Institutional Animal Care and Use Committee
APPLICATION TO PERFORM CLINICAL RESEARCH
Revision date: June 2015
DATE RECEIVED: / APPLICATION NUMBER: / ROUND: / AUF INACTIVE DATE:
DATE APPROVED:
DATE EXPIRES: / PHS FUNDED / DOD FUNDED / AGRICULTURE / USDA / AMENDMENT DATE: / ROUND: / AMENDMENT APPROVAL
IMPORTANT -- ALLOW 4-6 WEEKS FOR APPROVAL
INCOMPLETE FORMS MAY CAUSE REVIEW TO GO INTO THE NEXT REVIEW CYCLE DELAYING APPROVALTHIS FORM MUST BE SUBMITTED AS A WORD FILE VIA EMAIL TO:
ABBREVIATIONS AND ACRONYMS SHOULD BE SPELLED OUT AND EXPLAINED THE FIRST TIME THEY ARE USED.
Approval is for a maximum of three (3) years from the date of approval. Continuation of the approved animal usage beyond three years requires renewal of the AUF and complete IACUC review.
Note:
Clinical research is defined as any research activity or study design that involves data obtained from a population of client-owned or privately-owned animals and is divided into:
1. Routine diagnostic and therapeutic interventions (standard-of-care) for veterinary patients/agricultural animals, and
2. Any deviation from that standard-of-care that is associated with the clinical study.
This form pertains ONLY to that portion of the study protocol that deviates from standard-of-care.
PRINCIPAL INVESTIGATOR
(As designated by Contracts & Grants)
LAST NAME: / FIRST NAME: / MIDDLE INITIAL: / ZPID NUMBER:
ACADEMIC RANK / TITLE: / PRIMARY COLLEGE:
DEPARTMENT: / CAMPUS TELEPHONE NUMBER:
MAILING ADDRESS: / FAX NUMBER:
NET ID: / EMERGENCY NUMBER:
CO-PRINCIPAL INVESTIGATOR
(Regular / Fixed-term / Visiting / Adjunct / Clinical Faculty, Research Associate, Specialists, Postdoctoral Fellows)
LAST NAME: / FIRST NAME: / MIDDLE INITIAL: / ZPID / STUDENT NUMBER:
ACADEMIC RANK / TITLE: / PRIMARY COLLEGE:
DEPARTMENT: / CAMPUS TELEPHONE NUMBER:
MAILING ADDRESS: / FAX NUMBER:
NET ID: / EMERGENCY NUMBER:
PRINCIPAL INVESTIGATOR'S ASSURANCE
I agree to abide by all federal and state regulations, Michigan State University (MSU) policies and Institutional Animal Care and Use Committee (IACUC) guidelines concerning the use of animals.
All use of vertebrate animals shall be covered by an Animal Use Form (AUF) that has been reviewed and approved by the MSU IACUC and that IACUC approval shall be obtained prior to enrolling animals and/or performing any animal procedures described in this form.
The personnel performing all animal manipulation including, but not limited to, experimental techniques, surgery, euthanasia, assessment of pain and distress, determination of humane endpoints, etc. are adequately trained and have completed all required training prior to performing those procedures. This training must be documented.
I will immediately notify the Attending Veterinarian or designee regarding any unexpected study results that negatively impact the animals. Any unanticipated pain or distress, morbidity or mortality associated with the clinical study will be reported to the Attending Veterinarian or designee.
Any proposed changes to this protocol must be reported by sending an amendment form to the IACUC outlining the changes. IACUC approval must be obtained prior to performing the revised animal procedures described therein.
I will maintain appropriate animal records (e.g., census, health, veterinary care, euthanasia, surgery, diagnostic, anesthesia, etc.).
I will do everything within my power to safeguard the health and well-being of each animal under this protocol.
I accept responsibility that all personnel working on this project are aware of, and will follow the approved procedures outlined in this form.
As required by federal regulations I assure that the activities described do not unnecessarily duplicate previous experiments.
I understand that approval of projects is for a maximum of three years from the date of approval. I understand that the IACUC can call for a complete re-review of the project as needed.
By submitting this form, I agree to follow up activities to include post approval monitoring by the IACUC or agent of the IACUC at least annually.
I understand that the information contained herein does not materially conflict with and/or deviate from information contained in related grant proposal documents submitted to extramural funding agencies listed in the protocol.
PRINCIPAL INVESTIGATOR SIGNATURE / DATECO-PRINCIPAL INVESTIGATOR SIGNATURE / DATE
TITLE OF STUDY AND FUNDING AGENCY
(if you have more than one project to put on this form, please copy & paste this page as many times as needed)
Title of Study (this has to match the grant title):
Funding Source
PHS / NIH / DOD / Federal Funding other than PHS / NIH / DODInternal / University / Private (includes foundations, companies, and other organizations)
Contracts & Grants Application or Account Number:
Scientific merit of this project assessed by: (Funding agency, name of department representative, etc.)
