All Protocol Submissions/Requests Must Have Veterinary Pre-Review and Be Signed Off By

All protocol submissions/requests must have veterinary pre-review and be signed off by the University at Albany Veterinarian prior to submission to the IACUC.

Investigators should contact the Veterinarian, Dr. Antigone McKenna ([email protected]) and allow enough time for consultation. Submissions will not be considered for IACUC review until this has been completed.

To avoid delays, please be sure to include all supporting, applicable attachments. Incomplete submissions may be returned without review.

 Grant/Contract Application  Supplemental Forms  Any other documents referenced in the application  CITI Animal Care and Use Training Completion Reports

After veterinary consultation, submit completed and signed protocol requests to:

IACUC Office of Regulatory & Research Compliance MSC 309 University at Albany Albany, NY 12222 [email protected] Voice (518) 437-3850 Fax (518)437-3855

An IACUC protocol may be approved for up to 365 days. In order to continue research thereafter, the IACUC must review the approved project at interval of no less than once annually.

A protocol may receive up to 2 continuing annual reviews (i.e., maximum total approval time is three years.) Once a protocol has reached the three-year mark, a new application must be submitted for de novo review.

If you have any questions or need assistance in completing your application, please feel free to contact the Office of Regulatory & Research Compliance at [email protected]. Staff members are available to assist and guide you through the review process.

Please remove this page before submitting protocol

1 Date Received ORRC Assigned : JG ___ TR ___ AB___

Date: ______

Submission # Date of determination: ______IACUC Protocol Submission Form Version 11.01.13

Initial De novo submission (replaces previous protocol at end of 3rd year) - Previous protocol #

Project Title: Anticipated Duration of Study: from to (May state “upon IACUC approval”) Principal Investigator (PI) Information: The PI is the individual who has absolute responsibility for the overall conduct of all activities involving vertebrate animals, including all technical, compliance and administrative aspects. The PI is responsible for controlling the technical direction and academic quality of the project and for ensuring the project is carried out in compliance with the terms, conditions, and policies of the sponsor, the IACUC, and the University at Albany. Note: Copy of CITI Animal Welfare Training Completion Report must be attached for PI/Co-OI and all Key Personnel including faculty advisor.

Principal investigator: Name Department University at Albany College of Nanoscale Science and Affiliation: Engineering The Neural Stem Cell Institute Other (specify): Position and Title: Faculty Staff UAlbany Graduate Student* Other specify : () TITLE:

E-mail Address must be UAlbany domain email address Address: CITI Completion Report Phone: ORRC Use ONLY: Attached? Yes No Verified :_____

Co-Principal investigator: (Individual designated to oversee research in PI’s absence and Faculty Advisor, when PI is Student) Name Department University at Albany College of Nanoscale Science and Affiliation: Engineering The Neural Stem Cell Institute Other (specify):

2 Position and Title: Faculty Staff UAlbany Graduate Student* Other specify : () TITLE: Address: E-mail Address: CITI Completion Report ORRC Use ONLY: Phone: Attached? Yes Verified :_____ No

If there are additional co-investigators or Key Personnel, please complete and attach Additional Key Study Personnel Form

3 Sponsor Funded Research Studies

Federal regulations require those components of a grant application or contract proposal related to research involving vertebrate animals are congruent with the application/proposal. University at Albany policy extends this review to all funded protocols, whether funded internally or extramurally.

Is this research supported by funding? Yes -- Internal External Source: Sponsor/Agency/Department Name:

NO – SKIP TO SECTION “Study/Activity Information”

Funded Research Information

If you have applied for funding/have been funded, attach a copy of the grant/contract application

Status: Awarded Award pending; JIT information has been requested Other (specify): PI Name on Award: Title of Award/Application: COEUS Proposal Number: University at Albany Office of Sponsored Funds Grant Administrator Name:

4 Study/Activity Information

The following information is required for all projects and is required to be in layperson’s terms. Objectives must be described in clear and short statement (DO NOT EXCEED 500 words) written in LAYPERSON’S LANGUAGE (language that is understandable to a college undergraduate student).

DESCRIPTION

Provide a BRIEF description of the proposed research. The description should focus on THE PURPOSE OF THE STUDY, as well as the PROCEDURES TO BE USED. AVOID SELF- CITATIONS (500 CHARACTER LIMIT)

BENEFIT

Explain how the information gained in this study will benefit human or animal health, the advancement of knowledge, and/or serve the good of society. This information is intended to inform the committee why it is important to conduct this study.

