Clinical Trials and Ancillary Studies Conducted within NIH-Funded Clinical Trial Research Networks (UG3/UH3 - Clinical Trial Required)

The National Institute of Neurological Disorders and Stroke (NINDS), in conjunction with additional Institutes/Centers (ICs)at the National Institutes of Health seek to support projects proposing Clinical Trials and Ancillary Studies that are conducted within NIH-Funded Clinical Trial Research Networks. The program will encourage applications for multi-center clinical trials to be conducted within an established Clinical Trial Research Network funded by one of multiple NIH Institutes and Centers. Following peer review, the IC will prioritize studies to be conducted within the established network infrastructure with cooperative oversight by the administering IC. The program will use the bi-phasic, milestone driven UG3/UH3 cooperative agreement activity code. Awards will initially support an up to 2- year milestone-driven planning and start-up phase, with possible transition to an implementation (UH3) phase of up to 5 additional years. Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. For additional information, potential applicants are encouraged to contact program staff listed below.

Other Eligible ApplicantsIndian/Native American Tribal Governments (Other than Federally Recognized);Eligible Agencies of the Federal Government;U.S. Territory or Possession;Faith-based or Community-based Organizations;Regional Organizations;Non-domestic (non-U.S.) Entities (Foreign Institutions).

The major elements in evaluating proposals include assessments of: (1) the scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) the soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) the degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific...

This program has no statutory formula. Matching requirements are not applicable to this assistance listing. MOE requirements are not applicable to this assistance listing.

Not Applicable.