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.
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.
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.
IACUC approval of an animal use protocol is valid for one year. Continuing annual review and approval must be obtained through submission of the Animal Protocol Renewal Application Form. « NEEDS LINK
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.
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.
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
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.
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.
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):
Yes. There are three processes which may be used.
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.
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:
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:
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.