Remember To Follow the Single IRB Policy

Funding News Edition: August 05, 2020
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Do you know when you must use a single institutional review board (sIRB) for human subjects research? Here’s a refresher on NIH’s Single IRB Policy for Multi-Site Research.

sIRB Policy Summary

For non-exempt human subjects research using a single protocol at multiple U.S. sites, you must identify an sIRB of record that will conduct the ethical review of your protocol. This policy requirement supports the Revised Common Rule 45 CFR 46.114, eliminating the unnecessary administrative burden of multiple IRB reviews.

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 detailed in NIH’s January 22, 2020 Guide notice, requirements of 45 CFR 46.114 now apply to career development (K) and fellowship (F) awards.

If your study was not required to follow the sIRB policy before January 20, 2020, you may continue to use multiple IRBs for the duration of your award’s current competing segment. When you renew your grant for an ongoing study, you must use an sIRB.

Identify Your sIRB

Your chosen funding opportunity may specify which IRB you must use. If it 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

For applications to NIH, you will provide a statement identifying your proposed sIRB of record when you Respond to Pre-Award Requests (“Just-in-Time”).

Applicants to NIH do not need to attach an sIRB plan when applying, although a plan is required for applications to the Agency for Healthcare Research and Quality. Learn more in the Section 3.2 Instructions.

If you plan delayed-onset research, your Justification Attachment must explain how your study will comply with sIRB policy. Find more instructions on Delayed Onset Study(ies).

More sIRB Information and Contacts

Your sIRB review will follow the approach NIAID describes in the Human Subjects Certifications—IRB or IEC SOP and in the IRB or IEC Approval section of Research Using Human Subjects.

During the just-in-time process, direct your award-specific questions about sIRB compliance to your assigned grants management specialist.

For general questions about NIH sIRB policy, contact SingleIRBpolicy@mail.nih.gov.

Contact Us

Email us at deaweb@niaid.nih.gov for help navigating NIAID’s grant and contract policies and procedures.

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