SUNY Downstate Health Sciences University
Office of Research Administration
The Institutional Animal Care and Use Committee (IACUC)
Before I can begin any research or teaching using animals, what form is required for IACUC review and approval?
Complete the Institutional Animal Care and Use Committee protocol form and submit it to the IACUC Coordinator at email@example.com for processing prior to the protocol submission deadline for the IACUC review date you desire.
I have a new person that will be working in my lab. How do I add them to a protocol?
There are strict requirements that must be met in order to receive the privilege to work with animals. Those steps are detailed and must be documented as indicated on the New Scientists Questionnaire Word File.
Use of Designated Member Review (DMR) for Animal Study Protocol Review Subsequent to Full Committee Review (FCR)
Not necessarily; All IACUC members have agreed that the quorum of members present at a convened meeting may decide by unanimous vote to use DMR subsequent to FCR when modification is needed to secure approval. However, any member of the IACUC may, at any time, request to see the revised protocol and/or request FCR of the protocol. The designated member review process, as described in the PHS Policy, is equal in authority to the full committee review process and requires no further review by the committee until the de novo three year review time has expired.
What form is required for annual review and approval of animal use protocols?
IACUC approval of an animal use protocol is valid for one year. Continuing annual review and approval must be obtained through submission of the
Do my protocols and grant proposals have to match?
Yes. As a condition for accepting federal funds, SUNY Downstate must certify that the work described in the funded proposal has been approved by the IACUC. The Institutional Animal Care and Use Committee (IACUC) has the delegated responsibility to fulfill the Federally mandated Institutional requirement to assure consistency between grant proposals and animal research protocols. This institutional requirement is described in the Public Health Service (PHS) Policy, National Institutes of Health (NIH) Grants Policy Statement, and by the Office of Laboratory Animal Welfare (OLAW). Institutions are responsible for ensuring that the information the IACUC reviews and approves is congruent with what is in the application/proposal.
- In reviewing the animal research protocol, the IACUC must approve of the project's proposed use of live vertebrate animals in addition to the components [of the application or proposal] related to the care and use of animals.
- The institution [must] 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.
- Before the NIH will make an award to an institution, it must have verification that the IACUC has reviewed and approved those sections of the application that involve use of vertebrate animals, in accordance with the requirements of the Policy.
This verification of consistency is a side by side, unidirectional comparison, i.e. the procedures described in the grant must also be described in the IACUC protocol (grant protocol). The verification does not include judgment of scientific merit. The primary focus of the Scientific Review Boards is scientific merit and the primary focus of the IACUC is animal welfare. For NIH grants, it is the responsibility of the Principal Investigator to indicate any significant changes in the use of vertebrate animals in the Progress Report Summary section of their Non-Competing Continuation Progress Report (PHS 2590).
MANAGING GRANT and PROTOCOL INCONSISTENCIES - The IACUC Chair will make all final determinations as to whether the protocol and proposal are inconsistent. The Principal Investigator will be consulted regarding any apparent inconsistency. As noted above, significant changes require that the PI notify the extramural Program Official. Verification of this request and subsequent approval must be shared with the IACUC.
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 to receive future funding.
The IACUC office has notified me that my animal protocol expires in 90 days. I am very busy and do not have time to submit my protocol. Can I request an extension of approval?
NO. Protocol approval is good for one year (365 days). If an investigator does not respond to requests for either continuation after years 1 and 2 or for renewal after year 3 prior to the approval anniversary date, the protocol will be inactivated. If any animal work takes place without IACUC approval, such as during the time a protocol is inactive, the animal research is no longer in compliance with Federal regulations. Lapses of approval must be reported to relevant Federal agencies in accordance with Federal regulations. The protocol will remain inactive until such time as the annual update or renewal is completed and approved. Reference OLAW FAQ#8
Is it permissible for the IACUC to provide an administrative extension of the three year protocol review and IACUC approval so as to avoid protocol expiration?
