Frequently Asked Questions
Q: Who can be a Principal Investigator (PI)?
A: The Animal Welfare Act Regulations (AWAR) state thata 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 IACUC require a PI to be a faculty member. However, a Post-Doctoral fellow may be 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.
Q: Where are IACUC policies located?
A: IACUC policies are only accessible via the intranet.
Q: What are the responsibilities of a Principal Investigators in conducting animal studies?
A: Below are representative categories of PI’s responsibilities regarding studies involving laboratory animals.
PIs must ensure that:
1. IACUC documents (e.g., Initial applications, Continuations, etc.) 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:
i) Are properly supervised;
ii) Are trained to conduct species-specific procedures for animal care and use (e.g., surgery, euthanasia, health monitoring);
iii) Are trained to recognize sign of pain and distress in laboratory animals;
iv) Are familiar with all the provisions described in IACUC approved protocols (e.g. use of anesthetics and analgesics, humane endpoints, etc.);
v) Are informed and trained to deal with potential hazards (biological, chemical, radiological) involved in a study;
vi) Are trained to follow specific SOPSs and to use personal protective equipment (PPE) to protect them from the particular hazards associated with the study;
vii) Practice ethical behavior on all aspects of animal care and use.
Q: What is the duration of the approval of an IACUC protocol?
A: Protocols are approved for a period of three years. After three years, PIs must submit a continuation application, which is reviewed 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 theexpiration date of the protocol.
Q: How are IACUC protocols reviewed?
A: Protocols are reviewedaccording 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 CRC IACUC Handbook.
Q: How quickly can I expect an IACUC approval?
A: Protocols that involve minimal pain and distress to laboratory animals are generally reviewed by designated member review (DMR). DMR have 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, major surgeries, etc.) are reviewed by the full committee at a convened meeting (FCR). FCR meetings are held twice a month on Wednesdays. FCR have a turnaround time of approximately 3-4 weeks.
Q: Where can I find a list of approved analgesics and anesthetics and the recommended dosages for common laboratory animal species?
A: This information may be found on the website of the Center for Comparative Medicine and Surgery.
Q: What are common mistakes that delay approval of IACUC applications?
A: Some suggestions to avoid having protocols sent back to you for corrections:
- Protocol: Please complete all required section of the protocol form, including the Safety/Biosafety modules.
- 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-scientists members of the IACUC.
- Study Design: Do not copy and paste highly technical sections of an extramural application into the Study Design of the IACUC application. The description of the design should be informative and understandable to scientists who are non-specialist 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.
- Study Design: The narrative should also contain a brief statement of the significance of the study for human or animal health.
- Procedures: Each procedure should be described under an appropriate title in a separate section of the Procedure tab. Do not describe multiple, unrelated procedures under a single title.
- 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 of major surgeries, or chemical carcinogenesis).
- Humane Endpoints: Humane endpoints should not be confused experimental endpoints. Humane endpoints refer to the humane termination of an animal due to serious deteriorations in its health conditions.
- 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 was calculated (e.g., statistics, previous experience, etc.).
Q: Where can you find assistance in calculating statistical estimates of the numbers of animals needed in a study?
A: The Center for Biostatistics of the Icahn School of Medicine offers a free clinic and fee for service consultation. Refer to their website for contact and additional information.
Q: How do I perform a literature search for alternatives to the use of animals and procedures that may cause pain and distress?
A: An example of literature search:
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, social isolation, etc.);
iii) Search a reasonable range of years (e.g., 2000-present);
iv) Provide a concise statement regarding the outcome of the search.
For more comprehensive regulatory information please visit this site.
Q: What are the definitions of “significant changes” in a study protocol?
A: According to regulatory agencies, significant changes are defined as:
i) Changing surgeries/procedures from non-survival to survival;
ii) Changing or adding procedures that would have a greater degree of invasiveness and/or result in greater pain, distress;
iii) Changes in housing and/or use of animals in a location that is not part of the animal program overseen by the IACUC;
iv) Changes in the species used in a study;
v) Changes in study objectives;
vi) Changes in Principal Investigator (PI);
vii) Procedural changes that may that impact personnel safety.
For more extensive information regarding regulatory definitions of major vs minor changes in a protocol please visit this site.
Q: What should I do if I need to add a Significant Changes to an approved protocol?
A: If the proposed significant changes (e.g. adding major surgery) fall within the overall scientific aims of the approved study you need to 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 (GCO, (212)824-8300) for advice and information regarding such requirements.
Q: How do I add a new strain of mice to my (mouse) protocol?
A: In order to add a new strain on mice toan existing approved mouse protocol you need to submit an amendment to the protocol:
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, and;
iv) Describe if the mice have a normal or pathologic phenotype, and;
v) Amend all other appropriate sections of the IACUC forms including the Study Design.
Q: What documentation is required when the Mount Sinai is the primary awardee but a collaborator at a different Institution would perform some animal work?
A: The following are required:
a) All sites where animal work would be performed must have an NIH/OLAW 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 (MOU) regarding reciprocal duties for maintaining regulatory compliance. Once the required signatures are received, a copy of the MOU should be attached to the PI’s Mount Sinai protocol record.
e) A Material Transfer Agreement may need to be filed by the Mount Sinai PI (see below).
Note: The types of collaborations may vary (e.g., domestic, international, third party, etc.). For clarification regarding the required documentation needed for your specific collaboration, contact the IACUC office at 212-241-0153, firstname.lastname@example.org for assistance.
Q: What is a Material Transfer Agreement and how do I initiate one?
A: A material transfer agreement (MTA) is an agreement that outlines the rights and responsibilities of the Mount Sinai Health System and an external party (e.g. academic institutions, industry) regarding the transfer and use of research materials (e.g. animals, human tissue, plasmids, cell lines, chemicals, drugs, etc.) by the recipient. This is an important document which aims to protect the interests of PIs and Mount Sinai. Contact the Mount Sinai Innovation Partners for more information and assistance at 212-659-9680.
Q: My IACUC protocol has been approved. Whom do I contact to discuss animal housing?
A: The Center for Comparative Medicine and Surgery (CCMS) office should be contacted at 212-241-3008 for assistance.
Q: How do I withdraw an expired study protocol?
A: If the study will be discontinued, The PI must:
i) Submit a Final Report to the IACUC;
ii) Submit A final to the Grants and Contracts Office;
iii) Notify the Finance department;
iv) Notify 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.
(See Closing an IACUC Protocol under the For Investigators section of the IACUC website)