IIMS-FIRST Program Study Approval Process

• All required study submission materials must be received by the FIRST Program as specified below before final approval to conduct the study can be given.
• Initial evaluation of resources and cost can be achieved by submission of a draft or final Protocol and a completed Schedule of Visit Assessments. In order to plan resources and budgets, these materials can be submitted at the study planning and budgeting stage of grant or protocol development and/or prior to final IRB approval.

Purpose & Mechanism of Cost Leveraging

The CTSA grant to the IIMS allows for cost-leveraging to extend limited resources more broadly throughout the IIMS. Every submitted request for IIMS-FIRST Program support will be evaluated for study-related costs to the IIMS. Depending upon the availability of resources and in accordance with IIMS priorities to support translational research, cost-discounts will be applied as specified by the IIMS-FIRST Program Clinical Service Core Policy.

With submission of the Protocol and Schedule of Visit Assessments, study protocols will be evaluated for resource requirements and costs to determine the extent to which FIRST Program resources are available to support the study. Study-related costs will be estimated by program staff and cost-discounting will be available according to the policies established for the IIMS (see IIMS-FIRST Program Clinical Service Core Policy). Usually, the process of evaluation and cost estimation can be completed within 2-5 days of submission. Once costs are estimated and discounts are applied, a mutually agreed-upon cost per visit will be negotiated with the investigator and charged after satisfactory delivery of services. These costs are designed to be competitive and may be discounted based upon IIMS priorities.

Agreed upon study visit costs will be assessed monthly for research support services rendered by the FIRST Program. If the account is a UT-Health Science Center account, the account will be charged monthly by interdepartmental transfer (IDT). If the account is located outside of the UT-Health Science Center, then an invoice will be issued to the Investigator at their host institution. All revenue will be deposited into a FIRST Program Cost Recovery Account and will be reinvested in program resources to enable further extension of support to other clinical studies.

Approval Request, Submission Materials

FORU:

A single copy of the following materials must be submitted to gain approval to conduct clinical study procedures:

• The Application Form
• An IRB-approved Grant or Study Protocol (if one exists beyond the IRB Forms)
• Schedule of Assessments Template
• A completed IRB-Form C and IRB-stamped Consent Form
• A copy of the IRB Approval Letter

BRU:

• Complete STVHCS Protocol Submission Documents 

The application Protocol may be described in NIH grant format, formal Study Protocol format, or investigator-initiated format. These protocol elements may be submitted to the IIMS-FIRST Program prior to final IRB approval. However, final FIRST Program approval of the study will not be given until a final IRB-approved protocol, IRB-Form C, Consent Form, and documentation of IRB Approval is received by the FIRST Program Coordinator. Please send electronic format documents to Deborah Mote at the FIRST Program.

A template Visit Schedule of Assessments can be found here. The visit schedule must be customized for the particular study to show what procedures will be done at what visit schedule, etc. in order to:

• illustrate the study schedule of which study procedures/assessments will be conducted at what study visits;
• identify which of those study assessments will be done at the FIRST program site if not all procedures are done there; and
• identify which procedures will be performed by FIRST Program staff if investigators/ study coordinators will be doing some of those assessments themselves.

The Visit Schedule of Assessments form requires:

• the investigator to estimate the length of time of each study visit at the FIRST program site;
• If any food provision or dietary consult is required for your study, this information must be indicated on the Schedule Timeline;
• If study procedure schedules or timelines differ for two different study groups (i.e., patients and controls), then a separate Visit Schedule of Assessments must be submitted for each population group.