» Single IRB Reviews

Facilitating IRB approval for collaborative studies

Many institutions are working to reduce duplicative effort and the administrative burden associated with carrying out human participant studies by relying on one Institutional Review Board (IRB) to review and approve studies when multiple sites are involved.  This is called the single IRB (sIRB) approach and is required by some federal sponsors.  Chapman also applies this approach more widely for non-federal projects when Chapman and collaborating institutions agree that one IRB review is sufficient to approve the study and protect the rights and welfare of human participants.

sIRB reviews may be appropriate when:

  • Chapman and at least one other institution are engaged in the research (see details about “engagement” below)
  • An institution holds the primary funding for a project that includes subawards, and the parties agree that one institution will take the lead in reviewing the human participant research
  • The Chapman principal investigator (PI) has adequate resources to support the compliant conduct of a multi-site study
  • The collaborating institution has a Federal Wide Assurance (FWA) in good standing with the Office of Human Research Protections and has the policies and procedures in place to oversee and take responsibility for oversight of the research
  • The study is permitted under Chapman's Human Research Protection Program
  • The study undergoes either expedited or full board review (sIRB is not used for exempt studies)
  • The institutions agree to the terms of a reliance agreement, also known as an IRB authorization agreement

Chapman's researchers are responsible for following the instructions below for requesting approval for either Chapman or another qualified institution to be the IRB of record.

It's important to note that while sIRB reviews help avoid duplicate IRB reviews, it does not change the investigator's or Chapman's responsibilities for oversight of the research where Chapman personnel and students are performing human participant research. Therefore, Chapman and not its investigators will make the final determination about sIRB reviews.

When are multiple institutions "engaged" in research?

An institution is engaged in the research when an individual or individuals affiliated with the institution will obtain:

  • data about participants through intervention or interaction, or manipulation of the participants’ environment, or
  • for research purposes, identifiable private information or identifiable biological specimens from any source, or
  • informed consent from human participants for the research.

Note: If an individual only shares IRB-approved recruitment materials (such as handing out a flyer or forwarding an email) and will not answer questions about the study or obtain informed consent, they are not engaged in the research. In addition, if an individual is only receiving de-identified data and will not have a way to re-identify that data (e.g., through access to a code key or via indirect identifiers), they are also not considered to be engaged in research.

Submission Processes

When Chapman relies on an external IRB

The Chapman IRB must first review the project based on the criteria for when a Single IRB is appropriate above to determine whether to rely on another institution's IRB. To begin the process:

  1. Log into Cayuse IRB and begin a new initial submission. On the first page, choose "Continue with a request to participate in a study approved by an external IRB." 
  2. It is the PI's responsibility to provide the following information in Cayuse:
  • A list of Chapman personnel "engaged in research" and their latest training credentials
  • Information about potential conflicts of interest related to Chapman researchers
  • Funding information
  • Lead PI on the study at the external institution and the IRB point of contact (if known). If this is not known, the OOR will contact the external institution’s IRB office.
  • A copy of the approved protocol and consent forms, including Chapman's consent forms if Chapman will be consenting research participants, and a copy of the IRB approval letter from the external IRB.
  1. Submit the research in Cayuse IRB for review.

The OOR will review the information to determine if the Chapman IRB will rely on another institution to be the IRB of record.  If so, the OOR will contact the IRB of record to execute a reliance agreement. If not, the OOR will inform the PI of the decision and why it was not approved.

 

Note: Chapman researchers may not begin working on the project until the reliance agreement is finalized, and the OOR issues a formal IRB acknowledgment letter.

When external institutions rely on Chapman’s IRB

The Chapman IRB must first review the project based on the criteria for when a Single IRB is appropriate to determine whether it should act as the IRB of record.

There are two ways to request that another institution rely on Chapman as the IRB of record – at the time of the initial submission of the research or through a modification if the Chapman IRB has already approved the study.

