Protocol Preparation and Submission

Protocol Preparation (section specific information)

Personnel (PE)

Personnel: Include all staff, professional and technical, that will have direct contact with the animals, will need to edit or prepare the protocol, who should be contacted in case of an animal emergency, and who will order animals for the protocol. Only the Principal Investigator can initiate and submit a protocol; however once initiated the PI can select personnel and assign them editing rights allowing the designated individual to develop the protocol.

Principal Investigator: The Principal Investigator (PI) must be a full-time employee with an appointment as Research Associate or higher at MSKCC or Instructor or higher at WCMC, and should normally be the PI on any grants associated with the protocol. The PI receives all correspondence from the IACUC and is required to share applicable correspondence with staff listed on the protocol. The PI is required to submit the protocol or subsequent amendments.

Contact person: The contact person is the individual who is/will be contacted regarding the animal’s health and/or its disposition when morbidity requires action. All correspondence from the IACUC will be sent to the PI as well as the contact person. Only one contact person is permitted per protocol.

Animal requisitioner: Staff who have permission to order animals for the protocol.

Animal user: Staff who will handle animals and will conduct some or all of the procedures described in the protocol.

Sponsorship (GI)

Provide all funding instruments that are associated with the protocol. All grants using animals must have a corresponding approved IACUC protocol. Internally funded projects, not subject to external peer review, must be signed by the Program or Department Chair as a confirmation that the scientific merit of the proposal has been reviewed and is determined to be worthy of conduct.

PHS Policy IV.D. requires the institution to verify, before award, that the IACUC has reviewed and approved those components of grant applications and contract proposals related to the care and use of animals. This position is reiterated in NIH Grants Policy Statement under Part II, Terms and Conditions. The signature of the authorized institutional official on any PHS application or proposal indicates the organization's commitment to comply with the laws, regulations, and policies to which an activity is subject. Institutional submission of IACUC approval, subsequent to submission of the application/proposal, must represent approval of the information originally submitted in the application/proposal, or include notification of any significant changes required by the IACUC.

It is an institutional responsibility to ensure that the information the IACUC reviews and approves is consistent with that contained in the application/proposal to be funded.

Duplication of Effort (DE)

Federal and state regulations require that the Investigator determine that the proposed studies have not been conducted previously. This is normally achieved by a bibliographic literature search. This search also allows the Committee to determine the scientific suitability of a particular model. It is not necessary to include the abstracts retrieved, except in select cases, to distinguish proposed studies from published studies.

Experimental Plan(s) (XP)

An experimental plan must be completed for each species to be used on the protocol.

Animal Numbers (XE)

State the number of animals to be used over the next 3 year period for each species. This number must match exactly any subsequent justifications and descriptions in the protocol.

Animal Justification (AJ)

Explain how the number of animals requested will be utilized. Include the determination of animal number per group. Please briefly detail the experimental design so that the reviewer(s) can ascertain how the number of animals requested will be used. Include a table or flowchart as appropriate.

A common misconception about the review process is that the primary purpose is to severely restrict the number of animals used by an investigator. Rather, it is essential that the number of animals requested be based on a clear and rational experimental design permitting the investigator to address a hypothesis. Whenever possible, the number of animals requested should be justified in the following terms: the number of animals per group X the number of groups X the number of time points X the number of experiments to be performed. The determination of the number of animals per group is critical and should be justified. The Guide for the Care and Use of Laboratory Animals states that statistical methods should be used whenever possible to justify the number of selected animals.

In some cases, personal or published experience can provide justification for selecting group sizes. However, it is preferable to calculate the group size required to achieve statistical significance based on the magnitude of the difference one needs to detect (power computation). Free software is available for power analysis at http://www.uib.no/isf/people/doc/ssd.htm. The number described in this section must match the numbers entered in Section XE.01. You need not describe the experimental design here, only the calculation of the number of animals required. The IACUC strongly recommends that a table or flow chart be included.

Assessment of pain and distress: (USDA Categorization) For each species, indicate the number of animals that will be used in each USDA category (C, D, and/or E). The reviewers are concerned with the degree of pain and/or distress imposed on the animals and the methods investigative staff will use to prevent, relieve or minimize its occurrence.

