Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Human Genome Research Institute (NHGRI)

National Institute of Mental Health (NIMH)

National Institute of Neurological Disorders and Stroke (NINDS)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Research on Women's Health (ORWH)

Funding Opportunity Title
Pediatric Biospecimen Procurement Center (BPC) Supporting the Developmental Gene Expression (dGTEx) Project (U24 Clinical Trial Not Allowed)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

New

Related Notices
  • July 22, 2020 - Notice of Pre-Application Webinar for Developmental Genotype-Tissue Expression Project (dGTEx). See Notice NOT-HG-20-052.
Funding Opportunity Announcement (FOA) Number
RFA-HD-21-008
Companion Funding Opportunity

RFA-HG-20-039, U24: Laboratory, Data Analysis, and Coordinating Center (LDACC) for the Developmental Genotype-Tissue Expression Project

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.865, 93.172, 93.242, 93.853, 93.313

Funding Opportunity Purpose

The NIH is coordinating efforts for establishing a Developmental Genotype-Tissue Expression (dGTEx) project, to catalog and analyze transcriptional profiles from a wide variety of tissues obtained from neonates, children, and adolescents in a post-mortem setting. The purpose of this funding opportunity is for support of a Biospecimen Procurement Center (BPC) to enroll suitable pediatric donors and provide high quality tissue samples for analyses to the Laboratory, Data Analysis, and Coordinating Center (LDACC). The BPC will work closely with the LDACC to optimize tissue collection, preservation and transfer of specimens.

Key Dates

Posted Date
June 23, 2020
Open Date (Earliest Submission Date)
November 03, 2020
Letter of Intent Due Date(s)

30 days prior to application due date

Application Due Date(s)

December 3, 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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

March 2021

Advisory Council Review

May 2021

Earliest Start Date

July 2021

Expiration Date
December 04, 2020
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The NIH is coordinating efforts for establishing a Developmental Genotype-Tissue Expression (dGTEx) project, to catalog and analyze transcriptional profiles from a wide variety of tissues obtained from neonates, children, and adolescents in a post-mortem setting. The purpose of this funding opportunity is for support of a Biospecimen Procurement Center (BPC) to enroll suitable pediatric donors and provide high quality tissue samples for analyses to the Laboratory, Data Analysis, and Coordinating Center (LDACC). The BPC will work closely with the LDACC to optimize tissue collection, preservation and transfer of specimens.

Background

This initiative is based on the NIH-wide Common Fund Genotype-Tissue Expression (GTEx) project (https://commonfund.nih.gov/gtex) that began in 2010. The purpose of GTEx was to build a comprehensive public resource to study gene expression patterns and regulation in adult tissues. The goals of GTEx were to correlate gene expression and genetic variation within the same individual across numerous tissues and examine individual variation within a tissue across an adult population. The GTEx Portal (https://www.genome.gov/Funded-Programs-Projects/Genotype-Tissue-Expression-Project)provides open access to data including tissue gene expression profiles, expression and splicing quantitative trait loci (eQTLs and sQTLs) and sample statistics. This resource has been extensively used and benefits the scientific community, such as in drug discovery and repurposing as well as in drug safety and toxicity studies. The success of GTEx in adults lays the groundwork to initiate a similar project to understand the typical patterns of gene expression during human development.

Organs and tissues are made up of a complex mixture of different cell types, each with essentially the same genetic code but distinct biology, due presumably, in part, to differences in gene expression patterns. Just as some genes are differentially expressed across different cell types, some are turned on and off at different times during development within the same cell type. Despite considerable variation in expression patterns across tissues and across individuals, these patterns are relatively stable throughout adulthood, when most human gene expression studies have been done. The changes in gene expression that occur during postnatal development are largely unstudied, and yet lead to important milestones in health and disease such as the onset or cessation of growth spurts or puberty, and the development of childhood conditions such as asthma or attention deficit-hyperactivity disorder.

