Institutional Animal Care and Use Committee (IACUC) s1
Protocol # A______
Sponsored Programs Administration- IACUC
Office of the Vice President for Research, Creative Activities and Technology Transfer
1735 NDSU Research Park Drive, Dept. 4000, PO Box 6050
Fargo, ND 58108-6050, Phone (701) 231-8114, Fax (701) 231-8098
Request for Change in Protocol Form
For institutional review only
Protocol Number Protocol Title
Principal Investigator Department
Campus Address Contact Phone
E-mail Address
List any additional contact information for animal-care issues (optional):
The information provided in this form accurately represents the changes I propose to make to a previously approved IACUC protocol. I am aware that the Principal Investigator Certifications that I agreed to (on the original protocol form) remain in effect with this change in protocol.
Principal Investigator Date
Chair, Head, Director or Dean Date
(if Pi is Dept. Chair/Head/Director, the Dean must sign)
The signature above certifies acknowledgment that this research is in keeping with the standards set by your department/unit, all NDSU policies and that facility, equipment and personnel are appropriately committed to this project
IACUC Chair Date
Carefully review the form to ensure it is complete, contains sufficiently detailed responses to all questions and all attachments. Incomplete submissions will be returned or held until completed, without IACUC review or approval, potentially delaying the research. Contact the IACUC office for questions or assistance at 231-8114.
Original Protocol Type:
Biomedical
Agricultural
Teaching
Wildlife
Breeding
Herd management
1. I am proposing a change that would (check all that apply):
Change the previously approved category.
Increase the number of animals used for the project. http://www.ndsu.nodak.edu/ndsu/doetkott/StatConsult.html for help on justifying numbers
Introduce new techniques or procedures not described in the previously approved protocol.
Other. (Please describe.)
2. Please provide a description or explanation of the proposed changes. Provide sufficient detail to allow evaluation by the IACUC. (Questions that might be addressed include: Has the research or development question changed? Describe any changes to procedures, their frequency and time points, over the course of the experiments. Include any changes in the dose and/or route of administration for any drugs used. Describe changes to methods used in behavioral studies.)
3. Alternatives to Animal Use: Only fill this out if the category changes to D or E or you are indroducing a new technique that will increase the category.
Federal regulations require the use of alternatives to procedures that may cause more than momentary or slight pain or distress to animals (USDA Policy 12 - Written Narrative for Alternatives to Painful Procedures: http://www.aphis.usda.gov/ac/policy/policy12). Alternatives include the following concepts:
§ Replacement of vertebrate animals with in vitro models, computer models or less sentient animals;
§ Refinement of experimental procedures to minimize pain or distress (e.g. early endpoints, use of analgesics, anesthetics or sedatives; techniques that reduce stress in the animal); or
§ Reduction in the number of animals by using appropriate statistical methods in the design and analysis of the study, reduction in variability by using animals of defined genetic or microbiological status, and maximizing the data gained from an individual animal.
(Practicing the Three R's:)
Indicate how alternatives were considered in the design of the study, or why alternatives were not found to be suitable for accomplishing the goals of the study:
Methods used to search for alternatives (indicate all that apply):
Literature Search conducted
Name of databases/searches utilized (e.g., AGRICOLA, NORINA, ALTWEB, etc):
Key words used:
Years searched: From: To:
Date the search was completed:
Consultation with colleagues: Names:
Dates:
Other information services utilized (elaborate, providing specific information):
Request for Change in Protocol Form 09/2009 Page 3 of 3