IACUC Application Process

• IACUC Application Forms
  • Form A: Use for new proposals and major changes to an approved protocol
  • Form B: Use for continuing approval and minor changes to an approved protocol
  • Form C: For triennial renewal  
• Submit the appropriate application to the IACUC Coordinator, Claire Riner, with the electronic signatures. You may inquire about the expected time frame of the approval process.
  • Respond to reviewer's questions to the protocol in writing and, if requested, in-person at a convened IACUC meeting.
  • If you receive a Memo to Secure Approval addess all issues raised in the memo and submit an accordingly revised application.
• After receiving Final Memo of Protocol Approval
  • Conduct health exam and complete Medical Questionnaire (all personnel on the protocol)
• Post-approval
  • Begin animal work after completion of Health exam/questionnaire and animal training
  • Report any unexpected findings to the vetenirarian, Dr. Jeffrey Lee, the animal facilities IACUC and submit appropriate form for protocol changes, if needed. 
  • Remember to submit protocol continuation or renewal proposal as appropriate no later than thirty (30) days before protocol expiry.

California State University Los Angeles
Institutional Animal Care and Use Committee

Policies and Procedures

PROTOCOL SUBMISSION AND REVIEW PROCESS

The IACUC is charged with reviewing proposals* that involve animals to ensure that the criteria established in the PHS Policy and the Animal Welfare Regulations (AWRs) are implemented.

In compliance with PHS Policy and the Animal Welfare Regulations, animal care and use protocols to be reviewed by the Institutional Animal Care and Use Committee (IACUC) at CSULA are submitted to the IACUC chair via the Office of Research, Scholarship, and Creative Activities (ORSCA), located in Library N 2026D, and receive full committee review, which requires a convened meeting of a quorum of the IACUC members. This process applies to all new and three-year re-review protocols, continuing reviews and amendments, regardless of funding source.

Approval process for new and three-year re-review of protocols

Investigators will be required to submit proposals for new and three-year re-review of protocols using Form A. The IACUC chair, with the help of the ORSCA staff, will post a downloadable form in the ORSCA website. This form, approved by the IACUC, will be kept updated with periodical revisions.

1) Before the meeting

New and three-year re-review protocols must be received in the ORSCA office no later than 30 days prior to a scheduled IACUC meeting. Schedule of meetings is posted on the ORSCA website. Each protocol will be consecutively numbered in order of receipt. It will be screened by the IACUC Coordinator to reconcile the content with information supplied to the Grants and Contracts Office. At this point, protocols that are incomplete in any way may be returned to the investigator for further information.

This document will be filed in the ORSCA office for as long as indicated in the Federal guidelines (see section E.1. of the Guidebook).

With the assistance of the IACUC Coordinator, the chair will send a copy of the protocol to all IACUC members, including the Animal Care Department (ACD), accompanied by a memo stating who the pre-reviewers will be and indicating the deadline for IACUC members to forward questions about the protocol to one of the pre-reviewers (specified in the memo).

The chair will designate two members to serve as pre-reviewers. One of the pre-reviewers will usually be the Consulting Veterinarian. Once the deadline is passed, the pre-reviewers are responsible for an in-depth review of the proposal and can also take the initiative to contact the investigator prior to the meeting for clarifications, additional information, or in anticipation of questions the IACUC may raise. Clarifications received from the investigator in writing will become part of the protocol.

The use of pre-reviewers will facilitate full committee review by distributing the workload among IACUC members so that each member has responsibility for in-depth review of only a portion of the proposals the IACUC will review. Pre-reviewers may also take responsibility for describing the proposal to the full committee and answering questions about the proposal during review by the committee.

In addition, this pre-review process will facilitate full committee review by anticipating most, if not all, of the questions that usually arise during the meetings, allowing the investigator to address those questions in advance, and thus minimizing the subsequent administrative work and having to return protocols for revision.

Any housing or husbandry concerns raised by the ACD should be addressed to the Consulting Veterinarian at least one week before the meeting, who will bring them to the attention of the IACUC members during the meeting.

2) During the meeting
Full committee review of proposals requires a convened meeting of a quorum of the IACUC members. The PHS Policy and AWRs are explicit that proposals reviewed by the full committee must receive the approval vote of a majority (>50%) of the quorum present in order to receive approval. No member may participate in IACUC review or approval of a protocol if that member has a conflicting interest (e.g. is personally involved in the project) except to provide information requested by the IACUC. A member who has a conflicting interest may not contribute to the constitution of a quorum and is excused from the final discussion and voting.

Categories of IACUC Actions:
As a result of their review of a protocol, the IACUC may take one of several different actions depending upon the findings of the committee: approval, modifications required to secure approval, or withhold approval. The IACUC may also defer or table review if necessary.

a)   Approval
When the IACUC has determined that all review criteria, based on the PHS Policy and AWRs, have been adequately addressed by the investigator, the IACUC may approve the proposal, thus providing the investigator permission to perform the experiments or procedures as described.

b)   Modifications required to secure approval
The IACUC may require modifications to the proposal before granting approval. Appropriate use of the pre-review process will minimize these occasions.

