sIRB for Multi-Site Research

For applications with due dates on or after January 25, 2018, and contract solicitations published on or after January 25, 2018, NIH expects that all sites participating in multi-site studies, which involve non-exempt human subjects research funded by the NIH, will use a single Institutional Review Board (sIRB) to conduct the ethical review required for the protection of human subjects.

The NIH policy applies to all biomedical and behavioral studies that:

  • Are funded through grants, cooperative agreements, or contracts submitted to NIH on or after January 25, 2018, and
  • Involve non-exempt human subjects research, and
  • Involve multiple domestic sites, all of which are conducting the same protocol.

The sIRB NIH policy does not apply to:

  • Foreign sites; or
  • Studies funded through career development (K), institutional training (T), and fellowship (F) awards; or
  • Sites for which federal, state, or tribal laws, regulations or policies require local IRB review; or
  • collaborative projects in which multiple sites are involved but different sites may complete different parts of the study.

Other exceptions to allow for local IRB review may be considered by NIH based on compelling justification. These other exceptions must be reviewed and approved by NIH.

Read more about exceptions to the NIH sIRB Policy.

Steps Prior to a Grant Application

Yale serving as the Primary Awardee

The actions described below must be completed prior to the grant application.

  • Request a Letter of Support from the Yale HRPP Office. You can request assistance with estimating the sIRB review fees for the budget at the same time.
  • Budget for the costs of the sIRB review and ‘IRB Liaison’ position to help with coordinating submissions from all sites to the IRB.
  • Select the IRB that will serve as the single IRB of Record for all domestic sites participating in the research.
  • Obtain approvals from the Human Research Protection/IRB Offices from all participating sites.
  • Draft the sIRB Plan and distribute to site PIs for input.

Steps Prior to Grant Application

Another institution serving as the Primary Awardee, Yale will receive a subaward/subcontract

  • Request a Letter of Support from the Yale HRPP Office.
  • Review the sIRB Plan drafted by the overall PI.

Steps Post Award

All research where Yale ceded review to an external IRB

Although agreements with external IRBs may include different division of responsibilities, Yale as an institution will generally remain responsible for review of compliance with local requirements such as training, locally required ancillary reviews, conflict of interest disclosures, or review of Yale specific language in the consent forms. Yale HRPP requires that a record of the research study be created in IRES IRB. Follow the steps for external IRB review:

  • Draft/obtain from the coordinating center the protocol and consent templates.
  • Submit the documents in IRES IRB requesting use of external IRB;
  • If Yale is the primary awardee, coordinate with the site PIs to submit the protocol documents to their HRPP/IRB Offices per local policies and procedures’
  • Once the Authorization to Use external IRB is received, submit to the sIRB.
  • Once the research is approved by sIRB, update the approval dates in IRES IRB.