Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Human Genome Research Institute (NHGRI)

Funding Opportunity Title
Research on the Impact of and Methods for Implementing Regional Genomic Medicine eConsult Services (U01 Clinical Trials Optional)
Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type
New
Related Notices
  • August 31, 2022- Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
  • August 5, 2022- Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.
Funding Opportunity Number (FON)
RFA-HG-24-001
Companion Funding Opportunity
None
Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)
93.172
Funding Opportunity Purpose

This Notice of Funding Opportunity (NOFO) solicits applications for sites to conduct research on the impact of and methods for implementing regional clinician-to-clinician genomic medicine eConsult services.

Key Dates

Posted Date
January 09, 2024
Open Date (Earliest Submission Date)
April 30, 2024
Letter of Intent Due Date(s)

April 30, 2024

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date
May 30, 2024 Not Applicable Not Applicable November 2024 January 2025 April 2025

All applications are due by 5:00 PM local time of applicant organization. 

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.

Expiration Date
May 31, 2024
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 How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) 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. Notice of Funding Opportunity Description

Purpose

This Notice of Funding Opportunity (NOFO) invites applications for sites to participate in the Genomic Medicine eConsult Research Network, hereafter referred to as the ‘eConsult Network.' The eConsult Network will consist of 2-3 sites working with NHGRI to conduct research on the impact of and methods for implementing regional clinician-to-clinician genomic medicine electronic consult (eConsult) services. Specifically, sites will be funded to research how to best design, implement, and sustain regional genomic medicine eConsult services; provide outreach to potential users, including those at underserved settings; and assess the impact on key stakeholders while developing successful implementation strategies and resources that can be broadly shared and adopted.

Small businesses that are interested in the research and development of solutions that enable regional eConsult services can apply to the related funding opportunities, PAR-24-106 or PAR-24-107.

Definitions

For the purposes of this NOFO, the following definitions are used:

  • Electronic consults (eConsults) refers to electronic messages sent between clinicians about general or patient-specific questions. These communications are clinician-to-clinician and do not directly include the patient.
  • Regional eConsult services are defined as those providing services to multiple unaffiliated healthcare organizations.
  • Genomic medicine eConsult services respond to questions from the full breadth of specialties that utilize genomic medicine in caring for patients. These services are prepared to give advice on a wide range of topics, such as diagnostic approaches, test result interpretation, and medical management recommendations. 
  • Implementation science is the study of methods to promote the adoption and integration of evidence-based practices, interventions, and policies into routine health care and public health settings to improve the impact on population health.
  • Implementation science framework refers to strategic or action-planning models that provide a systematic way to develop, manage, and evaluate interventions and make the spread of evidence-based interventions more likely.
  • Medically underserved areas/populations are geographic areas and populations with a lack of access to primary care services (Health Resources and Services Administration).

Background 

Non-regional eConsult services (i.e., those within a single organization or system) have been established by many institutions in non-genomic specialties. They’ve been shown to reduce specialty clinic appointment wait times, healthcare costs and utilization, and patient travel costs and burden, and to improve primary/specialty communication. Previous research has demonstrated the feasibility of eConsult services and identified factors promoting successful implementation including compatibility with existing workflows, clarity of communications, technologic simplicity, and protected time for consultants. In addition to the benefits seen in non-regional services, regional eConsult services have successfully provided specialty care in large, disadvantaged populations with historically poor access to specialty care. Regional eConsult services can promote equity of access by enabling patients to obtain the care that they need without referrals to other providers.

The use of genomic testing in primary and specialty care remains scant, in part due to lack of understanding and confidence with interpreting genomics among non-genetic clinicians and lack of access to genetic specialists. Despite the potential support that genomic medicine eConsult services could provide, these services are rare.

The August 2022 Genomic Medicine XIV Meeting on Genomic Learning Health Systems highlighted the need for consult services to support clinicians in providing medical care that incorporates genomics, especially in lower-resourced settings that do not have genetic experts. The subsequent NHGRI Genomic Consultation Research Working Group explored the current status of genomic eConsult services at their institutions and research needed to successfully implement these services elsewhere.