The American Physiological Society has defined stimuli as painful to animals if those stimuli: (a) are detected as pain in humans; (b) approach or exceed tissue damaging proportions; and/or (c) produce escape or avoidance behavior in animals.

The United States Government Principles for the Utilization and Care of Animals require "The avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices. Investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in other animals, unless the contrary is established. Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved should be painlessly killed at the end of the procedure, or, if appropriate, during the procedure".

The following guidelines should be used in selecting the appropriate category:

Category C: Animals should be listed in Category C if no pain and/or distress will be inflicted on the animals, or if the procedures will be associated with only minor or momentary pain and/or distress not warranting the use of drugs. Some examples of procedures that would be classified under Category C include: subcutaneous or intraperitoneal injections of non-irritating substances, venipuncture, short-term non-surgical catheterizations, gastric lavage or gavage, administration of non-toxic oral medications, sacrifice and tissue harvest, etc. Category C procedures do not require an evaluation of alternatives to painful procedures in Section AM.01: Alternative Methods.

Category D: Animals should be listed in Category D if, during the course of the proposed study, they will experience pain or distress which will be relieved by the use of appropriate drugs or other methods such as humane euthanasia. Any animal undergoing procedures, wherein the animal is subjected to the effects of anesthetic drugs should be listed in Category D. The classification of procedures into USDA Category D requires a written evaluation and literature search of alternatives to painful procedures in Section AM.01: Alternative Methods. Your experimental plan and Section AU.01: Special Considerations should indicate how and when pain or distress would be induced, how it will be monitored (e.g., behavior), and how it will be alleviated (analgesics, anesthetics, or euthanasia).

In order for the IACUC to understand how pain and distress will be alleviated, it is necessary to describe how the existence of pain or distress will be determined. For example, the response to noxious stimuli indicates the need to administer additional anesthesia. Note: The use of "paralytic muscle relaxants" must be accompanied by the use of an anesthetic agent. In this case, special techniques, such as the monitoring the animal's EEG, heart rate, and blood pressure must be used to assess anesthetic depth as the animal is unable to move, even if experiencing pain, under the effects of a paralytic. Describe, in detail, how you will ensure that the animal remains anesthetized.

In conscious animals, signs of pain and distress may include failure to groom, reduced food and water intake, decreased activity, rubbing, licking, pawing or guarding a body part, vocalization, and change in responsiveness. As a simple rule, assume that if the procedure would cause more than momentary pain to a human, it would be painful to an animal. The following are examples of studies which would be included in Category D:

  1. Survival and non-survival surgical procedures conducted under anesthesia
  2. Use of an animal model in which natural or experimental disease occurs resulting in painful or distressful conditions which are relieved once detected.
  3. Studies employing tumor implantation in which a defined endpoint is specified before or at the time pain or distress occurs. In general, the IACUC considers tumor-bearing animals as USDA Category D. If, for scientific reasons, you can neither eliminate pain and distress nor euthanize animals prior to tumor pain or distress developing, include the animals in Category E.

Category E: Animals should be listed in Category E if they involve subjecting animals to a painful/stressful procedure without the use of anesthetics or analgesics or relief of stress. Examples include prolonged manual restraint; toxicity testing in which toxicity cannot be relieved; or, studies that involve death as the endpoint. Category E procedures are strongly discouraged and will be carefully evaluated, therefore a clear and unequivocal scientific justification must be provided. Please note that procedures classified under Category E are not permitted where the sole purpose of the exercise is to instruct or train inexperienced personnel.

Special Considerations (AU)

Physical restraint: Physical restraint of animals may cause distress and/or pain. To minimize distress, the period of restraint should be the minimum required to accomplish the research objectives and the animals placed in restraint equipment should be conditioned to the equipment prior to initiation of the studies. Animals that are physically restrained must be carefully monitored throughout the period of restraint. Completely explain procedures involving restraint and justify the need to conduct them. Include the methods whereby the animal will be monitored and how any pain and/or distress that might arise will be handled. Restraint for short periods (minutes), e.g. to administer injections, is not considered restraint as defined in this question.

