Reliance (Single and Central IRBs)

Definitions

• Central IRB: An IRB of Record that is specifically established to conduct the ethical review for all sites participating in a program that usually includes more than one multi-site study. (e.g. the NCI Central IRB)
• Collaborative Study: Human research involving more than one institution and/or site participating in the same research protocol, where each site completes a portion or portions of procedures. 
• Cooperative Research: Human research covered by (45 CFR 46) involving more than one institution and/or site.  When conducting cooperative research, each institution and/or site is responsible for safeguarding the rights and welfare of human participants and for complying with this provision.  Any institution and/or site located in the United States that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States.
• IRB of Record: The IRB that is responsible for the ethical review of human research on behalf of an institution and/or site or individual investigator.
• Lead Site: The primary awardee of a federally funded grant who is responsible for identifying the selected sIRB for cooperative research. For non-federally funded research this role is identified as the primary institution and/or site whom develops a research protocol.
• Multi-Site Study: Human research involving more than one institution and/or site participating in the same research protocol.
• Participating Site: An institution or site engaged in multi-site research, where a local investigator is responsible for the conduct of human research at their institution or site.
• Relying IRB: An IRB that has designated through an agreement to cede review to an external IRB for a particular study.
• Single Institutional Review Board (sIRB): An sIRB is the selected IRB of Record that conducts the ethical review for one or more sites participating in cooperative research.

(Unless required by the FOA or contract solicitation, you do not have to create a Central IRB. For many studies, the institutional IRB can serve as the single IRB of record).

In cases where the HU IRB is relying on another IRB for the ethical oversight of a research study, it is critical for the HU investigator to report all ongoing study activity to the HU IRB after initial approval. The HU IRB must be able to ascertain that study activity remains in adherence to institutional policies and requirements.