No. In accordance with PHS Policy provision IV.C.2, the IACUC must conduct a complete protocol review, also called the "de novo review" at least once every three years. The IACUC may not extend the three-year approval by any means other than IACUC review and approval using the procedures of IV.C.2. When IACUC approval expires, the protocol is no longer valid and all animal activities must stop. For more information, see the last Division of Comparative Medicine FAQ. Continuation of animal activities beyond the expiration is a serious violation of PHS Policy and must be reported to the NIH Office of Laboratory Animal Welfare.
For the three-year protocol renewal, if there are no major protocol changes over the previous approval period, can a short form be used that would only detail new or modified procedures instead of the full protocol form.
No. PHS policy requires that every three years, all protocols be reviewed by the IACUC as if they were new (de novo). Using a short form that focuses only on changes does not satisfy this Federal requirement. In this context, "de novo" means that the criteria and procedures for review of projects specified in IV.C. of the PHS Policy must be applied not less than once every three years. The IACUC must make the determination that the project conforms with the criteria at IV.C.1.a-g. of the PHS Policy. These criteria address such factors as pain and distress, pain relief, animal husbandry, veterinary care, personnel qualifications and methods of euthanasia. In addition to confirmation that projects are in compliance with the PHS Policy, the IACUC must also determine that the project is being conducted in a manner consistent with the "Guide for the Care and Use of Laboratory Animals" (Guide), unless departure is justified.
I need to make some changes to my protocol; when do I need to submit an amendment and what changes are considered significant?
In accord with our "Assurance of animal welfare" on file with the Federal Public Health Service, Office of Laboratory Animal Welfare, a distinction must be made between minor (administrative) and major (significant) changes to an existing approved protocol. The IACUC procedures for reviewing proposed significant changes in ongoing research projects are the same as those described for review and approval of new protocols under PHS Policy IV.C. Significant changes must be reviewed by the IACUC using the full committee review (FCR) or Designated Member Review (DMR) process. The FCR or DMR process may take up to 1 month to review and approve. Administrative changes are processed usually within a few days of submission.
Examples of changes that are major (significant):
- Change in purpose, specific aim or objectives of a study.
- Change in Principal Investigator.
- Change in protocol that would require an animal to undergo more than one survival surgery.
- Change in protocol that would require animals to be fed, housed or cared for in a way that is not standard for that species, or does not meet that species' minimum requirements.
- Increase in the degree of invasiveness of a procedure or discomfort to an animal.
- Change in protocol that would eliminate or restrict an animal's access to veterinary care.
- Change of species.
- Addition of USDA-regulated species.
- A greater than 10% increase in the number of animals needed
- The withholding of analgesics.
- The duration, frequency, or number of procedures performed on an animal.
- Addition of survival surgical procedure.
- Addition of a painful procedure.
- Change in protocol where death becomes the experimental end point.
Can changes to a protocol be handled administratively?
Yes. There are three processes which may be used.
- In accordance with IACUC policy, the following specific protocol changes may be handled
administratively in consultation with the IACUC authorized Attending Veterinarian.
The veterinarian serves as a subject matter expert to verify that compliance with
IACUC policy is appropriate for the animals affected by the proposed changes. Consultation
with the veterinarian is documented. The veterinarian may refer any request to the
IACUC for review for any reason and must refer any request that does not meet the
parameters of IACUC policies. These changes include:
- anesthesia, analgesia, sedation, or experimental substances;
- euthanasia to any method approved in the AVMA Guidelines for the Euthanasia of Animals
- duration, frequency, type, or number of procedures performed on an animal.
