Relying on External sIRB
UTSW Human Research Protection Program (HRPP) supports the requirement for single IRB review by collaborating with multiple external IRBs.
Start-up Process to use External IRB
An overview of the start-up process to use an external IRB is outlined below.
Step 1: Submit Reliance Request form
- To initiate the reliance process, fill out and submit a Reliance Request form. In this step, administrative personnel will submit a request to the single IRB that UTSW wishes to rely on them to serve as the IRB of record. The single IRB will then determine if they will indeed serve as the IRB of record for UTSW.
- On the form, select “Request to Rely on an External IRB” and continue filling out the application.
- Once application has been submitted, an email with next steps will be sent out to PI and administrative contacts.
*Remember: Reliance agreements for single IRB review are used ONLY to cede the IRB review of protocols. All institutionally required ancillary reviews must still be sought and obtained locally. For example: Conflict of Interest, Radiation Safety (SHUR), Stem Cell Research Oversight (SCRO), Biosafety (IBC), Laser Safety, Protocol Review and Monitoring Committee (PRMC), etc. are still required. In addition, local performance site approvals are required from applicable sites including the UT Southwestern HRPP.
*Highly recommended, but optional: Request a meeting with one of our analysts on Bookings before getting started.
Step 2: Prepare site-specific forms
- Consent Forms: Add Site-Specific Required Language for Consents. Local context language is UTSW-specific information that needs to be inserted into the consent form template(s) when UTSW agrees to rely on an external IRB.
- If the Reviewing IRB is listed in the link above, select the associated document. Otherwise, select the "UTSW" document.
- Pre-review of consent forms by UTSW HRPP is not required before submitting to the Reviewing IRB provided this information has not been rejected or changed by the CRO or Sponsor.
- HIPAA Authorization Form (if required): Prepare a separate HIPAA Authorization Form for the UTSW submission if not combined with consent form and Reviewing IRB is not serving as the privacy board (e.g., NCI CIRB, NMDP, etc.)
- Other site-specific materials: Prepare any site-specific recruitment materials or other documents and send to the Single IRB for approval.
Step 3: Submit forms to reviewing sIRB for local site approval
- Submit the study as instructed directly to the Single IRB or through the study’s CRO, Sponsor, or Lead Institution.
- Work with lead coordinating site/center (usually the sponsor or CRO or site PI has to submit to the IRB of record) to submit documents to IRB
Step 4: 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.
- For more information on which sections to fill out in eIRB, view “reliance submission process” sheet.
* Note: Leave the eIRB study in DRAFT until the single/External IRB approval letters for the local site(s) (UTSW, Parkland, Children’s, etc.) have been uploaded. UTSW HRPP office review will not begin without these letters.*
Step 5: Site activation and begin enrollment
- Once ancillary committee (if applicable), performance site, coverage analysis, and contract are all reviewed and approved, UTSW Reliance team will accept the study on behalf of the UTSW Human Research Protection Program (HRPP).*
- Study may begin enrollment once activated!
*Note: Until performance site, coverage analysis, and contract are approved, the HRPP office will issue an “acceptance” letter, but enrollment may not begin until a second “activation” letter is sent when performance site, coverage analysis, and contract are all complete.
Subsequent Submissions & Study Closure Process
External IRB amendments/modifications resulting in changes to the local site application when UT Southwestern IRB is not the IRB of record must be approved by the Human Research Protection Program Department (HRPPO). Examples include (but are not limited to):
- change to the consent form which will require acknowledgment by HRPP Reliance Team
- change to the protocol or documents to ensure the most up-to-date protocol records in eIRB
- change that affects any of the required ancillary reviews
- change in local (site) PI or other local study personnel
- change to COI management plans
How do I submit a modification?
Please submit any materials external IRB has approved/acknowledged in modification smart form in eIRB, and attach IRB approval letter.
- Submit amendments received from the lead research team in eIRB by selecting “Relying on a non-UT Southwestern IRB” as the type of modification (on the modification Smartform)
- Upload the following in eIRB:
- The clean ICF/Protocol/HIPAA as a revision to the current ICF/Protocol/HIPAA in eIRB
- Amendment approval letter from external IRB in eIRB
- Attach a redline copy of the changed documents in the modification Smartform.
Investigators are responsible for reporting any unanticipated problem (e.g., adverse event) or noncompliance to the reviewing IRB according to their event policy and timeline. Also, report to UTSW HRPP local events that meet the local UPIRSO and UADE or Noncompliance Review Policies. Visit Reportable Events page for more information.
Each study will be required to submit an annual update utilizing the Continuing Review smart form in eIRB. The study expiration date in eIRB will be set 30 days after the IRB expiration date. This will allow researchers enough time to receive the IRB reapproval, prepare the eIRB CR application, and submit required materials. If the eIRB expiration date passes for reliance studies, you are not required to stop your study; however, you should submit the CR application as soon as possible to prevent a study suspension.
How do I submit a Continuing Review for a reliance study?
- In Continuing Review smart form, select “This study requires an Annual Update instead of Continuing Review.”
- Attach the renewal approval letter from IRB of record to the continuing review Smartform.
- Fill out pertinent information.