When researchers plan to participate in a collaborative or multi-site study, which IRB (or IRBs) should complete an ethical and regulatory review depends on several factors, including:

  • funding agency requirements; 
  • the level of IRB oversight needed based on potential risk to participants;
  • the nature of human participant research to be conducted by each institution; and
  • which other institution(s) IRB's are involved, and what their internal processes and policies require in such cases. 
One IRB Reviews

In some situations, to avoid duplicative reviews and increase efficiencies, the JMU IRB will consider acting as the IRB of record or ceding IRB review to another institution's IRB. The IRB at each participating site will need to formally cede their IRB review to the reviewing IRB using a fully-executed authorization agreement, sometimes called a reliance agreement.

An IRB Authorization Agreement is a document permitting one institution's IRB to cede review (the “Relying IRB”) to another institution's IRB (the “IRB of Record”) for a particular study involving human participants. In this way, only one IRB reviews and approves human subject research activities for both institutions, avoiding duplicative review and regulatory oversight.

Single IRB Review

A Single IRB (sIRB) is the IRB of record, selected on a study-by-study basis, which provides the ethical review and related administrative coordination for all sites participating in a multi-site study and assumes responsibility for all human participant research compliance.

Under the revised (2018) Common Rule, federally-funded multi-institution studies, with very few exceptions, are required to use an sIRB for review and approval of cooperative studies conducted in the United States. This applies to all cooperative research applications and contract proposals submitted on or after January 20, 2020. 

For NIH studies, a version of the sIRB requirement has been in effect since January 2018. NIH-funded multi-site studies involving non-exempt research must use an sIRB, when the same protocol is used at multiple domestic study sites.

The JMU IRB is currently not equipped to serve as the sIRB, but will comply with the requirements for a participating IRB when another institution serves as the IRB of record.

When JMU is the IRB of Record

When JMU will serve as the lead or coorindating institution for an Expedited or Full Board study, the PI will need to submit a protocol through the electronic Research Administration (eRA) software system and select "IRB Authorization Agreement" on the General Checklist. Once IRB approval is obtained, ORI will work with the other institution's IRB to negotiate and execute the agreement.

When JMU is NOT the IRB of Record

When JMU will rely on another institution to oversee a study, the JMU PI will need to submit a protocol through the eRA software system and select "Request to Rely on Another IRB" on the General Checklist. The majority of the protocol form will then gray out. In the Attachments section, upload the following documents:

  • The approved protocol submitted to the IRB of Record;
  • The IRB approval letter for the project from the IRB of Record;
  • All study materials (recruitment, consent form, interview questions, all study instruments) submitted as part of the application to the IRB of Record;
  • Name and email address for a contact at the IRB of Record (the person who will help set up an IRB authorization/reliance agreement); and
  • If available, the authorization/reliance agreement template from the IRB of Record

ORI will work with the other institution's IRB to negotiate and execute the IAA agreement.

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