Relying on External IRBs

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Overview

In an effort to encourage collaboration, reduce duplicate study submissions, and minimize the impact of multiple IRB reviews for the same protocols, UT Southwestern HRPP offers IRB reliance opportunities.  Reliance agreements allow the IRB of one institution to rely on the IRB review of another.  

Researchers at UT Southwestern may rely on an external IRB (commercial, academic, etc.) to review studies, whether it is for a single research project or a portion of the organization’s research portfolio.   The external IRB will meet federal regulations for the IRB review and the relying institution will ensure the conduct of the study meets requirements under the institution’s Federalwide Assurance.

When a UT Southwestern investigator wishes to rely on an external IRB, the request will be evaluated by the UT Southwestern HRPP to determine if reliance is appropriate. If reliance is agreed, written agreements outlining specific responsibilities of each IRB (institution)  will be executed.

Overview of the Steps for Submitting Reliance Studies to UTSW:

  1. Request Reliance:
    • Complete the Intent to Rely on External IRB to inform the UTSW Reliance team about possible reliance (except as noted below for existing agreements)
  2. Establish Agreement:
    • UTSW Reliance team will contact the reviewing IRB to establish a reliance agreement (if one doesn’t exist)
  3. Attend Pre-Reliance Meeting:
    • UTSW Reliance team will reach out to the PI and the study team to arrange for a Pre-Reliance meeting
  4. Submit HRPP application in eIRB:
    • PI and study team will submit the IRB approved study (including IRB approval documentation) in eIRB
  5. Obtain Ancillary Committee Approvals:
    • The study will be routed for ancillary committee approvals as applicable
  6. Obtain HRPP Acceptance:
    • UTSW Reliance team will accept the study on behalf of the UTSW Human Research Protection Program (HRPP)
  7. Obtain Performance Site Approvals:
    • The PI and study team will obtain performance site approval

Remember: reliance agreements for single IRB review are used to cede ONLY 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.  In addition, local performance site approvals are required from applicable sites including the UT Southwestern HRPP.  

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Regulations, Guidance, and Policies

The same regulatory framework applied to research reviewed by the UT Southwestern IRB applies for all external IRB reliance review requests. All research involving human subjects must follow one or more of the below regulations, policies, and/or procedures. 

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Agreements

In order to help facilitate human research by allowing investigators to avoid duplicative IRB review while at the same time protecting the rights and welfare of human research participants, the UT Southwestern Human Research Protection Program are willing to rely on the review of another specified IRB in most circumstances. The Human Research Protection Program has several negotiated IRB Reliance Agreements with other institutions that may be applicable when UT Southwestern researchers are involved in collaborative research. 

IRB Authorization Agreements in place at UT Southwestern

UT Southwestern has the following Memorandums of Understanding (MOUs) / Reciprocities in place:

Statewide Master Institutional Review Boards (IRBs) Reciprocity Agreement

(Formerly: UT System Reciprocity Agreement)

To expedite IRB approval for multi-site trials and studies, an IRB reciprocity agreement is in place among the following Texas Institutions of Higher Education:

  • The University of Texas at Arlington 
  • The University of Texas at Austin
  • The University of Texas at Dallas
  • The University of Texas at El Paso
  • The University of Texas of the Permian Basin
  • The University of Texas Rio Grande Valley 
  • The University of Texas at San Antonio
  • The University of Texas at Tyler 
  • The University of Texas Health Science Center at Houston
  • The University of Texas Health Science Center at San Antonio
  • The University of Texas Health Science Center at Tyler
  • The University of Texas MD Anderson Cancer Center
  • The University of Texas Medical Branch at Galveston
  • The UT Southwestern Medical Center
    • (includes Parkland, Children’s Health and Texas Scottish Rite Hospital)
  • Angelo State University 
  • Baylor College of Medicine
  • Rice University
  • Texas A&M University
  • Texas Tech University
  • Texas Tech University Health Sciences Center
  • Texas Tech University Health Sciences Center El Paso
  • The Methodist Hospital System
  • University of Houston
  • University of North Texas Health Science Center 

Instructions for requesting UT Southwestern to rely on another IRB under the Reciprocity Agreement:

Step 1: Request Reliance

  • Complete the UT Reciprocity Reliance Form 
  • Send it to HRPP@utsouthwestern.edu for signature

Step 2: Complete HRPP Application Process

  • Modify the Informed Consent/HIPAA as per the ICF Checklist for Local Context Language
  • Complete eIRB new study smart form application
  • Attach the following documents approved by the reviewing IRB:
    • study approval letters (showing UTSW as an approved study site),
    • Consent (including required UTSW ICF language) and HIPAA Authorization or waivers
  • All UTSW Investigators/Study Personnel must:
    • complete CITI training per UT Southwestern research training policy and
    • submit a Conflict of Interest disclosure annually

Note: As with any research, an institutional activation approval from each participating site (i.e., Parkland, Children’s Health, etc.) is required prior to initiating your research at those sites.

