Chapter 5: Institutional Authorization Agreements/Reliance Agreements

Aerial view of the 91��Ԫ campus and buildings around UM's Oval in Missoula, MT.

Research Compliance and Tech Transfer

Chapter 5: Institutional Authorization Agreements/Reliance Agreements

All U.S. institutions engaged in cooperative research conducted or supported by a Common Rule (part 45 CFR 46.114) agency are required to rely upon approval by a single Institutional Review Board (IRB) for the portion of the research conducted in the United States.

A Reliance Agreement (also called an Institutional Authorization Agreement, or IAA) is an agreement signed by two or more institutions engaged in the same human subjects research project. The Agreement permits one or more institutions to cede review to another central, or single, Institutional Review Board (IRB). This means that only one IRB will maintain primary oversight over a single project for several collaborators across institutions.

The National Institutes of Health (NIH) also have their own Single IRB policy. This policy applies to any NIH-funded or -supported non-exempt human subjects research study being conducted cooperatively and/or at more than one U.S. site. Please note that as of January 20, 2020, studies that are not subject to the NIH single IRB policy - such as domestic, multi-site, career development (K), fellowship (F) awards, and Other Transaction (OT) awards – must still use a single IRB as required by the provisions in 45 CFR 46.114(b).

The 91��Ԫ IRB will not enter into reliance agreements for Exempt-level research. In such cases, all collaborating investigators are responsible for applying to their own institution’s IRB. Reliance Agreements will be put in place for Expedited and Full Board-reviewed studies.

A Reliance Agreement is needed if your study is Expedited or Full Board-reviewed AND one of the following is true:

You are a Principal Investigator (PI) on a human subjects research project reviewed at the 91��Ԫ, and you plan to have non-UM colleagues engaged in the project as well or,
You are a UM researcher and you will be an investigator on a human subjects research project, but the PI is at another institution.

Cooperative research for which more than a single IRB review is required by law, including tribal law, is not subject to the Single IRB provision.

1. Current Reliance Agreements

The 91��Ԫ 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.

The 91��Ԫ and Salish Kootenai College (SKC) have an Independent Authorization Agreement for all research with human subjects covered by SKC’s Federal-wide Assurance. Any research approved by the SKC IRB is generally approved by the UM IRB. Notification via a copy of the approval documents, including a copy of the application and any approval letters, should be submitted to the UM IRB.

If the 91��Ԫ provides IRB review of research concurrently with the collaborative institution’s IRB, all the policies and procedures, rules, regulations, and laws described in this document shall apply to 91��Ԫ's review just as they would in non-collaborative research IRB reviews.

2. UM IRB Reliance on Another IRB

Regarding any cooperative research projects that fall within the jurisdiction of the UM IRB, the 91��Ԫ 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 IAAs on the 91��Ԫ's behalf and may delegate this authority, provided the delegation of authority is recorded in writing.

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

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

The IAA must contain the 91��Ԫ's Federal Wide Assurance (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��Ԫ IRB and IO.

When the 91��Ԫ relies on another IRB for review, the UM IRB office 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.

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

3. UM IRB Serving as the IRB of Record

The 91��Ԫ 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 office shall consider the following criteria:

Whether other institution has the capacity to meet the standards of the University of Montana’s 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��Ԫ's capacity to be sufficiently informed about the other institution's local research context and local applicable laws and rules.

The IAA must set forth the 91��Ԫ'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 91��Ԫ 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.

4. 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 is not required. Frequently each site's IRB will review the protocol for the research to be conducted at its site.

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.

5. UM Engaged in Research at Another Site Whose Personnel is Not Engaged

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

6. UM Serving as IRB of Record for 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��Ԫ is involved in the conduct of or funding of the human subjects research at the entity; (b) the IO or 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 appropriate criteria are met, then the UM IRB may enter into an appropriate IAA.

7. UM IRB as Coordinating Center for a Multi-Center Protocol

When the 91��Ԫ serves as the coordinating center for a multi-center human subjects research protocol, the UM IRB will require the 91��Ԫ 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, protocol modifications, interim findings, etc.) to all participating sites.