- Addition of another strain of the same species
- Change of sex in the animal to be used
- Addition of sample collection times - not to exceed standard limits
- In accordance with IACUC policy, the following changes may be handled administratively without additional consultation or notification: increase in previously approved animal numbers < 10% except for protocols using USDA regulated species; Replacing a procedure with another less painful, stressful or hazardous that achieves the same specific objectives; Changing experimental design to reduce the use of animals; Reducing or eliminating previously approved water or feed restrictions; Addition or deletion of animal usage location; Removing a proposed experiment from a protocol. Addition of minor procedure provided the change is not expected to increase pain or distress e.g., changes in needle gauge, surgical instruments, vehicle for injections, and use of post-mortem tissue (if not exceeding standard limits); Addition of or change in dosage of an experimental drug in the same class as one previously approved
- Changes that may be handled administratively without policy guidance, consultations, or notifications include: protocol title changes; contact information or training updates of the PI or study personnel; correction of typographical errors; correction of grammar; and change in personnel, other than the PI. All personnel are appropriately identified, adequately trained and qualified, enrolled in occupational health and safety programs and registered with the public safety office as required by the IACUC.
What should I do if I want to bring a visitor to the animal facility?
Facility Access and Security - Only authorized personnel are permitted entry into animal facilities. All animal facilities are sealed by locked doors and are accessible only by key or by key card access.
Employees who work in the animal facility, research staff listed in an IACUC-approved animal protocol that involves animals housed in a particular animal facility, and specified service personnel who may require occasional access for routine services (e.g., Facilities Management, Environmental Health and Safety, IACUC staff) are permitted access to animal facilities.
Access may be suspended or revoked if the employee does not observe animal facility regulations and procedures. Examples of situations in which access could be suspended or revoked include: allowing unauthorized persons to gain access into an animal facility; leaving animals in distress without reporting their condition to animal care staff; repeated or serious deviations from IACUC-approval protocols; placing personnel and animals at risk of harm. Employees requiring access to centralized animal facilities must complete the online Collaborative Institutional Training Initiative (CITI) animal care and use training module and have an occupational health screening prior to obtaining the access required. New personnel must be added to an approved protocol, via the principal investigator's submission of a protocol amendment before, animal facility access will be approved.
Approved Visitors - Occasionally, non-employees may require access to animal facilities. These individuals may involve research collaborators visiting from other institutions, regulatory or accreditation site visitors, equipment vendors or maintenance personnel. SUNY DMC wants to protect research animals and minimize any possibility of disease transmission between animals and visitors. Access is granted to only one location to help prevent the transmission of adventitious pathogens between facilities.
The visitor's host must notify the veterinarian and the animal facility supervisor, in writing, at least THREE DAYS PRIOR to the visit, the name of each visitor, his/her institution or agency and purpose of the animal facility visit, date(s) involved, and contact information for the host. An employee of the facility must escort all hosts and visitors the entire time they are in an animal facility. Visitors will be asked to sign a guest book and required to wear a visitor's badge before entering a facility. Unauthorized persons (including visitors, friends, and children) are not permitted in the facilities without the approval of the veterinarian and the animal facility manager.
I understand that the social housing of social animals is the default; what do I do if I need to house animals singly?
First review the Social Housing policy then determine if your need to singly house animals is scientific or colony management based. If the need to singly house animals is Scientifically driven then you must request approval from the IACUC if you have not already done so on the protocol form. To request a new exemption to social housing that is scientifically justified, you must submit the social housing exemption protocol amendment form to IACUC@downstate.edu. Please note that the IACUC has approved program wide social housing exemptions that are NOT considered to be scientific or study based; those are as follows and are NOT the subject of this exemption:
- Standard practices in breeding colony management that result in the need to periodically single house animals, including: 1. Single housing breeder males between mating with females, 2. Single housing pre-parturient females, 3. Single housing animals of either sex at weaning when the litter makeup contains a single male and/or a single female at the time of weaning.
- Standard practices in managing surgery or other technical procedures including: 1. Single housing animals for fasting prior to surgery or other procedures that require general anesthesia, 2. Single housing animals for up to 14 days for post-operative recovery and observation. The need to single house animals for greater than 14 days post-operatively must be outlined in the IACUC approved protocol.
- The unavailability of another socially compatible animal due to aggression or incompatibility
- Research attrition
What is meant by a "holding protocol" and when is it used?