Smart IRB

Smart IRB is a reciprocity agreement signed by hundreds of institutions across the United States. Smart IRB Master Reliance Agreement have been signed by UT Southwestern and CTSA Affiliates and Partners. For more information, refer to the website www.smartIRB.org.

Instructions for requesting UT Southwestern to rely on another IRB under Smart IRB:

Step 1: Request Reliance

  • The lead Site PI will place a request for through the Smart IRB Online Reliance System to add UTSW as a site. Once received, the UTSW HRPP Reliance Team will review the request and approve the reliance if appropriate.

Step 2: Complete HRPP Application Process

  • Modify the Informed Consent/HIPAA as per the ICF Checklist for Local Context Language
  • Complete eIRB new study smart form application
  • Attach the following documents approved by the reviewing IRB:
    • study approval letters (showing UTSW as an approved study site),
    • Consent (including required UTSW ICF language) and HIPAA Authorization or waivers
  • All UTSW Investigators/Study Personnel must:
    • complete CITI training per UT Southwestern research training policy and
    • submit a Conflict of Interest disclosure annually

Note: As with any research, an institutional activation approval from each participating site (i.e., Parkland, Children’s Health, etc.) is required prior to initiating your research at those sites.

National Cancer Institute Central IRB (NCI CIRB)

The Central Institutional Review Board (CIRB) Initiative is sponsored by the National Cancer Institute (NCI) in consultation with the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP). The CIRB enables an investigator to enroll patients into adult and pediatric NCI-sponsored clinical trials significantly faster than when employing traditional method of IRB review. The NCI CIRB will serve as the IRB of record for these studies. A detailed description of this process is available on the CIRB website link indicated above.

UT Southwestern will accept NCI CIRB review for all NCI sponsored cooperative group cancer trials.

Instructions for requesting UT Southwestern to rely on NCI CIRB:

Step 1: Confirm study participation:

  • Check the NCI CIRB website (https://www.ncicirb.org/) and confirm the study to be opened is on the NCI CIRB menu by Selecting “Studies List”

Step 2: Create an account with CTEP (First time users):

Step 3: Complete the Local Context Form

  • Once your NCI CIRB website access is approved, logon to the following site: https://irbmanager.becirb.com/
  • For first time users or to provide an annual update, complete an Annual PI Worksheet about Local Context. Contact the Reliance team if you need assistance.
  • Complete an NCI CIRB Study-Specific Worksheet About Local Context.
  • If you need additional assistance with the NCI forms, review the NCI CIRB Instruction Manual for Worksheet Completion in IRBManager https://www.ncicirb.org/- Select “How it Works”, Then “Independent Model Information”

Step 4: Complete HRPP Application Process

  • Modify the Informed Consent/HIPAA as per the annual approved institutional ICF Boilerplate (English or Spanish)
  • Complete eIRB new study smart form application
  • Attach the following documents approved by the reviewing IRB:
    • study approval letters,
    • Consent (including required UTSW ICF language) and HIPAA Authorization or waivers
    • The approval of study specific worksheet
  • All UTSW Investigators/Study Personnel must:
    • complete CITI training per UT Southwestern research training policy and
    • submit a Conflict of Interest disclosure annually

Note: As with any research, an institutional activation approval from each participating site (i.e., Parkland, Children’s Health, etc.) is required prior to initiating your research at those sites.

Greater Plains Collaborative IRB (GPC)

The Greater Plains Collaborative (GPC) is an IRB reciprocity for a network of 12 leading medical centers in 8 states.  Reliance is decided by the GPC Governance.  The following IRBs have signed on to the GPC agreement:

  • University of Kansas Medical Center (KUMC)
  • Children’s Mercy Hospital, Kansas City, MO (CMH)
  • University of Iowa Healthcare (IOWA)
  • University of Wisconsin - Madison (WISC)
  • Medical College of Wisconsin (MCW)
  • Marshfield Clinic (MCRF)
  • University of Minnesota (UMN)
  • University of Nebraska Medical Center (UNMC)
  • University of Texas Health Science Center at San Antonio (UTHSCSA)
  • UT Southwestern Medical Center (UTSW)
  • University of Missouri (MU)
  • Indiana University (IU) 

If you believe your study qualifies for GPC reliance:

Step 1: Request Reliance

  • Send an email to HRPP@UTsouthwestern.edu and provide the UTSW PI name, Study Title and Lead GPC Site information.

Step 2: Complete HRPP Application Process

  • Modify the Informed Consent/HIPAA as per the ICF Checklist for Local Context Language
  • Complete eIRB new study smart form application
  • Attach the following documents approved by the reviewing IRB:
    • study approval letters (showing UTSW as an approved study site),
    • Consent (including required UTSW ICF language) and HIPAA Authorization or waivers
  • All UTSW Investigators/Study Personnel must:
    • complete CITI training per UT Southwestern research training policy and
    • submit a Conflict of Interest disclosure annually

Note: As with any research, an institutional activation approval from each participating site (i.e., Parkland, Children’s Health, etc.) is required prior to initiating your research at those sites.