First-year results from one genomic medicine eConsult service demonstrated rapid turnaround times and high rates of actionable recommendations and follow-through on those recommendations. More extensive experience in Ontario, Canada showed that genomic eConsults enabled many primary care providers (PCPs) to provide care without referring the patient and that most referring PCPs perceived the eConsult as valuable for patient management. Unfortunately, such services are currently targeted only to the clinicians within these institutions, so clinicians in locations without access to genomic specialists lack access to genomic medicine eConsults as well.

While regional genomic medicine eConsult services have been shown to be effective in Ontario, similar services are not available in the United States. A commercial diagnostics company recently funded eConsult services to Federally Qualified Health Centers in five metropolitan areas but included no genomic medicine. An eConsult network set up for San Francisco’s safety net system includes only cancer genetics. Indeed, a recent attempt to provide genomic medicine eConsults in one region was stymied by barriers such as inconsistent licensure laws and lack of consultants. Implementation research is needed to determine how to provide genomic eConsults to clinicians in locations without genomic expertise and to determine the impact of providing those services.

Research Approach 

The eConsult Network will consist of 2-3 sites and NHGRI. Each site will conduct research to determine the impact of and methods for implementing regional clinician-to-clinician genomic medicine eConsult services. This program is intended to address three overarching research questions: 

  1. What impact do genomic eConsult services have when they are implemented at the regional level?
  2. How can regional genomic eConsult services be implemented and sustained?
  3. Can tools be created and shared with others who are creating regional eConsult services?

To answer these questions, each site will establish an independent regional eConsult service within the United States and/or its territories and test different approaches to implementation, potentially addressing different barriers and facilitators unique to their situations. 

Applicants will identify a population for which to provide eConsults. For example, they can choose a geographic area and serve all healthcare facilities within the region or a noncontiguous selection of facilities, such as a collection of Federally Qualified Health Centers (FQHCs) or Indian Health Service (IHS) locations. It is NHGRI’s expectation that services will handle at least 1000 eConsult requests per year when at full capacity.

All sites must include at least two medically underserved populations/areas. Preference will be given to applications that include a variety of settings, such as academic medical centers, community hospitals, private practices, and safety net services; use multiple Electronic Health Record (EHR) platforms; and serve an array of patient communities.

Sites will be expected to use an implementation science framework, such as the Practical Implementation Sustainability Model (PRISM), RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance), or the Consolidated Framework for Implementation Research (CFIR). Because this program focuses on both impact and implementation, sites may choose an effectiveness-implementation hybrid design. These frameworks should guide the sites in addressing three operational goals: 

  1. Set up eConsult service
  2. Conduct outreach, promotion, and education
  3. Provide eConsults

Each site will engage consultants with relevant genomic expertise to respond to the wide variety of expected eConsult requests. They will also need to create an infrastructure that includes sufficient administrative and clinical staff to receive, triage, manage, and respond to eConsult requests. 

Outreach efforts could include informing clinicians of the availability and specifics of the genomic medicine eConsult service. Potential users include physicians and advance practice providers in a wide array of specialties such as internal medicine, pediatrics, and general surgery and their subspecialties such as cardiology and oncology and include practitioners who care for underserved populations and those in resource-limited settings. 

While providing eConsult services, sites will engage in continual improvement of the service through the utilization of an implementation science framework. 

Efforts to achieve the operational goals should be designed in a way that their impact and implementation can be measured. While the research at each site will be conducted independently, the sites (through the eConsult Network’s Steering Committee) will agree on common metrics to assess both the impact and the implementation of the services. 

The first year will be used to establish the eConsult services, establish the outreach and referral networks, and collaborate to develop and agree on metrics. A soft launch of a small number of eConsults could occur in the first year. A hard launch of the eConsult service will occur by the second year. Years 2-5 will see continued outreach, promotion, and education while the sites continuously evaluate and refine their procedures. In the final year, sites will disseminate and publicize their findings and tools.

Consultation with key stakeholders will begin in the first year and continue throughout the program to enhance availability and applicability to underserved settings, optimize efficiency, promote feedback, and evaluate impact. 

