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 ensure humane treatment of research animals and compliance with internationally accepted and Federal/State government mandated animal welfare standards. 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.

Application Process and Timing of Submissions for
New and Three-Year de novo Submissions

The appropriate forms must be completed in their entirety by the Principal Investigator and submitted to the UAWC Administrator for pre-review by a Departmental Representative.

For three-year renewals, applications and all related documents should be submitted for pre-review three months prior to the protocol's expiration date. For a list of what to include with submissions, please review the Submission Checklist.

Federal regulations require that a University Veterinarian be consulted in the planning of procedures involving animal care and use. Therefore, when preparing a new protocol, please consult a University Veterinarian on the proposed studies.

Once you have received your pre-reviewed protocol from the UAWC Departmental Representative, all revisions are to be incorporated into the protocol form. Keep in mind that the UAWC is a diverse group which includes non-scientific members, so technical language and abbreviations should be minimized.

When it’s time to submit the revised protocol for full committee review, please include the completed Submission Checklist along with the documents associated with the particular review.

Please refer to the UAWC Meeting Calendar for submission deadlines and meeting dates.

Note: When classroom activities 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 application. Please note that currently, a separate protocol submission form is required for each species-- excluding non-human primates.

Review Process

The review process begins with the pre-review by the Departmental Representative. 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 a convened UAWC meeting. It is to your advantage to follow this submission format to avoid delaying review and approval, since granting agencies will not release research funding for the use of animals until they have received confirmation of UAWC approval.

Copies of final protocols and responses to issues raised at pre-review are distributed to UAWC members one week prior to the meeting to allow members to review the materials thoroughly. Receipt deadlines are without exception and the UAWC is not obligated to review late submissions even in light of funding deadlines. At the UAWC meeting, members discuss each protocol and evaluate it for adherence to animal welfare laws, regulations, and policies. UAWC determinations are by majority consensus.

The possible determinations are: Approved (self explanatory), Modifications Required (there are issues which require clarification or correction), and Approval Withheld (there are some major areas of concern that may require in-depth discussion and resolution. The protocol, as submitted, is not acceptable and must be extensively revised and resubmitted for full committee review).

After a convened meeting, the UAWC Administrator sends electronic notification to the investigator with the UAWC’s decision to approve or withhold approval or of modifications required to secure approval-- including a written statement of the reasons for its decision. The investigator is given an opportunity to respond to the UAWC with clarifications and/or modifications at the next convened meeting. All records are maintained for review by Federal and State agencies responsible for animal welfare.

For Designated Reviews, once the UAWC Administrator has received the investigator's response to the UAWC, approval may be granted before the next convened meeting. For protocols requiring significant changes, the committee may ask that the application be revised and re-reviewed by the full committee at the next 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 annual review form completed by the investigator, which indicates that no substantive changes are proposed for the following year. If changes are proposed during an annual renewal, they should be included in an amendment form to be reviewed by the Chair and Attending Veterinarian. The annual protocol review process is initiated by submitting 1 electronic copy and 1 signed hard copy of the completed form to the UAWC Administrator 2 months prior to the protocol’s expiration date.

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. The information required is the same as that of new submissions.

Investigators must secure prior approval from the UAWC before making any revisions to the experimental procedures. Guidelines for amending protocols are available.