate statistical power for disease association, gene mapping and mutation detection.
The quality and quantity of genomic and phenotypic information have presented a challenge to the broad sharing of such data resources. Genetic and phenotypic information is currently distributed across a plethora of heterogeneous and autonomous information systems, each with their own interfaces, control languages, data models, and formats. The lack of data harmonization and federation amongst databases prevents optimal utilization of the data resources currently available. Going forward, it is necessary to provide uniform, integrated, and semantically-consistent structured data resources to fully access the power of broad data sharing and allow investigators to address the complex biology underlying mental illness.
In 1989, NIMH launched the Human Genetics Initiative (HGI) with the goal of creating a centralized national genomic resource aimed at accelerating gene discovery through the sharing of clinical information, DNA samples, and cell lines coordinated through an electronic database. Additionally, a stem cell repository for induced pluripotent stem cells (iPSCs) and related resources, was established in 2011. Collectively, these two resources are now referred to as the “NIMH Repository and Genomics Resource (NRGR)” and serve as the largest biorepository in psychiatry, providing access to high-quality biomaterials collected from nearly 200,000 phenotypically well-characterized control and patient subjects from a wide-range of mental illnesses across ancestrally diverse populations. Here, we refer to NRGR as the “Biorepository”. To date, the Biorepository has distributed almost a million samples to over 450 investigators world-wide and supported approximately 1,500 genetic research studies on mental illnesses. The Biorepository has supported over 800 publications, including many high-profile papers in psychiatric genetics, and several hundred replicated genetic findings reported from large scale genome-wide studies.
Continued support for the Biorepository provides for broad sharing of mental health research-related biosamples, with their affiliated clinical and genetic data, and continued development and enhancement of research resources that promote accelerated gene discovery in mental disorders.
The objective of this Funding Opportunity Announcement (FOA) is to develop, sustain, and enhance a centralized national biorepository which will improve and enrich psychiatric genomics research resources for broad sharing with the national and international scientific community.
It is expected that the Program Director(s)/Principal Investigator(s) (PD/PI) and the proposed collaborative team have direct experience in providing to the scientific community research resources and services for genetic studies, as well as, experience in establishing a cyber infrastructure for a mature scientific discipline.
Specific areas of scientific expertise required by the Biorepository include the following:
NIMH aims to support building, enhancing, and sustaining biorepository resources and data resources to support research resources in psychiatric genomics.
Biorepository Organizational Structure:
The Biorepository is expected to include both a Biologics Element and a Data Management Coordination Element. The Biologics Element (BE) will be responsible for processing and storage of biosamples. The Data Management Coordination Element (DMCE) will continue to maintain limited data management activities with several of these activities transitioning to the NIMH Data Archives (NDA https://data-archive.nimh.nih.gov), the details of which are described below under DMCE. NDA is a recently developed NIMH-based centralized data warehouse for the storage and distribution of all NIMH supported data resources resulting from human subjects’ research. To consolidate the clinical and phenotypic data of the Biorepository at the NDA, the DMCE will coordinate with the NDA team and the submitting investigators to deposit the data directly with NDA for all new studies initiated after award of the current phase of the Biorepository. This entails a shift from the previous data management functions of DMCE and begins the transition of data resources management to NDA. As part of this transition, DMCE is expected to retain limited data management functions and the addition of new coordination functions with NDA. DMCE will continue to develop and maintain the centralized web portal for the Biorepository.
A project management and organizational structure that provides for ongoing communication and sharing of data and resources between the major elements of the Biorepository and the NDA and other NIH designated repositories is critical for the success of the Biorepository. The project management and organizational structure must provide for the integration of work-flows, data, and web-based systems to create a single centralized system. Further details for each element are provided below.Biologics Element will provide cost-effective and high-throughput services of the repository at prices that are competitive with other academic producers which MUST include the following at minimum:
The Data Management and Coordination Element (DMCE) will:
It is expected that the data warehouse and web-based portal meet or exceed the NIH (https://gds.nih.gov/pdf/Trusted_Partner_Checklist.pdf) and Federal (FIMSA- https://cbiit.nci.nih.gov/contractor-security-guidance) standards for establishing data quality and database security.
