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Reliance

In order to maintain regulatory compliance, and to help facilitate human research initiatives, the Reliance Unit provides resources and support for researchers engaging in reliance activities with External collaborators. Engaging in reliance minimizes the need for duplicative IRB review while protecting the rights and welfare of human research participants. The resources and information found on the associated webpages provide a complete overview of the reliance process, from beginning to end. If you need additional information or have questions, please contact us at irbreliance@northwestern.edu.

Definitions:

  • 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 each site participating in cooperative research.

Below, you will find additional information and links to various pages, guidance documents, and information that pertains to reliance activities.