Species and Numbers of Animals

SECTION 1: Project numbers of animals will be utilized in this project for a year. Source/ Total Number* Genus / Approximate Type of Strain/Breed Vender name Sex to be used in Species name Age Animal* (if applicable) Entire Project

SECTION 2: Provide following information.

Justification for use of species:

Justification for use of more than one species (if applicable):

SECTION 3: Provide following information.

5 Are these animals experimentally naive? Yes No

*If No, provide a detailed history of each animal’s use previous to its use on this particular project. This includes behavioral, surgical, drug use etc. Please provide this information by type of animal (Type of animal refers to the condition of animals such as Adult, Pregnant, Neonates, Pups, Aged-animal, etc):

SECTION 4: Describe how the number of animals needed for the study was determined.

SITE Indicate Building name and Room number:

 Location where animals are to be housed:

 Location where procedures are to be performed :

 Location where surgery is to be performed:

Endpoint of Animals

SECTION 1: Specify the experimental endpoint criteria (e.g. percentage of body weight loss or gain, inability to eat or drink, behavior abnormalities, clinical symptomatology, or health abnormalities): [If your lab has IACUC approved SOPs please cite the SOP number: SOP# ]

SECTION 2: Indicate what will happen to the animals at the end point of the project. Please designate the number of animals for each category. If your lab has IACUC approved SOPs, please indicate SOP number.

Endpoint Description Numbers of animals Euthanized [SOP#] Number: Collect Samples (termination) Number: [SOP#] Transferred Another project Number: [SOP#] Please Specify: Returned to Colony Number:

Number: Sold Please Specify : →if this item is checked, provide information and documentation(s) for the sales Number: Other [SOP#] Please Specify :

6 SECTION 3: EUTHANISIA If the study involves euthanasia, please describe the method of euthanasia below: [if your lab has IACUC approved SOPs please cite the SOP number: SOP#]

Location where euthanasia is to be performed:

SECTION 4: If animals are to be sacrificed, describe the procedures to be used. (If pharmacologic agents are to be used, indicate agent, dosage, and route of administration): [if your lab has IACUC approved SOPs please cite the SOP number: SOP# ]

Description of Animal Procedures

SECTION 1: Please provide following information. Objectives must be described in clear and short statements (DO NOT EXCEED 500 words).

You are requested to conduct a literature search on section 2 (next page) for “Refinement”, which may relate to alternatives and duplication sections. Information IS REQUIRED TO BE IN LAYPERSON’S TERMS. Descriptions must be clear and brief sentence(s).

SCIENTIFIC JUSTIFICATION Explain why it is necessary to use animals for this purpose. What is the anticipated scientific or educational benefit that may result from this use of animals? Indicate why it is necessary to use the number and type of animals requested. Descriptions must be written in LAYPERSON’S LANGUAGE (language that is understandable to a high school student).

ALTERNATIVES. Can mathematical/computer models, cell culture or tissue culture systems, in vitro systems, or other non- animal method be used to reduce the number or eliminate the use of animals?

Yes No Specify:

DUPLICATION. Activities involving animals must not unnecessarily duplicate previous experiments. Provide written assurance that the activities of this project remain in compliance with the requirement that there must be no unnecessary duplication:

SECTION 2: REFINEMENT

To reduce the number or eliminate the use of animals, federal law requires alternatives to non-animal method / procedures if available. You are requested to conduct a literature search to determine that either (1) there are no alternative methodologies, by which you can conduct 7 this study, or (2) there are alternative methodologies, but these are not appropriate for your particular study. “Alternative methodologies” refers to reduction, replacement, and refinement of animal use, not just animal replacement. DO NOT attach print-outs of the searches.

ALTERNATIVES TO THE USE OF ANIMALS FOR PAINFUL PROCEDURES

Please provide 3 separate database searches. The date ranges for each database search are also required. Please provide the following information for each procedure. Duplicate the table as often as required.

Procedure: Databases searched (minimum of 3): e.g. Medline, Biosis, Agricola

Date search conducted: Date range of search (month/year): From: To: Keywords used:

Other sources used in addition to database searches: Current books/journals (specify): Professional communication with colleagues (specify): Animal Welfare Information Center (AWIC-http://www.nal.usda.gov/awic/):

Other (specify):

SUMMARY OF FINDINGS:

SECTION 3: Other specific information relate to animal procedure: if your lab has IACUC approved SOPs please cite the SOP number also.

