The SMU Animal Care and Use Program, including the IACUC, is established and supported by SMU Policy 10.9 Animal Care and Use. The main role of the IACUC is to ensure that the welfare of animal research subjects is protected. This is done through the approval of all research with animal subjects and continued monitoring of previously approved studies.

Authority of the IACUC

The Public Health Service Policy on Human Care and Use of Laboratory Animals enumerates the authority granted to the IACUC. An IACUC shall:

• Review the University’s program for humane care and use of animals and inspect the University’s animal facilities every six months
• Review concerns involving the care and use of animals at the University
• Review and have the authority to approve, require modifications in (to secure approval), or withhold approval of all research activities related to the care and use of animals, and significant modifications thereto
• Be authorized to suspend an activity involving animals

Committee Members

The IACUC must have at least five members with varying backgrounds. The composition must include, at a minimum: one veterinarian with training or experience in laboratory animal science and medicine, who has direct or delegated authority and responsibility for activities involving animals at the institution; one practicing scientist experienced in research with animals; one member whose primary concerns are nonscientific areas, and one member not affiliated with SMU. The Assistant Vice President for Research Integrity and Operations will appoint members to the IACUC after consulting with the Director of Research Compliance and the IACUC Chair. The IACUC members will serve a two-year, renewable term.

Policies

Several IACUC policies regarding animal care and husbandry, research procedures, and IACUC processes have been established and approved. These policies are available for review in a Box folder. Only approved animal users and IACUC members have access to the Box folder. Contact Research Compliance to request access to the IACUC policies.

Application Process

Researchers must submit a complete Animal Use Protocol and Narrative, as well as any applicable supplement forms, to be reviewed. To do this, Researchers will access forms found on the SMU IACUC website and provide all documents to Research Compliance. Supplemental forms may be required in special situations; see each form for guidance and instructions.

• Breeding
• Physical Restraint
• Use of Paralytics
• Multiple Survival Surgeries
• Antibody Production
• Non-SMU Research / Housing Locations
• PI / PD Maintenance of Animals
• Housing Exception
• Variation in Standard Husbandry

Review Process

The Compliance Staff will review the application for completeness and request any needed information from the Researchers. When complete, the Compliance Staff will send application materials to the IACUC Chair who will determine the appropriate type of review: full committee review or designated member review.

Full Committee Review

Review by the full committee occurs at regularly scheduled committee meetings. A simple majority (quorum) of members must be present in order to approve, require modifications in (to secure approval), or withhold approval of a Protocol.

Designated Member Review

To initiate Designated Member Review (DMR), submissions are first presented by the Chair to the committee via email and queried if a designated member review is appropriate. If full committee review is not requested by at least one member of the committee within 72 hours (during business days), the IACUC chair may refer the submission to a qualified committee member (or members) for review. The designated member(s) shall have the authority to approve, require modifications to secure approval, or request a full committee review. When multiple designated members are reviewing a submission, they must be unanimous in their decision; otherwise the review must go to the full committee. Approval may not be denied via DMR.

Meetings AY 2019 - 2020

The IACUC meets on the second Wednesday of every month. New protocol applications should be submitted four (4) calendar weeks prior to a regularly scheduled meeting date. Continuing reviews and amendments should be submitted two (2) calendar weeks prior to a regularly scheduled meeting date.

Criteria Used to Evaluate an IACUC Protocol

• Transportation, care, and use of animals should be in accordance with the Animal Welfare Act and other applicable laws, guidelines, and policies.
• Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society.
• The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results. Methods such as mathematical models, computer simulation, and in vitro biological systems should be considered.
• Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative. Unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in other animals.
• Procedures with animals that may cause more than momentary or slight pain or distress should be performed with appropriate sedation, analgesia, or anesthesia. Surgical or other painful procedures should not be performed on unanesthetized animals paralyzed by chemical agents.
• Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved should be painlessly killed at the end of the procedure or, if appropriate, during the procedure.
• The living conditions of animals should be appropriate for their species and contribute to their health and comfort. Veterinary care shall be provided as indicated.
• Investigators and other Personnel shall be appropriately qualified and experienced for conducting procedures on living animals.

Possible Outcomes of the Review Process

Approved

No further action is required from the PI / PD and the research may be started. Researchers are NOT allowed to begin research until a letter has been received from the IACUC stating the study has been approved.

Approved Pending Modification / Training Completion

Minor changes to the Protocol or training completions are needed before research may begin. The IACUC will enumerate the requested changes and/or required training(s), and the applicant must re-submit the modified Protocol for confirmation.

Denied

The activity cannot be conducted as proposed. If this happens, the IACUC will work with the Researcher to find a way to conduct research if possible.

