Single IRB (sIRB) Process

TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO (TTUHSC El Paso)
SINGLE IRB (sIRB) PROCESS

A Single IRB means having one IRB of record (or Reviewing IRB), selected on a study-by-study basis, which provides the regulatory and ethical review for all sites participating in a specific multisite study.

All investigators applying for Federal funding in support of human subjects’ research that involves two or more domestic sites conducting the same protocol for non-exempt research should submit the request through iRIS.

sIRB Requirement

At TTUHSC El Paso, a single IRB will be required for the following types of non-exempt cooperative (multisite) research carried out within the United States:

This applies to new studies approved on or after January 20, 2020 supported by an agency that has signed on to the Common Rule. For a full list of HHS Departments and Agencies that follow the Common Rule, please click here.

Research supported by NIH.  Click here for the official notice from NIH: NOT-OD-16-094. There are some exceptions.  For more about the NIH exceptions and additional information on the single IRB requirement for NIH supported research (in effect since January 25, 2018) click here.

For industry-sponsored research, the requirement does not apply; however, these may be submitted and will be assessed on a case-by-case basis.

IRB Reliance Agreements

Agreeing to be the sIRB for a Multi-Site Study (MSS) is much like a contract negotiation. If applicable, each institution must sign an agreement that outlines the responsibilities and expectations of the reviewing and relying IRBs. All studies require a signed agreement, unless 1) the project is deemed exempt, or 2) TTUHSC El Paso has a standing agreement in place with the organization(s). 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.

TTUHSC El Paso has standing agreements in place with the following entities regarding sIRB review:

  • National Cancer Institution Central IRB (NCI CIRB) for Children’s Oncology Group studies
  • SMART IRB - a platform for IRBs to share IRB approval for single IRB review. TTUHSC El Paso is a member of the SMART IRB
  • UT System Master Agreement
  • StrokeNet
  • WCG IRB

What does the TTUHSCEP IRB require when requesting to rely on a Reviewing (external) IRB?

The use of a Reviewing IRB does not exempt TTUHSC El Paso from human research activity oversight. TTUHSC El Paso remains accountable for the conduct of human research by TTUHSC El Paso personnel. The PI and study personnel are required to comply with BOTH TTUHSCEP research policies AND the external IRB policies. Please note: TTUHSC El Paso written IRB approval is required prior to initiating research activities at the local site(s) and prior to initiating amendment changes at the local site.

The following training is required:

The following should be submitted via iRIS during the initial review process: 

  • Complete IRB application form which indicates the request to rely and/or review;
  • Full protocol;
  • Investigational New Drug (IND) or Investigational Device Exemption (IDE) number (if applicable)
  • Investigator’s Brochure (if the study involves an investigational drug or device);
  • Informed consent document using site-specific boilerplate language; this will be stamped for use on our campus (as applicable)
  • TTUHSC El Paso IRB-approved format and/or local context information
  • Authorization to Use and Disclose PHI for Research (HIPAA authorization), included with the biomedical consent template and/or HIPAA waiver request, included with the study application
  • Data collection forms;
  • Recruitment materials that include local context information (if any will be used);
  • Surveys, questionnaires, or videotapes (if any will be used);
  • Documentation of approval by other TTUHSC EP institutional committees as applicable;
  • Curriculum Vitae of PI (uploaded onto the iRIS account).
  • Signed Request to Rely form, flexibility addendum, or acknowledgment, if applicable
  • Copies of letters of assurance or cooperation with research sites i.e., local context form (as applicable);
  • Reviewing IRB approval letter, including type of review, approval and expiration dates, risk level. The TTUHSC El Paso IRB does not issue approval periods for Reviewing IRBs;

Once submitted, the TTUHSC El Paso IRB will verify that the project is eligible for review under a reliance agreement.

For general questions, send an email to: ELPASOIRB@ttuhsc.edu

During the conduct of the Research, it is the responsibility of the PI to submit the:

  • Continuing Review Form via iRIS(frequency as required by the Reviewing IRB)
    -Reviewing IRB Continuing Review Approval Letter with approval and expiration dates. The TTUHSC El Paso IRB does not issue approval periods for Reviewing IRB reviews.
  • Unanticipated Event Reports via iRIS(as required by TTUHSC El Paso for local subjects)
  • Amendments submitted via iRIS
    - Reviewing IRB amendment approval letter or documentation of why it is not needed
    - Any revised documents

Definitions

Reliance agreement

A formal, written document that provides a mechanism for an institution engaged in research to delegate IRB review to an IRB of another institution. Institutions may use different descriptive terms, (e.g., reliance agreement, cooperative agreement, IRB authorization agreement (IAA), or memorandum of understanding (MOU)). Agreements may cover single studies, categories of studies, or all human subjects research under an organization’s Federalwide Assurance (FWA).

Reviewing IRB

The IRB that is responsible for the review, approval and regulatory oversight of a multi-center research study and serving more than one site. This IRB is sometimes referred to as the IRB of Record. The IRB that conducts initial and continuing reviews, and will review modification to approved protocol and unanticipated problems or adverse events that may arise. The Reviewing IRB will have the authority to suspend the research for failure to comply with conditions of approval or regulatory requirements.

The Reviewing IRB will notify the federal or funding agencies of these events consistent with their policies and procedures and copy the Relying IRB on any such correspondence. The Reviewing IRB will serve as the IRB of record. The IRB may refuse, on a case-by-case basis, to serve as the IRB of record for another location.

Relying IRB

The IRB of the institution where the research will take place and which will rely on an external IRB which will serve as the IRB for a multi-center study.  The IRB may refuse, on a case-by-case basis, to rely on the review of another IRB.

IRB #1 Research Compliance Specialist II:                                          IRB #2 Research Compliance Specialist II:
Raquelle Rosales                                                                                  Brittney Espinoza
915-215-5271                                                                                        915-215-5709
raquelle.rosales@ttuhsc.edu                                                                 britespi@ttuhsc.edu
Room 5A111D                                                                                        Room 5A111C

 

Physical: 137 Rick Francis Dr., MSBII
Mailing: 130 Rick Francis Dr., MSC Number 31004
El Paso, Texas 79905