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Description of the Protocol Review Process

The University Animal Welfare Committee (UAWC) must review and approve all research involving the use of vertebrate animals. This review process is to assure humane treatment and compliance with internationally accepted and Federal/State government mandated animal welfare standards. The UAWC is able to conduct its review by asking very specific questions pertaining to animal welfare. Since the answers to these animal welfare questions must be integrated into the research itself, but is not typically elucidated in a granting agency application, the UAWC provides Scientists with standardized forms to facilitate this process. Use only the latest version of the forms as they are regularly updated to reflect new policies and requirements of the regulatory agencies.

Contents:
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 University Veterinarian and the UAWC Departmental Representative for pre-review. For three-year renewals, deferred protocols or major revisions, please submit your applications to the UAWC two months prior to the protocol's expiration date. For annual renewals and minor revisions, please submit your applications two weeks prior to the UAWC meeting.

Once you have received the results of the pre-review from the UAWC Departmental Representative and University Veterinarian, any revisions are to be incorporated into a final version of the protocol form. Keep in mind that the UAWC is a diverse group which include non-scientific members so minimize technical language and define abbreviations. Ten copies of the final version of the Protocol Form and 3 copies of the accompanying scientific proposal must be submitted to UAWC Administrator prior to the final UAWC submission date. Refer to the UAWC 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. In all cases, note that a separate protocol submission form is required for each species.

Review Process
The review process begins with the pre-reviews by the Departmental Representative and the University Veterinarian. The purpose of the pre-review is to identify issues that are either incomplete or unclear thereby preventing or delaying approval by the UAWC. 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 UAWC during a convened meeting. 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 UAWC review. Copies of final protocols and responses to issues raised at the pre-review are distributed to UAWC members by the UAWC Administrator in advance of the meeting. Submission deadlines have been established so UAWC members have the opportunity to review the materials thoroughly. Receipt deadlines are without exception and the UAWC is not obligated to conduct a review of a late submission even in light of funding deadlines. At the meeting, UAWC members discuss each individual protocol and evaluate it for adherence to animal welfare laws, regulations, and policies. UAWC approval voting is by consensus.

The possible actions taken by the UAWC are: Approved (self explanatory), Delegated (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 UAWC minutes. The UAWC Administrator sends written notification to the investigator of its decision to approve or withhold approval of those activities related to the care and use of animals, or of modifications required to secure approval. When approval is granted, a copy of the notification letter is also sent to the NYU Office of Sponsored Programs so that they may notify granting agencies. All UAWC records are maintained for review by Federal and State agencies responsible for animal welfare .

If the UAWC decides to withhold approval of an activity, the notification includes a written statement of the reasons for its decision. 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 Delegations, once the UAWC Administrator has received the investigator's response to the UAWC, 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 UAWC and investigators in order to promote research while maintaining high standards for animal welfare.

Approval and Expiration
Approval is for a period of ONE YEAR. An annual protocol review consists of review of an UAWC 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: UAWC approval number, UAWC 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 4 copies of the completed Annual Review Form to the UAWC Administrator prior to the next UAWC meeting submission deadline.

As PHS policy requires, a complete (de novo) protocol review and approval by a convened UAWC 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 UAWC approval.

Investigators must secure prior approval from the UAWC 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.

Regulatory Requirements
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.


This site has been established to provide access to all Federal and University animal welfare laws, regulations, policy and guidelines concerning vertebrate animals used in research and teaching. In addition, the latest versions of OVR record keeping forms and UAWC protocol review forms are available for downloading.

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