» IACUC Protocol Submission & Review Process

[2/12/20, updated]

The IACUC at Chapman implemented the protocol-processing software by Cayuse (eSirius) as of February 2020.  All existing protocols (the final PDFs, approval memos, etc.) were migrated into Cayuse with their original expiration dates.  Notifications for continuing (annual) reviews and three-year expiration come from the Cayuse system.

The URL for the production site is: https://chapman.esirius.cayuse.com/esirius3g/

The URL for the training site is: https://chapman.ntm-stg.cayuse.com/esirius3g/esRefreshHomePage.wc.  Note the "Non-Production" banner in red across the top.  Protocols written in training cannot be moved to production - content can be cut-and-pasted, however.

Registration to enroll and use either site is detailed on the User Authentication tab below.

  • Overview/Instructions
  • User Authentication
  • Review Procedures
  • Review Schedule
  • [11/25/20, updated]

    Highlights of the protocol approval process to work with animals:

    Enroll in the LAOHP with EH&S for occupational health.  The date of completion will be asked for in the Cayuse IACUC protocol.

    Obtain the appropriate regulatory and animal training, which includes fact-based material through CITI and hands-on technique capabilities through experience.  The details (dates of completion, content) will be asked for in the protocol.

    Review the "Overview of the Chapman University Cayuse IACUC Protocol Program" PowerPoint.  A draft (it is continuously being updated) is available at Chapman Cayuse training 2020 PPT for those with Chapman credentials.  It describes the mechanics of the protocol application.

    Other reviews and approvals - called ancillary items for IBC (biosafety), hazards (chemicals, radiation), controlled substances, permits, etc. - are asked about in the application.

    Campus animal facilities have their own specific requirements (e.g., orientation, access, safety) before an individual can begin working with animals.

  • [11/25/20, update]

    User authentication is a process within the Cayuse IACUC software known as registering.  User designations include the IACUC office, IACUC chair, IACUC members, PI (principal investigator and researchers), and vet (veterinarian).

    All personnel working with animals on an IACUC protocol - research or teaching - must complete appropriate training and be enrolled in the LAOHP (see other tab sections).  The PI is responsible for including them on the protocol - through the initial submission and in later amendments.  Individuals are responsible for maintaining records and documents of their own training for review by the IACUC.

    Register with the IACUC office to gain access (authentication, be enrolled) to use Cayuse IACUC.

    • A PI can have colleagues (students, post-docs, collaborators, etc.) to write and review sections of their protocols.  Analogous to lab groups, they are included in Cayuse as "group members".
    • Colleagues can be linked as members to many PIs.
    • Adding users and establishing groups is a function of the IACUC office as administrators of Cayuse.
    • External collaborators, non-Chapman personnel, can use Cayuse after being registered.
    • The IACUC office (not Cayuse) will issue a memo by email when registration has been completed.  It will include the user ID and password to access Cayuse IACUC.
    • Problems with authentication/registration should be resolved with the IACUC office.

    In order to register, send an email to the IACUC office with the following:  your name, lab group, academic degrees, brief summary of animal experience, CITI training completed, and date of enrollment in the LAOHP.

    PI stands for Principal Investigator.  Typically, a PI is a faculty member managing a research project.  At Chapman each PI has logistical and policy-based requirements with which to comply.  See the Office of Research Policies and Guidance web pageNote:  The Cayuse IACUC system often equates PI with the term "research staff members".

  • [11/30/20, updated]

    The review is initiated when receipt of a complete protocol application or amendment, including all required documents, is submitted to Cayuse and accepted by the IACUC Administrator.  Protocol approval is required at least every three (3) years.  Protocols requiring Institutional Biosafety Committee (IBC) approval must obtain it prior to or along with IACUC review and approval.  Principal Investigators (PIs) are strongly encouraged to consult with the campus veterinarian during the planning stages and prior to protocol submission, particularly for studies that have significant potential for pain or distress.  Experts from within or outside the University community or consultants may be asked to assist in review of protocols that are complex in nature.

    Administrative Review

    The IACUC Administrator is available to advise and review drafts of the protocol or amendments to approved protocols.

