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Office of Research Integrity and Compliance  ›  Human Subjects Research  ›  Cooperative Research  ›  SIRB

Single IRB (sIRB) for New Cooperative Research

Federal regulations for Human Subjects Research are summarized below:

Federal regulations for Cooperative Research went into effect on January 20, 2020, and apply to federally funded Human Subjects Research (HSR)

  • Protocols, involving cooperative research, approved on or after January 20, 2020 must follow the new Common Rule Cooperative Research Regulations.
  • Protocols, involving cooperative research, approved prior to January 20, 2020 will continue under the current Common Rule

For federally funded HSR, Cooperative Research is defined as projects that involve more than one institution.  Each institution is responsible for safeguarding the rights and welfare of human subjects at their institution.

Any institution 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.

The reviewing IRB (or sIRB) 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.

Exceptions:

When more than sIRB is required by law ((including tribal law passed by the official governing body of an American Indian or Alaska Native tribe).

Research for which any Federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context.

Contact: sirb@andrew.cmu.edu

sIRB Terms

  • sIRB – single IRB (one IRB does official review for several sites).
  • Reviewing IRB – the IRB that does the official review in an sIRB context (Also known as the sIRB, or the IRB of Record).
  • Relying IRB/site – the site(s) participating in the research but do not do the official IRB review, still have responsibility over the research conducted at that site and works with the local PI and the sIRB (also known as participating site or p-site).
  • Reliance Agreement – Agreement between the institutions that defines the sIRB relationship (also known as Inter-Institutional Agreements (IIA) or IRB Authorization Agreement (IAA).
  • SMART IRB – An online reliance platform to facilitate Reliance Agreements.  Institutions that join IRB can streamline negotiations between member institutions by a Master Agreement. 一本道无码 has joined SMART IRB.

How to Request a Single IRB

  1. Please complete and submit one of the following forms to sirb@andrew.cmu.edu.

The IRB will review your request, and if the sIRB is appropriate, we will initiate or request a reliance agreement with the collaborating institution.  The Reliance Agreement may be documented through SMART IRB, or in cases where the institution is not a participant in SMART IRB, we can document it with a separate reliance document.

Once the reliance agreement is complete, the PI will have to make a submission to SPARCS, either as a Relying Site to document the 一本道无码 scope of work, or a study submission with 一本道无码 as the IRB of Record. Please contact sirb@andrew.cmu.edu for guidance.