IACUC FAQ

Here you can find answers to frequently asked questions about animal care and use at Cornell (e.g., the IACUC, CARE, protocols, training, etc.).

General

There are several things that you need to do:

  1. Read the Cornell Animal Care and Use Policy 1.4, and understand your responsibilities.
  2. Complete Training – both Module I and facility-specific Module 2.
  3. Get access to the protocol management system, eSirius, by sending an email to the IACUC office requesting access to e-sirius.
  4. Submit a new IACUC Protocol (or be added to an Approved Protocol).
  5. Enroll in the Animal Users Health & Safety Program (AUHSP).
  6. Complete a Facility access request form for the facility where you want to house animals by contacting CARE.

For more information on the training requirements, see the IACUC policy on training. For more information on Protocol submission, see the Protocol Submission FAQ.

AUHSP clearance is NOT a condition for approval of the protocol, but is a condition for access to animal facilities.

For information on whom to contact for facility access, ask CARE@cornell.edu.

For assistance in beginning animal use for research or teaching, contact CARE or the IACUC.
 

An IACUC is an Institutional Animal Care and Use Committee. An IACUC is required by federal law. The Cornell IACUC is responsible for independent oversight of the Animal Care and Use program at Cornell University, and monitoring its compliance with applicable federal and state regulations and appropriate guidelines. See IACUC Membership and Responsibilities.

CARE is the Cornell Center for Animal Resources and Education is a service and a resource to the Cornell research and teaching community. The mission of CARE is to ensure animal welfare and facilitate research and teaching. CARE provides high quality animal care and veterinary services. CARE advises and educates researchers, staff and students on animal experimentation issues, promoting best practices for the responsible use of animals.

All teaching and research activities involving the use of vertebrate animals are reviewed and approved by the IACUC before any animals can be procured and work can begin. In addition to providing oversight over the animal care and use program in a variety of ways (Animal Care and Use Policy 1.4), the IACUC also serves as a resource to faculty, investigators, technicians, students, staff, and administrators, providing guidance in fulfilling the obligation to plan and conduct all animal use procedures with the highest scientific, humane and ethical principles.

CARE veterinarians are responsible for conducting veterinary pre-reviews of protocols. The Attending Veterinarian, or designated CARE veterinarian, is a voting member of the IACUC.

CARE also provides quality animal care for a wide variety of animals in several specialized facilities.

A protocol needs to be submitted if you will be conducting research, teaching, or testing for which you need to obtain or use live animals (all warm and cold-blooded vertebrates). If you are only doing in vitro work you do not need to submit a protocol.

ORIA is the Office of Research Integrity and Assurance and is responsible for many areas of research compliance at Cornell. Government regulations stipulate that when using humans, animals, or recombinant or synthetically derived nucleic acid molecules (r/sNA) in research, investigators must observe rules mandating responsible conduct in research.

ORIA provides the administrative support for the IACUC and supports Animal Protocol submission and review through eSirius. ORIA also supports the compliance functions that are necessary for the NIH Office of Laboratory Animal Welfare (OLAW) Assurance for Cornell and Cornell’s research registration with the United States Department of Agriculture (USDA).

Yes, Cornell has been fully AAALAC accredited since Fall 2003. AAALAC accreditation visits occur on a three-year cycle, and the next one will take place in 2021.

Public Health Service Policy designates the Office of Laboratory Animal Welfare (OLAW) with compliance oversight of animal use on PHS funded projects. The policy further requires that institutions receiving PHS funding file an Assurance with OLAW that speaks to the Institution's commitment to following the Guide, the government Principles, and all PHS Policy requirements. Accordingly, Cornell University has a current assurance on file with OLAW. In order to continue to be eligible to receive funds from PHS (primarily from NIH and related funding agencies), all animal use at Cornell must conform to the Assurance. Any deviation from it must be reported to OLAW.

