All work done with animals must be covered by an approved Animal Use Protocol (AUP). This document details what is being done to animals and why and by whom, justifies the species and the numbers of animals used, addresses how any possible pain and distress inflicted upon the animals will be minimized, and demonstrates that there are no alternatives to the proposed work and that it isn't unnecessarily duplicative. Protocols are valid for 3 years, and are reviewed annually. Any modifications to the protocol must also be approved.
By law, all protocols must undergo the review process. There is no legal way to perform an "administrative review", that is, there is no person at the University who can simply grant approval for your protocol.
THE LAW REQUIRES:
Every procedure done on animals must be covered by an approved animal protocol.
Every animal used in research must be covered by an approved animal protocol.
Every person doing research with animals must be covered by an approved animal protocol and have undergone the proper training.
Types of Protocols
There are three types of animal use protocols at Thomas Jefferson University:
- Animal Use Protocols. Animal Use Protocols cover any work done with a live vertebrate animals. A protocol can only cover a single species.
- Tissue Use Protocols. These protocols cover work done with animal tissues obtained from sources such as slaughterhouses, butchers, and tissue banks, or tissues harvested from animals on other research protocols that would otherwise be discarded.
- Avian Embryo Protocols. Avian embryos are not considered to be animals under the law. However, live chicks are. Investigators working with avian embryos know that, because of the imprecision involved in identifying the age of an embryo, an egg will, on rare occasions, hatch, and the chick is then humanely euthanized. This type of protocol covers this eventuality.
Investigators wishing to submit an animal protocol for approval must first complete a new protocol through the eSirius system which will be submitted to the IACUC for review.
The IACUC meets monthly, every 4th Tuesday of the month. The deadline for protocol submission for these meetings is the first Friday of each month, by 12:00 noon. Investigators requiring an accelerated review in order to meet Just In Time deadlines that fall outside of the regular review process can be accommodated; see below.
Before submission, all new or de novo (triennial review) protocols need to be pre-reviewed by an IACUC committee member. If you pay attention to the comments of your pre-reviewer, your protocol should be approved with minimum additional effort. However, if you do not obtain a pre-review this could cause the approval process to take longer then necessary. You can contact any IACUC member to request a pre-review.
To submit a protocol for pre-review please notify the IACUC Coordinator to have the protocol sent to the IACUC Member of your choice for pre-review through eSirius.
The completed and pre-reviewed protocol needs to be submitted via eSirius.
Accelerated/Just In Time Reviews
In order to accommodate the Just-In-Time process, the IACUC has a mechanism for performing accelerated reviews. In order to obtain an accelerated review, you must send a copy of your pre-reviewed protocol via email with a cover letter explaining why you are requesting an accelerated review and all relevant deadlines to Larry Harshyne, IACUC Chair, and CC it to Kathryn Clark, IACUC Coordinator.
Note that before ORA will inform the granting agency that your protocol has been approved, the protocol must receive approval (see below).
Federal regulations require that the entire IACUC be given an opportunity to review on your protocol. In practice, this requires a minimum of 24 hours.
Although the IACUC and the IACUC staff will make every effort to speed the approval of your protocol, the IACUC can not guarantee that your protocol will be approved in time. If your protocol is substandard and you can not answer the questions satisfactorily, it will not be approved. Note that approval is also contingent on the prior approval by the IBC and/or Radiation Safety if it includes work that would involve either of these offices. It is your responsibility to allow as much time as possible to the IACUC for it to satisfactorily review your protocol. If there is any chance that your grant proposal will be funded, it is in your best interest to prepare and pre-review your animal use protocol so that it can be submitted and reviewed in a timely fashion.
The approval process is as follows. The IACUC Chair assigns reviewers to all protocols. These assigned reviewers may decide to either a) approve the protocol, b) request clarifications and/or changes before approval, or c) refer the protocol to the entire committee for approval.
If changes are required for approval, you must answer the questions to the satisfaction of the reviewers. Once you have accomplished this, your protocol will be approved.
If your protocol is called for Full Committee Review, the entire IACUC will review the protocol, and at its next meeting will decide (by majority vote) whether to approve the protocol or request further clarifications and/or changes. Careful attention to the remarks of your pre-reviewer should prevent this scenario.
A more detailed explanation of the review and approval process can be found in the following policies:
- Review and Approval of Protocol Submissions
- Administrative Review/Approval of Protocol Modifications
- Administrative Approval of Protocol Modifications to Increase Animal Numbers
Final approval, however, is contingent upon the following factors:
- Personnel. All personnel listed on the protocol must have completed the required animal use training, i.e., have an RO-4 (Personnel Qualifications in Animal Care and Use) form on file after completion of bio-technique training, must have completed the required online training, and completed occupational health screening.
- Biosafety. If your protocol requires biosafety approval for any reason, your protocol will not be approved until you have obtained approval from the Institutional Biosafety Committee.
- Radiation Safety. If your protocol utilizes radiation in the animals, your protocol will not be approved without approval from the Radiation Safety Office.
- Chemical Safety. If you protocol includes the use of hazardous chemicals, you must have approval from Steve Baker in Environmental Health and Safety.
Modification of Protocols
Once a protocol is approved, any changes to the protocol require a modification before they can be carried out. Examples include:
- Adding new strains of animals
- Adding additional animals to the project.
- Adding new procedures
- Adding new experimental compounds
- Adding new experiments
Modification requests are submitted and reviewed along with regular protocol submissions. As with regular submissions, an accelerated review can be accommodated.
Since modifications done in the eSirius system are worked into the main body of the protocol, PIs are no longer limited to three modifications in a three year life span of the protocol. An unlimited number of minor/major modifications can be approved at the discretion of the IACUC. Minor modifications can include addition/deletion of personnel, addition of new study compounds of the same class as those already in the protocol, and the addition of new animal strains. Major modifications include adding new procedures, new experiments, changes in experimental design, etc.
Continuing Reviews of Animal Use Protocols
All animal protocols must be reviewed annually by the IACUC. Thirty days prior to the renewal date, the Principal Investigator will be sent a reminder email from the eSirius system. The protocol will also appear in the continuing review tab in eSirius. Instructions on how to complete a continuing review can be found here. Failure to return the form in a timely manner may result in the termination of the protocol.
De Novo Reviews of Animal Use Protocols
Animal Use Protocols expire after three years and must be renewed if work is planned to continue. This is because it is expected that you will have completed the studies in this amount of time, or that your research will have changed during this period. Additionally, there may have been changes in the regulations during this time. To continue the work, you must submit a new protocol that will again must undergo the approval process. If you do not wish to continue the work, contact the IACUC Office and terminate the protocol.
Starting at 120 days prior to the expiration date of the protocol, the Principal Investigator will be sent a reminder email from the eSirius system. The protocol will also appear in the De Novo review tab in eSirius. Instructions on how to complete a De Novo review can be found here. Failure to resubmit a new protocol form will result in the termination of the protocol.
Termination of Animal Use Protocols
Animal protocols may be terminated by either the investigator or by the IACUC. When a protocol is terminated, all animals on that protocol must either be transferred to an active protocol or be destroyed prior to the expiration date of the protocol to avoid risking an non-compliance issue.
An investigator can terminate a protocol by simply informing the IACUC Office of the date of termination. Protocols due for Continuing Review can be terminated by selecting the "withdrawn" option and those due for De Novo Review can be terminated by selecting the "lapse upon expiration" option. Someone from the IACUC office will confirm the termination with the PI.
Protocols may be terminated by the IACUC as the result of serious non-compliance.