Frequency of Observations: Describe the frequency with which the animals will be monitored for the adverse outcomes described above throughout the course of the study. Include the nature/scope of the observations. In general, animals on study in which adverse effects are reasonably expected to occur, should be monitored at least daily.

State the nature and frequency of observations to evaluate the health and well-being of this species during the course of the research:
Note: IACUC policy mandates that animals be observed at least weekly. Depending on experimental usage, observation frequency may need to increase to daily or multiple times per day. If daily observations are necessary, weekends/holidays must be included.

Adverse Outcomes: Consider reasonable adverse outcomes to procedures. Provide the method(s) by which such outcomes will be monitored and alleviated.

Food and/or water restriction: Food deprivation/restriction for < 12 hours prior to surgery is not considered restriction as defined in this question. Food deprivation/restriction for other reasons, unless deprivation/restriction is for behavioral training, or feeding a nutritionally deficient diet or a diet with an excess of nutrients, requires completion of this question.

In all instances where water will be withheld, unless for <12 hours prior to surgery, scientific justification must be provided.

If the proposed study requires the use of nutritional stress or water deprivation, animals should be placed in Category D or E, dependent on whether distress is alleviated when detected. Indicate how any pain and distress will be monitored during the course of the study, and how it will be relieved.

Any deviation from ad libitum provision of food and water, other than the customary 6-12 hour fasting period prior to administration of general anesthesia, is considered a restriction.

Therapeutic restrictions: This section will assist RARC in handling veterinary emergencies. Indicate what, if any, restrictions exist and what should be done if animals are found dead. Please Note: Special requests must be addressed to the RARC prior to commencing work.

In an emergency, animals will be treated to relieve suffering and preserve life, or if necessary, euthanized. Investigators will be contacted prior to diagnostic testing, therapy, or euthanasia whenever possible. In the event that contact is not possible, please respond accordingly and list restrictions on therapy where applicable.

Non-standard housing or abnormal environmental conditions: If the proposed study will involve deviations from normal husbandry or environmental conditions or prolonged imposition of abnormal conditions, check Yes and supply information on the degree and duration of variations from normal conditions. Provide justification and rationale, give the methods by which the animals will be monitored for pain and/or distress that might arise, and state how such pain and distress will be handled. If pain and distress cannot be alleviated, include the animals in Category E. The "Guide" recommends solid bottom caging, with bedding, for rodents. If your project requires that animals be housed in metabolic or wire bottom caging, complete this section.

A description of standard housing conditions can be found in RARC's Users Guide.

Procedure Selection (XF)

Anesthesia (AN): Select if anesthesia will be administered to conduct a surgical or technical procedure and/or implant/remove a device. Do NOT select if anesthesia use is limited to blood collection or for restraint when imaging. You may include multiple Anesthesia items into this experimental plan. As you include each item, it will be displayed in a list. Each technique is given a temporary name of 'TempTechName' until you assign it a pre-approved technique or name it yourself. Once it has been included, you may edit it, delete it, or review it by clicking on the appropriate icon next to the item. Once all your items have been included in this experimental plan, click "Save and Continue" to go to the next section.

The following Guideline is suggested for additional information: Guidelines for the Utilization of Anesthetics and Analgesics in Small Laboratory Animals

Ascites Production (AP): Select if monoclonal antibodies will be generated by ascites. MSKCC's and WCMC’s IACUC has established the following policy for producing monoclonal (MAbs) from established hybridomas:

MAb production should be conducted in vitro unless evidence is presented to the IACUC that in vitro techniques have been attempted (for the specific cell line for which mice are requested) and that insufficient antibody was produced or the resultant antibody did not have the desired biological activity. MSKCC's Core Monoclonal Antibody Laboratory or several commercial sources are suggested as sources to produce MAb in vitro.

The following Guideline is suggested for additional information: Guidelines for the Utilization of Rodents in Experimental Neoplasia and Ascites Production

Behavior/Training (BT): Select if you will be conducting behavioral assays or employ training techniques.

