UTSW Serving as the sIRB
UTSW can serve as the single IRB for multisite studies in most cases when required by the funding source or when single IRB will enhance efficiency and effectiveness of the review process. Decisions about whether to serve are made on a case-by-case basis. The graphic below summarizes the start-up process. Each step is outlined in the text that follows.
Before submitting a budget or grant application, contact UTSW HRPP to obtain an SIRB Review Fee Quote so that IRB Review Fees may be included. For federally funded research, a letter of support and sIRB plan may also be requested, if applicable. (For more details on when UTSW will serve as the sIRB, a description of sIRB Review Fees, and billing and payment procedures, download “Institutional Review Board (IRB) Serving as Single IRB (sIRB) Policy.”)
- Submit a Reliance Request.
- Choose Option 3, “Request for a Letter of Support for a grant submission.” This option includes the request for a Letter of Support, an sIRB Plan, and/or an sIRB Review Fee Quote.
Investigators are encouraged to schedule a consultation meeting well in advance of a budget or grant proposal deadline using this Reliance Bookings link.
Study Start-Up Process for Multi-site Studies
IRB Initial Review and Adding Local Sites:
When considering relying on UTSW IRB, the IRB will evaluate investigator’s plan to oversee the study and assist investigator with onboarding participating sites. The steps below give an overview of this process.
Step 1: Submit Reliance Request
- To initiate the sIRB process, fill out and submit a Reliance Request, Option 2 “Request for External Sites to Rely on UTSW IRB”. In this step, a designated authority will determine if UTSW can be the IRB of record for your study and other participating sites based on provided study detail and funding.
- If requesting to add non-affiliated study personnel who is engaged in research, select “Option 4.” Click here for guidance on adding non-UTSW affiliated Individuals.
- Investigators are strongly encouraged to schedule an Initial Consultation with the HRPP Reliance Team to discuss the role of the Lead PI and Designated Contact as additional responsibilities do apply.
Step 2: Enter study in Velos and eIRB
- You will need to have access to eResearch to create your study in Velos and eIRB. Request access by clicking here.
- Then create your study in Velos and eIRB by using this tip sheet.
- Use the UTSW Consent template for Parts 1 & 2
- Include IRB fees when working on budgets and contracts with the Sponsored Programs Administration office.
- Submit study in eIRB to obtain initial study approval for UTSW and affiliated sites before onboarded any relying sites.
- Please use “Single IRB Instructions” guidance to see which sections to fill out in eIRB.
- If the study design requires ancillary committee review(s), contact the committees and indicate in eIRB:
- Protocol Review Monitoring Committee (PRMC) for cancer -related studies
- Institutional Biosafety Committee (IBC) for biological agents
- Subcommittee for Human Use Radiation (SHUR) for radiation
- Radioactive Drug Research Committee (RDRC)
- Stem Cell Research Oversight Committee (SCRO)
- Laser Safety Committee
- Information Systems Acquisition Committee (ISAC)
* Please note, if ancillary review is required, UTSW HRPP cannot activate the study until the ancillary review is complete.
Step 3: Site Activation and Begin Enrollment
- Once the IRB, ancillary committee (if applicable), performance site, coverage analysis, and clinical trial agreements are complete and approved, an activation letter will be issued in eIRB and the study may begin enrollment
- Please note: The IRB will issue an approval letter, but the study will not be open for enrollment until at least one performance site has approved the study. At this point, an activation letter will be issued and the study may begin enrolling at the approved site.
After UTSW (or affiliate site) has been approved for the study, the following items will occur:
Step 4: Participating site(s) Complete On boarding Documents
- While the study is under initial review by the Single IRB, Reliance agreements will be set up between UTSW sIRB and the participating sites. UTSW Reliance Team will send a reliance agreement packet to each participating site through IREx, SMART IRB , or email.
Step 5: Submit Modification in eIRB to Add Participating Sites
- Submit a modification to add a site once the following documents are complete:
- Site Determination Letter/Reliance Agreement
- Institutional Profile (FormAA)
- Study Specific Sheet (Form AB)
- Site specific consent form (Part 2)
- Complete relevant sections in eIRB. Please use “Single IRB Instructions” for the sections to fill out in eIRB.
Subsequent IRB Review & Study Closure Process
- Investigator is responsible for submitting study changes for UTSW IRB review. Any changes to study such as (but not limited to) consent form, protocol, subject materials, drug information, etc. will need to be submitted in a modification for UTSW IRB review and approval and then to the relying sites.
- To add non-affiliated study personnel engaged in research, select “Option 4” in Reliance Request form. Click here for guidance on adding non-UTSW affiliated Individuals.
- Once the UTSW IRB approves changes, an amendment or modification can be submitted to local participating site(s) for acceptance. Those materials can then be used at participating site(s).
Each relying site is responsible for completing a sIRB Continuing Review Form (Form AC) and sending it to the Lead PI. The Lead PI is responsible for submitting a combined report to the UTSW IRB for approval.
- The Lead PI is responsible for notifying UTSW IRB of any event meeting UTSW’s requirement for reporting.
- For UTSW IRB reporting, go to Reportable Events page.
- Studies that are Federally-funded or where UTSW is the lead site on a multi-center trial with active sites, must remain open.
- The Lead PI is responsible for submitting continuing reviews at least annually per the approval letter.
- Inactivation is appropriate when the Lead Site and all relying sites report that:
- All enrollment is complete,
- All subject specimens, records, data have been obtained,
- No further contact with subject is necessary,
- Analysis of identifiable data is no longer necessary, and
- The sponsor or sponsor's representative has agreed the study may be closed at all sites.