Protocol Submission Process
Federal regulations and Mercer University Policy require that an investigator must receive a letter of approval of their application from the Institutional Animal Care and Use Committee before the investigator may begin the proposed activity involving the use of live vertebrate animals for research, teaching, or testing.
Please be advised that any investigator, with an animal protocol, can have their protocol previewed by an Institutional Animal Care and Use Committee (IACUC) member or a Veterinarian. If you wish to have a preview of your protocol, please contact Dr. Roger Broderson, the IACUC Chair at Broderson_JR@Mercer.edu or by phone at (478) 301-4101.
Protocol Approval
New animal use applications may be approved for up to (3) three years after which a new application must be submitted. An animal research application may be submitted for each significant technique or experiment. IACUC applications should be congruency with all PHS grant application submission. Implementation should occur when the IACUC application is approved.
Upon submission of an application, the investigator may receive from the ORC (Office of Research Compliance) an email regarding individuals recorded on the staff list who need to complete the Collaborative Institutional Training Initiative’s (CITI) animal training requirements or complete the form for the Occupational Health Program. The investigator, along with the individuals listed on the staff listing, will need to complete CITI the animal training requirements and complete the Occupational Health Program Form to move the overall application review process forward.
Veterinary Review
Before IACUC submission and review, a Mercer University veterinarian must review and sign the protocol application. For Veterinary Review and signature, please email a copy of your completed application to the university veterinarian below:
| Columbus-Macon-Savannah | Atlanta |
|---|---|
|
Rachel Wier, DVM, DACLAM |
J. Roger Broderson, DVM, Ph.D., DACLAM |
The veterinarian review will include the entire protocol, but will focus on animal care, anesthesia, analgesia, and other animal care activities. The veterinarian may identify specific concerns and offer suggestions to reconcile the concern. It is the investigator’s responsibility to provide the university veterinarian with any requested additional information.
Once the veterinary review is complete the application should be submitted as an email attachment with your signature and the signature of your department head or dean to ORC_Research@Mercer.edu
Protocol Modifications
Prior to the review of modifications of existing proposals (using the modification application) are sent to the Office of Research Compliance (ORC) for an administrative review of completeness.
Modification applications move forward to a veterinarian for the review of the listed pain and distress level, to verify and advise the proper and adequate use of analgesics, anesthetics, and tranquillizers, and for the proper method(s) of euthanasia.
Once the modification application is reviewed by the veterinarian each committee member is sent by paper, e-mail, or InfoEd (an electronic research administration software) a copy of the modification application.
IACUC Committee members have at least (5) five days to respond with any immediate concerns to the investigator and copy these concerns or questions to the ORC. Any member of the IACUC may request a convened full committee review of the modification submitted.
If full committee review is not requested or required, at least one member or more of the IACUC designated by the Chairperson and qualified to conduct the designated member review, review applications assigned to them as designated reviewer(s) and have the authority to approve, require modifications (to secure approval), or request full committee review of the application. When all concerns or questions are resolved, the designated reviewer will notify the ORC of approval and an approval letter is sent to the investigator.
Modifications are classified as being significant or not significant.
Significant changes are those changes that have or may have a direct impact on animal welfare including but not limited to changes:
- That have the potential to increase the level of pain or distress of the animal and includes all changes that involve anesthesia, analgesia, sedation, or euthanasia;
- In frequency, interval, type, number, or anatomical location of: procedures; and substances administered or otherwise delivered to the animal.
Examples of significant changes in ongoing research projects are:
- A change in the overall aims or objectives of the study
- A change which may involve an increase in the levels of pain, distress, and/or discomfort
- A change from non-surgery to surgery, from minor to major surgery, from non-survival to survival surgery, or from single to multiple survival surgery
- A significant increase in the number of animals used; (e.g. > 10% for laboratory rats and mice)
- A change in the genus or species of animals used
- A change in the principal investigator for a protocol
- The addition of the use of hazardous agents in animal procedures.
