For sIRB Applications, Tell Us You Have a Plan

Funding News Edition: September 15, 2021
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For nonexempt human subjects research using a single protocol at multiple U.S. sites, you must identify a single institutional review board (sIRB) of record that will conduct the ethical review of your protocol, as required by NIH’s Single IRB Policy for Multi-Site Research. Foreign sites and research training (T) awards are not subject to the sIRB policy, nor are other domestic sites at which sIRB review is prohibited by a federal, tribal, or state law, regulation, or policy.

As made clear in the August 23, 2021 Guide notice, you are not required to submit a plan describing the use of an sIRB at the time of application submission. It will suffice to provide the name of the sIRB of record when you Respond to Pre-Award Requests (“Just-in-Time”).

Your chosen funding opportunity announcement may specify which type of IRB you must use. If the initiative leaves that choice up to you, you have multiple options:

  • The primary grantee’s IRB
  • Another study site’s IRB
  • A central IRB organized to review the proposed study protocol
  • An independent, commercial, or unaffiliated IRB

When you plan delayed-onset research, your application’s Justification Attachment must explain how your study will comply with sIRB policy.

Find additional guidance in the NIH Application Guide section 3.2 Is this a multi-site study that will use the same protocol to conduct nonexempt human subjects research at more than one domestic site?.

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