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California State University, Long Beach
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IACUC Annual Report Form (rev. 10/1/10)

Download this form in Word Microsoft Word Format

Protocol Title:
Protocol Number: Date of Initial Approval:
Principal Investigator:
Department:
Campus Email Address:
Phone:
  1. Summary of Animal Usage
Part A.  Office of University Research will fill in the yellow and white areas; PI's fill in blue. See note under "wild caught."
PI calculates the Remainder total (Part A) and the Disposition total (Part B).
Total Number of Animals Approved by IACUC for this protocol Proj. Yr. 1 Proj. Yr. 2 Proj. Yr. 3
Species Name Number
Purchased
Transferred In from Other Protocols
or Wild Caught*
(* PI will adjust the numbers to account for wild caught animals)
Strain
Strain
Strain
Total
Remainder:
Part B.  Office of Research will fill in the white areas; PI's fill in blue.
Disposition of Animals
Project Year 1 Project Year 2 Project Year 3
Expended
Released
In Residence/Facility
Other (explain):_______________________________________
Transferred Out to Other Protocols
Adopted
Total:

Office of University Research record of numbers purchased, transferred in and out, and adopted (i.e., the white spaces) will be provided when you are advised of the Annual Report due date. The P.I. must correct the table to account for the number caught in the wild. The P.I. also completes the information for the blue spaces, and calculates the Remainder total and the Disposition total.

2.  Nature of the Protocol/Study. (Check [ X ] all applicable items.)

Survival (Chronic) Study
Prolonged Restraint
Inducement of a Disease State
Terminal (Acute) Study
Neuromuscular Blockers
Inducement of Behavioral Stress
Multiple Surgeries
Antibody Production
Blood/Tissue Collection
Transgenic Breeding
Other: (specify)
3.USDA PROJECT (Pain) CATEGORY: [   ] C      [   ] D          [    ] E         (IACUC provides)
  1. Protocol Status. Please indicate ( X ) the status of this project.
Request Protocol Continuance Request Protocol Termination
A. Active - project ongoing. D. Inactive - project never initiated.
B. Currently inactive - project was initiated but is presently inactive. E. Currently inactive - project initiated but project has not/will not be completed.
C. Inactive - project never initiated but anticipated start date is: B
F. Completed - no further activities with animals will be done.
G. Protocol ended. Project to continue under a new application number.
  1. Funding Source
Specify the funding source.
  1. Project Personnel Summary
Yes, there have been personnel/staff changes since the last IACUC approval was granted.
No, there have been no personnel/staff changes.

Note: For additions, the IACUC requires that any personnel changes must be approved by means of a Protocol Modification Request. You are only summarizing this year's activity here. List new names or show deletions only for those which a Modification Form was either previously approved or is submitted together with this Annual Report.

Additions: Name/Role/Responsibility for Project

Deletions: Name/Effective Date/Reason

  1. Progress Report: Present information from the original Protocol Application Section I.C. (procedures involving animal subjects) as updated by subsequent approved modifications. If the status of this project is 4.A. (active - project ongoing) or 4.B. (currently inactive - project was initiated, but is presently inactive), provide a brief update on the progress made in achieving the specific aims of the protocol.
  1. Problems/Adverse Events Summary: If the status of this project is 4.A. (active; project ongoing) or 4.B. (project was initiated, but is presently inactive), describe any unanticipated adverse events, morbidity or mortality, the cause(s), if known, and how these problems were resolved. If NONE, this should be indicated. Note: This is a summary of reports made to the Consulting Veterinarian and Animal Care Staff, which are required at the time of the problem or adverse event.
  1. Search for Alternatives
Replacement: Alternatives to the use of animals should be considered and used when possible. Since the IACUC approval or last renewal, have alternatives to the use of animals become available that could be substituted to achieve your specific project aims?
Refinement: (Address the following if your project involves USDA Category D or Category E.) Procedures that cause the least amount of pain or distress to the animals should be considered and used when possible. Since the IACUC approval or last renewal, have alternatives which are potentially less painful or distressful become available that could be used to achieve your specific project aims?
Reduction: The number of animals authorized under this protocol were justified in the original application and approved. (1) Since the IACUC approval or last renewal has anything changed which affects that justification?
Activities involving animals must not unnecessarily duplicate previous experiments. (2) Please provide written assurance that the activities of this project do not unnecessary duplicate previous work.
CERTIFICATION OF THE PRINCIPAL INVESTIGATOR: Signature certifies that the Principal Investigator understands the requirements of the PHS Policy on Humane Care and Use of Laboratory Animals, applicable USDA regulations and the Institution's policies governing the use of vertebrate animals for research, testing, teaching or demonstration purposes. Signature further certifies that the investigator will continue to conduct the project in full compliance with the aforementioned requirements.
Signature of PI: Date:

Using this form

This form is adapted from the OLAW model continuation report form at http://grants.nih.gov/grants/olaw/references/contop96.htm

Section 1 "Summary of Animal Use" is completed by the Office of University Research, except for numbers of animals caught in the wild and the "Remainder" (in Part A.), and wild-caught released and expended (in Part B.)
"Remainder" is equal to the Total Approved (or the previous year's Remainder) minus the number purchased, caught, or transferred in.
When authorized by the IACUC for multiple-species protocols, such as fish trawls, for example, the exact species/strain will not be listed, and instead only the combined total of all species.

Section 2 is completed by the PI.

Section 3 is completed during the review by the IACUC.

Section 4 is completed by the PI.

Section 5 is completed by the PI.

Section 6 is completed by the PI.

Section 7--Progress Report is completed by the PI. The progress in achieving the specific aims of the protocol should be described, including a brief summarization of the biomethodology involved (what exactly happens to the animals). The information in this section should be provided as an update to help the IACUC document the continued approvability of the research. For example, if 50 mice were used and the investigator had no progress to report, in light of the specific aims of the protocol, it would be reasonable for the IACUC to request clarification. It should, however, be recognized that scientific inquiry may involve "blind alleys", and failed experiments, thus resulting in little progress in the short- versus long-term.

Section 8--Problems/Adverse Events is completed by the PI. Any unanticipated problems or adverse events that have occurred should be reported at the time of the problem or event and summarized here in the Annual Report, including an explanation of how these events/problems were resolved. Depending on the information provided here, this response may also need to be factored into the IACUC's assessment of the ethical cost-benefit justification.

Section 9--Search for Alternatives: Replacement, Refinement, and Reduction is completed by the PI. Answer Replacement each year; answer Refinement each year if USDA Category D or E; answer Reduction each year.

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Prior to submission, the investigator is requested to share the completed Annual Report with the Attending Veterinarian, John Young, by attaching it to an email. Please note that this step may consume extra days prior to the IACUC agenda deadline.

Finally, the investigator is asked to sign the Annual Report Form, which contains a certification of his/her understanding and responsibility for conduct of animal activities in accordance with the PHS Policy, USDA regulations and the institution's IACUC policies. Signature here also attests to the accuracy of the investigator's responses. Requiring completion of this form, at every anniversary of the project (including the last), indicates to the investigator the seriousness of the IACUC's review and the importance of investigator accountability for his/her research activity; for reporting it accurately; and for justifying continuance of the research project for another year (or for the disposition of remaining animals if the project is ending). Accordingly, the IACUC, through its designated reviewer mechanism (when implemented for summer or winter periods by vote of the IACUC), is also held accountable for appropriate and responsible review of the IACUC protocol file, and for continuation approval of ongoing animal research, if it is still justified.

This method of IACUC continuing review.

At each review of an Annual Report all IACUC members will have available at the Committee meeting the original approved protocol.

A complete new IACUC protocol application form must be submitted if a project will extend beyond three years.

In summary, the review process and report form described meet the requirements of the PHS Policy and the USDA regulations for continuing review.

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