Sites are expected to solicit advice from those with varied expertise such as genetic counseling, implementation science, informatics, insurance and reimbursement, health disparities and access to care, liability and licensure, health economics, communications and marketing, and/or health education. Applicants are encouraged to establish an advisory group or panel.

Options for sustainability after the award period must be studied. In addition to traditional billing and reimbursement, researching creative solutions for sustainability is encouraged. Sites could also collect data that could be used to justify appropriate coverage of eConsult services to payors. 

In all phases of the project, tools will be developed for dissemination to other institutions that may implement eConsult services, such as guides for conducting outreach, templates for eConsult responses, or content for continuing education for clinicians.

The collaboration among the awardees and NHGRI will involve regular meetings to discuss obstacles, brainstorm and share solutions, review stakeholder input, and monitor progress. The eConsult Network will collaborate to establish common metrics so that outcomes from each site can be compared. The sites and NHGRI will share organizational activities such as organizing joint calls and meetings. The eConsult Network may identify additional areas of collaboration, such as in the development of common implementation tools.

Program Formation and Governance

This NOFO uses the Cooperative Agreement mechanism. Successful applicants will become members of the eConsult Network. Recipients are expected to work collaboratively with all members of the eConsult Network to meet network goals, in addition to the research goals outlined in their individual applications. Close interaction among recipients and NHGRI will be required to develop appropriate strategies and tools to carry out this program. A kickoff meeting for the eConsult Network will take place soon after awards are made to establish the Steering Committee and start the program’s activities.

Small businesses that receive awards though PAR-24-106 or PAR-24-107 for the research and development of solutions that enable eConsult services will have the option of participating in Network calls and meetings. However, they will not be voting members of the Steering Committee.

NHGRI

NHGRI is responsible for organizing and providing overall support and management for the eConsult Network. In addition to regular grant stewardship, the NHGRI Project Scientist(s) will be involved substantially with the recipients, consistent with the Cooperative Agreement mechanism. The NHGRI Project Scientist(s) will, together, be a voting member of the SC and have a single vote.

Steering Committee

A Steering Committee (SC) will be the main governing body of the eConsult Network. The Steering Committee will be established to guide the overall scientific direction of the eConsult Network. While each site will conduct their projects separately, the SC will establish standardized outcomes and metrics. The SC will be composed of the PD/PI(s) from each of the funded sites and NIH staff. Major scientific decisions will be determined by consensus, and as needed, by simple majority vote of the SC, where each funded entity and NHGRI will have a single vote. It is anticipated that the SC will meet at least once per month by conference call for the first 6-12 months of the project. During years 2-5, the SC will meet at least quarterly. Funded sites will take turns organizing and hosting in-person and virtual meetings. SC meetings are intended to be inclusive and all key collaborators and pre- and postdoctoral trainees, including those from underrepresented groups or those from different but related disciplines, should be encouraged to attend. Recipients will be expected to accept and implement policies approved by the SC as described in Terms and Conditions of Award.

Data Sharing

NHGRI recognizes that data sharing is essential to advance genomic research and will expect recipients to comply with the NIH Data Management and Sharing Policy (NOT-OD-21-013) and NIH Genomic Data Sharing Policy (NOT-OD-14-124). NHGRI supports the broadest appropriate data sharing with timely data release through widely accessible data repositories. Please follow the NIH guidance on writing a Data Management and Sharing (DMS) Plan here, and ensure the Plan is in alignment with NHGRI’s data sharing expectations, which are summarized at genome.gov/data-sharing. All resulting scientific data should be submitted to an established repository as described in the Data Management and Sharing Policy guidance and NHGRI’s guidance on where to submit scientific data

Per NOT-HG-21-002, NHGRI expects applications awarded under this NOFO to share comprehensive metadata; use standardized data collection protocols and survey instruments for capturing data, as appropriate; and use standardized notation for metadata (e.g., controlled vocabularies or ontologies) to enable the harmonization of datasets for secondary research analyses. To assist in improving data sustainability and utility, applicants are encouraged to align the development of their data sets using the FAIR Guiding Principles. Policies and standards related to data sharing and data integration to be implemented in this Network will be shared with the broader community.