Biologics (BI): Select if biologics other than tumors, cell lines, or cell stocks will be administered.

Blood Collection (BC): You may include multiple Blood Collection items into this experimental plan. As you include each item, it will be displayed in a list below. Each technique is given a temporary name of 'TempTechName' until you assign it a pre-approved technique or name it yourself. Once it has been included, you may edit it, delete it, or review it by clicking on the appropriate icon next to the item. Once all your items have been included in this experimental plan, click "Save and Continue" to go to the next section.

Select if blood will be collected even if collected at euthanasia. Blood collection can have a profound effect on a wide range of biochemical and physiological phenomena that may affect both the experimental results and the animal's well-being. The method of blood collection can also have adverse effects. RARC’s Veterinary Services can provide assistance in blood collection.

The following Guidelines are suggested for additional information: Guidelines for Handling, Restraint, Injection, and Blood Collection from Small Laboratory Animals

Guidelines for the Production of Polyclonal and Monoclonal Antibodies in Rodents and Rabbits

Breeding (BR): Select if the species described in this experimental plan are to be bred. If you are breeding animals you will be required to describe how they will be genotyped and identified.

Harem breeding is defined as cohousing two females with one male. The IACUC Policy for Maintaining Mouse Cage Population must be followed as detailed in the Guideline for Breeding Genetically Engineered, Inbred, and Mutant Mice. If you are conducting harem breeding you must provide the rationale for utilizing harem breeding.

Chemicals/Drugs/Irradiation (CD): You must provide the dose(s), volume(s), route(s) of administration, frequency of administration, and duration of administration for each agent and/or drug to be administered as well as irradiation information. If any of these substances are hazardous to humans, for example, carcinogens, mutagens, infectious agents, and/or radioisotopes, you will be requested to complete the Hazardous Agent section (HA) and the materials must be used in conformance with the policies of MSKCC's or WCMC’s Environmental Health and Safety department and the NIH Guide for the Care and Use of Laboratory Animals. Specialized facilities are available for conducting studies employing hazardous agents in the Research Animal Resource Center.

Genetically Engineered/Mutant Model (GM): You may include multiple Genetically Engineered/Mutant Model items into this experimental plan. As you include each item, it will be displayed in a list below. Each technique is given a temporary name of 'TempTechName' until you assign it a pre-approved technique or name it yourself. Once it has been included, you may edit it, delete it, or review it by clicking on the appropriate icon next to the item. Once all your items have been included in this experimental plan, click "Save and Continue" to go to the next section.

You may select a pre-approved Genetically Engineered or Mutant Line/Stock for your protocol (if available), or alternatively answer questions pertaining to one of your own design.

Some of the mouse strains may develop a phenotype in which the animal is subject to pain or distress. A phenotype which results in impairment of vital functions, clinical disease, and/or death is of particular concern. The phenotype of the genetically altered animal must be described. If the phenotype results in clinical abnormalities, explain them fully. Indicate how the animals will be monitored during the study, and how developing pain or distress will be alleviated. If the animal's identification and/or genetic makeup will be determined by utilizing tail biopsy or toe clipping procedures you are required to adhere to established IACUC policy.

Hazardous Agent Use (HA): If the materials you are using were identified as hazardous in other protocol sections:chemicals/drugs/irradiation or tumors/cell lines/cell stocks, or is(are) a recombinant nucleic acid(s) you will be required to complete this section and the relevant information already provided will be prefilled.

An agent is considered hazardous if it or its metabolites are potentially hazardous to humans. OSHA considers all human derived cell lines and stocks, even those passaged in culture multiple times to be hazardous and should be handled at BSL-2. Contact MSKCC's or WCMC’s Environmental Health and Safety Department if you need further assistance.