The primary goal of the Developmental Genotype-Tissue Expression (dGTEx) project is to establish a resource database and associated tissue bank to study gene expression patterns in multiple relatively healthy reference neonatal, pediatric, and adolescent tissues, and to make this resource broadly available for furthering research. This will aid in the interpretation of genome-wide association study (GWAS) and other genomic study findings, many of which do not correlate with protein-coding changes, but instead point to regulatory regions of the genome. In addition, a major advance since the previous GTEx project (that measured gene expression in whole tissue samples) is the availability of tools to study RNA expression at the single-cell level. The dGTEx resource will be a powerful tool to provide a comprehensive dataset of gene expression across a wide range of human tissues throughout development, filling a gap in genomic databases across developmental stages.

Scope

The Biospecimen Procurement Center (BPC) will consist of components supporting the procurement of pediatric post-mortem biospecimens which include identifying potential donors; acquiring multiple tissue and fluid samples from each donor; and using appropriate methods to collect, handle, and store samples. Additional responsibilities include, but are not limited to, providing expert pathological review of each specimen, collecting clinical and other types of data, and conducting ethical, legal, and social implication (ELSI) research. The BPC will incorporate the following components:

Administration and Data Management

This component will provide oversight for the BPC and be responsible for the coordination and management of the entire biospecimen procurement project. It will establish effective administrative structures for the day-to-day management of the project, including arrangements for internal quality control and quality assessment. It will create data collection forms and maintain appropriate data repositories. This component will also coordinate efforts of pathological evaluation and quality management teams to perform acquisition of biospecimens and associated clinical data. This component is also responsible for the formulation of standard operating procedures and compliance for donor enrollment and sample collection. This component will also coordinate communication with NIH program staff regarding the BPC.

Biospecimen Collection

This component will coordinate biospecimen procurement and associated clinical data from donors. It is highly likely that collaboration with multiple tissue source sites (TSS) will be required for meeting the procurement goals. Due to the sensitive nature of collecting pediatric tissues it may be helpful to collaborate with organ donor organizations and medical examiners to facilitate donor recruitment. In addition, these samples will be collected under broad consent for general research use without any restrictions, according to NIH data sharing policies. This component will collect tissues from a minimum of 30 donors (preferably more) from each of the four age intervals indicated below. Post-mortem tissues will be collected from individuals who died after experiencing an acute event, such as but not limited to asphyxiation, brain hemorrhage or death, sudden infant death, trauma, cardiac death, drowning or suicide. This component will be responsible for ensuring the collection of specimens using best practices for each tissue that will minimize the risk of abnormal or degraded tissue and that will result in the generation of high-quality nucleic acids for whole tissue and single-cell analyses in close collaboration with the LDACC. Special expertise will be necessary for the collection of some tissue types (e.g. brain) for optimal collection and precise localization of dissected material (see additional considerations). As many tissues as practicable will be collected (at least 20-30 tissues per donor), similar to what was collected in GTEx. The actual tissues collected, and their prioritization for collection, will be determined in conjunction with the dGTEx Steering Committee. Maintaining adequate donor diversity, in terms of sex/gender, race, and ethnicity will be an essential factor for donor selection. The four age intervals to be collected are:

Early post-natal (0-2 years)

Early childhood (2-8 years)

Pre-pubertal (8-12.5 years)

Post-pubertal (12.5-18 years)

Biospecimen Evaluation, Processing and Transport

This component will work closely with the LDACC to optimize tissue collection, preservation and transfer for genomic analyses. Collected organs will be evaluated, dissected, sampled and preserved by an experienced team for whole tissue and single cell gene expression analyses using best practices for each tissue type. This BPC component is also responsible for providing standardized collection kits for biospecimen collection to the TSS. Upon receipt of samples from the TSS, this component will conduct an initial evaluation and provide a centralized temporary storage of biospecimens, with the exception of brains, which will be processed separately (see below). The initial evaluation includes preparation of histological slides of the samples and scanned images for pathological review by certified pathologist(s) to verify the organ source and to characterize both general and organ-specific pathological characteristics. In addition, this component is responsible for proper shipping of the samples to the LDACC for molecular analyses.

