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Children's Hospital of Orange County (CHOC), MemorialCare Health System (MHS) and UC Irvine (UCI) - CMU IRB Reliance

What is the CMU IRB Reliance?

Children's Hospital of Orange County (CHOC), MemorialCare Health System (MHS) and UC Irvine (UCI), have established an IRB Reliance agreement that allows human subjects research to be reviewed by a single IRB rather than submitting for IRB approval at each institution where the research will take place. This agreement is intended to simplify and streamline the IRB review process by facilitating single-IRB review. The agreement is referred to as the CMU IRB Reliance (pronounced SEE-MOO). This agreement only applies to IRB review; it does not affect other institutional reviews required by each institution (e.g., feasibility, conflict of interest, radiation safety, etc.).

Terms to Know:

An IRB Reliance Agreement is a formal, written agreement that documents the mechanism by which institutions engaged in human subjects research delegate IRB review to another institution’s IRB. These agreements are also called Trust and Rely IRB agreements.

Reviewing IRB is the IRB of Record. This IRB conducts initial and continuing review of the research, as well as reviews any amendments/modifications to the approved research and any unanticipated problems that may arise during the conduct of the research. The Reviewing IRB has the authority to suspend or terminate research for failure to comply with conditions of approval or regulatory requirements. The Reviewing IRB will notify the applicable federal agencies of these events consistent with the IRB’s policies and procedures in cooperation with the Relying IRB, as applicable. The IRB may refuse, on a case-by-case basis, to serve as the Reviewing IRB.

Relying IRB will rely on the Reviewing IRB for review of the research. The Relying IRB will work with the Reviewing IRB when unanticipated problems and instances of noncompliance occur at the Relying IRB’s institution. The Relying IRB may refuse, on a case-by-case basis, to rely on the review of another IRB.

The Project Principal Investigator or ‘PPI’ is the primary individual responsible for submission of required applications and reports to the Reviewing IRB. The PPI is responsible for communicating with relying investigators at other sites to assure coordination of research activities and promote compliance of research with applicable regulations including those of the Reviewing IRB. Generally, the PPI is the prime awardee of study funding.

The Relying Investigator or ‘RI’ is the Principal Investigator or Lead Researcher (LR) at the Relying institution. The RI is responsible for completing any forms as required by the Relying IRB to register the research at the Relying Institution and to report any amendments/modifications and continuing review information to the PPI for submission to the Reviewing IRB. The RI is also responsible for reporting any unanticipated problems, including safety information, violations, audits and inspections to the PPI for reporting to the Reviewing IRB.

Determining the Reviewing IRB

Consider the following criteria to determine which site should serve as the Reviewing IRB: [Click here for a flowchart of this criteria]

1. Do all research procedures substantially or entirely take place at one site?

  •     IF YES: The reviewing IRB is the institution where the research will take place.
  •     IF NO: Continue to # 2.

2. Is the research funded?

  •     IF YES: The reviewing IRB is the prime awardee institution.
  •     IF NO: Continue to # 3.

3. Does the study have a PPI?

  •     IF YES: The reviewing IRB is the PPI's primary institution. 

NOTE: If the research collaboration does not meet any of the above criteria, the HRP/IRB Directors at the applicable institutions will determine the Reviewing IRB by mutual agreement.

EXAMPLES:
  1. UCI is the prime awardee on a contract. The research takes place at CHOC, MHS and UCI. UCI IRB is the Reviewing IRB.
  2. The research is a collaboration between CHOC and MHS investigators. The PPI is a MHS investigator. MHS IRB is the Reviewing IRB.
  3. UCI is the prime awardee on a NIH award; however all research activites take place at CHOC. CHOC IRB is the Reviewing IRB.

The CMU IRB Reliance Submission and Review Process

A new CMU IRB Reliance request may be submitted during the initial IRB review of a study or it may be submitted as an amendment/modification to an IRB-approved study. Review the flowchart below for an overview.

Flowchart- IRB Submission and Review Process

Pre-Submission Steps

PPI Responsibilities:

  1. Reviews the CMU IRB Reliance webpage.
  2. Makes an initial evaluation that study meets eligibility criteria for the CMU IRB Reliance.
  3. Makes an initial evaluation as to which site will serve as the Reviewing IRB.
  4. If there are any questions, PPI contacts their home institution’s CMU contact for guidance.