Public Health Service Policy requires each animal-using grantee institution to have "a committee to maintain oversight of its animal program", and defines animal to include all vertebrates. That committee is the IACUC (Institutional Animal Care and Use Committee). Review of the animal program and each proposed use of animals is its designated role. The animal protocol form in eSirius is the mechanism by which animal uses are proposed, reviewed and approved. In addition to review and approval of all animal use at an institution, the IACUC is charged with oversight of the overall animal care and use program, including facilities, training, occupational health, Standards of Veterinary care, etc.

e-Sirius

eSirius is a Web-based content management system that Cornell University currently uses to manage the submission, review, and approval of protocols concerning the use of non-human vertebrates. In addition, eSirius provides functionalities for ordering animals, invoicing, and census data in participating Cornell animal facilities. The eSirius content management system also provides reports to support the state and federal compliance and monitoring functions of IACUC, CARE, and ORIA.

Principal Investigators, and anyone affiliated with Cornell University whom the Principal Investigator delegates responsibility to enter protocol information or order animals can use eSirius. A Cornell NetID is required for access to eSirius.

In addition, members of the IACUC, and staff in various offices which support the IACUC, use eSirius on a regular basis, as do staff in animal facilities.

Request access to e-sirius by submitting this form to the IACUC Office at IACUC@cornell.edu. A Cornell NetID is required for access to eSirius.

For protocol and amendment content related problems and questions, first consult the protocol Narrative Guide, and the Amendment Guide, help documents, and then contact the IACUC.

Online Protocol Submission with eSirius

Animal Use (IACUC) Protocols are submitted on-line using eSirius. After you have entered the protocol information and you successfully completed the ‘Error Verification’ process in eSirius, when you click on the ‘Submit to the IACUC Office’ button on the Submit Protocol Page in eSirius, the protocol is submitted for IACUC Review. You can still add and edit protocol information before it is submitted, and anytime subsequently if it is in "PI" status. The process is similar for Amendments and for annual reviews.

New protocols, three-year renewals of protocols, continuing review forms with annual progress reports, and protocol amendments can all be submitted through eSirius.

The policy of Cornell University is that only full-time faculty members may routinely serve as Principal Investigators or Project Directors on sponsored projects. Certain other titles are allowed to serve as Principal Investigators under special circumstances. View the IACUC PI Eligibility Policy for further information.

Members of your staff or laboratory may have access to eSirius and enter information into unfinished protocols. Please email the IACUC office to request access for other staff members. As PI you are the only one who can actually “submit” the protocol to IACUC. In doing so you agree to abide by the various university, state, and federal policies and guidelines which apply to the use of live animals in research and teaching.

If you have completed the 'Error Verification' process in eSirius that checks to see that all the required fields are complete, and filled in any required fields that you missed, then from a technical point of view when the "Submit to the IACUC Office" button is clicked, the protocol has be properly submitted. However, this does not necessarily mean that all of the content information that the IACUC will need to approve the protocol is in the protocol. Following both the pre-review and IACUC meeting review processes you may need to add or modify the information in the protocol. When the protocol is APPROVED you will get an official notification of the approval.

The status of your protocol(s) (and pending amendments) is shown on your eSirius 'Home Page'. The eSirius content management system will also automatically e-mail you notices of changes in protocol (and pending amendment) status. **Please note that once a protocol or amendment is approved, it is no longer available on your eSirius Home Page.

Once approved, protocols and amendments are no longer visible on your eSirius Home Page. To search for them, go to "Get a list of my protocols," and click "Search" on the next page. You may also go to "Amendment Search" and click on Search to find a list of all current amendments.

IACUC Specific

Members of the IACUC staff, CARE Veterinarians, the AUHSP working group, and IACUC members will pre-review your protocol for approximately two weeks following the first "submission deadline" after you submit it. Two IACUC members take primary roles when your protocol is discussed at the IACUC meeting. Following the IACUC meeting you will primarily interact with the IACUC office to resolve any remaining issues.

Submission deadlines (usually the day of an IACUC meeting) and IACUC Meetings (usually the third Thursday) occur once each month throughout the year. See the current Schedule.

The review process takes at least one month, and make take additional time depending on many factors. The status of the protocol will change over time and you can use eSirius to follow the protocol as it makes its way through the review process.

