For Investigators

The responsibilities of the PI include:

• Ensuring that all PIs and individuals working with the animals are qualified or will be trained to handle, care for, and perform experimental procedures on the animals described in the IACUC application, per federal, state, and institutional requirements
• Providing all personnel with access to the PI’s  protocol
• Making sure that the protocol does not represent an unnecessary duplication of previous experiments
• Ensuring that aseptic techniques are used when surgical procedures are performed on study subjects
• Using Good Laboratory Practices within the laboratory
• Reporting any changes in a previously approved IACUC protocol to the IACUC for review and approval. Such changes cannot be initiated without prior IACUC review and approval. 
• Providing annual progress reports or updates regarding experimental outcomes as required by the IACUC
• Notifying the IACUC immediately of any relationship which constitutes a conflict of interest
• Identifying occupational health hazards related to the protocol and to providing the necessary training and equipment to minimize risks to staff
• Requiring research personnel to use personnel protective equipment while working with hazardous materials or in areas where such equipment is required
• Ensuring that all personnel use laboratory coats and proper attire while working in the laboratory
• Reporting to the IACUC any injuries to research personnel or adverse events related to the study within five business days of the occurrence  
• Promptly reporting to the IACUC any violations to animal or human health and well-being, or violations of IACUC policies and procedures. Reporting may be confidential without fear of reprisal.
• Recognizing that failure to adhere to federal, state, and institutional policies related to animal care and use may result in the suspension or revocation of my privilege to perform animal research at the Mount Sinai Medical Center
• Promptly notifying the IACUC and submit a final report when a protocol is closed.

Purpose 
Pre- Intra- and Post-operative monitoring of animals that undergo surgical procedures ensures the preservation of animal welfare and regulatory compliance ^1,2,3,4. 

As such, Principal Investigators who perform surgical procedures on animals at the Icahn School of Medicine at Mount Sinai must complete a surgery and postoperative record.  

Click here to view the Rodent Surgery and Post Op Record Report.

Surgical Record Content  
List the names of the anesthetic and analgesic to be administered, dosage(s), route (s), timepoints for administration and the name of the individual administering the drug(s) for each animal. Postoperatively, animal body weights, body condition scores, analgesics, (dose, route), and the name of the individual administering the drug(s) also need to be recorded. 

Protocol Congruency
Principal Investigators must ensure congruency of surgical procedures, agents and timepoints performed with those described in their approved IACUC protocol. Unapproved procedures, techniques and non-approved agents used in a study without IACUC approval represent non-compliance and must not be performed without IACUC approval. 

Record Retention
Surgical records must be maintained on file either digitally or in paper form held within a binder and made readily available for IACUC review upon request.

The record is an official document and should not be discarded.

Refer to the IACUC Policy on Surgical Procedures.

References

1. 9 C.F.R. §2.35 Recordkeeping Requirements

2. AAALAC International FAQ Veterinary Medical Care #4

3. The Guide for the Care and Use of Laboratory Animals, p. 115

4. US Government Principals for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training, Section V. 

Purpose:
The food/fluid regulation log is required to track the intake and output of food and fluids (e.g., timepoints, quantities, observation) and monitoring of animal health. 

This ensures the animal(s) receive adequate hydration and nutrition. Documenting animal food and fluid intake is critical for animal welfare, experimental reproducibility, and validation. 

Click here to view the Food and Fluid Regulation Logs.

Protocol Congruency
Principal Investigators must ensure congruency of food and fluid regulation and timepoints performed with those described in their approved IACUC protocol. Unapproved procedures, techniques and   non-approved agents used in a study without IACUC approval represent non-compliance and must not be performed without IACUC approval. 

Daily Monitoring

Record: 

• The date and time of each entry
• Animal ID numbers
• Baseline weights, body condition score and any other relevant pre-regulation data.
• Each animal’s 85% baseline weight should be noted at the start of the study.
• Food Given: document that animals have received daily food rations
• Food Intake: Specific food and beverages consumed, the amount of food offered and consumed, timepoints including any refusals or spillage.
• Fluid Administered: document that animals have received daily fluid volume(s) as noted in an approved IACUC protocol
• Fluid Intake: document that animals have received daily food rations
• Hydration: should be reflected by the presence of urine and feces as well as skin turgor
• Body weight: must be recorded as documented in the approved IACUC protocol or more frequently, if needed
• Body Condition Score: must be recorded as documented in the approved IACUC protocol or more frequently, if needed.
• Initial /Name of the individual monitoring the animal(s).

Record Availability and Retention

A COPY OF THE FOOD/FLUID RESTRICTION LOG MUST BE KEPT IN THE VIVARIUM SO THAT ANIMAL HUSBANDRY TECHNICIANS AND REGULATORY BODY INSPECTORS CAN VERIFY THAT ANIMALS HAVE BEEN FED AND/OR RECEIVED DAILY FLUID RATIONS BY LABORATORY PERSONNEL.

• Food and Fluid Regulation records must be maintained on file either digitally or in paper form held within a binder and made readily available for IACUC review upon request. The record is an official document and should not be discarded.

General Comments: Ensure that any changes in animal health and well-being are noted and reported to the IACUC, CCMS Veterinarians, animal husbandry  and/or CCMS Veterinary technicians immediately (e.g., dehydration, overhydration, adverse events, unexplained changes in weight, etc.).

Investigators must communicate with facility supervisors and animal husbandry staff regarding periods of restriction. A CCMS service request should be submitted for cages that house animals that are on food and water restrictions must be housed in clearly marked cages. Signage must be placed on cages and include emergency contact information and procedures for which animal care personnel will provide food if animal care staff cannot verify that the animals have been fed by the laboratory personnel.

Refer to the IACUC Policy on Food and Fluid Regulation.

References

• Animal and Plant Health Inspection Service Animal Care (APHIS AC). 2011. Policy #11: Painful and Distressful Procedures.
• Animal Welfare Act Regulations. (n.d.). 9 CFR. Chapter 1. Subchapter A. Part 2.38 (f) (2) (ii).