    When the PI chooses, s/he will move the draft protocol (or amendment) to the review stage within Cayuse, which generates a notification.  The Chair, in consultation with the Administrator, will recommend one of two review methods:  Designated Member Review (DMR) or Full Committee Review (FCR).  The Administrator will email a "call for reviewers" to all IACUC members with the protocol title and the recommendation.

    Designated Member Review (DMR)

    IACUC members indicate their interest to review the protocol as DMR to the IACUC administrator, who initiates another notification via Cayuse to them to begin the conduct of the review.  Any member of this DMR sub-committee may request a FCR (see next) within five (5) business days if they deem it necessary.  Following a FCR request, a full committee meeting must convene with a properly constituted quorum.  If no requests for FCR are received, the IACUC Chair will appoint one qualified committee member, along with the committee’s veterinarian, to lead the review process as the DMR.  

    The DMR members review the protocol and state the following options:

    • Approve the protocol or amendment if all criteria are met and satisfied
    • Request revision(s) to the protocol or amendment if outstanding issues are present in order to secure approval
    • Request FCR when further review of the protocol or amendment is warranted.

    The protocol travels back-and-forth between DMRs and the PI team with the IACUC administrator facilitating the exchange and maintaining confidentiality.

    Full Committee Review (FCR)

    The FCR occurs during a convened meeting of the IACUC, held face-to-face (or electronically with real-time communication).  Committee meetings are generally scheduled monthly on the third Wednesday.  Changes do happen during holidays and when a need for a special meeting is requested.

    Quorum is assured at the FCR meeting and lack of a conflict of interest (COI) is established.  Members may recuse themselves.  Consultants may be included, but they do not have a vote.  Those present review and discuss the protocol.

    The following outcomes of a FCR may occur:

    • Approval by a majority affirmative vote
    • Revisions requested of the PI team to secure approval
    • Defer or table review of protocol if more clarification or outside consultation is needed
    • Withhold approval of protocol if it has not adequately addressed all requirements necessary

    If the IACUC is unable to approve a protocol, the PI is notified through Cayuse with a detailed report of the requested revisions.  Revisions may be approved administratively (the Chair and the Administrator participating) or by a DMR sub-committee.

    Modifications to an Approved Protocol:

    Investigators who desire to make modifications (also called amendments) to an approved protocol during its approval period must submit a modification for approval prior to initiating the change.  Modifications include 1) administrative changes such as addition or deletion of research personnel, 2) significant changes such as modifications to the study design or objectives, the number of animals or species used, increases in pain or distress, changes to therapeutic or experimental agents or changes in euthanasia methods, and 3) all others remaining.  Approval of a modification does not alter the existing protocol's expiration date.

    Amending personnel to an approved protocol:  The PI completes an amendment process with Cayuse and submits it electronically to the IACUC office.  Appropriate CITI training and LAOHP enrollment (both current) should be done beforehand, as approval cannot be granted without them.  Personnel must be familiar with the protocol contents.  The IACUC office can approve this amendment for anyone but the PI, typically within a few days.  A change of PI requires an IACUC member to review and approve.

    VVC or Veterinary Verification and Consultation:  The VVC is another process for obtaining a near-to-immediate approval of a change to an approved protocol.  It has limitations, so the IACUC office needs to be approached for specific situations.  For example, a PI realizes "today" that the protocol-approved anesthetic drug in her inventory has expired and a procedure is scheduled for the same day.  The veterinarian can be consulted to verify the use of an anesthetic replacement and IACUC paperwork can be completed later.  What the veterinarian cannot do independently in this example is approve/verify another kind of procedure.  Again, note the restrictions and talk with the IACUC.

  • Committee meetings are generally scheduled monthly on the third Wednesday.  Changes do happen during holidays and when a need for a special meeting is requested.

    Investigators who plan to submit an animal use protocol for review should write and complete submit an application in Cayuse at least four weeks prior to the intended start date to allow sufficient time for IACUC member review.  Student investigators must have a faculty member or academic professional staff serve as an advisor (with responsibilities) on his or her project and the protocol must be submitted under the advisor's name.

    As described elsewhere, there are different kinds of protocol review (administrative, DMR, FCR).  The IACUC determines the review type and that could mean a longer time to conduct the review.  Please keep that in mind as you plan the study.