      • If the IACUC determines that a proposal is approvable contingent upon receipt of a very specific modification (e.g., receipt of assurance that the procedure will be conducted in a fume hood), or clarification of a specific point, the IACUC may handle these modifications or clarifications as administrative details that the Chair or designee could verify. In these cases, the protocol will be approved following verification, without waiting for the next committee meeting, and will be reflected thus in the minutes.

      • If a study is unusually complex or involves untried or controversial procedures, the IACUC may wish to impose restrictions, (e.g., approval for the use of a limited number of animals as a pilot study with a written report of interim results, or close monitoring by veterinary or other qualified personnel.) If such modifications represent significant departures the IACUC can ask the investigator to revise the protocol to reflect the modifications imposed by the IACUC.

      • If the proposal is missing substantive information necessary for the IACUC to make a judgment, or the IACUC requires extensive or multiple modifications, then the IACUC can require that the protocol be revised and resubmitted.

Anything less than full IACUC approval is not adequate for initiation of animal activities or for submission of an IACUC approval date to PHS in conjunction with a grant application. Therefore, the IACUC will avoid using terms such as “conditional approval,” "provisional approval” or “approved pending clarification”, or else describe them (e.g., in IACUC minutes, memos to investigators, etc.) in sufficient detail to be fully understood.

c)   Withhold approval
When the IACUC determines that a proposal has not adequately addressed all of the requirements of the PHS Policy and AWRs as applicable, the committee may withhold approval.

d)   Defer or table review
If the proposal requires clarification in order for the IACUC to make a judgment, or committee members with certain expertise are not present, the IACUC wishes to seek external consultation, or any of a number of other reasons prevent the IACUC from conducting its review, then the IACUC will defer or table review. Good communication between the IACUC and the investigator can ensure that this action is needed infrequently. However, should it be necessary, the chair will inform the investigator, so that he or she can respond or plan accordingly.

3) After the meeting

The PHS Policy and AWRs require the IACUC to notify investigators and the institution in writing of its decision to approve or withhold approval, or of modifications required to secure approval. In all cases the IACUC chair will notify the investigator in writing, and a copy of the memo will be sent to the Animal Care Department and another will be filed in the ORSCA office. For approved proposals, before an official approval letter is sent to the investigator, the chair must receive (via the ORSCA office) and approve a ‘final version’ of the proposal, which incorporates any additional information or modifications requested by the IACUC committee members. Once the final version of the proposal has been received and approved by the chair, the signed original proposal and approval letter will become part of the investigator’s file in the ORSCA office; a copy of the proposal and approval letter will be forwarded to the Animal Care Department. For approved proposals, the IACUC Coordinator will enter a notation in the IACUC proposal database to remind the investigator of the next renewal date.

Approval process for continuing applications and minor amendments to protocols

A subcommittee of two IACUC members, usually the IACUC chair and one other member on a rotational basis reviews continuing protocols and minor amendments to proposals. These items must be received by the OSRP at least 30 days prior to a scheduled meeting. They are presented to the full IACUC as a list on the agenda indicating the type of review (e.g., continuation without changes, addition or change of procedures, addition of personnel, etc.). The subcommittee may refer the review to the full IACUC for discussion if either member requests further review.

Requests for approval of continuing protocols receive final review and approval at the fully convened meeting of the IACUC by majority vote of the quorum present. The IACUC actions in this regard are identical as those described above.

Frequency of Review of Approved Protocols

The PHS Policy requires that a complete IACUC review of PHS supported protocols be conducted at least once every three years. The three-year period begins on the actual date of IACUC approval; the IACUC may not administratively extend approval beyond the three years.

AWRs require an annual review, which may be a monitoring mechanism whereby the IACUC requires the investigator to annually report on the status of the protocol, verify that completed activities were conducted in accordance with the approved protocol, describe any proposed departures from the approved protocols, and solicit information about activities projected for the upcoming year. (Proposed significant changes would require IACUC review prior to initiation.) For this annual review, it will be sufficient that the investigator submits a signed Form B.

1. When asked "Which Course do you plan to take?" (Step 6) choose the one that is most relevant to the research that will be conducted.
    
2. Scroll down and answer Question 1 through 4 (Step 7). If you are not doing lab animal research, leave question 1 blank. Question 2 is required for any type of Institutional Research. For question 3, select the course(s) that encompass your research.
    
3. After registering, click on the name of the course that appears under California State University Los Angeles section to start your training. CITI allows users to log out and come back later to work on the modules listed under each course.
    
4. Once the relevant course(s) are successfully completed and passed, click "Print Report" for each course and save each one as a pdf. 
    
5. Please email your CITI certificate(s) to [email protected] and include the protocol number and PI’s name.