Ancillary Studies to Ongoing Clinical Projects (R01 Clinical Trial Not Allowed)
Funds available for studies attached to existing clinical projects, no clinical trials; application process simplified with minor changes.
This grant is no longer accepting proposals
National Institutes of Health has archived this opportunity.
Funder: National Institutes of Health
Due Dates: April 9, 2025 | August 6, 2025 | December 5, 2025 (all: New, Renewal, Resubmission, Revision)
Funding Amounts: Up to $300,000 direct costs per year, for a maximum of 4 years per project
Summary: Supports time-sensitive ancillary studies leveraging ongoing clinical projects (no clinical trials) to enhance scientific value and maximize existing investments.
Key Information: Accelerated review/award process; must justify time-sensitivity and obtain parent project approval.
Description
This opportunity supports ancillary research studies that are conducted in conjunction with active, ongoing clinical projects (the "parent project"). The goal is to leverage existing patient cohorts, infrastructure, data, and biological samples to address new, time-sensitive research questions that are not part of the original parent project. The parent project may be an interventional clinical trial, an observational study, or a disease-specific repository actively collecting data or samples.
Ancillary studies must not propose a clinical trial and must not interfere with the parent project or unduly burden participants. The focus is on maximizing the scientific value of existing investments and resources, particularly in areas relevant to the mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), though the parent project itself does not need to be NIAMS-funded.
Applications must clearly justify the need for an accelerated review and award process, as well as the time-sensitive nature of the proposed research (e.g., need to collect samples before the end of recruitment, analyze fresh specimens, or collect post-intervention data before a trial ends).
Examples of eligible research include, but are not limited to:
- Mechanistic studies (cellular, molecular, genetic, or epigenetic mechanisms)
- Biomarker discovery and validation
- Novel outcome measures
- Studies of disease comorbidity, risk factors, or sex differences
- Methodological advances for study design or data analysis
Applications that do not require concurrent data/sample collection with the parent project (e.g., secondary analysis of existing datasets, use of preserved samples) are not responsive.