Plan for Enhancing Diverse Perspectives (PEDP)

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP) as described in NOT-MH-213-10, submitted as Other Project Information as an attachment (see Section IV).

Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material. The PEDP will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions.

Non-Responsive Applications

Applications with one or more of the characteristics listed below will be considered non-responsive and will not be reviewed:

  • Services that are not regional (i.e., do not provide services to at least two unaffiliated healthcare organizations).
  • Services that focus on specific  specialties or focuses of genomic medicine, such as those only providing eConsults for oncology or prenatal concerns or those only addressing specific types of questions, such as test result interpretation.
  • Research on non-genomic medicine eConsults. While we encourage incorporating genomic medicine eConsult services into broader services with multiple specialties, this NOFO will only fund research on genomic medicine eConsults.
  • Applications that do not propose both impact and implementation outcomes. 
  • Applications that do not create and disseminate implementation tools.
  • Applications that do not contain a Plan for Enhancing Diverse Perspectives.

Pre-Application Webinar and Program Website

NHGRI will hold a pre-application webinar for potential applicants on Tuesday, February 6, 2024 at 2 pm ET (1pm CT / 12pm MT / 11am PT). Participation in the webinar is optional and not required to submit an application. Information about the webinar can be found at: https://www.genome.gov/event-calendar/eConsult-Webinar. The webinar connections will open 15 minutes in advance of the start time. During the webinar, NIH staff will give an overview of the NOFO and application submission process and field questions from potential applicants. Attendees can ask questions during the webinar and are encouraged to email questions in advance to Renee Rider at Renee.Rider@nih.gov.

For those who cannot attend, a recording of the webinar will be posted on the above website. Questions and answers from the webinar and other frequently asked questions will also be posted.

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

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

Funding Instrument

Cooperative Agreement: A financial assistance 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 NOFO.

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 NOFO.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Funds Available and Anticipated Number of Awards

NHGRI intends to commit $3.0M total costs in FY 2025, $3.2M in FY 2026, and $3.5M each year in FY 2027-2029 to fund 2 awards.

Award Budget

Awards are limited to $870,000 direct costs in FY 2025, $940,000 in FY 2026, and $1,020,000 each year in FY 2027-2029.

Award Project Period

The project period for this NOFO is 5 years (FY 2025-FY 2029).

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

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 Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

  • 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.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
    • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; 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 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 their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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 NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

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, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

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 NOFO. 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 How to Apply - Application Guide except where instructed in this notice of funding opportunity 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:

Renee Rider, JD, MS, CGC
Telephone: 301-443-4336
Email: Renee.Rider@nih.gov

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

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.

Plan for Enhancing Diverse Perspectives

In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP may be no more than 1-page in length and should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

  • Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
  • Description of any planned partnerships that may enhance geographic and regional diversity.
  • Plan to enhance recruiting of women and individuals from groups historically under-represented in the biomedical, behavioral, and clinical research workforce.
  • Proposed monitoring activities to identify and measure PEDP progress benchmarks.
  • Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.
  • Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds.
  • Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).
  • Publication plan that enumerates planned manuscripts and proposed lead authorship.
  • Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp.

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

Site budgets should include the costs required for active participation in the eConsult Network, including regular teleconferences and meetings of the steering committee and any working groups. For budgeting purposes, applicants should include monthly 1-2 hour virtual meetings during year 1 and one in-person (2 days, 1-2 nights in Bethesda) meeting. In years 2-5, applicants should budget for quarterly virtual meetings and one in-person (2 days, 1-2 nights in Bethesda) meeting.

Each site’s budget should include funds for outreach, promotion, and education; infrastructure, such as the eConsult platform; and clinical costs, such as reimbursing the consultants for their time. Each site should budget for an eConsult service that is expected to garner at least 1000 eConsults per year when operating at full capacity.

DMS Costs

Budgets should include any funds required to support sharing of scientific data under this NOFO. NIH provides guidance on allowable costs for data management and sharing here.

PEDP implementation costs

Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7: https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm). 

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:

While developing their research plans, applicants should consider whether their research involves a clinical trial according to NIH's Definition of a Clinical Trial. Studies that propose clinical trials have additional instructions below. Clinical trials that are misclassified will need to be withdrawn; thus, particular care should be paid to the classification.

