Research Integrity & Compliance:Obtaining Approval for Research and Teaching Activities With Animals

The East Texas A&M IACUC Review Process

The use of animals is defined as any activity involving vertebrate animals in which the natural lifestyle or movements of the animal may be materially altered. All research, testing, teaching or any other use involving animals, animal carcasses, tissues and fluids must be approved through a protocol by the Institution Animal Care and Use Committee (IACUC).

Throughout the entire research process, from the planning stages, to conducting research and interpreting your results, you will be known as the project’s Principal Investigator (PI). As the Principal Investigator of a research or teaching protocol involving the use of animals, you must submit your protocol application and all corresponding documents to obtain approval to conduct any research, testing and/or teaching that involves animals. Additionally, you must meet certain responsibilities required of all PIs working with animals.

Preparing for Protocol Review

Before submitting your protocol, you must first demonstrate you are properly trained and ready to begin work.

  • CITI Training – Research Compliance will verify that you have completed all necessary training and have submitted certificates of completion.
  • Safety Training – All participants on the protocol must participate in the Occupational Health and Safety program. Health and Safety Questionnaires must be completed and approved.
  • Documentation – The project will receive a protocol number after Research Compliance has verified training for all PIs, staff and students.

Send all forms to [email protected].

Types of Protocol Review

All protocols will be reviewed by either full committee review (FCR) or designated member review (DMR).

  • Full Committee Review (FCR) – All IACUC members receive copies of the proposed research document(s). Full Committee Review requires a convened meeting of a quorum consisting of >50% of the IACUC members. During the meeting, the committee will take actions on the proposed research document(s).
  • Designated Member Review (DMR) – All IACUC members receive copies of the proposed research document(s). If no member requests that the document(s) receive a Full Committee Review, the Chair designates two members to review the proposed research document(s). The designated members have authority to approve, require modifications or request a Full Committee Review.

After protocol review, the IACUC may take one of several actions as defined below:

  1. Approval – The IACUC determines review criteria have been met, and the PI may begin experiments or procedures as described in the protocol.
  2. Modifications required for approval – The IACUC determines that the protocol may be approved contingent upon receipt of a very specific modification(s). This action results in the protocol being sent to DMR for administrative approval.
  3. Withhold approval – The IACUC determines review criteria have not been met.

Submitting a Protocol

Step 1: Prepare to Submit Your Protocol Application

  1. Complete online trainings for Responsible Conduct of Research and Laboratory Animal Welfare through the Collaborative Institutional Training Initiative (CITI) program (research, teaching or testing only).
  2. Download the IACUC Protocol Review Checklist to ensure you follow correct procedures throughout the research process.
  3. Complete an Animal Care & Use Protocol (AUP) Application form.
  4. Complete the Protocol Risk Assessment Questionnaire.
  5. Submit the completed protocol application and the Protocol Risk Assessment forms via email to [email protected], or hand-deliver them to Research Compliance in Velma K. Waters Library 225B.
  6. Each participant listed on the protocol must complete the Occupational Health & Safety Program Questionnaire.
    Important note: the information in the questionnaire is confidential. Each participant must personally deliver their own form to the Research Compliance office in Velma K. Waters Library 225B.

When signing the Animal Use Protocol (AUP) application, you certify the following:

  1. You will limit discomfort and injury to animals to that which is unavoidable in the conduct of valid scientific research or teaching.
  2. You will consult a veterinarian before performing potentially painful procedures.
  3. You will obtain appropriate licenses and permits for collecting wild animals (if appropriate) and attach this documentation to the protocol application.
  4. You will follow a Letter of Assurance and all applicable state and federal laws governing animal welfare.
  5. All personnel will be appropriately trained, educated about and provided with appropriate protective equipment when working with animals and any associated hazards.
  6. Any work with animals is limited specifically to what is approved in the approved protocol application.
  7. All researchers will abide by all Standard Operating Procedures SOPs, rules, regulations and policies for research.

You should submit protocols to the IACUC for review in advance. Please refer to the IACUC meeting schedule to review submission deadlines.

If you are unsure if your project involves the use of animals, please contact Research Compliance.

Step 2: Administrative Review

Research Compliance will review all protocol application submissions for completeness. If necessary, the IACUC or veterinarian may request clarification on certain items listed on the application.

