NIH’s Single IRB Policy: Contact the IRB First

If you’re planning to submit a grant that involves a multi-site study to NIH, it’s important to know that you must now contact the IRB before you submit your grant. A new NIH policy requires the use of a Single IRB for the review of multi-site, non-exempt human research studies, with few exceptions. A plan for the use of a Single IRB (sIRB) must be included with the grant application, so applicants must engage the IRB early in the proposal development to determine appropriate arrangements for IRB review. If our IRB determines that another institution’s IRB may serve as the reviewing IRB, you still need to submit an external IRB submission to our IRB via CATS IRB. 

But before we go further, let’s distinguish between a multi-site study and a collaborative study:

  • Multi-site study: more than one participating site will conduct the same protocol 
  • Collaborative study: each participating site conducts a different component of the research 

The NIH policy requiring sIRB review does not apply to collaborative studies. 

Investigators conducting multi-site studies that require review by a Single IRB may have the option to use SMART IRB. Contrary to its name, SMART IRB is not an IRB. SMART IRB is a platform supported by NIH that is designed to facilitate IRB reliance and enhance collaboration between institutions. SMART IRB includes a master reliance agreement, online reliance system, and supporting documents. Penn State is a SMART IRB participating institution. However, the use of the SMART IRB master reliance agreement may not be appropriate for all studies; an IRB staff member must consider its use with each sIRB plan or study on a case-by-case basis. IRB staff can provide resources to assist investigators in the development of the sIRB plan and can answer questions regarding the use of the SMART IRB.

Investigators at Penn State DO NOT have the authority to enter into or invoke the use of any reliance agreement, including the SMART IRB master reliance agreement, nor should they commit to any reliance arrangement verbally or in writing without consulting IRB staff. Penn State has specific criteria for when our IRB will rely on another institution's IRB for review so reliance on another IRB should not be assumed. Therefore, it’s important to contact the IRB program during proposal development for a grant that involves multi-site research! 

If you and your colleagues are conducting a multi-site study, it’s important to know the following:

  • Contact the IRB staff as early as possible BEFORE submitting your grant
  • Only the IRB has the authority to determine reliance and enter into a reliance agreement
  • Even if it is proposed that another IRB will serve as the reviewing IRB, you must still submit an external IRB submission to Penn State’s IRB

If you are developing a proposal or have questions about reliance arrangements or SMART IRB, please contact your assigned IRB Analyst, or for general inquiries, contact the IRB program at irb-orp@psu.edu.