Reliance Arrangements for IRB Review
University of Montana IRB Relationships with Other Institutions: Effective May 13, 2011
The University of Montana 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, the University of Montana and the other institutions may choose to provide concurrent review within their own jurisdictions. Alternatively, the University of Montana 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 University of Montana 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 University of Montana 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 University of Montana's review just as they would in non-collaborative Research IRB reviews.
University of Montana IRB Reliance on Another IRB
With regard to any cooperative Research projects that fall within the jurisdiction of the UM IRB, the University of Montana 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 University of Montana's behalf and may delegate this authority, provided the delegation of authority is recorded in writing. The IO has delegated this authority to the University of Montana 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 University of Montana standards. If the other IRB is part of an AAHRPP-accredited HRPP, then it will be presumed that the University of Montana 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 University of Montana local research context and applicable laws and regulations.
The IRB Authorization Agreement (IAA) must set forth the University of Montana'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 University of Montana IRB.
When the University of Montana 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 University of Montana IRB
The University of Montana 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 University of Montana Human Research Protection Program (HRPP). Where the Human Subjects Research activities would take place.
- Which institution's facilities and personnel would be involved.
- The University of Montana'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.
The IRB Authorization Agreement (IAA) must set forth the University of Montana'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 University of Montana 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: 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.
University of Montana Engaged in Research at Another Site Whose Personnel Is Not Engaged
Occasionally, the University of Montana may conduct Research at a non-University of Montana site that has an IRB and FWA, but personnel at that site are not Engaged in the Research. In such cases, the University of Montana PI must provide the UM IRB documentation from the non-University of Montana IRB to the effect that its approval is not required. University of Montana should also require evidence of permission granted by the other institution to the University of Montana 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 University of Montana 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.
University of Montana as Coordinating Center for a Multi-Center Protocol
When University of Montana serves as the coordinating center for a multi-center Human Subjects Research protocol, the UM IRB will require the University of Montana 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 Authorization Agreements have been entered into by all sites. At the time of initial review of the protocol, the UM 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.
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