Frequently Asked Questions

A: The Animal Welfare Act Regulations (AWAR) state that a principal investigator (PI) is “an employee of a research facility, or other person associated with a research facility, responsible for a proposal to conduct research and for the design and implementation of research involving animals.” (AWAR, p. 23).

The Icahn School of Medicine at Mount Sinai and Institutional Animal Care and Use Committee (IACUC) require a PI to be a faculty member. However, a post-doctoral fellow may also be a PI on a grant and listed as such on the IACUC protocol, as long as a senior faculty mentor is also listed on the application.

A:  IACUC policies are only accessible via the intranet.

A: The representative categories of PI’s responsibilities regarding studies involving laboratory animals are as follows. The PI  must ensure that:

1. IACUC documents (e.g., initial applications and continuations) are approved and up to date before starting any study involving animals.
2. All laboratory personnel involved in an animal study are listed in the relevant, approved IACUC protocol.
3. Members of the laboratory staff are:
• Properly supervised
• Trained to conduct species-specific procedures for animal care and use (e.g., surgery, euthanasia, and health monitoring)
• Educated to recognize signs of pain and distress in laboratory animals
• Familiar with all the provisions described in IACUC approved protocols (e.g., use of anesthetics and analgesics and humane endpoints)
• Informed and trained to deal with potential hazards (including biological, chemical, and radiological) involved in a study
• rained to follow specific standard operating procedures and to use personal protective equipment to protect them from the specific hazards associated with the study
• Prepared to practice ethical behavior in all aspects of animal care and use

A: Protocols are approved for a period of three years. After three years, PIs must submit a continuation application, which the committee will review as if it were a new application. Please note that approval of an amendment to a protocol during the three-year period does not change or reset the expiration date of the protocol. 

A: Protocols are reviewed according to principles and guidelines contained in the Animal Welfare Act (AWA), AWA Regulations, the “Guide for the Care and Use of Laboratory Animals,” the Public Health Service Policy on Humane use of Laboratory Animals, as well other sources of regulatory information, such as the IACUC Handbook.

A: Protocols that involve minimal pain and distress to laboratory animals are generally reviewed by a designated member review, which has a turnaround time of approximately 10 days. Protocols that involve risks of pain and distress to the animals (e.g., cancer studies, toxicity tests, induction of disease states, and major surgeries) are reviewed by the full committee at a convened meeting. These meetings are held twice a month on Wednesdays. FCR have a turnaround time of approximately three to four weeks. 

A: You can find this information on the website of the Center for Comparative Medicine and Surgery.

A: Here are some suggestions to avoid having protocols sent back to you for corrections:

1. Protocol:Please complete all required sections of the protocol form, including the safety/biosafety modules.  
2. Lay Summaries:Please write the summary in lay terms. Be informative, but avoid using complex scientific terminologies and acronyms that would be unfamiliar to the lay and non-scientist members of the IACUC.
3. Study Design:Do not copy and paste highly technical sections of an extramural application into the study design section of the IACUC application. The description of the design should be informative and understandable to scientists who are non-specialists in your field, and, importantly, it should include concise descriptions of the animal procedures/techniques used to achieve each of the aims of the study.
4. Study Design:The narrative should also contain a brief statement of the significance of the study for human or animal health.
5. Procedures:Describe each procedure under an appropriate title in a separate section of the procedure tab. Do not describe multiple, unrelated procedures under a single title. 
6. Health Monitoring Plan: The health monitoring plan for a given procedure should be commensurate to the risk for producing pain and distress in an animal (e.g., blood sampling does not have the same health consequences as major surgeries or chemical carcinogenesis).  
7. Humane Endpoints:Do not confuse humane endpoints with experimental endpoints. Humane endpoints refer to the humane termination of an animal due to serious deterioration in its health. Experimental endpoints means the study is completed.
8. Justification of Animal Numbers for Species:The justification of animal numbers should include a concise description of experimental and control groups, and of how the animal numbers per group were calculated (e.g., statistics, previous experience).