Appeals of IACUC Decisions

Appeals to decisions made by the IACUC on project applications may be made in writing and submitted to the committee Chair within 30 days of the decision notification. The appeal should include the investigator’s position and any new, relevant information. If the IACUC Chair believes that the new information warrants an appeal, the full IACUC will hear the appeal at the next meeting. The IACUC’s determination of the appeal is final. However, if the appeal is denied, the Researcher may submit a revised Protocol for consideration.

Changes to the Protocol

Any proposed changes to the study must be approved by the IACUC via full committee review or designated member review. This includes, but is not limited to, changes to animal species, strain, source, and numbers; procedures; study Personnel; work location; Funding source; and contact information. A Modification Form must be completed and approved by the IACUC before any changes can be implemented. It is the responsibility of the PI / PD to ensure that research staff conforms to the approved Protocol during the study.

Closing Out a Protocol

It is the responsibility of the PI / PD to inform the IACUC once all research activities related to a specific Protocol are completed. To do this, the PI / PD will complete and submit a Closing Report. This must also be completed before departure from SMU.

Yearly Progress Reports

An animal use Protocol is approved for a period of three years. For the first two years of the research, on the anniversary of the original approval, a Yearly Progress Report must be submitted for review. The Yearly Progress Report is a brief update on animal numbers, unanticipated and adverse events, progress, refinements, and training. The Yearly Progress Report will be reviewed by full committee review or designated member review.

Triennial de novo Review

Upon the third anniversary of the original approval of an animal use Protocol (after two Yearly Progress Reports), an entirely new (de novo) application must be submitted for review. Researchers will follow the procedures used for initial application submission. In addition, a Three Year Progress Report must be submitted with the de novo application. The de novo application and Three Year Progress Report will be reviewed by full committee review or designated member review.

Post-Approval Monitoring (PAM) Program

The mission of SMU’s Research Compliance Post-Approval Monitoring (PAM) Program is to protect all research participants (human and animal) and to educate our investigators in the conduct of research that is safe and in compliance with federal, state, and institutional regulations. In addition, the PAM program helps to maintain a comprehensive compliance program for the SMU research community and provides assurance that research is being conducted ethically and in accordance with an approved Protocol. The PAM program consists of auditing and/or monitoring of both human and animal subjects research.

Research Compliance performs human and animal subjects research compliance audits and submits the resulting audit reports to the Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), and other institutional officials. These compliance audits serve as a confidential quality assurance measure internal to the institution.

What studies are chosen for an audit?

Any study that meets the definition of human and/or animal subjects research may be selected for a random audit. In addition, studies involving the following factors may be chosen for audit:

• Conducted by or transferred to a new Principal Investigator / Project Director (PI / PD)
• Indications that study subjects may be at increased risk (e.g., PIs / PDs with a high volume of studies, studies with minimal or no external oversight, inclusion of vulnerable populations, past or present subject safety or noncompliance issues, involvement of investigational drugs or devices, etc.)
• Excessive Unanticipated Event Report (UER) submissions, as determined by the IRB Chair or Research Compliance

Finally, investigators may request an audit of their own studies to ensure continuing compliance in their research plan.

Questions?

To ask a question, express concerns, or provide suggestions about the PAM program at SMU, please send a message to Research Compliance or call 214-768-2033.

Non-Compliance

Non-compliance occurs when research with animal subjects is conducted in a manner that disregards or violates federal, state, or local regulations or SMU policies. Once the IACUC becomes aware of potential non-compliance, they are required to investigate the matter. Once the investigation is complete, one of three outcomes will be determined: No Non-Compliance Found, Non-Compliance Issues Found, or Serious Non-Compliance Issues Found. Depending on the severity of the issues, the IACUC corrective actions include, but are not limited to:

• Modification(s) of the animal use Protocol through amendments initiated by the PI / PD
• Monitoring of animal use activity
• Education or training for PI / PD and/or research staff
• Corrective plan
• Suspension or termination of previously approved activities or the IACUC-approved Protocol, which requires a majority vote of a quorum of members at a convened IACUC meeting
• Restrictions on research Personnel
• Notification of Funding agency

Standard Operating Procedures (SOPs)

Several SOPs regarding animal care and operations been established and approved. Many of these SOPs are available for review in a Box folder. Only approved animal users and IACUC members have access to the Box folder. Contact Research Compliance to request access to the LARC SOPs.

Training

Personnel must complete a training session provided by the LARC facility manager before access can be authorized to the vivarium. This in-person training includes a tour of the LARC and covers topics such as risk assessment, PPE, hygiene, equipment, animal handling, and reporting of animal welfare concerns. Contact Courtney Yates for more information.

