91´ÎÔª

91´ÎÔª IRB Relationships with Other Institutions:  Effective May 13, 2011

The 91´ÎÔª acknowledges that each institution that is  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, the 91´ÎÔª and the other institutions may choose to provide concurrent review within their own jurisdictions. Alternatively, the 91´ÎÔª IRB (UM IRB) may enter into a written agreement per which the UM IRB relies on the review of another qualified IRB or vice versa.

The 91´ÎÔª and Montana State University have an Independent Authorization Agreement for all research with human subjects covered by the respective university’s Federal Wide Assurance. 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 UM IRB and Montana State University IRB.

Concurrent IRB Review

If the 91´ÎÔª provides IRB review of Research concurrently with the IRB review of the collaborative institutions' IRBs, all of the policies and procedures (P&Ps), rules, regulations, and laws described in these P&Ps shall apply to 91´ÎÔª's review just as they would in non-collaborative Research IRB reviews.

91´ÎÔª IRB Reliance on Another IRB

With regard to any cooperative Research projects that fall within the jurisdiction of the UM IRB, the 91´ÎÔª may rely on another appropriately constituted IRB for the review of the Research.

The Institutional Official (IO) or designee has the authority to make the decision whether or not to rely on another IRB. The IO/designee is authorized to execute Institutional Authorization Agreements  (IAAs) on the 91´ÎÔª's behalf and may delegate this authority, provided the delegation of authority is recorded in writing. The IO has delegated this authority to the 91´ÎÔª IRB Chair.

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

• Whether other IRB's policies and procedures meet 91´ÎÔª standards. If the other IRB is part of an AAHRPP-accredited HRPP, then it will be presumed that the 91´ÎÔª standards are being met; however, accredited status does not in itself necessarily suffice as a basis for the IO/IRB Chair's decision.
• Where the Human Subjects Research activities 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 the 91´ÎÔª local research context and applicable laws and regulations.

The UM IRB Chair shall ensure that any required Authorization Agreement is appropriately signed by the lO/designee for each institution involved.  No research may begin with human subjects until the Authorization Agreement is fully executed (signed and received by each IRB).

The IRB Authorization Agreement (IAA) must set forth the 91´ÎÔª'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 Human Subjects Research 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 should be included in an appropriate template for use by the 91´ÎÔª IRB.

When the 91´ÎÔª relies on another IRB for review, the UM IRB Chair shall ensure that a periodic assessment is done of the reviewing IRB's actions to ensure appropriate oversight, including sensitivity to the UM IRB's local Research context.

Records of the IAAs shall be kept by the UM IRB Office.

Another Institution's Reliance on The 91´ÎÔª IRB

The 91´ÎÔª 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 IO/IRB Chair shall consider the following criteria:

• Whether other institution has the capacity to meet the standards of the 91´ÎÔª Human Research Protection Program (HRPP). Where the Human Subjects Research activities would take place.
• Which institution's facilities and personnel would be involved.
• The 91´ÎÔª's capacity to be sufficiently informed about the other institution's local research context and local applicable laws and rules.

The UM IRB Chair shall ensure that any required Authorization Agreement is appropriately signed by the lO/designee for each institution involved. No research may begin with human subjects until the Authorization Agreement is fully executed (signed and received by each IRB).

The IRB Authorization Agreement (IAA) must set forth the 91´ÎÔª'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 Human Subjects Research 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 should be included in an appropriate template for use by the UM IRB.

The 91´ÎÔª shall facilitate communication with the relying institution about UM IRB actions on the Human Subjects Research that is subject to the IAA, in accordance with its specific provisions.

Records of IAAs shall be kept by the UM 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: -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.

91´ÎÔª Engaged in Research at Another Site Whose Personnel Is Not Engaged

Occasionally, the 91´ÎÔª may conduct Research at a non-91´ÎÔª site that has an IRB and FWA, but personnel at that site are not Engaged in the Research. In such cases, the 91´ÎÔª PI must provide the UM IRB documentation from the non-91´ÎÔª IRB to the effect that its approval is not required. 91´ÎÔª should also require evidence of permission granted by the other institution to the 91´ÎÔª investigators to conduct the Research at their site.

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

The UM IRB may serve as the IRB of record for an entity that does not have its own IRB if (a) the 91´ÎÔª 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 UM 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 UM IRB may enter into an appropriate IRB Authorization Agreement.

91´ÎÔª as Coordinating Center for a Multi-Center Protocol

Due to resource limitations, the 91´ÎÔª IRB will not serve as the coordinating center for a multi-center or multi-site project involving human subjects.

Industry-sponsored projects must be reviewed by an independent IRB

• “Industry” includes pharmaceutical companies and other for-profit businesses, which may include spin-off companies from the 91´ÎÔª.
• Examples of independent IRBs include:  and .
• Such projects still must be “registered” with the UM IRB, a UM protocol number assigned, and an IRB Authorization Agreement established (in which oversight is ceded to the independent IRB).  Contact the UM IRB for further instructions.

Applicable Regulations

45 CFR Part 46, including 45 CFR §§ 46.IO2(f); 46.IO3(b)(1)-(2); 46.IO9; 46.111; & 46.112. 21 CFR Parts 50 and 56, including 21 CFR §§ 56.IO9; 56.111 & 56.112. 38 CFR Part 16, including 38 CFR §§ 16.IO29f); 16.IO3(b)(1) — (2); 16.IO9; 16.111; & 16.112