- Animal numbers or species; (see Guide for the Care and Use of Laboratory Animals, p. 25)
- House or use animals in a location that is not part of the animal program overseen by the IACUC
- The scope of an approved animal activity (see NIH Grants Policy Statement Part 2 8.1.2.5.)
- Change of Principal Investigator
- Changes that affect personnel safety
*Significant changes must be approved by one of the valid IACUC approval methods (full committee or designate member review) described in the PHS Policy IV.C.2.
Not significant (minor) changes may be handled by the IACUC staff without IACUC review and approval. However, the IACUC is to be informed of the changes at a convened meeting. Changes include but are not limited to:
- Total increase in animal number for animals not regulated by USDA that does not exceed 10% of the number reviewed and approved by the IACUC
- Change that would result in less discomfort or invasiveness to the animal, except the changes described the significant changes section
- Change in stock, strain, or genetic modification, unless the new stock, strain, or modification results in abnormalities that require special support;
- Change to house or use animals in a location that is currently used for the same purpose and is part of the animal program overseen by the IACUC;
- Change in personnel other than the Principal Investigator (PI) (An appropriate administrative review must be conducted to ensure that all such personnel are appropriately identified, adequately trained and qualified, enrolled in applicable occupational health and safety programs, and meet other criteria as required by the IACUC. The IACUC should have a procedure in place to ensure that this review is conducted.)
- Correction of typographical errors
- Correction of grammar
- Contact information updates
- Animal tissue received from a certified vendor, discarded by a MU investigator, or another assured institution, and does not meet any of the following criteria; (1) have any manipulations (such as dietary changes, biopsies, etc.) of live animals occurred specifically for an investigator’s research use (2) the animal being euthanized specifically for an investigator’s research.
*The IACUC staff may defer, at any time, to the IACUC to review not significant (minor) changes for approval by one of the valid IACUC approval methods (full committee or designate member review).
Congruency Review
Mercer University is an assured institution and is required and responsible for assuring congruency between animal activities described in grant applications and all IACUC approved activities. A congruency review occurs to ensure the animal activity outlined in the research proposal has approval by the Institutional Animal Care and Use Committee (IACUC) in an active approved protocol as required by federal granting agencies.
It is the institution’s responsibility to ensure that the IACUC has approved the proposed use of animals described in a grant application or contract proposal. It is an institutional responsibility to ensure that the research described in the application or contract is congruent with any corresponding protocols approved by the IACUC. The determination of congruency must occur any time prior to grant award.
To prevent non-congruence between the information submitted to PHS, NIH, NSF, or Contracts, the information contained in corresponding IACUC protocols, the IACUC, and the Office of Research Compliance have implemented a process for congruency review. The focus areas of the congruency review consist of:
- Species
- Proposed total animal numbers
- Procedures
- Euthanasia when not consistent with the recommended AVMA guidelines
- Research strategy and design approach
- Methodology, analyses, and design strategy for specific aims of the project
To assist the IACUC with the congruency review the investigator should submit along with the IACUC application, when applying to PHS –NIH, NSF, or other supported PHS agency, the vertebrate animal section, the research strategy, and the design approach sections.
When a contract or sub-award is pending submission, the IACUC should receive the proposal’s scope of animal use for a congruency review of the elements and activities described in the approved or proposed animal application.
For existing approved protocols, contracts, or sub-awards needing congruency review investigators should submit supporting documents such as the vertebrate animal section, research strategy, design approach sections, or other information pertaining to the species, proposed total animal numbers, procedures, euthanasia, design approach/research strategy.
Send completed form to:
Attention – Ms. Ajuania White ORC_Research@Mercer.edu
Material Transfer Agreements
Material Transfer Agreements (MTAs) are contracts that protect the rights of both the receiver and the provider of these materials. The Office of Research Compliance processes contracts that have materials coming into or going outward-bound Mercer University. Examples of materials are live animals or custom antibodies. For further information, please contact the Office of Research Compliance. ORC_Research@Mercer.edu