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FAQs

1. How do I request reliance on an IRB not listed above?

Complete the Intent to Rely on External IRB to inform the UTSW Reliance team about possible reliance.

2. What are my responsibilities as a relying PI?

As Principal Investigator at the Relying Institution for a study that may be overseen by an external IRB, you should be aware of your responsibilities. Review the Relying Investigator Guidance and Checklist for details of your responsibilities.

3. How do I submit a reliance study in eIRB?

Reliance studies submission can by initiated in Velos and then completed in eIRB. All mandatory fields should be completed. In question 5.3.1 of the eIRB smart form, the answer should be Yes. In section 16, the fourth option should be checked “Relying on a non-UT Southwestern IRB (This review type is applicable when any research-related activities will occur at UTSW or its affiliated institutions under the jurisdiction of an external IRB (For example, CIRB or other UTSW-approved external IRB)).

Upload all study documents into section 19. The IRB of Record Approval letter to section 19.2.2 and the Informed Consent, HIPAA and Protocol to section 19.2.3.

The Investigator’s Brochure may be uploaded in the corresponding drug page in the study smart form.

4. How do I submit an amendment for a reliance study?
  1. 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 Smart Form).
  2. Upload the following in eIRB:   
    1. The clean ICF/Protocol/HIPAA as a revision to the current ICF/Protocol/HIPAA in section 19.2.3.
    2. Amendment approval letter from external IRB in section 19.2.2.
  3. Attach a redline copy of the changed documents in the modification smart form.
5. How do I submit a continuing review for a reliance study?

Regardless of the study status, always check the box that “This study is a CIRB or a Humanitarian Use Device”.

Complete all the required fields.

Attach the renewal approval letter from IRB of record to section 7.1.1 of the continuing review smart form.

6. How do I add a foreign language short form for a reliance study?

To add a foreign language Short form, you will have to obtain approval from the IRB of record first, then you can submit it in a modification in eIRB for UTSW HRPP to acknowledge it.

For NCI-CIRB studies, if the short form is listed in the documents approved as part of the Annual Institutional Worksheet, then you can submit it to UTSW HRPP without prior approval from NCI-CIRB.

7. How do I change the PI for a reliance study?

NCI-CIRB Studies: you will have to submit a new study specific worksheet through IRB Manager, and then you may submit a modification in eIRB to change the PI. The new Study Specific worksheet approval must be uploaded in section 19.2.2 of the study smart form.

All other external IRBs: the external IRB must approve the PI change first, then you may submit the modification to eIRB to change the PI.

8. Who Decides Which IRB Reviews?

The Institutional Official (IO) is vested with the authority to make the decision whether or not to review for or rely on another IRB.

At UTSW, the IO is the Vice Provost and Dean of Research.

9. Can I use a foreign language Short form for NCI CIRB studies if it is approved by UTSW HRPP?

No, the institutional signatory contact have to submit any foreign language translated short form to NCI CIRB within the Annual institutional Worksheet about Local Context for approval. You may then customize it to your study and submit it to UTSW HRPP for acceptance.

10. I’m trying to submit a reliance study but the application is not simple as it was described. Why not?

You must answer question 5.3.1 of the study smart form as YES and check the option “Relying on a non-UT Southwestern IRB (This review type is applicable when any research-related activities will occur at UTSW or its affiliated institutions under the jurisdiction of an external IRB (For example, CIRB or other UTSW-approved external IRB)."

11. How long does it take for an IRB Authorization Agreement (IAA) to be finalized?

IAA review and signature usually takes 7-10 business days.

MOU and Reciprocity agreements may take longer.

12. What is the timeframe for acceptance of the review of the IRB of record?

If the application is completed correctly, and informed consent local context language is included, the acceptance letter will usually be issued in 7-10 business days.

Delays may occur if agreements have not been signed or if ancillary/safety committees have not issued final approval.

13. An unanticipated problem (e.g., adverse event) or noncompliance occurred on my study locally. Who do I report it to?

You must report the event to the Reviewing IRB (e.g., NCI CIRB or Commercial IRB) according to their reportable event timelines and also report to the UTSW HRPP according the HRPP Policy.

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Definitions

“Affiliated Institution” with the UT Southwestern    
Central IRB  
External IRB  
Internal IRB  
Individual Investigator Agreement (IIA) 
IRB of Record  
Lead Study Team  
Local context required language  
Memorandum of Understanding (MOU)  
Overall or Lead Investigator  
Point of Contact  
Reliance Agreement (IRB Authorization Agreement or IAA)  
Relying IRB  
Relying Study Team  

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