Protocol Submission

To use the CRC, investigators must submit protocols to the Institutional Review Board (IRB) and the Internal Scientific Advisory Panel (ISAP). Both committees independently evaluate safety and scientific issues, as well as the ethical merits of the proposal. Please click here to learn more about the IRB and the ISAP, or to review the 2012 ISAP review schedule.

Types of Submissions Accepted

The extent to which a grant funds the costs for hospitalization and ancillary tests performed on the CRC subjects depends upon the type of research being performed. The NIH defines the categories of CRC inpatient and outpatient research subjects as follows:

  • Subjects or patients are volunteers who are not expected to benefit directly from participation in the research
  • Subjects are patients and are in the CRC for both research and diagnostic/therapeutic purposes
  • Subjects are participants in industry-initiated/sponsored research projects

The grant covers the costs of testing on research-only and research-diagnotstic/therapeutic patients. It also covers the cost of hospitalization for research-only subjects. It does not cover the cost of non-research tests which may be performed coincidentally or as a convenience to the subject. The grant also does not cover the cost of the hospital room and medical care for research-diagnostic/therapeutic patients or industry-initiated/sponsored participants.

Who Can Submit a Protocol

The principal investigator submitting a protocol need not be a physician, but must have faculty status at the University of Chicago. Non-physician PIs must include a physician co-investigator committed to taking medical responsibility for subjects, whether they are patients or volunteers. Projects from other institutions are welcome, however, they must have a lead UChicago investigator.

Citing CRC Support

Continued availability of CRC services depends on annual reporting to NIH regarding the use of facilities and publications resulting from work performed under CRC auspices. Please remember to credit the ITM-CTSA in the grants portion of your publication by using the following reference:

This publication was made possible with support from the University of Chicago Institute for Translational Medicine (ITM), grant number UL1TR000430 from the National Center for Advancing Translational Science (NCATS) a component of the National Institutes of Health (NIH), and NIH Roadmap for Medical Research.

How to Submit

To submit a CRC protocol, download and fill out the Protocol Submission form, then send as one PDF document to Sonja Johnson-Hall, CRC Operations Manager, at sjohnso2@bsd.uchicago.edu.

Protocol Submission form (PDF)

Protocol Submission form (Word)

Your request will be added to the CRC Document Management System, where you will be able to view your submissions. Every effort is made to review CRC Protocol Submissions within two weeks.


 
 

CSTA National Consortium

Contact Information

    Institute for Translational Medicine

    The University Of Chicago
    5841 South Maryland Avenue
    Q301C, MC7100
    Chicago, Illinois 60637
    773.702.6980
    CTSA UL1 TR000430