The Use of the Division of Comparative Medicine's (DCM) "Holding Protocol" is described in detail below:
BACKGROUND/PURPOSE: The purpose of the Holding Protocol is to provide a mechanism for holding animals not on study or assigned to a current protocol. All animals maintained at SUNY Downstate must be covered by an active, approved IACUC protocol to meet Federal and State animal welfare laws and regulations. The IACUC has the responsibility to ensure all animal use activity meets current animal welfare laws regulations, policies and guidelines. This policy specifically addresses the holding of animals on a DCM animal holding protocol.
Holding protocol policy roles:
- Researcher: The investigator should work with the IACUC to ensure that protocols are active and current and will remain so for any anticipated or ongoing animal use.
- IACUC: Provide a mechanism for rapid transfer of animals in cases where it is necessary to protect the wellbeing, welfare, or prevent the wastage of the animals.
- Attending Veterinarian or designee: Will maintain a Holding Protocol for the purpose of receipt of animals that would otherwise be euthanized for lack of an existing protocol.
PROTECTIVE MEASURES REQUIRED: Personnel protective equipment is required appropriate to the species and any treatments being given.
POLICY: Eligibility for Participation: Use of the Holding Protocol is intended to be temporary.
- Situations which may result in the use of this protocol, might include:
- Animals ordered without an approved protocol (non-compliance situation)
- Animals originating from inactive (or terminated) protocols.
- Animals on a protocol under investigation for potential issues of non- compliance where the welfare or well-being of the animals is in question.
- Investigators without an IACUC approved protocol having animals that may require immediate housing at SUNY Downstate.
- Investigators that are leaving SUNY Downstate and do not have the necessary approvals for transfer to the new institution.
- Requests to place animals on the DCM Holding protocol will be generated by the PI, the IACUC Chair, the IACUC Coordinator, or the AV (or designee).
- An investigator requesting the use of the DCM Holding protocol must complete the "DCM Holding Protocol Request Form" and submit to the DCM Director or designee.
- Transfer Required Due to Termination of Approved Protocol: IACUC and DCM authorized transfers from expiring protocols will be generated through currently produced monthly reports: Protocol Expiration Memo and New Numbers for Expiring Protocols. These reports will be generated and sent to DCM within 2 business days after the IACUC convened monthly meeting. These reports are the authorizing source documents for DCM staff to transfer animals to the DCM Holding Protocol.
- Transfer Required Due to Non-Compliant / Adverse Event: The IACUC Chair, DCM Director and/or the Attending Veterinarian (or designee) are authorized to initiate the transfer of animals from an active protocol to the Holding Protocol. These actions will be reported to the IACUC at the next regularly scheduled meeting.
- DCM will transfer animals within 3 business days of receipt of transfer request from the PI or from instructions by the IACUC.
- No experimental procedures are allowed on animals maintained on the DCM Holding Protocol. Routine management only is permitted
- Breeding performed to maintain viability of specific lines may occur under this protocol. Expansion colony breeding is not authorized. DCM will perform all procedures necessary to maintain colony viability.
- Feeding, sanitation, and environmental enrichment will be provided according to the approved protocol.
- DCM must be notified of any pre-existing conditions of note prior to transfer of animals
onto the Holding protocol (for PI-initiated actions); and will coordinate with the
PI concerning any special conditions when the transfer request is initiated by the
IACUC. Examples include but are not limited to:
- Existing surgical implants.
- Zoonotic disease.
- Special dietary needs.
- Past surgical history.
- Viral vectors.
- Poor fecundity.
- Fees: Per diem, procedure, or the fees for support of the animals on the Holding Protocol will be charged to the investigator (or department) while their animals are on the Holding Protocol. DCM may place a surcharge for animals on the DCM Holding Protocol. The Director, DCM may waive this surcharge as appropriate.
- NOTE: Federal grant funds may NOT be used for support of any animals in a holding protocol status due to non-compliance or failure to obtain IACUC approval for a 3 year replacement protocol. NOTE: New faculty transfers to SUNY Downstate may use federal funds for support of animals on a holding protocol, until such time that a protocol is approved.
- A copy of the form to request transfer to the holding protocol by principal investigators is located on the IACUC forms website.