Members of the IACUC staff, CARE Veterinarians, the AUHSP working group, and IACUC members will pre-review your protocol or amendment approximately two weeks following the "submission deadline." When the pre-review period is over, the IACUC Administrator will change the status of your protocol so that you may respond to the questions and requests made as part of the pre-review process. You will get an e-mail to this effect. The window of time that you can enter your responses in your protocol in eSirius is approximately one week. The IACUC Administrator will then place the protocol on the IACUC Meeting Agenda (usually a week before the scheduled meeting), and you can no longer access it. During the IACUC Meeting additional questions or requests may be generated when your protocol is discussed. Following the meeting the IACUC Administrator will enter these questions and requests into eSirius, and you will be notified regarding the need to respond.

Your timely and complete response to the pre-reviews is likely to markedly increase the chance that your protocol will be approved during the IACUC Meeting. Conversely, failing to respond will significantly lengthen the time between the submission deadline and when you get approval to proceed from the IACUC.

If there is a compelling need, the IACUC Chair will review the reason for the request to deem if it warrants an expedited review. If the reason is justified, the protocol or amendment needs to be submitted to the IACUC office for review. If a single member of the IACUC requests a full committee review, the submission must go to a full committee meeting. Expedited reviews are granted on an exceptional basis only.

The approval process takes a variable amount of time depending on many factors. The status of the protocol will change over time and you can use eSirius to follow the protocol as it makes its way through the approval process. The following is a typical scenario:

Creating a New Protocol: When you create a new protocol, it will be in the UN-FINISHED list on your eSirus Home Page. You can then take as long as you need to fill out the sections of the protocol. If you click the 'Finish Later' button (on the bottom of each eSirius page) you may log out of eSirius and log back in at a later time, and your UN-FINISHED protocol will be there as you left it. When you think you have all the sections filled out, complete the ‘Error Verification’ process in eSirius which checks to see that all the required fields are complete, and fill in any required fields that you missed.

Submitting a Protocol: When the ‘Error Verification’ process is complete click the 'Submit to the IACUC Office' button, and the protocol will move to the NEW PROTOCOLS list on your eSirius Home Page. Your protocol will enter the Review and Revision process at the next submission deadline date.

Review and Revision: While the protocol is under review and revision you can see the date of the last action and the type of request that was made on your eSirius Home Page. The Error Verification process does not necessarily mean that all of the content information which the IACUC needs is in the protocol. Members of the IACUC staff, CARE Veterinarians, the AUHSP working group, and IACUC members will pre-review your protocol or amendment approximately two weeks following the "submission deadline." When the pre-review period is over, the IACUC Administrator will change the status of your protocol so that you may respond to the questions and requests made as part of the pre-review process. You will get an e-mail to this effect. The window of time that you can enter your responses in your protocol in eSirius is approximately one week. The IACUC Administrator will then place the protocol on the IACUC Meeting Agenda (usually a week before the scheduled meeting), and you can no longer access it. During the IACUC Meeting additional questions or requests may be generated when your protocol is discussed. Following the meeting the IACUC Administrator will enter these questions and requests into eSirius, and you will be notified regarding the need to respond.

Your timely and complete response to the pre-reviews is likely to markedly increase the chance that your protocol will be approved during the IACUC Meeting. Conversely, failing to respond will significantly lengthen the time between the submission deadline and when you get approval to proceed from the IACUC.

Approval of the Protocol: When the IACUC is satisfied that all issues have been resolved the protocol will be APPROVED, and it will no longer be visible on your eSirius Home Page. You will get an official e-mail notification of the approval.

Your approval notification contains the date the protocol will expire (generally three years after the approval date). The need for Annual continuations and for the three-year renewal of the protocol will show up in your Alerts on your eSirius Home Page. You will also get courtesy e-mail reminders. However, it is the PI’s responsibility to make sure that Annual and three-year renewals are submitted and approved before the expiration date.

Contact the IACUC Administrator immediately! You may need to stop all animal work until your annual continuation is approved.

