TTUHSC El Paso Reliance Agreements

List of TTUHSC El Paso Reliance Agreements

TTUHSC El Paso has signed several IRB Authorization Agreements. Many of these agreements are individual IRB Authorization Agreements or reliance agreements signed for a particular research study. TTUHSC El Paso also has signed multi-study agreements for studies done under the auspices of a consortium or network. Negotiating IRB reliance agreements takes time and effort, TTUHSC El Paso IRB encourages researchers to use the SMART IRB Agreement.

SMART IRB Agreement: 

SMART IRB is a platform designed to ease common challenges associated with initiating multisite research and to provide a roadmap for institutions to implement the NIH Single IRB Review policy (effective date: January 25, 2018). The SMART IRB is an integrated, comprehensive platform that allows flexibility in the size and scope of collaboration to enable IRB reliance for multisite studies across the nation, regardless of funding status. More than 1000 institutions have signed the SMART IRB reliance agreement. TTUHSC El Paso is a participating institution. When you have a new multi-site study and would like to use the SMART IRB reliance platform, check to see if all the sites in your study are participants in SMART IRB platform by visiting the SMART IRB website. 

State of Texas Master IRB Reciprocity Agreement: 

TTUHSC El Paso has signed the State of Texas Master IRB Reciprocity Agreement, which serves to reduce duplicative IRB reviews. Multi-site studies involving more than one of the participating institutions may request to rely on one IRB. Consider using this agreement any time you are conducting research with institutions in Texas.

Commercial IRBs:

TTUHSC El Paso will be offering the option to rely on commercial IRBs for multi-center industry sponsored trials on a case-by-case basis. Currently, TTUHSC El Paso has agreements with commercial IRBs through the SMART IRB platform:

Advarra IRB

WCG IRB

More information can be found in the guidance on working with a commercial IRB. Commercial IRBs may be used as the sIRB for NIH funded multi-site studies.

Working with Commercial IRBs

On a case-by-case basis, and with the permission of the TTUHSC El Paso IRB, TTUHSC El Paso researchers may choose to rely on an independent or commercial IRB when conducting industry sponsored multi-center clinical trials. Researchers may also request to use an independent or commercial IRB as the sIRB under the NIH sIRB mandate.

To request for TTUHSC El Paso IRB permission to rely on a commercial IRB, submit a request at: Single IRB (sIRB) Reliance Intake Form.

If a study sponsor requires use of an IRB that TTUHSC El Paso does not have an agreement with, this will require that a reliance agreement be established.  Please contact the IRB and Research Contracts and Agreements to engage in the agreement process at the earliest opportunity, as it may take time to negotiate the terms.

 

How long it may take to finalize an agreement depends on several factors, including the responsiveness of the other IRB and its experience with reliance agreements, as well as, whether language in the agreement requires negotiation. At a minimum, this may take at least 30 days. Study teams should keep this in mind when considering sIRB review.  The Vice-President for Research must sign reliance agreements prior to submission to an external IRB.

Most of the commercial IRBs that TTUHSC El Paso works with will revise the sponsor consent template to add the TTUHSC El Paso mandatory language (injury, local contact information, location, HIPAA authorization language). TTUHSC El Paso has an arrangement with commercial IRBs to ensure that the TTUHSC El Paso approved language for research related injury, local contact information, location, and HIPAA authorization is included in consent forms. If a sponsor does not agree to include the TTUHSC El Paso injury language or makes changes to the HIPAA authorization section, contact a TTUHSC El Paso IRB representative at ELPIRB@ttuhsc.edu.

Commercial IRB Fee Structure

For protocols reviewed and approved by an external IRB, the TTUHSC El Paso administrative fee will be $1300 for initial review and $1000 for the yearly maintenance fee.  Please note, this is in addition to the Commercial IRB review fee charged by the IRB selected. 

IRB Fee Billing Process

The IRB fee billing process is initiated and invoiced by the Research Contracts and Agreements Unit upon execution of the research contract.  Subsequent billing for continuing review or yearly maintenance fees is invoiced by the Research Finance Unit.