Montefiore Medical Center
The Institutional Animal Care & Use Committee (IACUC)
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The Institutional Animal Care & Use Committee (IACUC) must review and approve all research involving the use of vertebrate animals. This review process is to assure humane treatment and compliance with Federal and State government mandated animal welfare standards and MMC policies. The IACUC is able to conduct its review by asking very specific questions pertaining to animal welfare. Since the issues raised by these animal welfare questions must be integrated into the research itself, but are not typically elucidated in a granting agency application, the IACUC provides Scientists with standardized forms to facilitate this process. Use only the latest version of the forms since they are regularly updated to reflect new policies and requirements of the regulatory agencies.
Review
Process
Approval and Expiration
Regulatory Requirements, Alternatives, Reporting
Violations
Application Process and Timing of Submissions for
New and Three-Year Reviews
The appropriate forms must be completed in their entirety by the
Scientist and submitted to the Animal Care Manager and the Attending
Veterinarian for pre-review, not less than two weeks in advance of the
IACUC submission deadline.
Once the results of the pre-review have been received from the Attending Veterinarian, any revisions are to be incorporated into a final version of the protocol form. Keep in mind that the IACUC is a diverse group which include non-scientific members so technical language shoule be minimized and abbreviations defined. Ten copies of the final version of the Protocol Form and three copies of the accompanying scientific proposal must be submitted to the IACUC a minimum of two weeks prior to the scheduled IACUC meeting date. Refer to the IACUC Meeting Calendar for submission deadlines and meeting dates. When classroom activities are to involve the use of vertebrate animals, the Protocol Form must be submitted in advance of the semester in which the classroom activity is planned; the course syllabus and detailed descriptions of laboratory exercises must accompany the Protocol Form. Note that a separate form is required for each species.
Review Process
The review process begins with the pre-reviews by the Animal Care
Manager and the Attending Veterinarian. The purpose of the pre-review
is to identify issues that are either incomplete or unclear thereby
preventing or delaying approval by the IACUC. Once these issues are
identified, the investigator has the opportunity to respond to and/or
revise the Protocol Form in advance of presentation to the
IACUC during a convened meeting. Although this pre-review process
will materially improve the probability that the protocol will be
approved, it does not guarantee
approval by the full Committee. It is to your advantage to follow
this submission format to avoid delaying the review process,
particularly since granting agencies do not take final action on
research funding until they have received results of the IACUC review.
Copies of final protocols and responses to issues raised at the
pre-review are distributed to IACUC members in advance of the meeting.
Submission deadlines have been established so IACUC members have the
opportunity to review the materials thoroughly. Receipt deadlines are
without exception and the IACUC is not obligated to conduct a review of
a late submission even in light of funding deadlines. At the meeting,
IACUC members discuss each individual protocol and evaluate it for
adherence to animal welfare laws, regulations, and policies. IACUC
approval voting is by consensus.
The possible actions taken by the IACUC are: Approved (self
explanatory), Conditionally Approved (minor points require
clarification or correction but the protocol is generally
satisfactory), Deferred (there are some major areas of concern that may
require in-depth discussion and resolution), and Disapproved (the
protocol, as submitted, is not acceptable and must be extensively
revised and resubmitted as a new application). After a convened meeting
is held, committee actions are recorded in the IACUC minutes. The
secretary of the IACUC sends written notification to the investigator
of its decision. If the action taken by the Committee is other
than full approval, a detailed descrition of the issues raised by the
members is provided to the investigator along with the changes required
to secure full approval. When approval is granted, a copy of the
notification letter in addition to all IACUC records are placed on file
in the Office of Sponsored Programs so that they may notify granting
agencies and for review by Federal and State agencies responsible for
animal welfare .
If the IACUC decides to withhold approval of an activity, . the investigator is given an opportunity to respond in person or in writing prior to or at the next convened meeting. Investigators may be contacted by Committee members to clarify points and/or negotiate changes in the protocol. For Conditional Approvals, once the IACUC secretary has received the investigator's response to the IACUC, approval may be granted before the next convened meeting. For Deferred protocols, the investigator's response must be reviewed by all members at the next Committee meeting. It is important to remember that the approval process is one of discussion and negotiation between the IACUC and investigators in order to promote research while maintaining high standards for animal welfare. It is important to remember that research involving animals cannot be initiated or continue until full approval is granted by the Committee.
Approval and Expiration
Approval is for a period of ONE YEAR. An annual protocol review
consists of review of an IACUC protocol that is methodically identical
to the protocol previously approved within the last 12 months.These
protocols are reviewed as a "continuing submission". Principal
investigators must complete an annual
review form which indicates that no substantive changes have
taken place and provides the following information: IACUC approval
number, IACUC approval date, title of the project, species used, number
of animals to be used in the current year, number of animals to be used
in the overall project, identify any changes in personnel ( including
qualifications) whose activities on the project involve contact with
animals.
The annual protocol review process is initiated by submitting an Annual Review Form to the IACUC office. This form is sent to Scientists by the IACUC Secretary approximately three months prior to the anniversary of the last approval. Ten copies of the completed form should be submitted to the IACUC two weeks before a regularly scheduled meeting.
As PHS policy requires, a complete (de novo) protocol review and approval by a convened IACUC meeting is conducted for all protocols every 3 years from date of initial approval. Conditions of review and information required is the same as that for new submissions for IACUC approval.
Investigators must secure prior approval from the IACUC before making any substantive revisions to the experimental procedures. Substantive procedures are those which effect animal health or welfare. Guidelines for reporting changes are available.
The care and use of laboratory animals is regulated by:
Searching for Alternatives
Federal policy requires that scientists conduct a search for
alternatives for any procedure that causes more than momentary pain or
distress. Searching for Alternatives in
Animal Research reviews the principles involved in conducting a
search which fulfills the regulatory requirements.
Reporting Violations or Abuse (Whistleblower Policy)
Any individual observing or having knowledge of a violation of Federal
regulations or Montefiore Policy regarding the care or use of
vertebrate animals or observes or has knowledge of mistreatment of a
research animal should report this information either verbally or in
writing to the Chair of the IACUC (email:casper@aecom.yu.edu).
While anonymous reports will be accepted, it is preferred that the
informant be identified so he/she may be contacted in the event
additional information is required. All complaints made in good faith
will be promptly addressed and resolved by the Institutional Animal
Care & Use Committee. No action or reprisal may be taken against
any individual as a result of any such complaint made in good faith.
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