Use of an External IRB (Reliance)

For multi-site research with engaged external sites, arrangements may be made for institutions to rely on one another for IRB review. MSU may enter into a written agreement (Institutional Authorization Agreement (IAA) or IRB reliance agreement) to rely on an external IRB's review. The HRPP office coordinates the process to request use of an external IRB and the IRB reliance process. If use of an external IRB is permitted, the Principal Investigator is responsible for complying with the external IRB requirements and directives.

New Study Submission

The investigator submits a New Study submission through the Click(TM) Research Compliance System. See the What & How to Submit - Use of an External IRB for more information about the submission process.

Please note that an Acknowledgement Letter must be received where MSU accepts the external IRB’s approval. 

Reportable New Information to the MSU HRPP

In addition to reporting obligations with the external IRB, there is still an ongoing obligation to report the following immediately to the MSU Human Research Protection Program (HRPP):

  • Any audit (e.g. NIH or FDA)
  • Potential unanticipated problem involving risks to subjects or others (UPIRSO)
  • Potential subject complaint
  • Potential serious or continuing noncompliance with the federal regulations or the requirements or determinations of the IRB
  • Suspension or termination of IRB approval
  • Additional affiliate site(s)
  • Enrollment of prisoners
  • Potential conflicts of interest
  • Amendments to the executed contract, when appropriate
  • Change in the MSU principal investigator

Please visit the Reportable Events page to obtain more information, including reporting timelines.

External IRB Continuing Review

Please submit the external IRB’s continuing review approval letters to the MSU HRPP by updating the study through the project’s workspace.

Study Personnel

The Principal Investigator is responsible for ensuring the initial and ongoing qualifications of investigators and research staff. All individuals engaged in human subject research activities must receive and maintain current human subject training, must disclose conflict of interest in accordance with the MSU HRPP Manual 10-1, Conflict of Interest and are subject to MSU HRPP requirements, see MSU HRPP Manual 4-1, Applicability. It is the responsibility of the Principal Investigator to maintain oversight over all project personnel and to assure and to maintain appropriate tracking that these requirements are met (e.g. documentation of training completion, conflict of interest). Personnel changes should be reported to the external IRB as required by the external IRB; personnel changes do not need to be reported to the MSU HRPP unless the personnel change involves a non-MSU individual whose involvement may engage another institution in the research and/or clinical investigation with human subjects. In such instances, the change must be submitted to the MSU HRPP to determine whether the addition will impact the reliance.

Research Sites

Any research site(s) that will be engaged in research and/or clinical investigation with human subjects in addition to those initially approved with the external IRB must be submitted to the MSU HRPP to determine whether the addition will impact the reliance.

External IRB Closure

When this project is closed by the external IRB, please submit the external IRB closure letter to the MSU HRPP by updating the study through the project’s workspace.

Additional Requirements when using the National Cancer Institute Central Institutional Review Board (NCI CIRB)

Reportable Events

In addition to reporting obligations with the external IRB and those listed above, there is an additional obligation when using the NCI CIRB to report the following immediately to the MSU Human Research Protection Program (HRPP):

  • Changes to CIRB-approved MSU boilerplate text
  • Amendments to consent forms before such amendments are implemented

Informed Consent Document Revisions

The investigator must notify the MSU HRPP of any amendments to the informed consent document(s). The consent form template(s) with MSU specific information (CIRB-approved MSU boilerplate text) must be submitted by updating the study through the project’s workspace prior to use to assure that no language changes to the consent form(s) with the exception of NCI CIRB-approved boilerplate language have been made.

Research Sites

Any research site(s) in addition to those approved with the NCI CIRB must be submitted to the MSU HRPP and the MSU HRPP must then submit the site(s) to the NCI CIRB for review and approval before subjects can be enrolled at those sites.

Review Process