Applicants should plan for recovery of costs and service delivery costs for services and research resources that they will provide to the scientific community.
The award under this FOA will be governed by a Genomics Steering Committee (GSC) comprised of the PD(s)/PI(s), at least four external scientists/advisors, and the NIMH Project Scientist (see Terms and Conditions, below). The external scientists/advisors will be named after the award, to reduce conflicts for the peer review. The external scientist/advisors will be selected for their outstanding track record and expertise in the areas of scientific disciplines that is directly relevant to the Biorepository.
Applications with data collection plans that involve multiple respondent groups (e.g., clients/patients, therapists/providers, supervisors, administrators) should address provisions for human subject protections and consenting procedures for all participant groups, accordingly. The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring (NOT-MH-19-027). The application’s Protection of Human Subjects section and data and safety monitoring plans should reflect the policies and guidance in this notice. Plans for the protection of research subjects and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
NIMH intends to commit $10M total cost per year for 5 years, beginning in FY 2020.
Application budget needs to reflect the actual needs of the proposed project.
The total project period may not exceed 5 years.
Only the current awardees of the Center for Genomic Studies on Mental Disorders (U24), funded under RFA-MH-18-100, can apply. The decision to limit competition was made in consideration of the success of the current awardees in serving the psychiatric genetics community, as well as, the costs, risks, and logistical difficulties, such as substantial delays to ongoing NIMH projects supported by the biorepository, which would be incurred should the biorepository be moved to another location.
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.
A minimum effort of 4 person months for the contact PD/PI and 3 person months for non-contact PDs/PIs is required for a multiple PD/PI application.
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:
Facilities and Other Resources: Applicants are advised that the Facilities and Other Resources section should describe both physical resources and the intellectual and collaborative resources for executing the project.
Applicants must upload two pdf attachments as described here:
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
A minimum effort of 4 person months for the contact PD/PI and 3 person months for non-contact PDs/PIs is required for a multiple PD/PI application.
Research Strategy: Propose plans for continued support for the Biologics Element and the Data Management and Coordination Element of the Biorepository, including coordination with the NDA, as appropriate, as detailed below. Applications lacking description of these required Elements will be considered incomplete .
The Biologics Element:
The Data Management and Coordination Element:
Applicants should also address:
Additional Application Requirements:
Applicants must include biannual and annual milestones for the following: timely processing of sample submissions and requests; generation of DNA, RNA or cell-lines and iPSC-derivatives from deposited samples; integration of data; federation of data with other databases; development and implementation of the web-based access portal; tracking and monitoring of repository use; and curation and harmonization of clinical data. Achievement of milestones will be evaluated by NIMH, and funding of non-competing award years will depend on milestone accomplishment.
The following modifications also apply:
Consistent with achieving the goals for the Biorepository, applicants are required to describe a resource sharing plan that includes timelines, format, and mechanisms by which the Biorepository will share the data (e.g., demographic, diagnostic, clinical, genotypic, and family structure data) and biomaterials (cell lines and DNA samples) to qualified investigators, in accordance with all regulatory requirements, applicable federal, state, and local laws, and NIH and NIMH policies.
The Biorepository's data sharing plan should minimally include the following elements:
The NIH Genomic Data Sharing Policy will apply to any large scale human or non-human genomic data generated under this project, as well as the use of these data for subsequent research (https://gds.nih.gov/03policy2.html).
Applications must describe plans and resource capability to provide all the required functions and services.
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.
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.
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.
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 Center address the needs of the research resource that it will serve? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research resource?
What will be the effect of these research resources on other scientific activities that drive this field?
Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing critical biorepository functions, including knowledge of molecular biology, tissue and cell culture procedures, developmental and stem cell biology, psychiatric clinical data curation, laboratory informatics, bioinformatics, and computer and database structure research? Do the investigators demonstrate significant experience with coordinating collaborative basic or clinical research? If the Center 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 Center? To what extent have the PD(s)/PI(s) demonstrated experience in providing high-quality research resources and services for genetic studies on mental disorders to the scientific community? Does the applicant have experience overseeing selection and management of subawards, if needed?
To what extent are the PD(s)/PI(s)committed to the principles of free and open sharing of research resources for genetic studies of mental disorders?
