Montana State University (MSU) works with other institutions on collaborative research. Depending on the study, each institution may conduct its own IRB review, or one qualified IRB may review on behalf of another institution through a reliance arrangement.

When reliance is used, the Reviewing IRB is responsible for IRB review and oversight of the ceded study activities. The relying institution remains responsible for its local requirements, including institutional policies, applicable law, ancillary reviews, conflicts of interest, training, and any site-specific information needed for review. 

MSU may rely on another qualified IRB, and MSU may also serve as the Reviewing IRB for another institution when appropriate. MSU coordinates reliance arrangements through the IRB Office and uses standard documentation to support consistency across studies when possible. All reliance arrangements are documented and maintained by the MSU IRB Office.

Collaborative Research Oversight

Collaborative research may be reviewed in different ways depending on the institutions involved, the nature of the study, and whether a reliance arrangement is appropriate or required. The below outlines common oversight scenarios, MSU's role in each, the role of the partner institution, and the documentation typically used to support the arrangement. 

  • IRB of Record - MSU IRB
  • MSU Role - Conducts review and oversight under standard MSU procedures
  • Partner Institution Role - Not applicable
  • MSU Documentation - Standard MSU IRB submission

  • IRB of Record - Each institution's own IRB
  • MSU Role - Review's MSU's portion only
  • Partner Institution Role - Reviews its own portion only
  • MSU Documentation - Separate IRB approvals; no reliance documentation unless otherwise needed

  • IRB of Record - External reviewing IRB
  • MSU Role - Cedes IRB review
  • Partner Institution Role - Serves as Reviewing IRB and conducts review and oversight
  • MSU Documentation - Reviewing IRB Institutional Information Form as applicable and the external Reviewing IRB's required reliance/local context documentation, if any; SMART or non-SMART reliance documentation, as applicable

  • IRB of Record - MSU IRB
  • MSU Role - Serves as reviewing IRB and conducts review and oversight
  • Partner Institution Role - Cedes review; completes MSU's Reliance Agreement Packet
  • MSU Documentation - MSU Reliance Agreement Packet; SMART or non-SMART reliance documentation, as applicable

  • IRB of Record - One Reviewing IRB
  • MSU Role - Either serves as Reviewing IRB or relies on the designated Reviewing IRB, depending on the arrangement
  • Partner Institution Role - Same
  • MSU Documentation - Same as reliance pathways above (External rely on MSU/MSU rely on External); SMART or non-SMART reliance documentation, as applicable

  • IRB of Record - Tribal IRB or Tribal research review body, unless otherwise requested by the Tribe
  • MSU Role - Defers to Tribal review and maintains institutional documentation; does not conduct dual review unless expressly requested in writing by the Tribal entity; 
  • Partner Institution Role - Follows Tribal review requirements
  • MSU Documentation - Tribal approval or other Tribal documentation; MSU internal documentation, as needed (including Reliance Agreement execution as applicable)

  • IRB of Record - MSU IRB, if MSU accepts
  • MSU Role - May serve as IRB of record when appropriate and when sufficient local context can be obtained
  • Partner Institution Role - Provides institutional/local context and follows MSU oversight requirements; submits MSU IRB protocol
  • MSU Documentation - MSU IRB protocol submission via TOPAZ

Additional Information

When Is Another Institution Considered Engaged in Research?

Whether an institution is engaged in the research may affect the oversight arrangement and documentation needed for the study. In general, an institution is considered engaged in human subjects research when its employees or agents obtain data through intervention or interaction with participants, obtain identifiable private information or identifiable specimens for the research, or obtain informed consent for the research. 

An institution may not be engaged in some situations, such as when its role is limited to informing prospective subjects about a study, providing contact information for investigators, permitting use of its facilities, or performing certain routine services under the conditions described in OHRP guidance. Questions about whether an institution is engaged should be directed to the MSU IRB Office for determination. 

Standard Reliance Forms

MSU uses standard reliance documentation across studies when possible to support a more consistent process. In most cases, this includes a local context supplement and communication plan. Depending on the study, additional documentation may also be needed to document the reliance arrangement or provide institutional context.

Forms and Related Materials

Reviewing IRB Institutional Information Form (MSU Relying on External IRB)

MSU Reliance Packet (External Institution IRB Relying on MSU)

SMART IRB

When all participating institutions are part of SMART IRB, the reliance arrangement may be documented through the SMART IRB Online Reliance System or other SMART study-specific documentation, as applicable. MSU may still use its own standard forms, such as the Reviewing IRB Institutional Information Form, to support internal consistency and recordkeeping.

SMART IRB Resources

SMART IRB Reliance System

SMART IRB Study-Specific Template

Non-SMART Reliance Arrangements

When a study is not being handled through SMART IRB, MSU uses comparable institutional documentation to capture the same core information. This may include an MSU reliance acknowledgment, local context information, communication planning, and any other documentation needed to support the arrangement.

Reviewing IRB Institutional Information Form

Local context information helps ensure that the Reviewing IRB has the information needed to appropriately review the study for the relying site. Depending on the arrangement, this may include institutional requirements, applicable law or policy, ancillary reviews, conflict of interest information, training or qualifications, site-specific consent language, and local, community, or cultural considerations.

When MSU relies on another institution's IRB, MSU provides its local context information to that Reviewing IRB. When another institution relies on MSU, MSU obtains local context information from that institution through a supplement, equivalent institutional documentation, institutional profile, or other written communication maintained in the study record.

Communication Plans

For reliance studies, MSU expects the institutions involved to document how key communications will occur during the life of the study. At minimum, this should address approvals, amendments, reportable events, continuing review when applicable, consent changes, local context updates, and study closure.

Questions

Questions about collaborative research oversight, reliance arrangements, external IRB review, or reliance documentation should be directed to the MSU IRB Office - IRB@montana.edu.