An AUP number will be assigned to the protocol application. All future communications should reference this number.

After initial review, the application will be sent to the attending vet and the IACUC Chair for further review.

Step 3: Committee Review

Protocol applications may follow two possible review pathways: Designated Member Review (DMR) and Full Committee Review (FCR), described above.

In either case, the IACUC committee Chair will distribute the Animal Use Protocol (AUP) to the committee members for review. The committee will have a designated time period (typically 10 days) to consider the protocol. The committee Chair will consider all comments or concerns the committee members raise.

If the committee requires further clarification, the Chair will contact you via email. If at any time during the review period serious concerns arise, a committee member may call for Full Committee Review (FCR) of the protocol application.

If no members call for FCR, the Chair will assign a primary and secondary reviewer for Designated Member Review (DMR); these two members will be responsible for conducting a thorough review of the protocol, grant and all committee comments. Additionally, at least one of the reviewers may contact you, the Principal Investigator, for an interview. The Designated Reviewers must agree on the next course of action. They may approve the protocol, require modifications to secure approval or refer the protocol to FCR. The IACUC committee Chair will contact both you and Research Compliance by letter with the results of the DMR.

At any time during this review period, a committee member may call for a Full Committee Review (FCR) of the AUP. This occurs when the proposed research raises serious concerns. Additionally, any of the committee members may contact you, the investigator, for clarification.

The protocol will be brought before the next full IACUC meeting for discussion and consideration. You are not required to attend the meeting, but attendance is encouraged. If the committee requires further clarification, you will receive a pending approval memo requesting you to make and resubmit revisions within 30 days of receiving the memo.

The committee Chair will consider all comments or concerns that committee members raise. If further clarification is required, the Chair will contact you via email and request specific information.

Upon revision, the protocol may be reviewed under either the DMR or FCR rules. If a majority of the fully convened meeting of the IACUC votes against approval, the protocol will be disapproved. The IACUC committee Chair will contact both you and Research Compliance with the results of their determination. Research Compliance will track documents and send out reminders for annual review follow-ups.

The IACUC meets according to the schedule posted on the main IACUC page. You should submit protocols at least 30 days in advance for review. Please click here to see a list of the IACUC members. If you are unsure if your project involves the use of animals, please contact Research Compliance.

Step 4: Approval Outcome

Once approved, the IACUC Chair will prepare and send you an approval letter electronically via email. Additionally, you will receive a copy of the approved Animal Use Protocol.

The approved protocol will remain effective for three (3) years. Each year, the IACUC requires that you submit an Animal Use Protocol Continuing Review Form form via email regarding the status of each non-exempt and exempt teaching and research protocol. During the final year, you are required to submit the Closure Form.

Step 5: Changes to a Protocol

If you believe the project may undergo any significant changes (such as regarding personnel, species usage, animal procedures, anesthesia, post-operative care or biohazard procedures) you must submit the proposed changes for review and approval a minimum of 30 days in advance. Importantly, the approval for an amended animal protocol does not extend the original expiration date of the originally approved protocol.

Examples of amendments which might be requested include but are not limited to:

  • addition of new personnel or departure of personnel from a project;
  • changes in animal procedures, such as anesthesia, surgical procedures, feeding or sampling;
  • the need for additional animals or new species;
  • changes to animal housing sites or procedure areas;
  • changes in ultimate disposition of animals;
  • administrative changes such as a change in principal investigator, funding source or project title; or
  • designating personnel to act on behalf of the principal investigator to submit amendments, annual reviews and transfers.

You must complete all sections of the amendment form, describing the exact nature of the changes requested and a justification. Be sure to include any associated information normally requested on the AUP form. For example, if you are requesting an increase in animal numbers, please provide a justification for the increase and a justification for the number of animals requested. If you are adding personnel to a project, please describe their training and experience with the procedures they will perform.

Significant changes in procedures or experimental objectives may result in a request for a new AUP.

If an animal will be transferred from one protocol to another, you must complete an animal transfer form and submit it to Research Compliance with both investigators emailing their approval for the transfer.

Step 6: Closure of a Protocol

Submit the IACUC Project Closure Form no later than 30 days after completing your research.

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