A: The Center for Biostatistics at Icahn Mount Sinai offers a free clinic and fee-for-service consultation.  

A: You can conduct a literature search in the following manner:   

(i) Use PubMed to search MEDLINE.
(ii) Enter key words related to the species used, and the procedure name (e.g., mouse, craniotomy, laparotomy, prolonged restraint, and social isolation).
(iii) Search a reasonable range of years (e.g., 2000-present).
(iv) In the write-up, provide a concise summary of the outcome of the literature search.

The U.S. Department of Agriculture’s National Agricultural Library provides more comprehensive regulatory information.

A: According to regulatory agencies, significant changes include:

(i) Varying surgeries/procedures from non-survival to survival
(ii) Altering or adding procedures that would have a greater degree of invasiveness and/or result in greater pain, distress
(iii) Shifting housing and/or use of animals in a location that is not part of the animal program overseen by the IACUC
(iv) Changing the species used in a study
(v) Altering the study objectives
(vi) Varying the principal investigator  
(vii) Making procedural changes that may affect personnel safety

The National Institutes of Health’s Office of Laboratory Animal Welfare provides more extensive information regarding regulatory definitions of major versus minor changes in a protocol.

A: If the proposed significant changes (e.g., adding major surgery) fall within the overall scientific aims of the approved study, you must submit an amendment of the approved protocol. If, however, the proposed changes do not have objectives congruent with the ones (change in scope) of the originally approved study, you must submit a separate, new IACUC protocol. Note: Changes in objectives or scope of a study may also require prior approval by the funding agencies; please contact the Grants and Contract Office (212-824-8300) for advice and information regarding such requirements. 

A: In order to add a new strain of mice to an existing approved mouse protocol, you need to submit an amendment to the protocol. The amendment must:

(i) Explain concisely the rationale for adding the new strain in the Amendment section.
(ii) Describe which procedures the new mice would be subjected to.
(iii) Justify the number of new mice needed for the study.
(iv) Describe whether the mice have a normal or pathologic phenotype.
(v) Amend all other appropriate sections of the IACUC forms, including the study design section.

A:  The following are required:

a) All sites where animal work would be performed must have a National Institutes of Health/Office of Laboratory Animal Welfare Assurance.
b) The Mount Sinai PI must submit an IACUC protocol describing which animal studies would be performed at Mount Sinai and which would be contracted out. 
c) The PI at Mount Sinai must provide the IACUC with a copy of the approval letter from the collaborating institution for the subcontracted animal work. 
d) The IACUC Office will work with the collaborator’s IACUC Office to execute a Memorandum of Understanding regarding reciprocal duties for maintaining regulatory compliance. Once you have received the required signatures, attach a copy of this document to the PI’s Mount Sinai protocol record. 
e) The Mount Sinai PI may need to file a Material Transfer Agreement (see below).

Note: The types of collaborations may vary (e.g., domestic, international, or third party). For clarification regarding the required documentation needed for your specific collaboration, contact the IACUC office at 212-241-0153, iacuc@mssm.edu, for assistance.

A:  A material transfer agreement outlines the rights and responsibilities of the Mount Sinai Health System and an external party (e.g., academic institutions, or industry) regarding the transfer and use of research materials (e.g., animals, human tissue, plasmids, cell lines, chemicals, and drugs) by the recipient. This is an important document that aims to protect the interests of PIs and Mount Sinai. Contact Mount Sinai Innovation Partners for more information and assistance at 212-659-9680.

A: You should reach out to the Center for Comparative Medicine and Surgery at 212-241-3008 for assistance.

A: If the study will be discontinued, the PI must:

(i) Submit a final report to the IACUC.
(ii) Provide a final report to the Grants and Contracts office.
(iii) Notify the finance department.
(iv) Inform the Center for Comparative Medicine and Surgery vivaria accounts manager.
(v) Notify the Center for Comparative Medicine and Surgery vivaria regarding the disposition of animals covered by the expired protocol.

For additional information, see Closing an IACUC Protocol under the For Investigators section of the IACUC website.