Human Research Protection Program

Review by a Single IRB (sIRB)

What is Single IRB?

Single Institutional Review Board (sIRB) involves the use of one IRB of Record (or Reviewing IRB) for regulatory and ethical review for all sites participating in a multisite study. The purpose of using sIRB is to encourage collaboration, reduce duplicate study submissions, and minimize the impact of multiple IRB reviews for the same protocol. When a study is using an sIRB, HIPAA Privacy and IRB review are the only responsibilities of the reviewing sIRB. All other ancillary committees and institutional reviews must still take place at the participating institution(s).

When will UTSW support sIRB? 

  • Research is conducted or supported by any federal department or agency 
  • Required by regulation 
  • UTSW Faculty collaborates with external institutions 

When is sIRB NOT required? 

  • Exempt research 
  • Designated IRB is unable to meet the needs of specific populations 
  • Local IRB is required by federal, tribal, or state laws 
  • Research conducted is under career development, research training or fellowship awards 

What is a Reliance Agreement? 

A reliance agreement is a written memorandum of understanding (MOU) between two institutions that allows one IRB to rely on the review of the other IRB. It lays out all of the responsibilities and is typically signed by the FWA Human Protections Administrator (HPA) or Institutional Official (IO). Note that relying institutions must still comply with applicable state laws and institutional policies.  

Click here to initiate Reliance Agreement at UTSW! 

What are the types of External IRBs we work with at UTSW? 

HRPP works with investigators who have the role of a participating site in a multi-site study to identify and rely upon the appropriate external IRB. To request that HRPP defer IRB oversight to an external IRB, a Reliance Request application must be submitted in eIRB. 

The process for reviewing the Reliance Request application in eIRB varies based on the external IRB. 

Option A: Commercial IRBs are independent pay-for-service IRBs that provide regulatory and ethical review services for academic and non-academic institutions to conduct reviews of research involving human subjects. For example:

  • Advarra IRB
  • WCG IRB 

Option B: Cooperative Group IRBs are central IRBs that specialize in a particular type of research. For example:

  • National Cancer Institute (NCI) CIRB (click for more general information and for specific instructions) 
  • National Marrow Donor Program 

Option C: Any other external IRB (e.g., at another academic institution, federal agency, or another type of IRB, etc.). For example: 

  • Children’s Hospital of Philadelphia IRB 

When can I add Non-UTSW Affiliated Individual to a study? 

When non-exempt human participant research is being conducted with collaborating individual investigators, each collaborating individual investigator engaged in the research must obtain IRB approval from an appropriately authorized IRB. View below Guidance Document for more information.  

What are federal policies and regulations for sIRB? 

What are policies, regulations, and guidance being applied to external IRB review requests? 

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.