Funding agency review / Internally reviewed by:Is this project a Sub-Contract from another Institution?
Yes / NoIf yes, please provide the name of the institution:
Will this project have Sub-Contracts with another Institution(s)?
Yes / NoIf yes, please provide the name of the institution:
FOR THE ABOVE PROJECT THE FOLLOWING ANIMALS WILL BE USED
List the animals requested for use, including the Use Category for each. The Use Category applies only to the experimental portion of the clinical study, and not any procedure the patient is undergoing as standard-of-care. WHEN FILING AN AMENDMENT TO ADD ADDITIONAL ANIMALS, PLEASE DO NOT ADD TO THE EXISTING NUMBER – USE A NEW LINE.
Common Name / Use Category1
(ONLY ONE CATEGORY PER LINE) / Number of Client- or Private-Owned Animals Requested
over a Three year Period
BE SURE TO ACCOUNT FOR ALL ANIMALS SUPPORTED
BY THIS AUF / Total
Number
1Explanation of Use Categories:
Category B: Animals that will be bred or purchased for breeding, but not used for experiments. This includes breeders, offspring that cannot be used because of improper genotype or sex and any other animals that will not participate in the research studies.
Category C: Animals used in research, experiments, or tests which involve no pain or distress or only momentary or slight pain or distress that WOULD NOT REQUIRE anesthetic, analgesic or tranquilizing agents (examples: s.c., i.m., i.p. or percutaneous i.v. injection, a brief period of restraint, tissue harvesting after euthanasia has been performed).
Category D: Animals used in research, experiments, or tests where appropriate anesthetic, analgesic, or tranquilizing agents are used to avoid pain or distress (examples: major and minor surgery, tissue or organ collection prior to euthanasia, retro-orbital blood collection, prolonged restraint accompanied by tranquilizers or sedatives). Animals used in research, experiments, or tests which, if they experience pain or distress cannot be treated with an anesthetic, analgesic or tranquilizer, but the agent or procedure producing the pain/distress is immediately discontinued or the animal is euthanized to prevent pain and/or suffering.
Category E: Animals used in research, experiments, or tests involving pain or distress in which the use of appropriate anesthetic, analgesic, tranquilizing agents or other treatments that would relieve the pain or distress would have adversely affected the procedures, results, or interpretation of the teaching, research, experiments, surgery, or tests (examples: studies which allow endpoints that are painful or stressful, addictive drug withdrawals without treatment, pain research, noxious stimulation). IF YOU LIST ANIMALS IN THIS CATEGORY YOU MUST PROVIDE A DETAILED JUSTIFICATION (see Section I)
VETERINARY CARE and HOUSING
A. All animals involved in this protocol are client-owned or privately-owned. They are housed and cared for either in the Veterinary Medical Center according to standard operating procedures, or at home by their owner.
While in hospital, is patient care delivered by hospital personnel, including veterinarians, technicians, and veterinary students?
Yes / NoIf No, please explain:
DESCRIPTION OF CLINICAL STUDY PROCEDURES THAT DIFFER FROM STANDARD-OF-CAREB. Indicate all procedures to be performed on study subjects that are not standard-of-care and are part of the research activity.
Amputation (including toe/tail clipping) / 02Behavioral modification / 82
X / Clinical Trial / 94
Injections or inoculations / 83
Invasive procedure (e.g. endoscopy, biopsy)
Non-Invasive Procedure (e.g. radiographs, CT, ultrasound, MRI, Treadmill) / 92
Nutritional studies / 51
Pain Research (e.g. comparative studies of analgesia) / 31
Pharmacological studies/trials / 50
Restraint of a conscious animal longer than 3 hours (complete Section F) / 38
Sample collection from live animals (blood, urine, tissue, etc.) (answer Q 9) / 39
Sample collection (blood, urine, tissue, etc.) post euthanasia / 99
Surgical procedure, survival (complete Section A) / 45
Surgical procedure, multiple major survival (complete Section A) / 70
Weight loss / 49
Other, describe
C. Regarding the above procedure(s):
i. Describe how it differs from standard-of-care.
ii. If it is likely to cause any additional pain or discomfort, how will that be managed?
iii. Does the study include a surgical procedure?
No / Yes – Complete Section AJune 2015 Page D
PERSONNELPlease list in the table below all personnel who will work with live vertebrate animals or animal tissues as part of this Animal Use Form. Include Principal Investigator, co-Principal Investigator(s), Post-Docs, students, lab technicians, farm personnel, etc. The PI is responsible for ensuring that their employees and students are adequately trained in the specifics of their tasks. All trainings must be documented.
