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U01 Frequently Asked Questions

Some of the most common questions about the U01 are answered below.

Introduction

What is a U01 Multi-Center Clinical Study Cooperative Agreement Award?

​The cooperative agreement (U01) is an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of multi-center clinical study activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role. Thus, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as described in the following program announcement: PAR-11-157.


What role will NIDDK play in U01 Multi-Center Clinical Study Cooperative Agreement grant?

​The U01 Multi-center Clinical Study funding mechanism will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for directing and executing the proposed multi-center clinical study with NIH staff being substantially involved as a partner with the Principal Investigator, as described under Cooperative Agreement Terms and Conditions of Award in PAR-11-157.


Application

Who should I contact for prior consultation?

​You should contact the appropriate program director for the subject matter of the application. See the NIDDK Research Areas to identify the correct program director for your application.  If you are not sure of the appropriate program director, you can contact one of the program directors designated as contacts for information in the PAR and you will be directed to the appropriate individual PAR-13-268.


U01 Peer Review

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.