Single IRB (sIRB) Requirement Updates

As a reminder, the NIH sIRB mandate requiring the use of an sIRB, as a contingency for funding of NIH-multi-site research studies, went into effect January 25, 2018. Final NIH Policy on the Use of a sIRB for Multi-site Research

The upcoming compliance date for The Revised Common Rule’s Cooperative Research Provision (45 CFR 46.114) is January 20, 2020. Therefore, for cooperative research applications and contract proposals submitted on or after January 20, 2020, a sIRB must be used unless you meet the exceptions outlined in the HHS.gov link below.

The 2018 Final Revised Common Rule, requires that any institution located in the United States that is engaged in cooperative research as defined under 45 CFR 46.114 (a) must rely upon approval by a single IRB for that portion of the research that is conducted in the United States. The reviewing IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research. On November 22, 2019, the Office of Human Research Protections (OHRP) announced exceptions for two categories of research from the required use of an sIRB) (https://www.hhs.gov/ohrp/regulations-and-policy/single-irb-requirement/1... )

For guidance on requesting use of a sIRB mechanism for projects conducted at Pitt and all necessary steps to implement an sIRB project please go to:

•    www.hrpo.pitt.edu
•    Select “A-Z guidance”
•    Select letter “R”
•    Review documents under the “Reliance Guidance” header

Please contact irb.reliance@pitt.edu with questions.

1/17/2020

 

Headline Teaser

January 20, 2020 is the compliance date for the Revised Common Rule's Cooperative Research Provision (45 CFR 46.114)