1. Yes No Will this project involve animal identification methods such as ear tag, tattoo, collar, pen marks, dying far, etc? : if yes, specify the method:

2. Yes No Will this project involve other non-surgical procedures (e.g. husbandry procedures, tail biopsies, etc)? : if yes, specify the method: 8 3. Yes No Will this project involve infectious disease?

4. Yes No Will this project involve potential stresses (e.g., food or water deprivation, noxious stimuli, environmental stress)?

5. Yes No Will this project involve any of the following: (i) recombinant DNA (include transgenic animals); (ii) human or animal pathogens; (iii) biological toxins; (iv) administration of experimental biological products or (v) radioactive materials. If yes, mark appropriate item(s).

Recombinant DNA (include transgenic animals) Human pathogens Animal pathogens

Biological toxins Administration of experimental biological products Radioactive materials

Please note: If you checked any of the above boxes, you may need to submit protocols to the University Biosafety Officer, Institutional Biosafety Committee, Institutional Review Board and/or Radiation Safety Committee.

Supplement Forms Check List

Indicate below whether your project involves any of the following: For each item checked, complete the appropriate SUPPLEMENTAL FORM(S) and submit them along with a completed primary form. Additional information may be attached to supplement the required information as necessary. CHECK SUPPLEMENT If CONTENTS FORM applicable

Tissue/Blood collection in survival procedures Tissue/Blood collection in non-survival procedures

Tail Biopsy in mice and rats 1: Collection or Receipt of Biological Samples Samples (other than tail) from birds, rats of the genus rattus, and mice of the genus mus. Warm-Blooded Animals other than birds, rats of the genus rattus, and mice of the genus mus NOTE: “samples” include genetically modified organisms, body fluid, tissues, blood, and pathogens.

2: Behavioral Testing Single procedure Multiple procedures

9 Physical Restrain Food/Water deprivation Shock The use of infectious agents or biological toxins 3: Pain / Distress Other NOTE: other possible pain/distress items as follow; cold/hot exposure, forced exercise, uncontrollable aversive stimuli; if more than “momentary” pain/distress is involved, PI must submit pain/distress form. Please read detail for page 1 of Form 3 for USDA category. If your protocol involves any kind of drugs, please provide the list on the first page of FORM 4.

4: Drug Administration Administration of drugs used for sedation, anesthesia, analgesia, or tranquilizers. Use of Paralyzing / Neuromuscular Blocking Agents Administration of controlled substances other than sedation, anesthesia, 5: Biological Toxins analgesia, paralyzing agents (e.g., narcotics, carcinogens, infectious agents, etc.) (include controlled Use of biological, chemical, toxic, or radioactive substances substance) Administration Use of Narcotics, Carcinogens or other controlled substances

Single procedure Multiple procedures 6: Surgical Procedures Terminal Non-terminal

Housing: Caging, quarantine, light cycle, temperature/humidity control etc. 7: Special Animal Care Satellite Housing: Outside of the animal facility more than 12 hrs Requirements Care of animals by anyone other than animal care staff Animal Transfer : from the outside to the outside

8: Breeding Colony Establishment and Maintenance of a breeding colony

10 PRINCIPAL INVESTIGATOR’S ASSURANCE STATEMENT

I agree to abide by the Public Health Service (PHS) policy, USDA Regulations, the University of Albany Standard Operation Procedures, the Guide for the Care and Use of Laboratory Animals, the Animal Welfare Act (AWA), all federal, state and local laws and regulations and policies of the University of Albany.

Principal Co-Principal Investigator Certification

______Principal Investigator Signature Date:

Printed Name:

______Co-Principal Investigator Signature Date:

Printed Name:

Dean/Department Chair/Center Director Certification

______Department Chair Signature Date:

Printed Name: Dept:

University at Albany Veterinarian Certification

I have consulted with Principal Investigator and certify that:

1) all members of the research team involved in the care and use of animals have completed the required occupational safety and health program requirements; and 2) all painful procedures have been reviewed for the proper use of anesthetics and pain- relieving medications.

______Veterinarian Signature Date:

Antigone McKenna, DVM