Mandatory trainings (final approval of your protocol will be withheld until training has been completed). PROCEDURES TO BE PERFORMED
• IACUC Tutorial and IACUC Species Specific Tutorial (http://ora.msu.edu/train)
• Biosafety Principles for Animal Users (www.ehs.msu.edu)
• Medical Questionnaire (http://occhealth.msu.edu/resources/animal-contact)
Name, Title / Phone / MSU Net Id / Relevant Degreeor
Certification / If multiple species, state with which species personnel will be working / Mandatory Trainings Completed (see above) / PROCEDURES TO BE PERFORMED
Non-Invasive Activity / Anesthesia / Euthanasia / Sample Collection / Surgery / Surgical Assistance / Assess Humane Endpoints / Other / Date off Project
(Office Use)
i.e. John Doe, Professor / 517-432-9999 / Doej / DVM / cat, mouse / x / x / x / x / x / Husbandry
E. How have you determined that the personnel listed above are competent in performing anesthesia, euthanasia, surgery, and/or assessing humane endpoints?
June 2015 Page D
Michigan State UniversityInstitutional Animal Care and Use Committee
Animal Use Form for Clinical Research
Revision date: June 2015
DATE APPROVED: / APPLICATION NUMBER: / ANIMALS APPROVED: / QTY
LAY SUMMARY OF CLINICAL STUDY
It is NOT acceptable to use a section from your grant application, using highly technical terms. This information may be used for press releases and/or responses to Freedom of Information Act (FOIA) requests.
1. The lay summary must be written in a manner in which the non-scientific community members of the committee have an understanding of the benefit and scope of the project. It needs to be written similarly to a high school biology hypotheses statement.
RATIONALE FOR ANIMAL USE2. List the alternatives to the use of live animals that you have considered (e.g., the availability or appropriateness of the use of less invasive procedures, isolated organ preparation, computer simulation, and cell or tissue culture).
3. After considering the alternatives listed above, why do you think it is necessary to use live animals?
4. Justify the appropriateness of the species selected, rather than another or less sentient species.
5. Animal welfare regulations do not allow unnecessary duplication of previous experiments.
Does the proposed research duplicate previous work?
Yes / No / NA – This is a teaching activity involving different student groupsIf yes, explain why it is scientifically necessary to replicate the experiment:
SCIENTIFIC JUSTIFICATION FOR THE NUMBER OF ANIMALS TO BE USEDAll animals identified for use in this AUF must be accounted for
Justification of animal numbers is a critical component of AUF review and Investigators MUST provide adequate scientific justification for the animal numbers requested, determining the potential to Reduce the animal numbers requested, Refine the experimental endpoints to minimize pain and suffering, Replace animal usage with alternative scientific models)
6. Provide scientific justification for the number of animals to be used in this Clinical Study.
When possible, animal numbers should be determined by statistical power analysis. Alternatively, appropriate numbers of animals may be determined based on comparable studies for which the desired effect sizes were shown to be statistically significant.
PROCEDURES WITH THE POTENTIAL TO CAUSE PAIN AND/OR DISTRESS(Use Category D or E)
This section applies only to any deviation from standard-of-care that is associated with the clinical study, and not any diagnostic or therapeutic interventions that are part of that patient’s standard medical or surgical care.
7. With respect to the procedures proposed that have the potential to result in pain and/or distress (e.g. surgery, anxiety/depression models, etc.), how have you determined that there are no acceptable procedures that could be used instead?
USDA LITERATURE SEARCHA literature search is required by USDA for all animals used in biomedical research, testing, and/or education activities which include the potential for pain and/or distress
(Use Category D or E)
8. If you have Category D or E use, then you must complete question 8. Otherwise, go to question 9.
As the USDA believes that literature searches remain the most effective and efficient method for demonstrating compliance with the requirement to consider alternatives to painful/distressful procedures, please provide the USDA required information in the table below. (http://awic.nal.usda.gov/worksheet-alternatives-literature-searching)
If you need help developing a computer search, contact: Andrea Kepsel, Health Sciences Educational Technology Librarian () or (517) 884-0898
Database name(must search two databases) / Date search was performed / Years covered in this search / Keywords/Search Strategy
must include the words
“alternatives to pain & distress”
SAMPLE COLLECTION
(tissue and/or body fluids)
9. Complete the table below for any specimen collection from study subjects that are part of the clinical study.
Do not include any sample collection that is considered to be standard-of-care.
Type ofSamples Collected / Site of
Sample Collection / Method of
Sample Collection / Volume
of Sample / Number of
Samples / Frequency
of Collection
PROJECT DESCRIPTION
10. Please see the following link for guidance on the use of SOPs http://animalcare.msu.edu/iacuc-forms
Will you be referencing an approved SOP in this research?