If the U34 grant is appropriately productive (e.g., protocol finalization, manual of operations development), will a U01 grant application still require peer-review?
Yes. The U01 Multi-Center Clinical Study Cooperative Agreement application will undergo NIH peer-review. Specific review criteria used to evaluate U01 applications may be found within PAR-11-157 NIDDK Multi-Center Clinical Study Cooperative Agreement (U01) PAR-11-157
Why will U01 applications undergo peer-review if the multi-center clinical study has already been peer-reviewed as a part of the U34 Multi-Center Clinical Study Implementation Planning Grant?
The peer-review of the U01 Multi-Center Clinical Study Cooperative Agreement will evaluate whether the proposed study remains scientifically important and feasible. During the multi-center clinical study planning of the U34 Multi-Center Clinical Study Implementation Planning Grant, changes in the study protocol may be necessary to accommodate advances in the scientific field. Furthermore, the rationale and/or significance of the proposed study may become obsolete. Therefore, peer-reviewers will be asked to re-evaluate the significance, innovation, approach, investigator and environment criteria as described above.
How long after submission of the U01 Multi-Center Clinical Study Cooperative Agreement will NIDDK take to review and make a funding decision?
In order not to delay the initiation of the study, the peer review and award of a U01 grant will be completed within four months of the receipt of the U01 Multi-Center Clinical Study Cooperative Agreement application, when possible.