The use of hazardous agents in animals must be approved by each institution’s Environmental Health and Safety (EHS) department in consultation with RARC’s leadership, prior to initiating work with these agents. A Protection and Control Form (P&C Form) will be generated by various safety specialists. Once the form has been completed, you will be notified by email to review it and acknowledge that you will implement the recommended safety procedures and ensure the staff utilizing the agent(s) have received appropriate training. Once you accept these responsibilities the staff, which were identified in your protocol as handling the agent, will be notified by email to acknowledge they will adhere to the recommended safety practices. In addition, RARC must be contacted prior to implementing the use of a hazardous agent(s) as these studies will likely be conducted in specialized areas isolated from the general animal population. Please remember, all personnel who work with hazardous agents are required to obtain specialized training depending on the specific hazardous agent employed.

Immunization and antibody harvest (IM): Complete Freund's adjuvant (CFA) is hazardous to personnel and can be irritating to animals if not used properly. CFA must only be used once with consideration to volume and site of inoculation. Approval of the use of Freund's adjuvant is subject to the conditions specified in the Guidelines for the Production of Polyclonal and Monoclonal Antibodies in Rodents and Rabbits.

Surgery/Technical Procedures (SU): You may include multiple Surgery/Technical Procedures items into this experimental plan. As you include each item, it will be displayed in a list below. Each technique is given a temporary name of 'TempTechName' until you assign it a pre-approved technique or name it yourself. Once it has been included, you may edit it, delete it, or review it by clicking on the appropriate icon next to the item. Once all your items have been included in this experimental plan, click "Save and Continue" to go to the next section.

"Surgery" is defined here as any manipulation that penetrates and/or exposes a body cavity. "Survival Surgery" indicates that the animal will awaken from anesthesia even if for a short period. "Non-survival or Acute Surgery" means that euthanasia is performed while the animal is still under general anesthesia. Aseptic technique must be used on all animals (including rodents and rabbits) that undergo major survival surgery. In addition, for all non-rodent mammals these procedures must be performed in a facility designed for aseptic surgery and used exclusively for that purpose. RARC maintains specialized animal surgical suites for investigator use. Please remember, all personnel who will perform survival surgery on rodents must obtain specialized training prior to performing surgery.

The following Guideline is suggested for additional information: Guidelines for Conducting Survival Surgical Procedures in Rodents

Tissue/Fluid (non-blood) Harvest (TF): You may include multiple Tissue/Fluid (non-blood) Harvest items into this experimental plan. As you include each item, it will be displayed in a list below. Each technique is given a temporary name of 'TempTechName' until you assign it a pre-approved technique or name it yourself. Once it has been included, you may edit it, delete it, or review it by clicking on the appropriate icon next to the item. Once all your items have been included in this experimental plan, click "Save and Continue" to go to the next section. To acquire tissue for analysis and/or cell culture. To be considered tissue harvest, the animal is humanely sacrificed by an approved method of euthanasia before collection. Animals used for tissue harvest are listed in Category C. However, if tissues are acquired while the animal is under anesthesia, even if the animals are sacrificed at the time of or following tissue harvest, the animals must be listed in Category D.

Tumors/Cell Lines/Cell Stocks (TU): For each tumor, cell line or cell stock to be administered or which will develop, provide the designation, source (supplier), site(s) of administration or induction, site(s) of expected tumor growth, and volume of material injected/implanted per site (indicate NA if a specific response does not apply). If of rodent origin or if it has ever been passaged in rodents, the material must be tested by RARC for contamination with adventitious agents before administration. Most cell lines of human origin have been passaged in rodents at some time during their characterization and/or adaptation to cell culture. If unsure, assume the line has been passaged in rodents. Material of human origin must be indicated and handled by BSL-2 as prescribed by OSHA. If you indicate that one or more of the tumors, cell lines or cell stocks is of human origin, the hazardous agent section will be required and you will see human xenografts listed as a hazard. Individual human tumors, cell lines or cell stocks are not differentiated in the hazardous agent section.