You need to file a progress report and continuation annually. You need to renew your protocol within three years.

Cease all animal work immediately, and contact the IACUC Administrator. Any animals that you still have will need to be transferred to another active protocol or humanely euthanized. Any work you have done after the three-year approval period has ended is considered unapproved animal research and must be reported to regulatory and funding agencies.

Cease all animal work immediately! Any animals that you still have will need to be transferred to another active protocol or humanely euthanized.

On your eSirius Home Page click on "Submit an Amendment for an Existing Protocol". Select the protocol you which to amend from the List of Approved protocols, and click "Continue". Tick the checkboxes for the sections you will need to change, and click "Next". Complete the "Justification" section to let the IACUC know what your reason(s) are for asking for an amendment. Select and edit sections. See the Amendment Guide for what sections to complete and what is expected by the IACUC.

Protocol Content

Required pages in eSirius will be marked by a red bullet on the Table of Contents (left menu) in eSirius if you have not visited these pages. Within each page required sections (fields) in eSirius are marked with a red star (*), often on the extreme right side of the screen. All these required sections (fields) on the eSirius Protocol pages must be completed. Enter "Not Applicable" or NA if the section is not relevant to your use of animals. It is wise to mark even non-required sections NA, so that the IACUC knows that you considered the section.

Justification of Numbers section of my protocol?

Explain how you determined the number of animals required for the activities described in this protocol. Be sure that the numbers in this justification match the animal numbers in 13.1 and 13.12., and correspond with 5. Scientific Design. (Note: Approved numbers may not be exceeded without an amendment.) When your choice of species, strain or experimental model allowed reduction in numbers, include this information in the justification.

Whenever possible, the number of animals must be justified statistically with a power analysis. Certain kinds of activities (e.g. teaching, exploratory research, harvest of tissues for in vitro research) are not amenable to a power analysis. In such cases a rational basis for the number of animals requested must be provided. See Justification of Numbers Help for examples, and for resources for statistical analysis.

Alternatives section of my protocol?

Consult what the IACUC expects. In brief, provide a written narrative description of methods and sources used to consider alternatives to procedures that may cause more than momentary or slight pain or distress to animals. State how you determined that alternatives were not available.

Address the 3 R’s – Replacement (with non-animal systems, or species lower on the phylogenetic scale), Refinement (decreasing or eliminating pain or distress), and Reduction (in number of animals necessary).

If database searches are carried out, more than one database must be searched. See a more detailed Help Document for search strategies, resources, requirements, and examples.

If your protocol has animals from more than one species in USDA categories D or E, please provide separate information for each species.

Abstract section of my protocol?

(250 words or less) Briefly describe the major goals of the research and why the animal model you chose is the appropriate model. Write in non-technical language. All abbreviations/acronyms should be defined on first use. For example, how would you describe your work to a group of high school students? Be clear and concise; several sentences to one or two short paragraphs should be adequate.

Scientific Design section of my protocol?

Provide scientific justification for your experimental design, focusing on the use and need for animals to achieve your goals. This will be of variable length depending on the design complexity. For instructional protocols describe the exercises which involve the use of animals, and how this relates to the goals of the courses (attach a course syllabus). The purpose of this section is to enable the committee to evaluate how the proposed work or activity affects animal welfare, and whether the use of animals is appropriately justified. Details of post mortem procedures are not required and should not be provided.

Please do not simply attach a copy of your grant proposal!

How do I write the sequential list of Procedures section of my protocol?

Describe the order of procedures to be performed on live animals, so the IACUC can evaluate the impact on the animals, as related to animal welfare. Provide a timeline and/or a sequential list of all procedures (e.g. blood collection, surgery, behavioral training, administration of substances or test compounds, breeding, tumor induction etc.) to be performed on all live animals. Details of the procedures will be requested in subsequent sections and should not be incorporated here.