Does the application propose novel organizational concepts or management strategies in coordinating the resource the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts or management strategies proposed?
To what extent does the proposed Center employ novel concepts, approaches, or methods for the production and sharing of research resources, the integration of biorepository data and consolidation of data resources at NDA, the federation of that data with other public resources, and the implementation of a single user-friendly, web-based access portal?
Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the resource the the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the resource, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the resource is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the resource? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?
Will the data management system proposed/developed by the Center succeed in accelerating the discovery of genes producing vulnerability to mental disorders? To what extent does the applicant utilize state-of-the-art methods to create an efficient and secure cyberinfrastructure with a single web-based portal linked to a central database in a timely manner? To what extent does the applicant propose a transparent, understandable, and timely process for data access including a user-friendly web portal? Are there reasonable and timely plans for the central database to be logically federated with other NIH databases? To what extent does the applicant propose a logical, user-friendly, and timely system for providing public access to summary level data in a way that will facilitate use of the resource by the scientific community? Are reasonable, appropriate, and timely methods described to track and monitor repository use, both submitting and accessing, and the outcomes of such use, such as data and publications?
Evaluate the molecular biological techniques described in the application for appropriateness and timeliness in assuring a high rate of success in establishing cell lines from both blood and biopsied sources. Evaluate how appropriate and timely procedures were proposed for the preparation of primary cell lines, expansion of established iPSC lines, transformation of lymphocytes cells, and extraction of nucleic acids from cell culture and blood sources. Evaluate how appropriate and timely procedures were proposed for performing quality control measures to assure cell line purity, genetic stability, and, where appropriate, reprogramming efficiency of cell lines. Evaluate how appropriate and timely procedures were proposed for the preparation of nucleic acids and quality control measures to assure purity, and competence as substrates in molecular biology assays. Evaluate how appropriate and comprehensive the market analysis is to compare cost for iPSC production and quality control services, processing, production and storage of various derivatives from blood samples (DNA, RNA, plasma, CPLs, etc.) with that of other academic and commercial producers?
To what extent are there comprehensive and timely plans to integrate all functions of the data management and biological elements, NDA and other data repositories? How is the system proposed for tracking incoming and distributed data and biological resources state-of the art and comprehensive and provide for real-time data? Is there an appropriate and timely plan to integrate and sustain the existing resources? Evaluate whether the plans for publicizing these resources are adequate to ensure broad use. Evaluate the adequacy of the plans for facilitating use of the resource.
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 Center will operate contribute to the probability of success in facilitating the research resource it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?
To what extent does the proposed Center contain a description of the physical plant including appropriate and secure storage facilities assuring the integrity and viability of biological samples? To what extent does the proposed center's cyberinfrastructure include appropriate security measures, capacity for data integration and
growth, and backup plans? Does the proposed center have a dedicated stem cell facility for high-throughput production, handling and quality control of iPSCs? To what extent does the proposed center utilize robotic automation wherever possible and have an electronic system for tracking of all biosamples? To what extent does the proposed facility have capabilities for in-house high-throughput nucleic acid extraction and cell line generation from primary source cells (CPL, LCL), with quality control? To what extent does the proposed facility have capabilities for in-house, high-throughput genome wide data generation, with state-of–the-art methods?
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Renewals, the committee will consider the progress made in the last funding period.
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 NIMH, 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.
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.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.
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 award under this FOA will be governed by a Genomics Steering Committee (GSC) comprised of the PD(s)/PI(s), at least four external scientists/advisors, and the NIMH Project Scientist.
The PD(s)/PI(s) will have the primary responsibility for:
Applicants responsive to this FOA agree to:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
The role of the Project Scientist(s) will be to facilitate and not to direct activities.
Specifically, the Project Scientist(s) will:
The Program Officer will have responsibility for normal program stewardship. Specifically, the Program Officer will have the usual stewardship responsibility for monitoring the conduct and progress of the project to ensure milestones are accomplished in accordance with the timeline. The Program Officer will:
Areas of Joint Responsibility include:
Genomics Steering Committee (GSC)
Genetics Advisory Panel (GAP)
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 a Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. The three members are: 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. 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.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Geetha Senthil, Ph.D.
National Institute of Mental Health
National Institute of Mental Health
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.
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