All research plans must include the following components; however, applicants are not required to use these subsection headings.

Scope of eConsult Service. Applicants should describe the patient and clinician population for whom they will be providing eConsults. Applicants need to demonstrate that their customer base is likely to yield at least 1000 eConsults requests per year when the service is at full capacity. Applicants may use the assumption that 10 million people in a defined general population (that is, not drawn from a healthcare system population) will yield 1000 eConsults. Or, that 4.5 million patients registered in a collection of healthcare facilities will yield 1000 eConsults. Alternatively, applicants may use another calculation if they provide justification.

Applicants should also identify and describe the medically underserved populations/areas, medical settings (e.g., academic medical centers, community hospitals, private practices, and safety net services), EHR platforms; and patient communities that will be in the service’s catchment area.

Implementation Science Framework. Applicants should identify the framework(s), theory(ies), or model(s) that they will use. They should describe how implementation science will be used to develop, refine, and sustain the service.

Operational Goals. Applicants should clearly describe how they propose to meet the three operational goals. For each goal, applicants should propose impact and implementation questions, outcomes, and metrics.

  1. Set up eConsult service: Applicants should describe how they will lay the groundwork for and establish the eConsult service. At minimum, each application should have plans to establish an infrastructure (or augment one if it already exists) that includes information technology (IT), administrative, and clinical infrastructures. Applicants should describe the strategies they will test to overcome barriers to implementing eConsult services, such as handling requests from organizations using different EHR platforms or managing provider licensure in multiple states. Applicants should include their plans for engaging consultants in sufficient numbers and with sufficient expertise to answer the wide variety of expected eConsult requests.  
  2. Conduct outreach, promotion, and education: Applicants should describe their plans for outreach, promotion of the service, and education of potential users throughout the duration of the award. 
  3. Provide eConsults: Applicants should describe their plan for using an implementation science framework to improve the service as they provide eConsults. 

Timeline and Milestones. Applicants should provide a timeline for the project. Milestones describing clear and objective criteria for success should be provided and function as indicators of a project's progress.

Stakeholder and Advisor Consultation. Applicants should describe plans for consultation with key stakeholders. They should identify the proposed roles and expertise of the members of the advisory group or panel, but potential members should not be named in the application.

Network Meetings. Applicants should describe plans to attend in-person meetings once a year or more as needed. Applicants should also describe their ability and plans to host these meetings and related meetings such as informational meetings and exchanges with the scientific community.

Sustainability. Applicants should describe their plan for sustaining the eConsult service after NHGRI support has ended and the research they will do to refine the plan.

Implementation Tools. Applicants should describe the eConsult implementation tools they will develop for dissemination to other institutions who may subsequently wish to create an eConsult service. Such plans should cover the tools used to meet any of the program's operational goals.

Letters of Support. Applicants should provide letters of support from the experts who will respond to eConsults requests and describe their qualifications and commitment. Letters could also be provided for outreach partners, IT specialists, providers of eConsult platforms, and any other individuals who are critical to the success of the research program. 

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.

NHGRI is committed to the timely release of open-source software and well-documented data analyses including models and tools developed from proposed studies. Applicants should describe in the Resource Sharing Plan a plan for open dissemination of methods, protocols, software, and tools to the community such that they are readily usable and extensible, where applicable. These should be made freely available to others who may create eConsult services. For software produced by applications responding to this announcement, there is no prescribed license, but any software license selected by applicants should allow for unrestricted redistribution and modification of software.

  • Methods, protocols, tools, and software should be well-documented and where applicable made available via version-controlled public repositories.
  • In the Resource Sharing Plan, a plan for sharing software should describe how improvements or tool customizations will be managed and disseminated to the scientific community. Applicants should take responsibility for creating the original and subsequent “official” versions of a piece of software.

For a list of frequently asked questions about Best Practices for Sharing Research Software, see https://datascience.nih.gov/tools-and-analytics/best-practices-for-sharing-research-software-faq. After initial review, NHGRI program staff will conduct an additional administrative review of the plan for resource sharing and may negotiate modifications of this plan with the prospective recipient. The final negotiated version of this plan will become a term and condition of the award.

Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

  • All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

  • No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

See Part 2. 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. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply – 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 Section 7.9.1 Selected Items of Cost.

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 form. 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 NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier 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 NHGRI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NHGRI Referral Office by email at jennifer.troyer@nih.gov when the application has been submitted. Please include the NOFO number and title, PD/PI name, and title of the application.

Applications must include annual milestones. Applications that fail to include annual milestones will be considered incomplete and will be withdrawn. Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn before review.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described 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.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Specific to this NOFO:

  • How well does the applicant address significant barriers to implementing genomic eConsults in a variety of settings? Examples of significant barriers include, but are not limited to, licensure laws, reimbursement, or low-resource settings.
  • To what extent does the population that the applicant identified include a variety of healthcare settings, such as academic medical centers, community hospitals, private practices, and safety net services?
  • To what extent does the population that the applicant identified use multiple Electronic Health Record (EHR) platforms?
  • To what extent does the population that the applicant identified include a diversity of communities including at least two medically underserved populations/areas?
  • How useful are the tools that the applicant plans to create and disseminate likely to be to others who are creating eConsult services?
  • To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the project?
 

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?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Specific to this NOFO:

  • How much experience do the applicant(s) have with eConsult services?
  • How much experience do the applicant(s) have with implementation science?
  • To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required 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?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Specific to this NOFO:

  • Did the applicant provide eConsult service models that are sufficiently innovative to meet the goals of the project?
  • Did the applicant provide implementation plans that are sufficiently innovative to create a successful eConsult service?
  • To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?
 

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? 

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?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Specific to this NOFO:

  • Did the applicant(s) adequately justify the scope of their service such that it is likely they will obtain at least 1000 referrals per year when at full capacity?
  • To what extent could the approaches described for outreach, promotion, and education allow providers in lower-resourced settings to use the described service?
  • Is the plan for creating and disseminating implementation tools adequate?
  • How likely are the strategies for stakeholder engagement to result in identifying, understanding, and involving groups that have a stake in the outcome of this research?  
  • How likely are the plans for obtaining expert advice to result in acquiring the interdisciplinary expertise needed for this project? 
  • Did the applicant(s) describe adequate plans for obtaining sufficient numbers of consultants with expertise to address the breadth of expected eConsult requests? 
  • How likely are the strategies for sustainability to result in a service that is sustained after NIH funding ends? 
  • Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?
 

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?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Specific to this NOFO:

  • To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the project?
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.

 

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

 

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 three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Not applicable.

 

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.

 

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.

 

Not Applicable.

 

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

 

Not Applicable.

 

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 NHGRI, in accordance with NIH peer review policies and practices, 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 NOFO.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by National Advisory Council for Human Genome Research. 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.
  • Potential for broader application or generalization due to the proposed service’s inclusion of multiple settings, such as academic medical centers, community hospitals, private practices, and safety net services; use multiple Electronic Health Record (EHR) platforms; and inclusion of diverse patient populations.
  • Ability and commitment to investigative group to work effectively in collaborative efforts or consortia.
  • Programmatic balance, such as sites using different models or implementation frameworks, or investigating different barriers. 

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 2.4.4 Disposition of Applications.

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 recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. 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 NOFO 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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

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: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the HHS Office for Civil Rights website.

HHS recognizes that NIH 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 NOFO.

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 2 CFR Part 200.206 “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 2  CFR Part 200 , and other HHS, PHS, and NIH grant administration policies. The administrative and funding instrument used for this award will be managed as a cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients 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 recipient. Specific tasks and activities may be shared among the recipients and the NHGRI staff as defined below.

