Key Dates

Related Announcements

PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

Issued by

National Institute of General Medical Sciences (NIGMS)

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

Office of Data Science Strategy (ODSS)

Purpose

The National Institute of General Medical Sciences (NIGMS) announces the availability of funds for administrative supplements to Institutional Development Award (IDeA) Networks for Clinical and Translational Research (IDeA-CTR) (U54) awardees to advance the use of Electronic Health Records (EHR) for research. 

Accelerating the use of EHRs for research is a goal set in the 21^st Century Cures Act. In IDeA states, IDeA-CTRs have been leading the effort to encode EHRs of health research institutions and affiliated health clinics that serve rural populations into compliance with the Fast Healthcare Interoperability Resources (FHIR ) standard mandated by the 21st Century Cures Act, as well as harmonizing and integrating the data into Common Data Models (CDMs) suitable for research use.  This NOSI is intended to strengthen IDeA-CTRs’ EHR-related research infrastructure and explore ways of using the FHIR standard to capture, integrate, and exchange clinical data for research, with the goal of facilitating future clinical trials and observational studies.

Projects in one or more of the following areas may be proposed: 

• Assisting one or more IDeA-CTR-affiliated healthcare sites that rely on custom-made and/or outdated systems to adopt updated FHIR-compliant software with standardized terminologies and coding.
• Harmonizing FHIR-compliant EHR data using different terminologies to a single CDM within the IDeA-CTR, using standard Common Data Elements. 
• Projects that prepare the IDeA-CTR for using the FHIR standard to facilitate EHR-based research, such as:
  • Mapping the IDeA-CTR’s selected CDM to the FHIR resources.
  • Establishing FHIR servers/Application Programming Interfaces (APIs) for clinical data exchange. 
  • Integrating and interfacing Research Electronic Data Capture (REDCap) with FHIR.
  • Developing Substitutable Medical Applications, Reusable Technologies (SMART) on FHIR user-facing applications that connect to EHR and health portals. 

Multiple projects may be proposed by an IDeA-CTR as long as each addresses a unique research purpose and is led by a different Project Leader. 

Program Directors/Principal Investigators (PD(s)/PI(s)) and Project Leaders

• The PD/PI of an application to this NOSI must be the PD(s)/PI(s) of an active IDeA-CTR award. 
• Project Leaders must have prior experience relevant to the activities they propose to lead. A different Project Leader (or co-Project Leaders) may be designated for different activities. 
• A Project Leader supported by an administrative supplement award via this NOSI remains eligible to receive simultaneous research support as Project Leaders from a parent IDeA award, as allowable.

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

• PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-20-272 must be followed, with the following additions:

• Application Due Date(s) – May 15, 2023, by 5:00 PM local time of applicant organization.
• For funding consideration, applicants must include “NOT-GM-23-035” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
• The title of the administrative supplement must be identical to the title of the parent award.
• The terms and conditions of the parent IDeA award apply, including that the proposed research must not constitute a change in scope.
• Only existing awardees of the IDeA-CTR program are eligible to apply. The parent award must be active when the supplement application is submitted (e.g., within the originally reviewed and approved project period and not currently in a no-cost extension)
• Only one supplement request per IDeA-CTR will be accepted but this request may include multiple proposed projects.
• Budget: 
  • Requests may be for one year of support only.
  • The budget request for each project must reflect the actual needs and costs of the proposed activities and the total supplement request cannot exceed the total annual costs of the current award. 
  • As part of the budget justification, a statement regarding the plans for expenditure of currently available unobligated grant funds for the parent award should be included.
  • The PD/PI(s) cannot serve as Project Leaders for the proposed activities nor use the supplement to support research in their own laboratories; however, they may request funding for the administrative management of the supplement.
  • No funds from these awards can be used to procure access to commercially available EHR data.
  • Supplement awards may provide support above the established program budget limits for the parent grant award.
• The Research Plan Section should include the following elements:
  • The Project Summary should briefly describe the proposed activities, how they will collectively contribute to increased use of EHR for research, and how they align with the goals of the parent grant. 
  • The Specific Aims are limited to 1 page and should specify all activities that will be pursued. 
  • The Research Strategy may not exceed 6 pages. It should describe all proposed activities and expected outcomes. The research descriptions should address the following points, as applicable to the proposed activities:
    • For the adoption of FHIR-compliant EHR software, provide information on the number of sites, their anticipated numbers of unique patients, and a plan to work with sites to select a FHIR-compliant software vendor. Provide a timeline for installing and implementing the software. 
    • For the harmonization of EHR, justify the choice of CDM and describe the anticipated staff and compute needs for creating crosswalks, data conversion, harmonization and interoperability testing. Include a timeline with benchmarks.
    • For FHIR-related projects, include the following, as appropriate to the proposed work: Describe how EHR is currently obtained, managed, and accessed, including the process for obtaining consent, deidentification, and IRB approval, and identify areas where FHIR may provide an advantage over current practices and propose one or more pilots for testing or validation.  Use of publicly available resources for this purpose is encouraged. For each SMART on FHIR pilot that is proposed, include a description of its research purpose and design features. 

Reporting

Recipients will be required to include progress on the supplement project in the parent award's Research Performance Progress Report. The progress report should include information on scientific accomplishments and outcomes that were facilitated by increased capacity for conducting EHR-based research. The information will be used to assess the effectiveness of the award. 

Applicants are strongly encouraged to notify the program contact listed below that a request has been submitted in response to this FOA in order to facilitate efficient processing of the request.

Inquiries

Please direct all inquiries to:

Michele McGuirl, PhD
National Institute of General Medical Sciences (NIGMS)
Email: michele.mcguirl@nih.gov