1. Adding a relying institution to a new study (note that the Chapman IRB will not approve the study and research may not commence until Chapman and all participating institutions sign a reliance agreement). This approach is most appropriate when the project depends on Chapman and the relying institution to initiate the study at the same time.

  • Log in to Cayuse IRB and complete the initial submission as usual. When prompted, choose "Other Researchers Not Affiliated with Chapman” in Section 2: Personnel.
  • Provide the following information:
    • The name of the external institution engaged in the research
    • The name and email of the primary contact of the external institution’s IRB
    • The name and email of the PI of the external institution
    • The role of external investigators in the study
    • The Local Context Form from the external institution
  • OOR will review the information to determine if the Chapman IRB can act as the IRB of record. If it is determined that Chapman IRB will be the IRB of record, OOR will contact the institution to execute a reliance agreement.  If the request is not approved, OOR will inform the PI of the decision and why the request was not approved.

2. Adding a relying institution to an IRB-approved Chapman study

  • Log in to Cayuse IRB and start the Modification
  • Provide the following information in Cayuse IRB:
    • The name of the external institution engaged in research
    • The name and email of the primary contact of the external institution’s IRB
    • The name and email of the PI of the external institution
    • The role of external investigators in the study
    • The Local Context Form from the external institution
  • OOR will review the information to determine if the Chapman IRB can act as the IRB of record. If it is determined that Chapman IRB will be the IRB of record, OOR will contact the institution to execute a reliance agreement. If the request is not approved, OOR will inform the PI of the IRB’s decision and why the request was not approved.

Executing a reliance agreement

The Office of Research (OOR) will lead the process for Chapman to enter a reliance agreement that outlines the roles and responsibilities of each institution in the study.  Chapman uses a template agreement that research institutions generally accept.  OOR will work with the Chapman PI throughout the process and communicate any concerns or issues with the PI until the agreement is fully executed.  Once the agreement has been fully executed, the initial submission or the modification will be approved in Cayuse IRB, and the OOR will issue formal approval of the research. 

Chapman regularly collaborates with the following institutions:

Institution

Point of Contact

University of California, Irvine

 

Children’s Hospital of California

 

City of Hope

 

Reminder: Chapman and PIs have the same responsibilities for overseeing studies and notifying the IRB of issues whether or not a reliance agreement is involved.  Further, Chapman may be responsible for informing a relying institution of issues as well, so be sure to notify the IRB of any issues. 

Moreover, once a reliance agreement has been approved, Chapman researchers are responsible for initiating modifications for any changes in the project (e.g., changes in Chapman personnel) following the usual IRB process.

How long will it take?

Reliance agreements can be executed relatively quickly (about two weeks) for minimal risk studies with a partner that Chapman works with regularly, or they can take up to two months for complex studies or new relying institutions.  PIs are urged to build in additional time for this process to allow for unanticipated delays.

Definitions

  • IRB of record: The IRB responsible for the ethical review of human research on behalf of an institution or site, or individual investigator.
  • Office of Research (OOR): Chapman's Office of Research
  • Reliance agreement: An agreement executed by Chapman and one or more other parties to rely on another institution's ethical review of a human participant study
  • Relying institution: An institution that has agreed to cede review to an external IRB for a particular study

Frequently Asked Questions

  1. What’s the policy when Chapman researchers are the only participants in a study approved at an external institution, and they have an appointment at the external institution (e.g., they have an unpaid collaboration appointment)? Does the single IRB process apply?

If the faculty PI’s primary appointment is at Chaman, or if anyone at Chapman is involved in the study as a participant or researcher (e.g., other faculty PIs, students, postdocs), then the study should also be reviewed by Chapman.  Use the process for relying on another institution’s IRB.

  1. What if a researcher has part-time appointments or joint appointments at both institutions in a research study? At which institution should the person be listed?

The part-time employee should rely on the IRB at their primary employer (where there is a greater level of effort or a more senior role).  Chapman’s IRB would still be responsible for reviewing the study when its employees or students are involved.  This is true whether or not Chapman is the lead IRB.