Step 1: Complete the Preliminary Requirements for Research Privileges
Seton Research Administration accepts CITI training courses that were completed through Seton (Ascension) or UT Austin. Conflict of Interest and Human Subjects Training through CITI are required for all members of the research team. Good Clinical Practice (GCP) Training is strongly recommended.
CITI accounts that originated at Ascension (or another institution) must be affiliated with UT Austin. Once you affiliate your CITI account and bring over your existing modules, your training will be incomplete due to the additional requirement for one elective. You must then select and complete one elective by your next training due date.
- Affiliate Your CITI Account with The University of Texas at Austin
- Complete Human Subjects Research Training
- Complete Financial Conflicts of Interest (FCOI) Training
- Submit Financial Interest Disclosure (FID)
- Complete Good Clinical Practices Training
Step 2: Preparation of Research Materials, Budget & Contract
- Investigator-initiated studies: Work with experts in your department to develop your research and follow the requirements in the Topics to Address in the Research Proposal document.
- Sponsored Clinical Trials: Begin to revise the sponsor-supplied informed consent document to include all required elements and any additional elements of the Ethical & Religious Directives.
- For Both: Request a consultation with Research Support Services to determine the feasibility of conducting your research in an Ascension Texas Market facility.
- For all projects involving medical procedures or services that take place in Ascension Texas Market facilities, the PI and study staff must perform a preliminary coverage analysis to determine Standard of Care costs vs. Research costs.
- A contract may be required for any research study that
- Involves receipt or payment of funds from or to an external entity
- Involves use of equipment provided at no cost
- Involves the sharing of PHI, or
- Has a PI who is NOT a member of the Medical Staff or is not an Associate of Ascension
Step 3: Operational Review through the Site Approval Tool
All research conducted at any Seton or Providence facility, including Dell Children’s Medical Center that utilizes any Seton or Providence resource must be evaluated by Research Support Services. Investigators and their Study Team initiate this process by completing the Site Approval Tool.
Begin this process once all study-related documents are obtained from the Sponsor (or created, for Investigator-initiated studies). Be sure to have all relevant materials available for reference and uploading before you begin. Final Site Approval is contingent on IRB Approval and may be initiated in parallel.
Note: Regardless of affiliation, Industry-Sponsored Clinical Trials Agreements will be administered and negotiated by Seton and facilitated through the Site Approval Tool. Grant Agreements for PIs with UT Faculty appointments will be administered by Sponsored Projects Awards Administration.
Step 4: IRB Review through UT IRB access
IRB Approval is required for any project that includes human subject research. When creating your IRB proposal, adhere to the requirements of the Informed Consent Form Template. Submit your study to the appropriate IRB as follows:
- A Seton PI with any UT Faculty appointment (medical students, fellows, residents, or faculty adjunct) to any UT school must submit their proposed research to the UT IRB through the UT Office of Research Support and Compliance IRB Access page).
- A Seton PI without any UT Faculty appointment must submit to Seton IRB through TOPAZ.
- If applicable, obtain UT Institutional Biosafety Committee Approval. The IBC reviews protocols for safe handling of recombinant biological materials in studies involving biological samples that are collected, processed at, or transferred to UT facilities.
Note: Seton associates who support Dell Medical Faculty and are involved in an IRB submission must obtain a UT Austin EID to use the UT IRB Access system, by completing the Dell Medical Affiliated Research Staff Status Request Form. If you have previously been associated with UT Austin, you may already have a UT EID. To check if you already have a UT EID call UT Information Technology Services at 512-475-9400.
Step 5: Local Study Start-up Process
Once you have received final written IRB Approval, Site Approval and an executed contract, you will be contacted by the Research Support Services and Sponsored Projects Finance teams to schedule a local study start-up meeting. At this meeting you will:
- Set up your award cost center
- Add your project to ClinCard if applicable
- Learn about Time & Effort Reporting and other accounting requirements
- If applicable, register your study on ClinicalTrials.Gov a required step for research that involves an investigational drug or device