5. Protocol Review Process
Source of IACUC Submission Forms
IACUC protocol submission forms are available on the New Online Submission Forms page of the IACUC website. Please note that ACC (the Animal Care Committee) is the former acronym for the IACUC.
Because the forms are updated periodically, PIs are advised to download new blank forms as needed directly from the IACUC website. This is due to the fact that, after a limited grace period upon release of new forms, new submissions on old forms are no longer accepted.
Types of Protocol Submission Forms:
- Main submission forms for proposed uses of vertebrate animals in research or for instruction/teaching labs:
- New Protocol Review Form - Research
- New Protocol Review Form - Instruction
- Appendices A through H are selected and indicated by the PI in Section 12, item #6, of the above New Protocol Review Form. The appendices required vary with each proposed research or teaching activity and must be selected appropriately. Please contact the IACUC office if you have any questions on which appendices are appropriate for your proposed research project.
- The Certification of Compliance Assurance form will be sent to you by the IACUC senior administrative assistant shortly after the receipt of your new IACUC submission. It will be sent with the Protocol title, IACUC number and PI information already completed for you. Please print, READ, sign, and send the document via campus mail to the IACUC senior administrative assistant.
PI's are strongly advised to keep a copy of this document for their records, either in print or electronic form, as this represents the contract between the PI, Virginia Tech, and the federal government. It also includes instructions for future use or needs for the lifetime of the protocol.
- Amendment Forms must be submitted, approval must be granted and approval letter received by the PI before any changes in personnel, procedures, species, or animals numbers can be made in previously approved research or instruction protocols.
- Annual Continuing Reviews are normally completed via an email query form sent by the IACUC senior administrative assistant. PIs will receive either an email containing basic protocol information to which the PI would reply, completing the required protocol information, or they will receive an email instructing them to log into a link wherein they will be provided with the same basic protocol information and the PI will complete the required information in an online survey type of format.
Ordinarily, this is all that will be required of the PI. However, if additional information is required, the PI will be sent an "Annual Continuing Review Form - Research" or "Annual Continuing Review Form - Instruction," as appropriate to the protocol in question.
With the exception of the signed Certification of Compliance Assurance, of which the signed original is sent to the IACUC office via campus mail, all forms are to be emailed to the IACUC office at IACUC@vt.edu as attached Word documents.
Protocol Receipt, Processing, and Review:
Protocols are logged into the IACUC database upon receipt and are assigned an IACUC protocol number. Every protocol undergoes two initial independent reviews for completeness and content. A new submission is first sent to the IACUC administrator or designee for an Administrative Review. The protocol then undergoes a Veterinary Pre-Review by the Attending Veterinarian or other qualified veterinarian.
PIs may be contacted by either or both pre-reviewers to provide clarifications, corrections, or with requests to submit missing appendices before IACUC review. These reviews may take 48-72 hours after initial receipt of the protocol. Failure of a PI to respond to questions or queries in a timely manner will result in delays in IACUC review and approval.
Protocols which have successfully passed Administrative and Veterinary Pre-Review are prepared for IACUC Member Review. Each protocol is synopsized and sent in a weekly batch to the members.
The IACUC members are given 6 days to review the protocols and indicate their preference for action on each protocol. These actions include:
- Hold, and require minor modification, or
- Allow Designated Member Review (DMR) and approval, or
- Require full review at a convened IACUC meeting.
NOTE: USDA Pain Category E (see Definitions) protocols MUST be reviewed at a convened meeting of the IACUC and the PI is required to present and defend his/her protocol at the meeting.
Protocols will be reviewed at the first available meeting where:
- the protocol has completed all of its pre-reviews, and,
- the PI is available to attend. Meetings are typically held on the 3rd Thursday of each month, though the meeting schedule may vary due to holidays and other influences. Please plan accordingly when preparing for such a project.
Hold, and Require Minor Modifications: the IACUC member forwards his/her questions to the IACUC Senior Administrative Assistant, who then forwards those questions anonymously to the PI and requests a response and/or revisions to the protocol in question. If the response and/or revisions are acceptable to the member(s) who raised the question and requested the hold, the hold will then be lifted. Designated Member Review will then be allowed to take place.
