CRU Advisory Committee (GAC) review and approval of new research protocols can be done concurrently with IRB review which improves efficiency in processing new scientific proposals.

Investigators applying to conduct a study on the CRU must submit the documentation listed in the GAC application checklist.

Investigators requesting Core Laboratory Resource only need to contact the Core laboratory Director regarding the request and cost of the kits. Investigators seeking Informatics and/or Biostatistics only need to provide a letter regarding specific type and amount of support requested. Prioritization of needs and availability of resources will determine approval for Core Laboratory, Informatics and/or Biostatistics Only requests.

To download the application, click on the following link. When prompted, choose to save the form to your computer.

CRU Application

To submit the application and required supporting documents, follow the instructions at the bottom of the Checklist.

The IRB and GAC reviews are conducted independently, but protocols may be submitted to both Committees concurrently. A protocol submitted to either Committee is sent to all members for written comments.

• Administrative review of the study budget is done by the CRU Administrative Manager to ensure appropriate use of CRU resources, and to be certain that services requested of the CRU do not overlap with other sources of funding.
• GAC considers the application and written responses from committee members, and if appropriate, outside reviewers.
• As appropriate, critiques are returned to the investigators, and revisions and amendments of the protocol (when required by reviewer consensus) are requested.
• Revised protocols are evaluated by the committee for approval or further revision, if needed. Full GAC consideration occurs at the monthly GAC meeting following receipt of the final revised document. At this meeting, the essential aspects of the protocol are presented to the GAC membership by the Associate Program Director.

A majority vote by GAC members is required for approval of CRU resources. GAC approval is granted to those studies which are deemed satisfactory in the following categories:

• Hypothesis and specific aims
• Significance of work
• Preliminary data, if available
• Research design and methods
• Statistical design and analysis of data
• Justification of sample size (to asssure adequate statistical power)
• Minority and gender inclusions
• Human subjects principles/DSMP
• Justification for use of CRU resources