PAR-26-042: Research Grants in Clinical Informatics (R01 Clinical Trial Optional)

PAR-26-042: Research Grants in Clinical Informatics (R01 Clinical Trial Optional)

PAR-26-042 is an NIH Notice of Funding Opportunity from the National Library of Medicine (NLM) for R01 research in clinical informatics. NLM is seeking projects that design, implement, and evaluate informatics tools and methods for data-driven discovery, evidence-based decisions, and personalized or precision health care. The notice emphasizes approaches that can work across clinical settings and populations rather than tools tied to a single local installation.

The June 5, 2026 new-application date has passed. The next announced new-application deadline is October 5, 2026, followed by recurring NIH standard dates through February 5, 2029. This page remains a live opportunity listing because the NOFO has announced those future receipt dates; it is not a historical archive entry.

Key details at a glance

What this opportunity supports

NLM describes clinical informatics as work that turns complex health data into usable knowledge for clinicians, patients, and the public. The notice covers electronic health records, clinical notes, imaging data, and patient-generated data. A proposal can address discovery, analysis, organization, or management of those digital objects, but it should show why the resulting method is useful beyond one data source or one institution.

The program is aimed at research rather than routine maintenance or a product deployment funded without a clear research contribution. Applicants should state the intended use case, define the scope and scale of evaluation, compare the proposed method with existing approaches, and explain how accuracy, maintenance, downstream use, and limitations will be handled. NLM expects products to be durable and research outputs to be widely disseminated.

What counts as a strong fit

The NOFO says proposals should focus on clinical informatics methods that are:

• scalable across settings,
• reusable beyond one dataset or hospital,
• relevant to research and care improvement,
• capable of producing broadly useful outputs,
• supported by explicit metrics, benchmarking, validation, and maintenance planning.

The list of priority-aligned themes includes:

• improving information and knowledge tools for care teams and patients,
• next-generation clinical decision support,
• EHR usability and interoperability improvements,
• predictive analytics and prevention-oriented models,
• data integration and harmonization methods,
• AI methods with clear benefits to workflow, outcomes, or health system efficiency,
• and reducing administrative friction that drives clinician burden.

The initiative is also explicit about what it does not want:

• narrowly scoped projects with little generalizability,
• work focused only on social determinants/ETHICS-only framing without core informatics innovation,
• incremental patching of existing systems without meaningful novelty,
• projects that duplicate NLM products or databases,
• projects with most effort devoted to experimental research when only a small portion of the budget may be used for computational validation,
• or work that does not produce open-access datasets, methods, resources, or tools.

Projects narrowly focused on a single disease with little potential for broadly applicable tools are also non-responsive. Social determinants of health or ethical, legal, and social issues may not be the central focus. The notice says non-responsive applications will not be reviewed, so applicants should contact NLM’s scientific program staff if the fit is uncertain.

Who is likely to be eligible

The eligibility section is broad but strict where compliance is concerned. In plain terms, both institutions and investigators can be broad in scope as long as all submission rules are followed.

Eligible organizations and collaborators

The NOFO lists the following eligible organization categories:

• higher education institutions (public and private),
• nonprofits with and without 501(c)(3) status,
• small businesses and for-profit entities,
• local governments,
• some federal entities and eligible U.S. territory agencies,
• independent school districts, public or Indian housing authorities, tribal organizations, faith-based or community-based organizations, and regional organizations,
• eligible federal agencies and U.S. territories or possessions,
• non-domestic entities and non-domestic components of U.S. organizations.

The foreign-collaboration rule needs careful attention. NIH will not issue awards involving foreign subawards or subcontracts under this NOFO, and an application containing one is noncompliant. The restriction does not prohibit an unfunded international collaboration, a permitted foreign component, a foreign consultant, or procurement from a foreign vendor. A team using international expertise should have its grants office classify each relationship before the budget is finalized.

Individuals and applicant profile

Any individual with the skills, knowledge, and resources to conduct the research may serve as a Program Director or Principal Investigator with an eligible organization. Multiple-PD/PI applications are allowed under NIH’s multiple-program-director policy. This is an organization-led R01 mechanism, not an individual fellowship, so the institution must sponsor and administer the submission.

