Single IRB

The Single IRB Mandates

The federal requirement for single IRB (sIRB) review comes from two separate mandates:

Revised Common Rule

The revised federal Common Rule contains a new requirement for single IRB review for collaborative, non-exempt human subjects research that involve multiple institutions. This applies to all federally-funded or supported research (with the exception of Department of Justice funded projects). It went into effect January 21, 2020.

NIH Single IRB Policy

This is distinct from the Common Rule requirement and applies to most grants and contracts submitted to NIH on or after January 25, 2018 that involve multi-site, non-exempt human subjects research. The policy defines multi-site research as a subset of collaborative research that requires the use of a single IRB. It is important to identify when a project must comply with the NIH policy because there are specific, NIH requirements that must be present in the grant or contract applications for studies subject to this policy that do not apply to studies under the broader Common Rule requirement.

Exceptions to the Common Rule Single IRB policy:

The mandates do not apply to exempt human subjects research. Please see Section 9.2 Types of IRB Review of the Policy and Procedures Manual for more information about exempt determinations.

Single IRB review is also not required for sites that:

  • Are not located in the United States (foreign sites)
  • Sites that involve tribal nations
  • Many Veterans Affairs sites (check with individual VA to verify)
  • Sites for which review by the proposed single IRB is prohibited by a federal, tribal, or state law, regulation, or policy.

Guidance

Instructions to Request that Lurie Children’s Rely on an External IRB of Record

Instructions to Request that Lurie Children’s Serve as the IRB of Record

IRB Reliance Frequently Asked Questions

Proposed Language for Grant Applications Requesting to Use Lurie Children’s as Reviewing IRB

Helpful Forms

Formal Request from Relying Site or Individual

Lurie Children’s Reliance Request Form

Checklist for Required Consent/Assent Language when Relying on an External IRB

Lurie Children’s Template Reliance Agreement

Lurie Children’s Local Context Information Form