NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement (U01 Clinical Trial Not Allowed)

Notice of Funding Opportunity PAR-27-058 is a cooperative agreement issued by the National Institutes of Health and the National Institute of Dental and Craniofacial Research to support investigator-initiated prospective observational studies or biomarker validation studies. This assistance mechanism focuses on producing robust, unbiased, and reproducible data through rigorous experimental design, specifically targeting biomarker analytic and clinical validation, as well as genomic and omics analyses. The program allows for a project duration of up to five years with a funding limit of 500,000 dollars in direct costs per year. Clinical trials are not allowed under this specific solicitation. Applications are evaluated based on scientific merit, focusing on innovation, the clarity of study questions, the justification of outcome variables, and the appropriateness of the research environment. Required documentation includes a Data Management and Sharing Plan, a Quality Management Plan limited to three pages, and a Clinical Data Management Plan limited to two pages. Recipients must adhere to strict human subject protections under 45 CFR Part 46 and are required to make all final datasets, procedure manuals, and study materials available in the public domain. Eligible applicants must maintain active registrations in the System for Award Management, eRA Commons, and Grants.gov. Cybersecurity requirements include the development of an incident response plan and the notification of HHS awarding agencies within 48 hours of any cybersecurity incident discovery.