What to confirm before starting

At minimum, teams should ensure:

• the PI/PD and organization are registered in eRA Commons,
• organization has active SAM registration and a valid UEI,
• organization-specific accounts and signing authority are complete,
• no duplicate or highly overlapping application is pending in a way that violates NIH policy,
• the institution can support submission through ASSIST, Grants.gov Workspace, or an institutional system-to-system solution, with eRA Commons used to track the application.

Applicant organizations may submit more than one application when each is scientifically distinct. NIH will not accept duplicate or highly overlapping applications under review at the same time. This rule matters when a team is considering a new application alongside a resubmission or an application with multiple principal investigators.

What it funds (and what it does not)

The award budget is limited to $250,000 in direct costs per year and must reflect the actual needs of the proposed project. The maximum project period is 4 years, but the requested duration should follow the scientific scope. The notice does not promise a fixed number of awards or a fixed total program appropriation; awards depend on NIH appropriations and the submission of enough meritorious applications.

Funding model implications

This is a standard NIH R01-style framework with no mandatory cost sharing. In practice, teams should:

• budget to the data lifecycle, not just model development,
• include compute, staffing, evaluation, and dissemination,
• keep all spending defensible against requested scientific outcomes,
• and avoid overselling large infrastructure ambitions that exceed year-by-year direct cost limits.

The budget and period of support are part of the additional review considerations. Reviewers assess whether both are reasonable and justified in relation to the proposed research. A credible budget should therefore connect staff time, data access, computing, evaluation, documentation, and dissemination to the research plan instead of treating a software platform as an end in itself.

Strong and weak budget patterns (practical)

Strong pattern:

• clear tie between each major cost and a validated methodology milestone,
• explicit maintenance and dissemination resources,
• realistic compute and staffing curves,
• modest but adequate project management.

Weak pattern:

• heavy fixed overhead on internal tools without direct science output,
• no plan for reusable software/resource packaging,
• unrealistic expansion into clinical implementation with little budget basis.

Timeline and workflow: planning around the announced receipt dates

This opportunity uses a series of NIH standard receipt dates. The new-application date in the front matter is the next announced date, October 5, 2026. Renewal, resubmission, and revision dates are listed separately in the NOFO and are not interchangeable with the next new-application date.

Key dates

• Posted: February 11, 2026
• Open date: April 6, 2026
• First new application due: June 5, 2026, by 5:00 PM local time of the applicant organization
• Next new application due: October 5, 2026, by 5:00 PM local time of the applicant organization
• Later new application dates: February 5, 2027; June 5, 2027; October 5, 2027; February 5, 2028; June 5, 2028; October 5, 2028; February 5, 2029
• NOFO expiration: March 6, 2029

The NOFO encourages early submission so applicants have time to correct errors. When a due date falls on a weekend or federal holiday, NIH automatically extends it to the next business day. The applicant is responsible for viewing the application in eRA Commons before the deadline and for submitting a changed or corrected application by the due date. An application that misses the due date is subject to NIH’s late-submission policy.

Practical timeline for the October 5, 2026 new-application date

If you target October 5, 2026:

1. Confirm the applicant and registrations early. Check the organization’s SAM registration, UEI, Grants.gov registration, and eRA Commons status. Each PD/PI needs an eRA Commons account, and the organization needs a Signing Official account. Registration can take six weeks or more, so it should not be left to the submission week.

2. Shape the research plan around a generalizable method. Define the clinical informatics problem, intended users, data objects, comparison methods, evaluation metrics, and the settings to which the approach could transfer. Explain what is genuinely new and why a narrow disease or single-site focus is not the entire contribution.

3. Prepare the required plans. Build the Data Management and Sharing Plan, software dissemination plan, privacy protections for aggregated public or non-controlled-access data, and plans for accuracy, maintenance, documentation, and downstream use. If human subjects or a clinical trial is involved, make the study records and protections consistent with the research design.

4. Assemble the application package. Use NIH’s Research Instructions and the SF424(R&R) forms accessed through ASSIST, Grants.gov Workspace, or an institutional system-to-system solution. Check page limits, required registrations, PD/PI Commons identifiers, organizational UEI consistency, and the limited appendix rules.

5. Submit and inspect the result. Submit electronically through Grants.gov, complete tracking in eRA Commons, inspect the assembled application, and leave enough time for corrections. Paper applications are not accepted.