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

  • Determining research approaches, designing protocols, setting project milestones and timelines, and conducting research.
  • Ensuring that the software, tools, resources, materials, etc. produced as part of this project are released appropriately according to the Resource Sharing Plan.
  • Ensuring that the data produced as part of this project are released appropriately according to the Data Management and Sharing Plan.
  • Preparing abstracts, presentations and publications in a timely manner.
  • Adhering to policies regarding sharing of genomic and other types of data, data access, and standardized formats; timely publication; and intellectual property established by the NIH, NHGRI, and the Steering Committee (SC).
  • Not disclosing confidential information.
  • Interacting with other relevant NHGRI and NIH activities, as needed, to promote synergy and consistency among similar or related projects.
  • If applicable, the clinical trial(s) supported by this award are subject to the plan included in the application submitted to NIH and the NIH policy on Dissemination of NIH-Funded Clinical Trial Information (Public Law 110-85 and NOT-OD-16-149).
  • Participating in group activities, including a Network-wide Steering Committee and working groups to 1) develop common metrics for all data collection; 2) collaborate on common implementation tools, publications, etc.; and 3) share resources within the Network.
  • Abiding by common definitions, procedures, common data collection metrics, etc. as chosen by majority vote of the Steering Committee.
  • Collaborating with all Network sites to improve interoperability and transferability of tools and resources within and potentially outside the Network to facilitate adoption of genomic eConsult services by other health systems.
  • Collaborating with all Network sites in making Network findings and procedures as widely available and applicable as possible.
  • Sharing implementation strategies, tools, resources, and data of interest for review by the Steering Committee.
  • Cooperating with other recipients in the development and design of research methods, protocols, tools, and strategies as needed.
  • Accepting and complying with policies established by NIH, and with additional non-conflicting policies approved by the Steering Committee.
  • Cooperating with other recipients in the publication and dissemination of program results and the eventual release to the scientific community of methods, tools, and results, and other resources.
  • Assessing and disseminating data, protocols, and methods developed within and outside the Network.
  • Submitting periodic progress reports in a standard format, as agreed upon by the Steering Committee and NHGRI.
  • Attending and participating in Steering Committee and other working group meetings and accepting and implementing the decisions, guidelines, and procedures adopted by the Steering Committee and NHGRI, as appropriate.
  • Recipients will be required to accept and implement policies approved by the SC.
  • Organizing, hosting, and coordinating Network meetings and informational meetings and exchanges with the scientific community as needed to develop, promote, and disseminate the research program.
  • Providing reports, summary statistics, and data, as appropriate, in a timely fashion as agreed upon by the Steering Committee and NHGRI.
  • Recipients(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to Government policies regarding rights of access consistent with current DHHS, PHS, and NIH policies. NIH will have unrestricted access to and use of the data and software, including the right to transfer them to other resource projects for their use, distribution, and integration with other data. NIH expects that the recipient will grant other resources the ability to use and redistribute the data, including integrating the data with other datasets, without restriction, unless otherwise limited by consent requirements.

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

The Project Scientist/Scientific Officer (PS/SO) at NHGRI is a dual role held by a NHGRI Program Director. In the Project Scientist role, the Program Director will have substantial scientific and programmatic involvement during the conduct of this activity through technical assistance, advice, and coordination. In the Scientific Officer role, the Program Director will be responsible for the normal scientific and programmatic stewardship of the award and manages concerns about bias as it affects the project. The role of NHGRI PS/SO will be to facilitate and not to direct the activities. The PS/SO will be named in the Notice of Award.

The PS/SO will have the following substantial involvement:

  • Serving as a liaison, helping to coordinate activities among and for the recipients, including acting as a liaison to the NHGRI and as an information resource for the recipients about genome research activities. The PS/SO will also coordinate the efforts of the Recipient(s) with other groups conducting similar studies.
  • Reporting periodically on the progress of the Recipients to the NHGRI Director and to the National Advisory Council for Human Genome Research.
  • Assisting Recipient(s) in the development, if needed, of policies for dealing with situations that require coordinated action.
  • Providing advice on the management and technical performance of the award.
  • Assisting in promoting the availability of the data and related resources developed in the course of the award to the scientific community.
  • Being responsible for the normal scientific and programmatic stewardship of the award, including assessments of how well the recipient has met any milestones required for each year of funding.
  • Curtailing, withholding or reducing support for any Recipient that fails to make satisfactory progress toward the work scope that NHGRI approved, has ethical or conflict of interest issues, or fails to comply with the Terms and Conditions of Award.
  • Involving NIH or NHGRI staff who may assist the Recipient(s) as designated by the PS/SO.
  • Where warranted and consistent with authorship and conflict of interest requirements of journals in which the Consortium/Network decides to publish, co-authoring manuscripts through their role in scientific program management.
  • Reserving the right to terminate or curtail the study (or an individual award) and requiring the recipient to submit a close-out plan within two (2) months of the decision to terminate in the event of (a) failure to implement the study protocol, (b) a substantial shortfall in participant recruitment, follow-up, data reporting and dissemination, quality control, or other major breach of the protocol, (c) substantive changes in the agreed-upon protocol with which NHGRI does not concur, (d) reaching a major study objective substantially before schedule with persuasive statistical evidence, or (e) human subjects ethical issues that may dictate a premature termination.
  • Attending all Steering Committee 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.
  • Serving as a liaison between the Steering Committee and other federal agencies such as the Centers for Medicaid and Medicare Services (CMS) or the Health Resources and Services Administration (HRSA).
  • Serving on working groups of the Steering Committee as appropriate.
  • NIH staff will review and approve policies developed by the SC.

Areas of Joint Responsibility:

Close interaction between the participating Recipient(s) and the PS/SO will be required to manage, assess, and implement the eConsult Network. This is accomplished by:

  • Meeting regularly to share information on data resources, methodologies, analytical tools, data analyses, preliminary results, etc. Meetings will be scheduled at least once a month during the first 6-12 months and quarterly thereafter. In-person, two-day meetings will be held at least once a year, with the rest virtual.
  • Establishing best practices for data integration and collaborative analyses as appropriate.
  • Establishing best practices for documentation and dissemination of tools and resources created within the Network as appropriate.
  • Setting research priorities, deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches as warranted.
  • Encouraging key co-investigators and pre-and postdoctoral trainees, including those who are members of under-represented groups or those from different but related disciplines, are eligible to attend Network meetings, become involved in key consortium working groups, to lead and report on analyses, etc.

Steering Committee (SC): The SC will be the main governing body of the Consortium. The purpose of the SC will be to recommend directions for a consortium consistent with achieving the project goals, develop consortium policies to build synergy and improve communication and collaboration between the projects, and to provide a forum for discussing progress, challenges and opportunities for the consortium.

  • The SC will be composed of one representative from each of the grants awarded in the Network. Each PD/PI will decide who will be its representative. Multi-PI grants will have one representative. Each representative will have one vote; The PS/SO will be a voting member.
  • 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  SC and working group meetings.
  • The SC will develop its own operating procedures.
  • The SC may establish working groups to oversee the development and implementation of consortium policies including data or software releases, publications and standards, etc. Working groups may be either permanent or time limited, may include additional experts, depending on the needs of the research.
  • The PD(s)/PI(s) will be expected to play an active role in these working groups, as appropriate.
  • It is expected that most of the decisions on the activities of the SC will be reached by consensus. If a vote is needed, at least 60% of the voting members most vote in favor of the proposal.
  • If multiple sites in the Network opt to do a clinical trial, the SC will establish best practices for IRB interactions, patient consent or assent (as appropriate), and results reporting, and for collecting, formatting, documenting, and sharing data as appropriate.
  • The SC may make rules that govern the extent to which small businesses (funded through PAR-24-106 and PAR-24-107) may participate in Network calls and meetings.

Dispute Resolution

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NHGRI may be addressed by convening a Dispute Resolution Panel. It will be composed of 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 disagreement for one award, the first member may be chosen by that recipient. This special dispute resolution procedure does not alter the recipient'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. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

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

Awardees will provide updates at least annually on implementation of the PEDP.

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. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients 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 the threshold.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, 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 2 CFR Part 200 – Award Term and Condition 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 threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (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: 301-637-3015

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)

Renee Rider, JD, MS, CGC

National Human Genome Research Institute (NHGRI)
Telephone: 301-443-4336
Email: Renee.Rider@nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Lisa Oken

National Human Genome Research Institute (NHGRI)
Telephone: 301-594-5250
Email: Lisa.Oken@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 2 CFR Part 200.

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