Allow Designated Member Review and Approval: the Designated Member Reviewer(s) has/have the authority to conduct the final review on behalf of the entire IACUC. The DMR may also request additional information or revisions from the PI. Once the protocol has been accepted by the DMR Reviewer(s), that/those individuals are empowered to grant approval on behalf of the IACUC. However, the DMR does NOT have the authority to disapprove a protocol, but must return it to the full IACUC for action if they feel they cannot approve the protocol.
Full Committee Review: when protocols are sent to the members, as few as one member can call for full IACUC review at a convened meeting. All Category E protocols must be reviewed at a convened meeting and are automatically routed thusly. At the convened meeting with a quorum present, IACUC members will vote their preference, with a simple majority vote of the members present required.
The potential outcomes are:
- Require modifications (contingent approval), or
- Approval, or
- Table, or
Notification of IACUC Action:
If a protocol does not receive full approval, the PI will receive an email explaining what action the IACUC took, and what needs to be clarified or corrected before additional review took place.
Upon approval of a protocol, the PI will be sent an electronic copy (PDF) of the official approval letter. They will also receive a Word document version of their complete protocol, including all revisions that occurred through the review process. PIs are requested to retain both the approval letter and Word version of their protocol. They are also requested to review the protocol in detail with their applicable staff and students, and to PRINT their protocol and file it in a binder in the lab or otherwise near where the animal work is to occur, to ensure easy staff access to the official version of the protocol.
NOTE: Animal studies must NOT be started until the PI has received the official IACUC approval letter.
Protocol Lifespan and Length of Approval:
Protocols are approved by the IACUC for a 3 (three) year period. PIs will be required to provide specified information for annual continuing reviews and at the time of the protocol's expiration or voluntary (early) close-out at the conclusion of the study.
A PI may voluntarily close his/her protocol at any time but a closed protocol may NOT be re-opened. Once a protocol is closed in the IACUC database, a new protocol submission must be approved before work with animals on that project may resume.
Annual Continuing reviews are federally mandated and the PI will be sent a query for information as described above. Information required includes but is not limited to:
- Whether the protocol is active (e.g., ongoing or completed/closed)
- The number of animals used to date since the initiation of the study
- Confirmation of the USDA Pain Category, and the numbers of animals used by pain category
- A description of any adverse events affecting animal health and well-being
- Whether any personnel or other changes have occurred outside of the amendment process
Based on the PI's responses to the initial query, he/she may be asked to complete and submit an Annual Continuing Review Form or be referred to the Post-Approval Monitoring Officer for additional follow-up.
PLEASE NOTE that the Annual Review is NOT a substitution for the Amendment process at Virginia Tech as it is at some institutions. Planned changes must be made via the Amendment process. Unexpected events are required to be reported to the IACUC office at the earliest convenience of the PI, preferably with in 2 business days. See Amendment Submission and Review below.
In order to avoid interruption of animal use, PIs must submit and receive approval for a new protocol PRIOR to the expiration of the original protocol. Animals must NOT be used after a protocol has expired or has been voluntarily closed prior to its expiration date. However, unlike human subject research, work with harvested tissue and other data may continue after the expiration of a protocol.
Also, note that it is imperative that PIs and teaching and research personnel maintain strict tallies of the animals that they have utilized in their teaching and research. PIs must NOT exceed the number of animals approved on the original submission or any subsequent approved amendments. Failure to do so, resulting in exceeding approved animal numbers, will result in sanctions and, potentially, reporting to the Public Health Service/National Institutes of Health.
Amendment Submission and Review:
Changes in the original IACUC approved protocol CANNOT be implemented without IACUC Amendment approval. Amendment forms are available at https://www.research.vt.edu/iacuc.html, as described elsewhere in this tutorial, and are to be submitted as emailed Word document attachments.
Amendments are reviewed in two categories:
- Minor amendments can undergo administrative review and approval usually in 48-72 hours.
- Significant amendments must be sent to all IACUC members and are usually distributed via the same DMR
distribution that full submissions undergo. The IACUC may request a full new submission for significant changes that greatly alter the original research or teaching project. Allow 1-4 weeks for review time, unless the amendment is held over for Full Committee Review (FCR) at the next convened meeting.
Protocols are allowed three amendments (minor or significant) per protocol, though amendments that only address personnel changes do not affect this count. However, a change in PI DOES affect the count and is considered a significant amendment.