Ethical, Legal, Social Implications (ELSI)

Research should be done to assess the ethical, legal and social implications of the study, including: the attitudes and concerns of potential study participants, particularly those with diverse racial, ethnic, socioeconomic and religious backgrounds; the effectiveness of consent processes in informing participants of the risks and benefits of the study and ensuring informed decisions; and the psychosocial impact of participation in the study on families and healthcare staff. This component should include a plan to engage representatives of the affected communities before, during and after the project to ensure the research appropriately addresses the unique needs and expectations of grieving parents and to develop procedures for longer term follow up with families regarding research outcomes.

Additional Considerations

To minimize source variability, maximize resource sharing for the brain samples, and provide high quality location information, the BPC will also collaborate with an established team dedicated to human brain research, with expertise in the development/use of atlases and common coordinate systems (e.g., Allen Human Brain Atlas, BigBrain, BrainSpan, Talairach Coordinate System, Montreal Neurological Institute (MNI) Coordinate System), as well as image segmentation and registration tools (e.g, Insight Segmentation and Registration Toolkit (ITK)), for expert valuation, precise dissection, and optimal preservation of brain samples shipped to the LDACC for analyses. Brain tissue processing should be consistent with the most current approaches for “omic” studies at single cell resolution. These include the rapid freezing of unfixed slices, while minimizing the post-mortem interval (PMI) to ideally less than 8 hours, and the utilization of tissue preparation strategies that allow for direct comparison of the sampled frozen tissue with either immediately adjacent or contralateral fixed tissue. Whenever possible, long term storage of residual brains and specimens in coordination with existing publicly accessible brain banks such as the NIH NeuroBioBank is expected.

The award under this FOA will be a cooperative agreement (see Section VI.2 under Cooperative Agreement Terms and Conditions of the Award). The BPC will need to work with the Laboratory, Data Analysis and Coordinating Center (LDACC), and with NIH Staff in order to meet the goals of the dGTEx Project.

A Steering Committee will be the main governing body of the dGTEx Project. The Steering Committee will be composed of the PD/PI(s) from the Biospecimen Procurement Center funded by NICHD, the LDACC funded by NHGRI, and NIH program staff. In addition to the PD(s)/PI(s), key personnel from the BPC, including pre- and post-doctoral trainees, will be eligible to attend the Steering Committee meetings. The Steering Committee will establish subcommittees or working groups to facilitate collaborative work, standardize approaches, and achieve other goals of the dGTEx Project. The BPC will be expected to play an active role in these working groups which may include (but are not limited to) groups focused on specific project activities, such as providing general study results to participating families, Ethical, Legal, and Social Implications (ELSI) research, collaborative efforts with outside groups, or data sharing. In addition to the Steering Committee, an External Scientific Panel will be formed after awards are made to provide expert recommendations.

A Community Advisory Board will be established and throughout the project serve as liaison partnering with community-based representatives to address concerns from the family decision makers on tissue donation and general research results. Responsibilities may include, but are not limited to, educating the public about the project, impact of general research results, feedback on broad consent, and ensuring cultural and religious concerns are addressed.

Data Collection and Resource Sharing

Maintaining data security protection and the proper stewardship of data is of the utmost importance. Data security encompasses confidentiality, data integrity, and availability. Confidentiality includes managing data access to maintain data security and making data accessible to authorized users only for authorized purposes. The Notice for Use of Cloud Computing Services for Storage and Analysis of Controlled-Access Data Subject to the NIH Genomic Data Sharing (GDS) Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-086.html) allows investigators to perform genomic analyses on a cloud platform. The NIH security best practices and provisions (https://www.ncbi.nlm.nih.gov/projects/gap/pdf/dbgap_2b_security_procedures.pdf) should be implemented to protect the privacy and confidentiality of research participants and prevent unauthorized access to data. Investigators are expected to develop policies and procedures for notifying NIH and managing and mediating any loss of data or compromise of data confidentiality.