The IACUC requires precise endpoints for studies employing the passage, transplantation or induction of tumors. The use of "death as an endpoint" is strongly discouraged and its use must be scientifically justified. If animals cannot be euthanized, but analgesics drugs will be administered, provide the methods for monitoring for pain and distress and the clinical criteria for administering drugs. In general, the IACUC considers tumor-bearing animals as USDA Category D. If, for scientific reasons, you can neither eliminate pain and distress nor euthanize animals prior to tumor pain or distress developing, include the animals in Category E. (Important: Murine transplantable tumors must be examined for inadvertent contamination with zoonotic and murine viruses prior to use. Contact RARC @ 646 888-2400 or 212 746-1031 to make arrangements for testing).

The following Guideline is suggested for additional information: Guidelines for the Utilization of Rodents in Experimental Neoplasia and Ascites Production

Euthanasia (EU): You need to describe the method(s) or agent(s) used to euthanize this species. You may select a pre-approved Euthanasia technique for your protocol (if available), or alternatively answer questions pertaining to one of your own design:
Note: The guideline Recommended Methods of Euthanasia for Laboratory Animals should be consulted for additional information.

If animals are not euthanized at the end of the study, select OTHER and name your item "Final Disposition". Describe the final disposition of the animals in the subsequent screen.

You may include multiple Euthanasia techniques in this experimental plan. As you include each technique, it will be displayed in a list. Each technique is given a temporary name of 'TempTechName' until you assign it a pre-approved technique or name it yourself. Once it has been included, you may edit it, delete it, or review it by clicking on the appropriate icon next to the item. Once all your techniques have been included in this experimental plan, click "Save and Continue" to go to the next section.

The method of euthanasia must be performed using a humane approved method. The Public Health Service Policy on Humane Care for Laboratory Animals and New York State Law require that the latest recommendations of the American Veterinary Medical Association (AVMA) Panel on Euthanasia be followed unless the method to be used is specifically approved by the IACUC. Describe the method of euthanasia to be used in this section. Be sure to include the following information for each species used:

Methods of euthanasia which deviate from those recommended by the AVMA Panel must be justified. Note: Cervical dislocation, without the use of anesthetics, must be scientifically justified. It is essential to ensure that death has occurred before the body of any animal is disposed.

The following Guideline is suggested for additional information: Recommended Methods of Euthanasia for Laboratory Animals

Alternative Search

Federal and state regulations require that investigators determine that the proposed studies have not been conducted previously. This is achieved by conducting literature searches to determine if alternatives to the use of animals exist. An electronic database search must be conducted to determine that alternatives are not available. Alternatives are defined broadly as the 3 Rs: Reduction in the number of animals used, Refinement of techniques and procedures that reduce pain and distress and Replacement of animal with non-animal techniques.

The alternatives search is best approached by focusing on the fundamentals of the techniques. The techniques used in the animal research are the causes of potentially painful circumstances and this must be avoided or minimized. Alternative is an effort to find methods of accomplishing the goals of the research with less or no animal impact. Therefore, the search must focus on the techniques that may cause pain. (Give an example of such a technique).

There are many sources that can be consulted for alternatives to animal research. Sources available are:

The National Library of Medicine produces a bibliography of Alternatives to the Use of Live Vertebrates in Biomedical Research and Testing.

Databases available to assist with search:

To complete the alternative section please include a literature search summary that describes the database searched (i.e. Medline), the keywords used, and how the proposed studies differ from similar studies, if any, that were retrieved. Please use the sources above to accomplish this task.

Alternative Methods (AM)

If any animals are listed in Categories D and/or E, the IACUC is mandated by Federal regulations to confirm that investigators have sought and considered alternatives to a painful procedure(s). Alternatives are defined broadly as the 3 Rs: Replacement (with a non-animal model), Reduction (in the number of animals used), and Refinement (of technique so that less pain/distress results or fewer animals are used); In the narrative section indicate whether a non-animal alternative is available. If not, can:

  1. A painful procedure be replaced with a less painful procedure?
  2. The same procedure be used in a phylogenetically lower species? or
  3. The procedure be refined, for instance with analgesics, to minimize discomfort?

