NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement (U01 Clinical Trial Not Allowed)
Managed by the National Institutes of Health (NIH)
Application budgets are not limited but must reflect the actual needs of the proposed project.
Project duration of up to five years may be requested.
To support investigator-initiated observational studies or biomarker validation studies.
Focus on prospective collection of data/biospecimens or continued analysis of previously collected data/biospecimens.
Researchers in dental, oral, and craniofacial health.
Institutions throughout the United States and internationally.
Eligible organization types include higher education institutions, nonprofits, for-profit organizations, small businesses, local, state, and federal governments.
Non-domestic (non-U.S.) entities are not eligible to apply.
Applications are accepted from organizations based in the United States.
Foreign components are allowed, but non-domestic entities cannot apply.
Focus on observational studies or biomarker validation studies.
Studies must involve prospective data collection or analysis of existing biospecimens.
No specific budget limits, but budgets must reflect actual project needs.
Cost sharing is not required.
Applications are due by 5:00 PM local time on specified due dates.
Earliest submission date is January 5, 2025, with subsequent deadlines through May 7, 2026.
Applicant organizations may submit more than one application, provided each is scientifically distinct.
The NIH will not accept duplicate or overlapping applications.
Applications must follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide.
Include a Quality Management Plan and Clinical Data Management Plan.
Applications will be evaluated based on scientific and technical merit.
Review criteria include significance, innovation, rigor, and feasibility.
Applications will undergo peer review and may receive a second level of review by the national Advisory Council or Board.
Scientific and technical merit of the proposed project.
Relevance to program priorities and availability of funds.
Substantial involvement from NIH program staff is anticipated during project activities.
Non-domestic entities cannot apply, limiting international collaboration.
Investigators are encouraged to consult with NIDCR staff prior to application submission.
Applications that align closely with NIDCR priorities may have a competitive advantage.
Strong study design and methodology.
Ability to recruit and retain study participants.
Submitting overlapping applications.
Not adhering to application guidelines.
Engage with NIDCR staff early in the application process.
Highlight the relevance of proposed research to NIDCR's strategic goals.