Solutions to Enable Regional Genomic Medicine eConsult Services (R41/R42 Clinical Trial Optional)

Active
Yes
Status
Open
Release Date
January 9th, 2024
Open Date
April 30th, 2024
Due Date(s)
May 30th, 2024
Close Date
May 31st, 2024
Topic No.
PAR-24-107

Topic

Solutions to Enable Regional Genomic Medicine eConsult Services (R41/R42 Clinical Trial Optional)

Agency

Department of Health and Human ServicesNational Institutes of Health

Program

Type: STTRPhase: BOTHYear: 2024

Summary

The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for solutions to enable regional clinician-to-clinician genomic medicine eConsult services. The purpose of this funding opportunity is to develop products or technologies that will support the development and sustainment of eConsult services in the field of genomic medicine. Small businesses can submit Small Business Technology Transfer (STTR) Phase I and Fast-Track grant applications. The main objectives of the SBIR and STTR Phase I are to establish the technical merit and feasibility of the proposed research and development efforts. The Phase II continues the R&D efforts to advance the technology toward commercialization. The funding opportunity is open for applications until May 31, 2024. The specific objectives include addressing barriers to setting up eConsult services, conducting outreach and education about eConsult services, and providing eConsults. Solutions of interest include technologies that allow diverse Electronic Health Record systems to transmit and manage eConsult requests, artificial intelligence and machine learning solutions for triaging and creating responses, services or technologies for managing the administration of eConsult services, and educational products for providers. The funding opportunity is part of a larger initiative to establish the Genomic Medicine eConsult Research Network. Data sharing is expected, and applicants are encouraged to align their data sets using the FAIR Guiding Principles. A pre-application webinar will be held on February 6, 2024, to provide an overview of the funding opportunity and answer questions.

Description

Purpose This Notice of Funding Opportunity (NOFO) invites applications from eligible small businesses to develop solutions for commercialization that can be used to enable regional clinician-to-clinician genomic medicine eConsult services. Specifically, we seek products, such as technologies or services, that will allow for the development and sustainment of eConsult services.

Eligible United States small business concerns (SBCs) may submit Small Business Technology Transfer (STTR) Phase I, and Fast-Track grant applications. Small business applicants interested in submitting a Small Business Innovation Research (SBIR) grant application should submit to the related funding opportunity, PAR-24-106.

SBIR and STTR are phased programs. The main objective in SBIR and STTR Phase I is to establish the technical merit and feasibility of the proposed research and development efforts. An SBIR and STTR Phase II continues the R&D efforts to advance the technology toward ultimate commercialization. At the conclusion of an SBIR/STTR Phase II, it is expected that the small business will fully commercialize their product or technology using non-SBIR/STTR funds (either federal or non-federal). Small businesses that are eligible to submit Phase II applications for projects that were supported with a Phase I SBIR or STTR award are expected to submit the regular Phase II application as a "Renewal" application based on the awarded Phase I SBIR or STTR project. Only one Phase II application may be awarded for a specific project supported by a Phase I award.

NIH Fast-Track: An NIH STTR Fast-Track incorporates a submission and review process in which both Phase I and Phase II applications are submitted and reviewed together as one application to reduce or eliminate the funding gap between phases.

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. A solution is any source of value for the end-users and customers. A solution can be a product, technology, or service, such as physical/tangible device as well as digital services, software as a service, templates, educational materials, or non-physical/non-tangible products (including but not limited to digital applications, digital platforms, or service models). These and other comparable examples could be considered eligible solutions. 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 genomics among non-genetic clinicians and lack of access to genetic specialists. Yet, genomic medicine eConsult services are rare despite the potential support that these services could provide.

The August 2022 Genomic Medicine XIV Meeting on Genomic Learning Health Systems highlighted the need for consult services to support clinicians in providing genomic care, 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 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. Barriers such as inconsistent licensure laws, lack of consultants, and diverse Electronic Health Record systems have stymied efforts to create regional services. Solutions that can help eConsult services overcome barriers need to be developed.

Specific Objectives A variety of solutions that can enable eConsult services are needed. NHGRI will consider applications that address barriers to setting up eConsult services; conducting outreach, promotion, and education about eConsult services; and/or providing eConsults. Eligible small businesses can submit applications focusing on solutions that reduce costs, time, and/or increase access to regional genomic medicine eConsult services. Solutions of interest include, but are not limited to, those that address the following barriers:

Technologies that allow diverse EHR systems to transmit and manage eConsult requests, associated clinical information, and/or information needed for reimbursement. Artificial intelligence and/or machine learning solutions that can triage, identify common questions, create responses, or otherwise enable eConsult services. Services or technologies that help manage the administration of eConsult services, such as the reimbursement or multi-state licensure of consultants. Services or products that can be used to educate providers on the need for and use of eConsult services. Applications with one or more of the characteristics listed below will be considered non-responsive and will not be reviewed:

Solutions that focus on specific areas specialties of genomic medicine, such as those only providing eConsults for oncology or prenatal concerns. Solutions that do not enable regional services (i.e., work within a single healthcare system). Relationship to eConsult Network As part of a related funding opportunity, RFA-HG-24-001, NHGRI is soliciting U01 research 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 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 are eligible to apply for the U01 NOFO. Or, small businesses can choose to research and develop components of eConsult services, or other related solutions that would enable regional eConsult services under this STTR NOFO or the related SBIR NOFO (PAR-24-106).

Small businesses that are awarded under the SBIR or STTR NOFOs will have the option of participating in Network calls and meetings. However, they will not be voting members of the Steering Committee.

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). A FAQ with SBIR/STTR specific information is also available. 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. Scientific data that is shared 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 data shared under this NOFO to include 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.

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.

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