Consult a Care Veterinarian or contact CARE@cornell.edu. If, based on the consultation, it seems likely that an Exemption from Standards of Care will be needed, complete or amend Section 13.14 Exemptions from Standards of Care in your protocol. The final determination of whether deviations from the Guide or Ag Guide are needed, and are justified, rests with the IACUC and will be decided as part of the protocol/amendment approval process at a regularly scheduled meeting. Note: Cornell reports Exemptions from Standards of Care to the USDA annually, and the USDA is required to release this information to the public under the Freedom of Information Act (FOIA).

Complete or amend Section 13.3 Species Source in your protocol to indicate that client owned animals will be used. Be sure to attach a Client Consent Form to the protocol. Protocols using client owned animals will not be approved by the IACUC if the client consent form(s) is not provided.

Personnel & Training

To add a member to your research group, the PI needs to amend the protocol (see Changes in Personnel Information), accordingly:

  1. Read the Cornell Animal Care and Use Policy 1.4, and understand their responsibilities.
  2. Complete Training – both Module I and any other training assigned.
  3. Enroll in the Animal Users Health & Safety Program (AUHSP).
  4. Contact the facility manager where the animals are housed and complete Module 2 training.

Both Module I and facility specific Module 2 training are required of all personnel working with animals. The IACUC may require additional training before they are allowed to work with animals depending on the procedures they will perform. For more information on the training requirements see the IACUC policy on training.

Anyone who will be carrying out procedures on the animals covered by your protocol needs to be listed on the protocol, and the procedures they will be performing identified. Clinical staff who are performing routine clinical care or maintenance/husbandry do not need to be listed. Facility staff that are performing procedures specifically required by your research or teaching that go beyond routine clinical care need to be listed on your protocol.

The IACUC office offers semimonthly eSirius help sessions/workshops/labs for researchers who are planning to, or are in the process of, submitting new protocols, amendments, annual reviews, and three-year renewals in eSirius. Complete details and the workshop schedule can be found here.

Amendment Specific

Whenever you make a change to the protocol. This includes: changes in personnel performing procedures on the protocol; additions to animal numbers, changes to animal numbers in any of the USDA categories, changes or additions to any procedures (non-surgical procedures, surgeries, restraints, euthanasia methods), change in drugs, hazardous agents, changes to animal housing or procedure locations.

If your overall scientific goal(s) remain the same you should submit an amendment to cover any changes in the use of animals, including a change in animal species. A new protocol application is required when your scientific goals change. A new protocol is suggested if the changes in the use of animals are extensive (e.g., you will be making significant changes to nearly all protocol narrative sections).

On your eSirius Home Page click on "Submit an Amendment for an Existing Protocol". Select the protocol you wish to amend from the List of Approved protocols and click "Continue". Check the appropriate boxes for the sections you will need to change and click "Next". Complete the "Justification" section to let the IACUC know what your reason(s) are for asking for an amendment. See the Amendment Guide for what sections to complete and what is expected by the IACUC.

If you click the 'Finish Later' button (on the bottom of many eSirius pages) you may log out of eSirius and log back in at a later time, and your UN-FINISHED amendment will be there as you left it. Be aware that if you are amending sections of a protocol you cannot start a second amendment other than a personnel amendment.

NO!! The IACUC must approve amendments before you can proceed with the changes. Removing personnel can be done administratively, if the remaining personnel are qualified/trained to carry out all the procedures.

For amendment content help, first consult the protocol Amendment Guide help documents. The IACUC Office (contact the IACUC Administrator) and CARE (see CARE Help) are both available to provide assistance.

No, contact the IACUC office if you need to submit a personnel amendment while another amendment is under review.

The IACUC can see all changes made to the protocol in a 'Track Changes' protocol view.

Contact the IACUC Administrator. Amendments can be withdrawn administratively prior to approval.

Coordinate immediately, and closely, with the appropriate CARE (or CARE designated) veterinarian. Emergency CARE Contact Information. They are authorized to provide emergency veterinary care including changes to your approved procedures that will reduce pain, distress or illness in animals. They are also authorized to euthanize animals exhibiting unbearable pain, distress or illness (even if euthanasia was not authorized as part of your protocol).

