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.

Effective October 1, 2015, animal studies funded by the National Science Foundation (NSF) will be included in Mercer University’s noncompliance report to OLAW.

Before submitting a protocol application, please review the protocol submission process. Use the links below to quickly navigate the information. To download a form, go to Mercer Protocol Forms and Applications.

Protocol Approval

New animal use protocols may be approved for up to three years (depending on species involved), after which a new animal use protocol submission must be submitted. An animal research protocol may be submitted for each major technique or experiment to be used to the IACUC in anticipation of including several techniques or experiments in a grant application. For the immediate implementation to occur, the IACUC approved animal usage protocol is activated.

Upon submission of a protocol application, the investigator may receive an email regarding individuals listed on the staff roster who need to complete the Collaborative Institutional Training Initiative’s (CITI) animal training requirements or complete the forms for the Occupational Health Program. The investigator, along with the individuals listed on the staff roster, will need to complete the animal training requirements and complete the Occupational Health Program Forms to move the 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:

Macon Campus Atlanta-Savannah Campus

Dr. Melissa Kling
Kling_M@Mercer.edu

Dr. J. Roger Broderson
Broderson_JR@Mercer.edu

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.

For more information on animal care activities, view the IACUC’s SOPs and guidance documents.

Once Veterinary Review is complete, the application should be submitted as an email attachment with your signature and the signature of your dean to ORC_Research@Mercer.edu

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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, Contracts, and 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 shall 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 supporting documents for the vertebrate animal, the research strategy, and 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 pages one and six of the application and other supporting documents such as the vertebrate animal, 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

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Protocol Modifications

A modification form must be submitted to obtain IACUC approval for any significant changes to an approved study protocol.

*Please refer to OLAW guidance as to what constitutes a significant change to an approved protocol.

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.

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