Vice President for Research & Creative Scholarship
Vice President for Research & Creative Scholarship
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.
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.
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) has the sole authority to make the decision whether or not to rely on another IRB. The IO is authorized to execute Institutional Authorization Agreements (IAAs) on 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 shall consider the following criteria:
The IRB Authorization Agreement (IAA) must set forth 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 and IO.
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.
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 shall consider the following criteria:
The UM IRB Chair shall ensure that any required Authorization Agreement is appropriately signed by the lOs for both institutions involved, and that OHRP and any other appropriate governmental agencies are appropriately notified of reliance arrangements.
The IRB Authorization Agreement (IAA) must set forth 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 and IO.
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.
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 is not required. Frequently each site's IRB will review the protocol for the Research to be conducted at its site.
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.
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 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.
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
Office of the Vice President
Research & Creative Scholarship
University Hall 116
Fax: (406) 243-6330