Update: Single IRB Policy

The NIH single IRB (sIRB) policy applies to the domestic sites of new and competing renewal applications/proposals with due dates of January 25, 2018 and beyond for NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program.

If you are preparing an NIH application due on or soon after January 25th, 2018, you should contact the Human Research Protection Office (HRPO) immediately at irboffice@columbia.edu if your application proposes to:

  • Conduct non-exempt human subjects research; AND
  • The same research protocol will be conducted at multiple domestic sites.

If Columbia University is being proposed as one of the participating sites in an application to be submitted this month or soon after by another applicant organization, you must also contact the HRPO immediately. Moving forward, it is recommended that you contact the HRPO as soon as a decision is made to participate in a multi-site study to which the NIH sIRB Policy applies.

An official process that details the requirements for addressing the NIH sIRB Policy is being finalized, to be released shortly. In the meantime, PIs and/or departments can reach out to irboffice@columbia.edu to inform the HRPO about these applications. Upon receipt of your email, HRPO will send you an online form to be completed, and you will be provided with next steps.

In addition, we are offering several options to learn more about the sIRB process. An information session will be held on Wednesday, January 17th from 3:30 – 5:00 pm, which will include an overview of all the NIH Human Subjects and Clinical Trial policies affecting proposals due on or after January 25th, 2018. This session will include Columbia University’s implementation of the sIRB policy. It is open to all faculty and administrators. No RSVP required, and you can add this event to your calendar here.

On January 18th, our quarterly Research Administration Forums will also include sIRB on the agenda. More information about the Forums can be found here.

On January 25, 2018, the Monthly IRB-Investigator Meeting will also include information on requirements for and processes relating to the NIH Single IRB Policy.

Note: 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 you have any questions, please contact irboffice@columbia.edu.

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Stephanie F. Scott, Director of Policy & Research Development, SPA and

Alan Teller, Director of Operations, HRPO

Editor's note:

Also sent via listservs from Stephanie Scott and Alan Teller.

January 12, 2018