Report any unanticipated pain or distress, morbidity, or mortality to the appropriate CARE (or CARE approved) veterinarian, and notify the IACUC of any significant unexpected events that affect the welfare of the animals. Contact the IACUC to see if an amendment to your protocol will be required. Guidance can also be provided by CARE.

If there is a compelling need, the IACUC Chair will review the reason for the request to deem if it warrants an expedited review. If the reason is justified, the protocol or amendment needs to be submitted to the IACUC office for review. If a single member of the IACUC requests a full committee review, the submission must go to a full committee meeting. Expedited reviews are granted on an exceptional basis only.

For protocol and amendment content related problems and questions, first consult the protocol Amendment Guide help documents, and then contact the IACUC Administrator, (607) 255-3749.

For technical problems, or questions about the functioning of eSirius software, contact the eSirius Project Manager.

Animal Users Health and Safety Program (AUHSP)

AUHSP is the Animal Users Health & Safety Program. The AUHSP evaluates the human-health risks associated with direct and indirect contact with animals used in research and teaching at Cornell. The objective of the AUHSP is to ensure that health risks for every individual are managed to an acceptable level. The AUHSP is predicated on the assessment of risk.

Responsibility for the AUHSP rests among five principal units: the Institutional Animal Care and Use Committee (IACUC), the Cornell Center for Animal Resources and Education (CARE), Environmental Health and Safety (EH&S), the Office of Research Integrity and Assurance (ORIA), and Cornell Health.

The AUHSP Coordinating Committee, comprised of the directors of the five principal units, administers the program. The Coordinating Committee has responsibility for establishing institutional occupational health and safety policy and procedures for animal users and other individuals having direct or indirect contact with animals used in research and teaching.

Federal regulations and PHS policy require that each institution have an effective occupational health and safety program for individuals involved in work with animals. Cornell's AUHSP is designed to meet these regulatory requirements, and is an essential component of our Assurance with PHS (OLAW).

Funding: Proposals and Awards

Yes! Protocol approval is not a pre-condition for submission of a grant proposal, however, federal funding agencies and Cornell's Assurance requires that there will be an IACUC approved protocol in order to release the awarded funds. If you hear that your review score will likely mean funding, then you should be sure to submit a protocol and get it approved in a timely manner.

Plan to submit a protocol in a timely manner relative to the anticipated award date. Protocol review and approval take a minimum of one month after a submission deadline.

Do NOT start animal work (or order animals). If your protocol is in the review process, contact the IACUC Administrator to clarify the expected timeline for approval. If you have not yet submitted a protocol, do so as soon as possible. Contact the IACUC Administrator to ask for expedited review of the protocol, if you think this is justified. The Office of Sponsored Programs will not release funds for your use until it receives confirmation from the IACUC that your protocol has been approved.

Since the funds are being administered through Cornell, you must have an approved protocol from the Cornell IACUC. Submit a protocol immediately, if you have not already done so. If your collaborators at the other institution(s) have approved protocols (and the institutions are AAALAC accredited or have their own PHS Assurances), you must provide your collaborator(s) approval letter(s), a copy of their approved protocol(s), and evidence of accreditation or assurance as attachments to your protocol. You should be listed as a collaborator on the protocol(s) at the other institution(s). In addition, your collaborator(s) must be listed on your Cornell protocol.

Cornell may elect to enter into an Administrative agreement with the other institution(s), whereby the other institution is the IACUC of record, and Cornell would rely their review of work with live animals. Contact the IACUC Administrator for guidance.

If the other institution(s) is not AAALAC accredited and does not have a PHS Assurance, the Cornell IACUC may require that it review all activities with live animals.

Yes, as a condition for accepting federal funds, Cornell must certify that the work described in the funded proposal has been approved by the IACUC. While it is not expected that there will be a direct one-to-one correspondence between each proposal and a single protocol, it is required that the work being funded is covered by one or more approved protocols. Any discrepancies will at a minimum delay the release of funds, and will most likely involve amendments to protocols. A worst case scenario is that this could require modifications to the proposal and may jeopardize the specific funding request and the eligibility of Cornell to receive future funding.