The later new-application dates are available if the October submission is not ready, but the NOFO expires on March 6, 2029. Applicants should confirm the live announcement and any NIH policy notices close to the date they intend to use.

Application process and submission mechanics

The NOFO allows these electronic submission routes:

• NIH ASSIST,
• institution system-to-system,
• Grants.gov Workspace,
• eRA Commons tracking after submission.

Paper applications are not accepted.

Mandatory preparation before submission

• complete and maintain active SAM, UEI, eRA Commons, and Grants.gov registrations,
• ensure every PD/PI has an eRA Commons account and that the Commons ID is in the Senior/Key Person Profile credential field,
• keep the UEI consistent across the application, SAM, and eRA Commons,
• confirm that no foreign subaward or subcontract is included,
• determine whether human subjects research or an NIH-defined clinical trial requires a study record.

NOFO-specific preparation points

The call is explicit about sharing and reproducibility expectations:

• include a Data Management and Sharing Plan whenever the research generates scientific data,
• include a general plan for timely sharing of data and resources and a software dissemination plan,
• make methods, tools, and software well documented and, where applicable, available through version-controlled public repositories,
• use licensing terms that allow redistribution and modification, and allow another team to continue development,
• describe portable implementations and reproducible integration into automated pipelines where relevant.

The notice says all applications must address data management and sharing for reusability, regardless of the direct costs requested in any one year. Software and other resources need a sharing plan that covers code and later editing. The data plan must follow NIH’s current Data Management and Sharing Policy. The appendix is limited, and publications or other material may not be included except for blank questionnaires or blank surveys.

Application instructions that are easy to trip over

• strict NIH page limits still apply,
• software/tools licensing policy should enable redistribution and adaptation,
• appendix is limited to a narrow set of allowed materials,
• human-subjects workflow, clinical data safety, and review sections must be internally consistent.

Review criteria and reviewer expectations

Reviewer scoring follows NIH standards with NOFO-specific emphasis. Three review factors organize the scientific merit assessment:

Factor 1: Importance of research (significance + innovation)

Reviewers assess the importance of the problem, the scientific background, the gap being addressed, and the contribution of the proposed method. For this NOFO, they also assess whether the tool or approach can generalize beyond its specific use case and whether the innovation supports scalability across biomedical settings.

Factor 2: Rigor and feasibility

The approach must be scientifically sound and achievable. The notice calls attention to:

• clear experimental design,
• valid control logic where relevant,
• robust statistical or computational methodology,
• clearly justified sample size and data-quality strategy when relevant,
• explicit metrics for scope, scale, and use cases,
• benchmarking and comparison with existing methods,
• plans to address limitations, trade-offs, and risks,
• and plans for product accuracy, maintenance, and downstream-use communication.

Factor 3: Expertise and resources

Reviewers assess whether the investigators have the background and expertise to conduct the work and whether the environment has the institutional resources needed for successful execution. For multiple-PD/PI applications, leadership and coordination are also considered.

NOFO-specific overlays

Reviewers specifically check:

• whether tools are scalable and generalizable,
• whether benchmarking and comparisons are planned,
• whether risks and limits are addressed transparently,
• and whether product maintenance/long-term stewardship is planned.

Non-response risk

Because this is a targeted NOFO, projects not centered on clinical informatics scope can be rejected without full review. That is why alignment language in the project aims is critical.

Common mistakes and how to avoid them

1) Treating this as a generic AI grant

If the application presents a generic model without a clinical informatics problem, intended users, evaluation setting, and generalization plan, it may be nonresponsive. Describe the information need, workflow or decision context, data objects, measurable use case, and path to broader use.

2) Building a software-only narrative with weak validation

A technical demonstration without a validation plan is not enough. Include baselines, metrics, data-quality controls, limitations, reproducibility measures, and a credible way to assess accuracy and downstream use.

3) Ignoring open dissemination

The NOFO requires plans for broad dissemination, data management, and software availability. Explain how code, data, documentation, and later maintenance will be shared in a way that permits reuse and modification.

4) Underestimating compliance requirements

Registrations are eligibility prerequisites, not administrative details that can be completed after submission. Keep SAM, UEI, Grants.gov, and eRA Commons records aligned, and confirm every PD/PI credential before the application is submitted.

5) Substituting broad theory for scoped objectives

“Transform health data” is too broad without a measurable research question. Define the data, users, use case, metrics, comparison, and transfer path, while showing how the method can extend beyond a single pilot.

