The federal requirement for single IRB (sIRB) review comes from two separate mandates:<\/p>\n
The revised federal Common Rule contains a new requirement for single IRB review for collaborative<\/em>, non-exempt human subjects research<\/em> that involves 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.<\/p>\n 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<\/em>, non-exempt human subjects research. The policy defines multi-site<\/em> research as a subset of collaborative<\/em> 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.<\/p>\n The information on these webpages is designed for studies that must comply with either of these mandates, however it may also be useful for researchers wishing to use a single IRB for multi-institutional (multi-site or collaborative) studies that are not federally-funded.<\/p>\n \u201cMulti-site\u201d means that the same research procedures (i.e., protocol) are being conducted at one or more domestic sites and that each site is under the control of a local participating investigator. This typically involves a lead site that receives the grant or contract directly from NIH and that then establishes a subaward or subcontract to each participating site. The research could be a clinical trial, an observational study, or a basic clinical research study.<\/p>\n Protocols that address the same research questions, involve the same methodologies, and evaluate the same outcomes are considered to be the “same research protocol.” Additionally, sites that are accruing research participants for studies that are identical except for variations due to local context consideration would be considered to be conducting the “same research protocol.” If a study involves a separate site for study coordination or coordination of data and statistical analyses and the site is conducting the same protocol as the other participating sites, then all sites would be expected to rely on the designated single IRB.<\/p>\n If you are unsure whether a project you are proposing is subject to the NIH policy, work with the NIH program officer. You can also consult NIH\u2019s Single IRB Requirement Determination Workflow (PDF)<\/a> to help determine whether your project is subject to the sIRB requirements.<\/p>\n The mandates do not apply to exempt human subjects research.<\/p>\n The mandates do not apply to the following types of participating sites in multi-site research:<\/p>\n Note that a study may involve sites that must comply with the policy and<\/strong> other sites that are not required to comply.<\/p>\nNIH Policy<\/h3>\n
Contents<\/h3>\n
\n
Definition of “multi-site” for NIH funded research<\/h2>\n
“Same Research Protocol”<\/h3>\n
What to Do If You Are Unsure<\/h3>\n
Exceptions<\/h2>\n
Types of Research<\/h3>\n
Types of Sites<\/h3>\n
\n
Other Exceptions<\/h3>\n