Guidelines for Applying for Utilization of ITS-Clinical Research Center (CRC) Resources

The Institute for Translational Sciences-Clinical Research Center (ITS-CRC) welcomes research applications from clinical Investigators who wish to use CRC resources. Applications will be reviewed by the Scientific Review Committee (SRC) for scientific merit, research subject safety and suitability of requested CRC utilization. CRC resources can be used if specifically described in the CRC Resource Request Form, and approved by the SRC.

Application Requirements: (Arial 11 font is recommended; tables and figures must be readable, have legends and be referred to in the text).

  1. Cover memo (for new protocols, may be addressed to both the CRC and IRB)
  2. Study protocol, which may be one of the following:
    a. Grant application, (PHS 398 format preferred, or similar protocol) with Human Subjects section and Data and Safety Monitoring Plan)
    b. Protocol prepared in the CRC format with aHuman Subjects section and Data and Safety Monitoring Plan. Click to view the protocol template.
    c. Industry protocol (containing elements of a Human Subjects section and DSMP; otherwise the Investigator should prepare a separate Human Subjects section and DSMP)
  3. Consent form(s)
  4. IRB form(s) and all correspondence to and from the IRB
  5. CRC Resource Request Form
  6. Biosketches for the PI and Co-Is.
  7. Investigators brochure (if available)
  8. Grant or contract budgets. For modular budgets, please submit the year one detailed budget that you submitted to the Office of Sponsored Research

Other considerations:

  1. IRB approval is required for all CRC protocols before they can be to be initiated.
    a. For protocols already approved by the IRB, all prior correspondence to and from the IRB should be submitted to the CRC (as noted above).
    b. For new protocols, simultaneous submission to the IRB and the CRC saves time, because the review processes are bundled, and the PI can respond simultaneously to stipulations from both the IRB and CRC. For a simultaneous submission, the Cover Memo should be addressed to both the IRB and CRC and indicated on the IRB form.
    c. Note that the documents required by the CRC and the IRB are the same, with the exception of the Resource Request Form and biosketches which are required by the CRC but not the IRB.
  2. Investigators are urged to meet with CRC staff before submitting an application to discuss CRC resources that will be needed and determine whether anticipated utilization of resources is appropriate and to discuss cost charge-backs to the investigator.
  3. The CRC staff is available to help in preparing the application material (especially the Resource Request Form), and will pre-review all application documents for completeness and general suitability prior to placing the protocol on the agenda for the next SRC meeting. If major deficiencies are noted in pre-review, the CRC staff may recommend modifications before submission to the SRC, in order to avoid protocol deferral or disapproval.
  4. For funded studies, charge-backs to the grant should be expected. Please note that cost subsidies are granted for most studies. For industry-initiated studies, full research costs must be charged back to the industry grant that supports the study.

Grant applications: Investigators who are preparing new grant applications and anticipate using CRC resources should consult with the CRC staff to determine what charges should be requested in their grant application budgets to support use of CRC resources.

Other useful links: For protocol format and instructions for PHS 398 refer to:

http://grants.nih.gov/grants/funding/phs398/phs398.html
For guidance, about the appropriate format and language to use for the consent form, refer to the IRB website:
http://research.utmb.edu/irb/default.shtm

What to Submit: See above list. Get the Resource Request Form here!

Where to Submit: Email the application to ebruiz@utmb.edu

Submission Deadlines: Protocols should be submitted by the 22nd of each month and they will be reviewed by the Scientific Review Committee on the 1st Wednesday of the following month. Check with the CRC staff concerning deadlines for bundled SRC and IRB review, which is linked to IRB deadlines and may vary.

Award Notification: A review sheet will be communicated to the PI within a week after the SRC meeting.

Study Initiation: After obtaining SRC and IRB approvals, investigators are required to contact the Nurse Manager, Margaret Ottenbacher, at x21619 to schedule a Study Initiation meeting, which must occur before starting the study on the CRC. The purpose of this meeting is to assure that the CRC staff and the investigator’s staff understand what is expected of each other, and to be sure that the CRC resources will be available when needed. Medical coverage and other safety considerations are also discussed. A Primary Nurse is assigned to each new protocol, and educates the other nurses regarding the protocol requirements.

Investigator’s Responsibility for using the CRC: Responsibilities of CRC investigators include the following:

  1. Acknowledge the ITS - CRC in scientific publications: The following language is recommended:
    “This study was conducted with the support of the Institute for Translational Sciences at the University of Texas Medical Branch, supported in part by a Clinical and Translational Science Award (UL1TR000071) from the National Center for Advancing Translational Sciences, National Institutes of Health”.
  2. Report journal articles to Pub Med Central (PMC): According to the new NIH Public Access Policy, beginning April 7, 2008, final accepted peer-reviewed manuscripts arising from NIH funds must be submitted to PMC. Since the ITS - CRC is NIH funded, all CRC studies, whether individually funded by NIH or not, must be submitted to PMC, and the ITS-CRC grant number quoted. Details on this new NIH mandate may be accessed at http://publicaccess.nih.gov/ .
  3. Copy the ITS - CRC on all future IRB correspondence, and request both IRB and CRC approval for study modifications: All requests, forms, and other correspondence sent to the IRB should also be sent to the CRC. All amended documents must be attached, with changes identified using Track Changes. These requirements are the same as for the IRB.

Closing a CRC Study: A study should not be terminated with the CRC and IRB until data analysis is complete and publications have been prepared. A study may be closed to enrollment, but CRC resources may still be used for follow-up visits, data analysis, etc. If the study is to remain active and continue to use CRC resources, there must be current IRB approval.

When the study is completed, a memo should be sent to the IRB and CRC requesting that the study be closed.