Protocol Submission for New and Three-Year Reviews
1. A completed Protocol Form must be submitted to the University Veterinarian and the UAWC Departmental Representative for pre-review. Note that a separate form is required for each species. Be sure to give ample time in advance of the UAWC submission deadline. The purpose of the pre-review is to identify issues that are either incomplete or unclear and would prevent or delay 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.
2. Once you have received the results of the pre-review from the UAWC Departmental Representative and University Veterinarian, incorporate revisions into a final version of the protocol form.
3. Ten copies of the final version of the Protocol Form and 3 copies of the accompanying scientific proposal must be submitted to the UAWC for a full committee review a minimum of one week prior to the scheduled UAWC meeting date. Click here for submission deadlines and meeting dates. Submission deadlines have been established so UAWC members have the opportunity to review the materials thoroughly. These deadlines are without exception and the UAWC is not obligated to conduct a review of a late submission even in light of funding deadlines.
Note: 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.
Committee Review Process
Copies of final protocols are distributed to UAWC members by the UAWC administrator in advance of the meeting. 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 administrator of the UAWC 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 placed on file in the Office of Veterinary Resources 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 Delegation, 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.
Protocol 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 renewal 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 an Annual Review Form to the UAWC office. A Protocal Expiration Notice is sent to Scientists by the UAWC Administrator approximately three months prior to the anniversary of the last approval. Four copies of the completed form should be submitted to the UAWC. Annual renewals are reviewed by a delegated sub-committee of the UAWC.
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.