NHGRI and NICHD recognize that specimen and data sharing is essential to advance medical research and will expect awardees to address and adhere to NIH data sharing policies. Since the obtained biospecimens and the data derived from their analyses will be broadly shared with the biomedical research community for general data use, the informed consent document should include language that both the biospecimens and the derived data will be broadly shared without any identifying subject information with the biomedical community.

NIH intends that Project Datasets (including phenotypic, and other relevant data) and associated genomic data from this study will be widely shared with the scientific community for research uses through NIH-supported databases, such as the AnVIL. In addition, it is expected that individual-level genomic datasets generated for the dGTEx program will be designated in institutional certification documents as General Research Use (GRU) as described at https://osp.od.nih.gov/scientific-sharing/researchers-institutional-certifications/ when submitting datasets to NIH-supported databases.

Although NIH expects all project datasets from genomic studies selected as part of this FOA to be available through databases such as AnVIL, NIH does not intend for any single database to become the exclusive source of this program’s data. Information such as study protocols, software code and algorithms, descriptions, and publications are expected to be made available through databases such as AnVIL; other public web sites; and/or publication in the scientific literature.

Data on gene expression, phenotypic information, and sample and data analysis should be deposited in AnVIL on a timely and regular basis.

The dGTEx Steering Committee will develop and implement network-wide approaches for resource deposition and use including submission to national repositories as appropriate.

Timeline

During the first year of the program, the BPC and LDACC will work together to develop protocols for the procurement of tissues, transfer of samples, sequencing, data sharing, and ELSI research. Years 2-4 of the program will ramp up recruitment for a minimum of 120 donors (preferably more), to perform sequencing and basic analysis of gene expression. The last year of the project will ramp down any remaining recruitment, sequencing or analysis functions and publications.

Helpful informational items for applicants regarding the dGTEx project is available at https://www.genome.gov/Funded-Programs-Projects/Developmental-Genotype-Tissue-Expression

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed
New

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.

Clinical Trial?
Not Allowed: Only accepting applications that do not propose clinical trials

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

The NICHD intends to fund 1 award in fiscal year 2021, corresponding to a total of $12.15M over the five-year budget period. The actual amounts distributed per fiscal year are dependent on annual appropriations but are anticipated to be the following:

$3.35M for fiscal year 2021

$3.60M for fiscal year 2022

$2.40M for fiscal year 2023

$1.40M for fiscal year 2024

$1.40M for fiscal year 2025

The following NIH components intend to contribute the following total amounts to the award above distributed during the five-year budget period:

NICHD $10.15M

NINDS $1M

NIMH $1M

NHGRI intends to fund 1 award in response to the complementary companion FOA (RFA-HG-20-039)

Award Budget

Application budgets are limited andneed to reflect the actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. 

Required Registrations

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.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons.Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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.

Eligible Individuals (Program Director/Principal Investigator)

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.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

 

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101)

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guideexcept where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

John V. Ilekis, PhD

Telephone: 301-435-6895

Fax: 301-496-3790

Email: ilekisj@nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

 

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy:

Research Strategy must consist of the Subsections A-D, as defined below. Each Subsection should include, but is not limited to, each of the elements listed.

Subsection A: Project Overview

Describe the following elements:

  • The overall organizational structure of the BPC and the details for each component
  • The overall experience of the BPC in handling similar types of projects (i.e. biospecimen procurement from post-mortem donors)
  • How the various components will interact and coordinate with one another, including a plan for coordinating with the LDACC
  • Summarize the collective team expertise and organizational strengths, especially those that are relevant to multi-institutional endeavors

Subsection B: Administration and Data Management

Describe the following elements:

  • The strategies and processes that will be used to manage the BPC
  • Outline the administrative structure for the day-to-day management of the project
  • The procedures for internal quality control
  • The administrative staff and how staff members interact with one another and each BPC component
  • A planned and systematic process to review operations
  • A sample workflow management plan
  • A monitoring process for quality, quantity, and appropriateness of the services provided
  • Policies for managing records
  • A process to identify and investigate problems as appropriate
  • An informatics system for sample tracking and data collection

Subsection C: Donor Biospecimen Collection, Evaluation, Processing and Transport

Describe the following elements:

  • Prior experience and/or outline of plans to collaborate with organ donor organizations and medical examiners to facilitate donor recruitment
  • Donor screening and recruitment including proposed milestones
  • Process of kin informed consent/authorization and interviews
  • Clinical and medical data collection (including obtaining adequate clinical and pathology data to accompany the acquired tissues)
  • Coordination of sufficient numbers of expert clinical and technical personnel and facilities to enable the rapid deployment of resources to acquire post-mortem tissues resulting in high-quality nucleic acids (DNA and RNA) for purification by the LDACC
  • How the BPC will collaborate with an established team dedicated to human brain research, with expertise in the preparation of human brain tissue for single-cell transcriptomics analyses, development/use of atlases and common coordinate systems as well as image segmentation and registration tools in order to have expert valuation, precise dissection, and optimal preservation of brain samples; a plan for long term storage of residual brains in coordination with existing publicly accessible brain banks
  • Pathology-histology team for microscopic evaluations of collected specimen
  • Sufficient QA/QC of tissue samples for downstream assays and analyses.
  • Appropriate stabilization, suitable storage and shipment of obtained tissues, and transfer of associated clinical data, using best practices for sample collection, handling, fixation, and temporary storage of biospecimens

Subsection D: Ethical Legal and Social Implications (ELSI) Research

Describe the following elements

  • The personnel with the appropriate knowledge, expertise, and commitment of effort, to design, implement and analyze the data
  • A management plan that clearly delineates how the ELSI research will be integrated into the design and implementation of the tissue collection efforts
  • How IRB approvals from all relevant Institutions will be obtained if applicable
  • Community Advisory Board input on how to approach families for consent and follow-up of research results
  • Plans to identify and engage relevant communities and stakeholders
  • The relationship between the ELSI researchers and the tissue collection teams and how access to potential subjects for the ELSI sub-study will be granted

.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

    • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
    • A plan for sharing project datasets (phenotypic, environmental, covariate, genotyping data, gene expression, etc.) and associated genomic data should be provided. Awardees are expected to comply with the NIH Genomic Data Sharing Policy (https://gds.nih.gov/). The plan should also describe broad data sharing of project datasets for ‘General Research Use’ as defined by NIH at https://osp.od.nih.gov/wp-content/uploads/standard_data_use_limitations.pdf. Broad data sharing for general research use is strongly encouraged for dGTEx datasets. A plan to share computerized resources such as study protocols, results report templates, and bioinformatic tools should also be provided. Data on gene expression, phenotypic information, and sample and data analysis should be deposited in AnVIL on a timely and regular basis.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-definedclinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

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.

Overall Impact

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).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

 

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

 

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

 

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

 

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Additionally for this FOA, will the BPC’s conceptual design and overall operating plan effectively procure and preserve tissue samples across developmental stages? Does the BPC’s operating plan provide opportunity for collaboration, integration, and interaction with the LDACC? Are the BPC strategies adequate and appropriate for the dGTEx project? Is the data sharing plan appropriate?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

 

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

  • Is there demonstrated institutional experience and commitment to establishing and performing tissue collection protocols?
  • Are there sufficient expertise and experience of the proposed organizational and professional, technical, and administrative staff in the operation of a biospecimen procurement center?
  • Is the organizational and administrative structure to operate a biospecimen procurement center adequate to provide the required numbers of donors and tissues?
  • Is there a suitable plan to collect, track, and verify the collection of tissues and corresponding clinical data from donors?
  • Is there adequate expertise and experience in the operation of a low post-mortem interval autopsy program resulting in high quality nucleic acids from multiple tissues per donor?
  • Are there demonstrated expertise and facilities for storing and shipping biospecimens under various conditions?
  • Are the expertise and experience in collection and pathological evaluation of biospecimens under various conditions adequate?
  • Are there sufficient expertise and experience in the design and implementation of a qualitative Ethical, Legal, and Social Issues (ELSI) study?
  • Is the integration of the ELSI component with the proposed tissue collection efforts adequate?
  • Is there sufficient expertise for expert valuation, precise dissection, and optimal preservation of tissue consistent with the most current approaches for “omic” studies at single cell resolution?