Preparation checklist before you submit

Use this as a practical self-audit:

• Confirm the project is centrally focused on clinical informatics and is not a prohibited narrow or duplicative project.
• Map each objective to scalability, generalizability, and a defined clinical or biomedical use case.
• Define metrics, benchmarks, comparisons, data quality checks, limitations, and risk responses.
• Explain product accuracy, maintenance, downstream use, and long-term privacy protections where applicable.
• Prepare the Data Management and Sharing Plan and software dissemination plan.
• Keep requested direct costs within $250,000 per year and the project period within 4 years.
• Verify that no foreign subaward or subcontract is included.
• Align human-subjects and clinical-trial forms with the proposed research.
• Complete SAM, UEI, Grants.gov, and eRA Commons registrations before submission.
• Check the PD/PI Commons IDs, page limits, limited appendix, and consistent organizational identifiers.
• Submit electronically before the selected NIH receipt date and inspect the application in eRA Commons.

Frequently asked questions (FAQ)

Does this NOFO support clinical trials?

Yes. The announcement is clinical-trial optional, so an application may propose a clinical trial or a study without a clinical trial. If human subjects or a trial is included, follow the PHS Human Subjects and Clinical Trials Information instructions and include the required study record.

Is there a fixed number of awards or total program budget?

No fixed total program budget or guaranteed award count is stated in the NOFO. The number of awards depends on NIH appropriations and the submission of a sufficient number of meritorious applications. The application-level limit is $250,000 per year in direct costs.

Can non-U.S. organizations apply?

Yes. Non-domestic entities and non-domestic components of U.S. organizations are listed as eligible, and foreign components are allowed. NIH will not issue awards involving foreign subawards or subcontracts under this NOFO, so international arrangements must be structured and classified carefully.

What if an organization wants to submit more than one application?

More than one application is allowed when each is scientifically distinct. NIH will not accept duplicate or highly overlapping applications under review at the same time, including certain combinations of new and resubmitted applications.

What happens after submission?

Applications are checked for completeness, compliance, and responsiveness. Scientifically responsive applications undergo NIH peer review using the stated factors and receive a written critique. Recommended applications may receive a second level of review by the NLM Board of Regents. Funding decisions consider scientific and technical merit, available funds, and relevance to program priorities.

Official links and contact points

• Official NOFO: https://files.simpler.grants.gov/opportunities/131fabad-5506-431b-b87a-e564f1d8dcc4/attachments/61b6dce0-ffe6-4f50-b863-07b2ce70c1bf/PAR-26-042-Full-Announcement.html
• Submission systems: NIH ASSIST, institutional system-to-system submission, or Grants.gov Workspace, with eRA Commons tracking
• Application submission and compliance help: eRA Service Desk and Grants.gov Support Center
• Scientific contact: NLM Extramural Programs, [email protected]
• Peer review contact: Center for Scientific Review, [email protected]
• Financial and grants management contact: NLM Grants Management, [email protected]

How to assess fit before preparing an application

This NOFO is a strong fit when the central contribution is a new clinical informatics method or tool, the intended use is explicit, and the evaluation can show value beyond one local dataset or workflow. A proposal may use AI, clinical decision support, medical language processing, imaging, EHR analysis, or another informatics approach, but the technology is not the eligibility test by itself. The application must connect the method to NLM’s clinical informatics mission and explain how it advances knowledge or practice.

The notice is not a fit for routine platform maintenance, a duplicate of an NLM product or database, a project centered on social determinants of health or ELSI, or a narrowly disease-specific effort with little broader application. It also says that only a small portion of the budget may be used for experimental validation of computational approaches, so the research plan should not be dominated by experimental work that falls outside the stated informatics purpose.

The most immediate planning choice is the next new-application date, October 5, 2026. A team that needs more preparation can use a later announced new-application date, but should check the full NOFO, the NIH Application Guide, and current NIH policy notices before submitting. A late or incomplete application is not made timely by the existence of a later cycle, and the NOFO’s expiration date is March 6, 2029.

PAR-26-042 is therefore an active, recurring NIH R01 opportunity for organizations that can propose rigorous, generalizable clinical informatics research and meet the electronic submission, registration, data-sharing, and open-dissemination requirements.