Compliance

Human Subjects Research (IRB)

Single IRB (sIRB) a.k.a. Collaborative/Cooperative Research

CPHS acknowledges the challenges that may exist with multiple IRB reviews in collaborative and/or multi-site research projects. Under certain circumstances, to minimize duplicative IRB review, CSUMB may be willing to rely on the review of another institution’s IRB or provide review for another institution or individual investigator.

Projects that are subject to the Single IRB (sIRB) requirement must have reliance agreement(s) in place to enable a Single IRB to serve as the IRB of record (a.k.a. home IRB).

All requests for CSUMB to rely on another institution or for CSUMB to serve as the IRB of record for another institution are subject to the approval of the CPHS under the delegation of authority from the CSUMB Institutional Official (IO), the Provost and Vice President for Academic Affairs.

  • Generally, the IRB performing the review on behalf of CSUMB must be another academic institution in the United States that has a Federalwide Assurance (FWA) with the Office for Human Research Protections (OHRP) and has its own institution-based IRB.

    Reliances between CSUMB and another institution’s IRB are considered on a case-by-case basis. CSUMB researchers who are interested in a potential reliance on another institution’s IRB should fill out the request form at csumb.edu > Compliance > Checklists Forms and Policy > Other Protocol Types.

    In general, a reliance with another non-CSU or UC institution’s IRB may require additional, ancillary review(s) to formalize the agreement, and proposals to rely on an unfamiliar institution's IRBs may require escalation to the CSUMB Institutional Official (IO), the Provost and Vice President for Academic Affairs.

  • In general, requests for an external researcher or IRB to rely on a protocol reviewed at CSUMB by the CPHS must involve the engagement of the external researcher in a protocol lead by a CSUMB researcher.

    CPHS acknowledges the challenges that may exist with external IRBs processing reliance agreements in a timely manner. Under certain circumstances, to minimize delays in CPHS review, the CPHS may be willing to complete the review contingent upon the external IRB notification of their researcher's engagement in a CSUMB researcher's protocol.

    Reliances between CSUMB and another institution’s IRB are considered on a case-by-case basis. External researchers who are interested in a potential reliance on CSUMB should fill out the request form at csumb.edu > Compliance > Checklists Forms and Policy > Other Protocol Types.

    In general, reliance on CSUMB by another non-CSU or UC researcher or IRB may require additional, ancillary review(s) to formalize the agreement, and proposals to rely on an unfamiliar institution or IRB may require escalation to the CSUMB Institutional Official (IO), the Provost and Vice President for Academic Affairs.