 

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.

 

Not Applicable

 

Not Applicable

 

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

 

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.
  • Diversity of study patients, particularly with respect to inclusion of minority or underserved populations in the U.S., and relevance of proposed research questions related to diversity and health disparities

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

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.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

  • Determining research approaches, designing protocols, setting project milestones, and conducting research.
  • Preparing abstracts, presentations and publications in a timely manner and collaborating Project-wide in making the public and professionals aware of the program.
  • Providing reports and data in a timely fashion as agreed upon by the Steering Committee (SC).
  • Adhering to policies regarding genomic data sharing, data access, timely publication, and intellectual property established by the NIH and the SC.
  • Abiding by common definitions, protocols, and procedures, as chosen by majority vote of the SC.
  • Not disclosing confidential information obtained from other members of the program.
  • Submitting periodic progress reports in a standard format, as agreed upon by NIH and the SC, including metrics of the use and impact on the community
  • Transferring in a timely manner detailed data to the LDACC, using agreed-upon formats and processes
  • Assessing and disseminating data, protocols, consent materials, and methods developed for or derived from the LDACC within and outside the Project.
  • Ensuring their site receives the appropriate approvals for sharing of data between the BPC and LDACC
  • Attending and participating in SC and other working group meetings and accepting and implementing decisions made by these groups.
  • Interacting with other relevant NIH activities, as needed, to promote synergy and consistency among similar or related projects.

Adopting a “diversity first” perspective, encouraging recruitment of non-European Ancestry (EA) donors, whenever possible.

NIH staff have substantial involvement that is above and beyond the normal stewardship role in awards, as described below:

The Project Scientist (PS) will have substantial scientific involvement during the conduct of this activity through technical assistance, advice, and coordination. Additionally, the program official will be responsible for the normal programmatic stewardship of the award and will be named in the award notice. The role of NIH staff will be to facilitate and not to direct the activities of the BPC and LDACC awardees. It is anticipated that decisions in all activities will be reached by consensus of the program and that NIH staff will be given the opportunity to offer input to this process. The PS will participate as a member of the SC and will have one vote. The PS will have the following substantial involvement:

  • Participating with the other SC members in the group process of setting research priorities, deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches as warranted. The PS/SO will assist and facilitate the group process and not direct it.
  • Serving as a liaison, helping to coordinate activities among and for the awardees, including acting as a liaison to the NIH, and as an information resource for the awardees about genome research activities. The PS will also coordinate the efforts of the program with other groups conducting similar studies.
  • Attending all SC meetings as a voting member and assisting in developing operating guidelines, quality control procedures, and consistent policies for dealing with situations that require coordinated action. The PS will be responsible for working with the BPC and LDACC as needed to manage the logistic aspects of the program.
  • Reporting periodically on the progress of the program to NIH Leadership.
  • Serving on working groups of the SC and the External Scientific Panel, as appropriate.
  • Assisting awardees in the development, if needed, of policies for dealing with situations that require coordinated action.
  • Providing advice in the management and technical performance of the award.
  • Assisting in promoting the availability of the data and related resources developed in the course of this program to the scientific community at large.
  • Participating in data analyses, interpretations, and, where warranted, co-authorship of the publication of results of studies conducted through the program.
  • Being responsible for the normal scientific and programmatic stewardship of the award, including meeting the milestones required for each year of funding and will be named in the award notice.
  • Curtailing, withholding or reducing support from any awardee that fails to achieve its goals, makes substantiate changes in the project without prior approval of the PS/SO, fails to make sufficient progress toward the work scope with which NIH concurred, has ethical or conflict of interest issues, or fails to comply with the Terms and Conditions of Award.
  • Involving other NIH staff who may assist the awardees as designated by the PS.
  • Serving as a liaison between the SC and the External Scientific Panel (ESP).
  • Attending ESP meetings in a non-voting liaison member role and arranging for timely preparation and distribution of meeting minutes.

