Pilot and Feasibility Grant

The overall mission of the ROAR pilot & feasibility grant is to support small projects which advance diagnosis, enhance clinical trial readiness, and improve therapies and outcomes for individuals with organic acidemias. Potential pilot projects may include data-mining of existing data, genotype-phenotype correlations, observational studies, patient-reported outcomes assessments, focus groups with patients and advocacy groups, interventional clinical trials (with prior NIH approval), biomarker studies, ancillary studies to ROAR clinical projects, or other similar projects. Upon completion of funding, we expect that the data generated from ROAR pilot projects will be leveraged for larger grant applications and larger projects within and outside the consortium. Moreover, we expect that the data generated will inform the design of future clinical trials and clinical studies in organic acidemias and ultimately, will impact the lives of individuals with organic acidemias by improving the diagnosis, management, and treatment for these disorders. Of note, funds cannot be used to support research projects involving animal models.

Annual funding of up to $40,000 (total cost, including indirect costs) is available to support one pilot project for a one-year period. The ROAR Consortium intends to fund at least 1 award this cycle starting on October 15, 2026.

Investigators must have a doctoral degree to be eligible to apply (e.g., MD, DO, PhD, etc) and must be affiliated with U.S.-based institution within or outside of the ROAR Consortium. Applications from early-stage investigators are highly encouraged.

1. Project title
2. Project abstract (0.5 page limit)
3. Specific aims page (1 page limit)
4. Proposal with background, significance relative to ROAR mission, preliminary data (if available), and research plan (5 page limit).
5. References (not included in 5 page limit)
6. If applicable, the following human subjects sections should be included (not included in 5 page research proposal page limit)
   1. Conditions or focus of study
   2. Eligibility criteria
   3. Inclusion across the lifespan
   4. Inclusion of women and minorities
   5. Recruitment and retention with recruitment status
   6. Study timeline
   7. Planned and actual (if applicable) enrollment reports
   8. Protection of Human subjects
7. NIH biosketch of applicant (5 page limit)
8. If the applicant is not a ROAR investigator, a sponsoring ROAR investigator will supply a letter of support (1 page limit)
9. Detailed budget with justification

Applications will be scored with standard NIH scoring criteria.

Scoring criteria will include:

1. Project relevance to ROAR mission
2. Significance of the project to field of rare organic acidemias research
3. Potential to provide preliminary data for future grant applications

1. Attend ROAR consortium activities including the monthly ROAR team calls and annual ROAR consortium in-person meeting to provide periodic project updates.
2. Present the results of the project at the annual ROAR consortium in-person meeting or on a monthly ROAR team call.
3. Acknowledge the ROAR consortium support on manuscripts published upon completion of the project.
4. Provide a progress report within 30 days of completing the program.

Applications should be submitted as a single PDF using Arial font (11 point) and ½ inch margins by the deadline above through the RDCRN grants portal (RDCRN Grants Portal).