Montana State University Relationships with Other Institutions

Montana State University (MSU) acknowledges that each institution engaged in multi-institutional or collaborative research bears independent responsibility for protecting the rights and welfare of human subjects and for complying with all applicable federal regulations. 

For such collaborations, MSU and partnering institutions may elect either:

  • To conduct their own IRB review within their respective jurisdictions, or
  • To establish a formal Institutional Authorization Agreement (IAA) whereby one IRB relies on the review and continuing oversight of another qualified IRB.

MSU and The University of Montana and Montana State University have an IAA covering all human subjects research under each institution's Federalwide Assurance (FWA). Notification of IRB approval is provided to the non-reviewing IRB for documentation purposes. This arrangement prevents duplicate review o the same project by both institutions.

Concurrent IRB Review

If MSU conducts IRB review concurrently with another institution’s IRB, all applicable MSU policies, procedures, and federal regulations remain in effect for MSU’s portion of the review.

For research conducted on Tribal Lands, MSU does not perform dual IRB review. Instead, MSU defers oversight to the appropriate Tribal IRB or research review body, which serves as the IRB of record for that project. Researchers must provide MSU with documentation of Tribal IRB approval (e.g., application, approval memo, or continuing review letter) via TOPAZ or to the IRB Program Manager for record keeping.

If a Tribe formally requests that MSU conduct a pre-review or serve as the reviewing IRB, this must be supported by written authorization from the Tribe (such as a council resolution, THPO letter, or ordinance).

Under 45 CFR 46.114, the Single IRB (sIRB) mandate does not supersede Tribal sovereignty; Tribal law and policy govern whether independent review is required for federally funded or cooperative projects involving Tribal Nations.

Montana State University IRB Reliance on Another IRB

MSU may rely on another appropriately constituted IRB for review of cooperative research that falls within the MSU IRB’s jurisdiction.

Research Integrity & Compliance designates the IRB Chair as the authority to determine whether reliance is appropriate and to execute Institutional Authorization Agreements (IAAs) on behalf of MSU.

In deciding whether to rely on another IRB, the IRB Chair considers:

  • Whether other institution has the capacity to meet the IRB standards of Montana State University;
  • Where human subjects research activities will occur;
  • Which institution's facilities and personnel are engaged; and
  • The capacity of the reviewing IRB to understand and apply MSU's local research context, applicable state laws, and institutional policies.

Each IAA must include:

  • The FWA numbers for both parties;
  • The project title, PI, sponsor, and scope of the agreement;
  • A clear statement identifying which party is relying and which is reviewing; and
  • Procedures for ongoing communication of IRB actions (approvals, amendments, continuing reviews, or unanticipated problems).

All executed IAAs are maintained on file by the MSU IRB Office.

Another Institution's Reliance on the Montana State University IRB

MSU may provide IRB review for another institution pursuant to a signed IAA.

In deciding whether to serve as the reviewing IRB, the IRB Chair considers:

  • Whether the other institution can meet the IRB standards of Montana State University;
  • Where human subjects activities will occur;
  • Which institution's facilities and personnel are involved; and
  • MSU's ability to remain informed about the other institution's local context, laws, and cultural considerations.

The IAA must be signed by the Institutional Official or designee for each institution and include all required elements listed above.

Records of IAAs are maintained by the MSU IRB Office.

Research Conducted at Multiple Sites and Multiple IRBs

For research conducted at more than one site where each site is engaged in human subjects research, reliance on a single IRB may or may not be required. Often, each site's IRB reviews the portion of the study conducted at its site; alternatively, the sites may execute IAAs to avoid redundant review.

  • Effective September 25, 2017: NIH-funded, domestic, multi-site human subjects research must be overseen by a single IRB, except when Tribal law or policy requires independent review.
  • Effective January 20, 2020: Under the revised Common Rule, federally supported cooperative research must likewise use a single IRB, with the same exception for Tribal IRBs.

Researchers should consult with MSU IRB during proposal development or pre-award to determine the appropriate reliance or deference arrangement.

Single IRB Review

Per 45 CFR 46.114, single IRB review is required or federally funded cooperative research unless more than one review is required by law, including Tribal law enacted by a federally recognized Tribe.

Participating organizations must hold active FWAs. For non-federally funded projects, partners may choose joint review or reciprocal reliance to avoid duplication of effort, provided protections are equivalent across sites.

Serving as IRB of Record for an Entity That Does not Have its Own IRB

MSU IRB may serve as the IRB of record for an entity that lacks its own IRB when:

  1. MSU is engaged in or funding the research;
  2. The Institutional Official or IRB Chair approves the arrangement in advance;
  3. MSU can assess the local research context appropriately; and
  4. The external entity holds or obtains an FWA if federally funded.

If these criteria are met, MSU may formalize the reliance through an IAA.

Montana State University as Coordinating Center for a Multi-Center Protocol

When MSU serves as the coordinating center for a multi-center research project, the MSU PI must ensure that each participating site either:

  • Secures IRB approval from its own IRB prior to beginning human subjects research activities, or
  • Establishes an executed IAA covering reliance on the reviewing IRB.

At the time of initial review, the MSU IRB will evaluate the project's communication plan for sharing unanticipated problems, amendments, and interim findings among participating sites.

Form Access

To establish or document reliance, complete the MSU Institutional Review Board (IRB) Authorization Agreement via DocuSign or download the form.