Submission of the CMU IRB Reliance

  1. PPI completes and collects necessary documentation from RI(s) and includes with submission to the Reviewing IRB. There may be instances when the PPI and the RI is the same individual (i.e. PI with multiple affiliations). In this scenario, the PI must complete and submit the requisite documents as both the PPI and RI.
    1. PPI Assurance Form (PPI Signs)
    2. RI(s) Assurance Form  (RI at each site signs)
    3. RI(s) Worksheet on Local Context (RI(s) complete specific to each relying site) 
      1. CHOC: RI Worksheet    Note: For CHOC RI(s), this worksheet may be completed in the Study Registration Record; if you have any questions please contact the CHOC CMU contact
      2. MHS:   RI Worksheet
      3. UCI:    RI Worksheet
    4. The template for the CMU Consent Form is composed of three (3) parts and all three must be submitted to the Reviewing IRB. There are also two (2) assent documents that must be submitted when applicable.
      1. Consent Cover Letter for Adults and Children Over 12 (PPI & RI(s) complete as separate letters specific to each site)
      2. Consent Part A (PPI to be used at all sites)
      3. Consent Part B  (PPI & RI(s) Complete Specific to Site)
        1. CHOC: Consent Part B
        2. MHS: Consent Part B
        3. UCI: Consent Part B
      4. Assent Form for Children Ages 7-11 (PPI Completes – if applicable)
      5. Assent Form Addendum for Female Minors (PPI Completes – if applicable)
  2. PPI submits either a New Application or an Amendment to the Reviewing IRB.
    1. CHOC: CHOC IRB Guidance Manual, CHOC IRBNet
    2. MHS: MHS IRB Application Instructions
    3. UCI: New IRB Application (eAPP) or Amendment (eMOD)
  3. The PPI and the RI(s) should now begin securing all Departmental, School and Institutional approvals (e.g., other regulatory committee approvals). 
    1. UCI: Additional Approvals Required
  4. The RI(s) complete any forms as required by the Relying IRB to register the project at the Relying Institution.
    1. UCI: IRB Reliance Registration Form

Review and Approval of the CMU IRB Reliance Submission

  1. The Reviewing IRB and Relying IRB(s) will communicate with each other to address any concerns related to the reliance request. Each site will decide on a case-by-case basis whether the reliance request is acceptable.
  2. The Reviewing IRB will send the approved study documents to the PPI and the Relying IRB(s).
  3. Once the Reviewing IRB approval has been issued, the PPI at the reviewing institution may initiate research at their respective site if all institutional requirements have been met (e.g., contract finalized).
  4. RI(s) must not initiate research at their respective institutions until the Relying IRB has issued a IRB Reliance Letter and releases the institution specific IRB approved documents to the RI(s).

Amendments

  1. All renewals and amendments/modifications must be submitted to the Reviewing IRB via the PPI according to its policy. All changes (e.g., a change in procedure, number of subjects, personnel, study locations, new recruitment materials, study instruments, etc.) must be prospectively reviewed and approved by the Reviewing IRB before they are implemented.
  2. The RI(s) complete any forms required by the Relying IRB to modify the project at the Relying Institution.
  3. The RI(s) must not implement the revised protocol until the Relying IRB has issued an IRB Reliance Letter and releases the institution specific IRB approved documents to the RI(s).

Renewals

  1. All renewal applications must be submitted to the Reviewing IRB via the PPI according to its policy.
  2. In addition to submitting the Reviewing IRB's renewal application, the following documents are required at the time of continuing review:
    1.  
  3. The RI(s) complete any forms required by the Relying IRB to register the renewal at the Relying Institution.
  4. All Departmental, School and Institutional approvals (e.g., other regulatory committee approvals) must be secured.
  5. The RI(s) must not continue research at their respective institution until the Relying IRB has issued an IRB Reliance Letter and releases the institution specific IRB approved documents to the RI(s).

    Adverse Events or Unanticipated Problems

    1. The PPI must report all unanticipated problems to the Reviewing IRB according to its policy, including unanticipated problems that occur at the RI(s) institution.
    2. The Reviewing IRB will review any incident(s) and notify the Relying IRB as applicable (i.e., constitutes a reportable event – unanticipated problem involving risk to subjects or others)

    Closing Report

    1. The PPI must submit a closing report to the Reviewing IRB according to its policy.
    2. The Reviewing IRB will review the closing report and notify the Relying IRB once offically closed.
    3. The Relying IRB sends acknowledgement of closing report to RI and Reviewing IRB.

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