Montana State University Relationships with Other Institutions

Montana State University acknowledges that each institution that is engaged in multi-institutional, collaborative research is responsible for safeguarding the rights and welfare of human subjects and for complying with applicable federal regulations. With respect to such collaborative research, Montana State University and the collaborating institutions may choose to provide concurrent review within their own jurisdictions. Alternatively, the Montana State University IRB (MSU IRB) may enter into a written institutional authorization (IAA) agreement whereby the MSU IRB relies on the review of another qualified IRB or vice versa.

Montana State University and The University of Montana and Montana State University have an IAA for all research with human subjects covered by the respective university’s Federal Wide Assurances. Notification via a copy of the approval memo to the PI from the IRB is sent to the non-reviewing IRB.  This relieves a PI from having a proposal reviewed by both the MSU IRB and The University of Montana IRB.

Concurrent IRB Review

If Montana State University provides IRB review of research concurrently with the IRB review of the collaborative institutions' IRBs, all of the policies and procedures, rules, regulations, and laws described in these policies and procedures shall apply to Montana State University's review just as they would in non-collaborative research IRB reviews.

For research on Tribal Lands, the MSU IRB will review protocols concurrently with the Tribal IRB review, which is the standard procedure requested for research on Tribal Lands.  In addition, MSU IRB will defer to the Tribal IRB for oversight of projects on Tribal Lands, and the Tribal IRB will serve as the single IRB of record in multi-site projects on Tribal Lands.

Montana State University IRB Reliance on Another IRB

With regard to any cooperative research projects that fall within the jurisdiction of the MSU IRB, Montana State University may rely on another appropriately constituted IRB for review of the research.

The Office of Research Compliance has designated the IRB Chair with authority to make the decision whether or not to rely on another IRB. The IRB Chair is authorized to execute Institutional Authorization Agreements (IAAs) on Montana State University’s behalf.

In deciding whether or not to rely on another IRB, the IRB Chair shall consider the following criteria:

  • Whether other IRB's policies and procedures meet Montana State University standards.
  • Where the human subjects researchactivities would take place. 
  • Which institution's facilities and personnel would be involved.
  • The capacity of the other institution and its IRB to sufficiently to be informed about Montana State University’s local research context and applicable laws and regulations.

The MSU IRB Chair shall ensure that any required IAA is appropriately signed by the IO/designee for each institution involved.

The IAA must set forth Montana State University's FWA number and, for research subject to federal regulations, the FWA of the other party to the Agreement. The IAA should identify by title, respective Pls, sponsorship and the scope of the IAA. The IAA should clearly state which party is relying on the other for IRB review, and how the relying party will be kept informed of the reviewing IRB's actions. Further details are included in the MSU IRB-approved template posted on the website.

Records of the IAAs shall be kept on file by the MSU IRB Office.

Another Institution's Reliance on the Montana State University IRB

Montana State University may provide IRB review of human subjects research for another institution pursuant to a signed IAA.

In deciding whether or not to provide IRB review for another institution, the IRB Chair shall consider the following criteria:

  • Whether other institution has the capacity to meet the standards of the Montana State University Human Research Protection Program (HRPP).
  • Where the human subjects researchactivities would take place.
  • Which institution's facilities and personnel would be involved.
  • Montana State University's capacity to be sufficiently informed about the other institution's local research context and local applicable laws and rules.

The MSU IRB Chair shall ensure that any required Authorization Agreement is appropriately signed by the lO/designee for each institution involved.

The IAA must set forth Montana State University's FWA number and, for Research subject to federal regulations, the FWA of the other party to the Agreement. The IAA should identify by title respective Pls, sponsorship, and the scope of the IAA. The IAA should clearly state which party is relying on the other for IRB review, and how the relying party will be kept informed of the reviewing IRB's actions.

Records of IAAs shall be kept on file by the MSU IRB Office.

Research Conducted at Multiple Sites and Multiple IRBs

For research that takes place at more than one site in which all of the sites are engaged in research, reliance by one IRB on another may or may not required. Frequently, each site's IRB will review the protocol for the research to be conducted at its site.  Unfunded research may be overseen by the IRB at each site, or they may enter into an IAA.

Effective September 25, 2017: NIH-funded multi-site, domestic, human subjects research must be overseen by a single IRB, with the exception of Tribal IRBs. Researchers should consult their IRB during the grant application process.

Effective January 20, 2020: Common Rule Agency-funded multi-site, domestic, human subjects research must be overseen by a single IRB, with the exception of Tribal IRBs. Researchers should consult their IRB during the grant application process.

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

The MSU IRB may serve as the IRB of record for an entity that does not have its own IRB if (a) Montana State University is involved in the conduct of or funding of the human subjects research at the entity; (b) the IO/IRB Chair approves of the arrangement in advance; (c) the MSU IRB can develop appropriate means by which to consider the local context of the research; and (d) if the research involved is being supported by a federal agency, and the entity is engaged in research, then the entity must have an appropriate FWA in effect. If the foregoing criteria are met, then the MSU IRB may enter into an appropriate IAA.

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

When Montana State University serves as the coordinating center for a multi-center human subjects research protocol, the MSU IRB will require the MSU PI to ensure that IRB approval has been obtained from the IRB at each participating site prior to the initiation of human subjects research at that site or, alternatively, that appropriate IAAs have been entered into by all sites. At the time of initial review of the protocol, the MSU IRB will assess the procedures for dissemination of protocol information (e.g., unanticipated problems involving risks to participants or others, protocol modifications, interim findings, etc.) to all participating sites.

This is the form you will need to complete and gather signatures on in order to work with another institution.

Name of Institution or Organization Providing IRB Review 

 

08/01/2018