Areas of Joint Responsibility:

Close interaction among the participating investigators will be required, as well as significant involvement from the NIH, to manage, assess, and implement dGTEx. In addition to the PD(s)/PI(s), key co-investigators and pre- and postdoctoral trainees, especially those who are members of under-represented minority groups or those from different but related disciplines, are eligible to attend these meetings.

Steering Committee: The SC will be the main governing body of the Project. The SC will be composed of all the PD(s)/PI(s) of each awarded cooperative agreement in this program (BPC and LDACC) and the PS for this Project. Cooperative agreements with multi-PI arrangements will have a single vote to be decided as desired within the multi-PI award. The SC may add additional members, and other government staff may attend the SC meetings as desired. It is anticipated that additional coordination mechanisms may be set up with other U.S. and international groups that may collaborate with the program. Awardees will be required to accept and implement policies approved by the SC.

The SC may establish subcommittees or working groups, in order to facilitate collaborative work and standardize approaches, or to achieve other goals of the Project. Members may include representatives from the program, other NIH staff and other experts, as appropriate.

The PI(s)/PD(s) will be expected to play an active role in these working groups, which may include (but are not limited to) groups focused on specific cross-project activities, such as data standardization, outreach and education, or international data sharing.

The awardees and the PS will meet as the program SC three times a year (2 in-person and 1 via webinar) to share information on data resources, methodologies, analytical tools, data analyses, preliminary results, etc.

NIH and the grantees will work with and provide information to an External Scientific Panel (ESP). The ESP will be responsible for reviewing and evaluating the progress of the project to facilitate members of the Project meeting their individual and collective goals. The ESP will provide recommendations to NIH Leadership. The ESP will meet at least once a year. During part of this meeting, there will be a joint meeting with the SC to allow the ESP members to interact directly with the awardees. The ESP will make recommendations regarding progress of the Project and present advice about changes, if any, which may be necessary in the Project to NIH Leadership.

Awardees and the PS agree to work collaboratively toward:

  • Sharing experiences and expertise across participating awardees and developing consensus approaches to integrating, harmonizing, analyzing and disseminating data for dissemination to other Project members, the broader scientific community, and NIH-designated databases.
  • Establishing best practices for data integration and collaborative analyses as appropriate.
  • Inventorying, harmonizing and analyzing Project data.
  • Developing and refining approaches and evaluate comparability of different approaches.

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 SC 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.

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative 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.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threatensubmission by the due date, and post-submission issues)

Finding Help Online:http://grants.nih.gov/support/(preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email:GrantsInfo@nih.gov(preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support(Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email:support@grants.gov

Scientific/Research Contact(s)

John V. Ilekis, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6895
Email: ilekisj@mail.nih.gov

Jyoti Dayal, MS
National Human Genome Research Institute (NHGRI)
Telephone: 301-280-2307
Email:jyotig@nih.gov

Tara Dutka, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-451-3074
Email:Tara.dutka@nih.gov

Daniel Miller, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-5680
Email:daniel.miller@nih.gov

Elena Gorodetsky, MD, PhD
Office of Research on Women’s Health (ORWH)
Telephone: 301-594-9004
Email:egorod@mail.nih.gov

Peer Review Contact(s)

Mark G Caprara, PhD
Center for Scientific Review (CSR)
Telephone: 301-827-3076
Email: capraramg@mail.nih.gov

Financial/Grants Management Contact(s)

Bryan Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

Section VIII. Other Information

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.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.


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