Per Diem and Technician Time Charges

Historically, the University has subsidized total costs directly associated with the Laboratory Animal Research Center (LARC). This University subsidy has eased financial burden on researchers. To recover a portion of the money spent on animal care, the Office of Research and Graduate Studies has established per diem and technician time programs under the authority of SMU Policy 10.9 Animal Care and Use Policy.

Details

Per diems will be charged for each day or fraction of a day that a cage is within the LARC. Per diems will not be pro-rated. Cage counting will be based on LARC standard practices. All animal cages must be marked with the appropriate IACUC Animal Protocol number, so per diems can be charged to the correct account. Charges will be collected on a monthly basis.

Included in the per diem rate:

• Animal husbandry and health checks
• A standard daily maintenance diet
• Cage, equipment, and facility washing and sanitizing
• Bedding
• Enrichment materials and devices
• Animal care supplies used in the animal holding area (cleaning, disinfectants, etc.)
• Protective clothing, gloves, and masks used by animal care personnel
• Regulated medical waste services
• Colony monitoring via the sentinel program

Per-diem rates for animal care are based on the cost analysis and recovery procedures outlined in the National Institutes of Health (NIH)’s Cost Analysis and Rate Setting Manual for Animal Research Facilities. Per diem rates are reviewed and published on an annual basis.

Subsidization

Subject to review by the IO, the University may subsidize per diem charges up to a total $4500. Subsidies may only be applied toward cages related to work described in a Proposal Initiation Authorization Form (PIAF). If the grant proposal is not awarded, the PI may petition to the IO for additional funding.

Rates effective 9/1/2019 - 9/1/2020

All cages will be charged at the rate of $0.90/day.

Technician Time

Technicians are available to LARC users for assistance with various animal husbandry tasks that are not included in per diem rates. These tasks include breeding assistance, euthanasia, blood draws, tail clips, ear tagging, and more. The cost of technician time is $25/hour. Time will be rounded to the nearest quarter hour, and billing will occur monthly. LARC users will be offered 1 hour/week of technician time free of charge; any time used after the first hour will be charged at the hourly rate. Technician time will also be charged if technicians are used to mitigate protocol non-compliance.

Implementation

Per diem and technician time rates go into effect on 9/1/2019. All grant applications must include appropriate per diem and technician time estimates.

All individuals working in or having access to SMU animal research facilities and/or research animals must participate in the Occupational Health and Safety Program (OHSP). The program comprises risk assessment, medical clearance, and respirator fit testing, if applicable. Medical clearance and respirator fit testing occurs at a private occupational health provider, and is provided at no cost to Personnel. Enrollment in the OHSP must take place before Personnel can be added to an IACUC Protocol or granted access to the research animals or the LARC. Enrollment will be updated on a yearly basis.

Contact Environmental Health and Safety for more information.

All research Personnel listed on an IACUC Protocol must complete required training before they can be granted access to research animals or the LARC, and training must be renewed every 3 years. Animal Care and Use training is offered via the Collaborative Institutional Training Initiative (CITI Program). It consists of 29 - 35 required modules, depending on your situation, and should take 2 - 3 hours to complete. You can find assistance with the CITI Program in the documents below.

Assistance with logging in to an existing account and adding the appropriate course(s)

Assistance with creating a new account and registering for the appropriate course(s)

Assistance with associating your existing account with your SMU credentials

Continuing Education

ORGS will offer continuing education opportunities to SMU animal users on a regular basis.

The SMU Institutional Animal Care and Use Committee (IACUC) relies on the observations of individuals to ensure the well-being of all research animals. All Personnel are encouraged to contact any of the individuals or offices listed below if they:

• see animals that appear to be in pain/distress;
• witness or are involved in an incident that may impact the welfare of laboratory animals at SMU;
• have a concern about the conduct of Personnel handling laboratory animals; or
• have a concern about Protocol integrity or possible scientific misconduct.

All reviews and investigations will be dealt with confidentially to the extent reasonably possible, and SMU ensures that no individual will be discriminated against or be subject to any reprisal for raising a concern or reporting a violation to any regulation or standard pertaining to animal care and use.

A concern or report can be made anonymously through the SMU Fraud Reporting Program.

• Guide for the Care and Use of Laboratory Animals
• Office of Laboratory Animal Welfare (OLAW)
• Animal Welfare Act
• Animal Welfare Regulations
• AVMA Guidelines for the Euthanasia of Animals
• Occupational Health and Safety in the Care and Use of Research Animals
• Policy on Humane Care and Use of Laboratory Animals
• SMU IACUC Forms