You are required to provide a written narrative description of the methods and sources used to determine that alternatives were not available for each painful procedure conducted. For example, if your study involves conducting 2 procedures that meet criteria for USDA category D or E, then you need to conduct and describe alternative searches for each procedure. Sources of information on alternatives include: Biological Abstracts, Index Medicus, the Current Research Information Service (CRIS), the Animal Welfare Information Center operated by the National Agricultural Library, the National Library of Medicine, and The Institute of Laboratory Animal Resources, National Research Council. Access to these sources is available via the IACUC’s web site.

Location of Use (LU)

Animals may be moved from RARC managed facilities to perform select procedures. The areas involved will be inspected by the IACUC on a routine basis to determine that conditions suitable for both animals and personnel are present. Procedure areas used for survival surgery are inspected to ensure that conditions of safety and asepsis can be met. Animals must never be removed from RARC for more than 12 hours, without specific written consent from the IACUC. Animals cannot leave MSKCC or WCMC unless prior approval is obtained from a RARC veterinarian @ 646-888-2400. This includes transport of animals to/from MSKCC and WCMC if the animals are housed at the other institution.

Use of animals in patient care areas: It may be necessary to move animals to hospital facilities for specific tests. In such cases, the approval of the Facility's Director must be granted in writing and attached to the protocol form. A RARC veterinarian must be consulted to ensure that adequate precautions are implemented prior to the conduct of any work and written Guidelines must be established which describe the procedures to be instituted for the conduct of the study. You may be required to provide a detailed plan for transportation and/or decontamination of the area(s).

Protocol Finish

The Principal Investigator is the only individual authorized to submit a protocol created under their name. The term Principal Investigator refers to the faculty member who is directly responsible for the conduct of the research. For RO1 type grants this would usually correspond to the Principal Investigator; for Program Projects (PO1 and similar multi-component awards) it would correspond to the Principal Investigator on the individual projects. For proposals that will not be subject to peer review, the protocol must be reviewed for merit by the department and the signature of thePrincipal Investigator's departmental or program chair is required as an indication of its scientific worthiness. Additionally, these signatures confirm that the research will be conducted in conformance with regulations, policies, and principles as stated in the protocol form.

This is the completion point of this protocol. You may either: Save your work and return to this protocol at a later time. Save this protocol and submit it for approval. If you are finished with this protocol and plan to submit it for approval, PREVIEW your protocol and quickly read over it to see if here are errors or anomalies. Once you have reviewed it, you may contact the IACUC Administrator to request a pre-review before you submit it. If you have failed to complete any section you will receive a pop up indicating incomplete sections. The specific sections will be highlighted pink in the navigation panel on the left of your screen.

Signature: You will be required to enter your login and password as an electronic signature. You will receive a confirmation email upon submission. If you do not receive the confirmation please contact the IACUC office.

If, at the end of your study, the animals are to be transferred to another investigator, you must submit an online animal transfer form via the online eTransfer application. Animals may only be transferred for use on an approved protocol. If animals are to be transferred out of MSKCC or WCMC, contact the RARC office at MSKCC (646 888-2400) or WCMC (212 746-1022).

Lay Language

The IACUC is required by law to have at least one lay member serving community interests on the Committee. Thus, sections of the protocol must be fully comprehensible to the layperson. Even scientists or veterinarians may be unfamiliar with your area of study, and thus, please take care to define key terms and abbreviations.

Submission Deadline Dates

Protocol Submission Status

In Progress = Editable by its owner
In Review = Under review
Responses Required = Reviewed and responses to the review are required, and may require modifying the protocol before resubmitting
Approved = Reviewed and has been approved.
Disapproved = Rejected by the IACUC.

Consultation and Pre-Review

RARC's EQA staff are available for consultation on a variety of subjects including new technique development, protocol preparation, and pre-review. To facilitate the animal protocol review process, EQA staff coordinate a pre-review program in which the proposed protocol is reviewed by EQA staff and discussed with investigative staff prior to IACUC submission. Contact the EQA at rarc_eqa@mskcc.org or rarceqa@med.cornell.edu and provide an electronic copy of your completed or partially completed protocol or protocol amendment. Submissions are reviewed and critiqued on a first-come, first-served basis. Please allow five business days to complete the pre-review.