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Use of an External IRB (Reliance)

For multi-site non-exempt research with engaged external sites, arrangements may be made for institutions to rely on one another for IRB review. MSU may rely upon another institution’s IRB review under the SMART IRB Agreement or via an IRB Authorization Agreement (IAA). The IRB Reliance Office coordinates 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 in addition to providing any information requested by the MSU HRPP.

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.

If the MSU HRPP agrees to rely on the external IRB, a Reliance Acknowledgement Letter must be received before MSU becomes engaged in research with human subjects. 

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 to the MSU 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

  • Change in MSU principal investigator

  • Additional non-MSU research site(s) or non-MSU personnel in some circumstances

  • Enrollment of prisoners

  • Potential conflicts of interest for MSU investigators or research staff

  • Changes in funding (e.g. contract amendments, new or additional funding)

  • New consent form(s) or changes to approved consent forms that impact MSU local context consent language

Please visit HRPP Manual 8-11, External IRB Submissions, for more information on reporting. 

External IRB Continuing Review

The IRB Reliance Office will follow-up via email or through Click with the MSU PI to confirm the status of the study and whether there is continued IRB oversight and approval by the external IRB for MSU’s involvement.

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 that involve MSU individuals conducting the research, the MSU principal investigator, or non-MSU individuals whose involvement could impact MSU need to be reported to the MSU HRPP.

Research Sites

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

External IRB Closure

When the project is closed by the external IRB, the external IRB closure letter must be submitted to the MSU HRPP.

More Information

Please visit HRPP Manual 8-11, External IRB Submissions, for more information. 

Review Process