IACUC members are appointed by the President of James Madison University, who serves as the Institution's Chief Executive Officer (CEO) for purposes of animal research oversight. Federal regulations require the CEO to formally appoint IACUC members and ensure that the committee is properly constituted.

Recommendations for membership may be solicited from current and former committee members, Deans, Academic Unit Heads, and other university stakeholders. When making appointments, the university seeks to ensure that the committee includes the expertise, experience, and perspectives necessary to effectively oversee JMU's animal care and use program.

Committee membership is structured to meet all federal requirements and includes individuals with scientific, veterinary, non-scientific, and community perspectives to support thorough and balanced review of animal research activities.
Federal regulations and JMU's Animal Welfare Assurance require the IACUC to include at least a veterinarian, a scientist experienced in animal research, a non-scientist, and a community representative. These are minimum requirements, not maximums.

JMU appoints additional members to ensure the committee has the expertise needed to review the variety of animal activities conducted at the university. Additional members may provide expertise in areas such as animal care, health and safety, regulatory compliance, research administration, statistics, or other fields relevant to the humane and responsible use of animals.

Having a larger committee also helps ensure diverse perspectives during protocol review, supports thorough oversight of the animal care and use program, and allows the IACUC to maintain a quorum when members are unavailable or have conflicts of interest.

In short, a committee with more than the minimum number of members provides broader expertise, more robust review, and greater continuity in IACUC operations.
In addition to meeting federal membership requirements, IACUC members are selected to represent the breadth of animal research and animal care activities conducted at JMU. The committee includes individuals with diverse professional backgrounds and areas of expertise to ensure that protocols receive comprehensive and balanced review.

Members may include scientists, veterinarians, animal care personnel, non-scientists, and community representatives. This diversity helps the IACUC evaluate animal research from scientific, regulatory, animal welfare, and public perspectives.

To prepare for their responsibilities, all IACUC members complete the CITI Program course "Essentials for IACUC Members." Members are also encouraged to complete species-specific training courses for animals housed on campus and are required to review applicable Standard Operating Procedures (SOPs) for the Biology and CHBS animal facilities.

In addition, members participate in continuing education through training sessions provided by the Attending Veterinarian and are informed of external training opportunities as they become available. Training completion is documented and maintained by ORIC to ensure members remain current on animal welfare regulations, policies, and best practices.
Facility inspections and post-approval monitoring are required components of JMU's animal care and use program. Under the Guide for the Care and Use of Laboratory Animals, PHS Policy, and JMU's Animal Welfare Assurance, the IACUC must inspect all animal facilities, including animal study areas and satellite facilities, at least once every six months. These inspections help ensure that animal activities are conducted in accordance with approved protocols and that animal welfare, personnel safety, and regulatory requirements are being met.

JMU uses NIH's Semiannual Program Review and Facility Inspection Checklist as a guide when conducting inspections. In addition to the semiannual inspections, post-approval monitoring may be conducted to verify that previously identified findings have been addressed and that approved animal activities continue to align with the protocol.

Inspections should not be viewed as punitive. Rather, they are an important part of maintaining a high-quality animal care and use program and helping investigators identify and address potential issues before they become compliance concerns.

The IACUC's role is to ensure that animal research is conducted in compliance with federal regulations, institutional policies, and animal welfare standards. Committee members review protocols and animal facilities carefully because even small details can impact animal welfare, researcher safety, data quality, and regulatory compliance.

Questions and requested revisions are not intended to create barriers to research. Rather, they help ensure that protocols accurately describe approved procedures, risks are appropriately addressed, personnel are adequately trained, and animals receive proper care. Thorough review also helps protect investigators, research staff, and the university's animal care and use program.

The IACUC recognizes that conducting research is a collaborative effort and strives to work with investigators to achieve both scientific objectives and compliance requirements.

Administrative and compliance-related questions should be directed to ORIC. ORIC provides administrative and compliance support for the IACUC, including protocol management, recordkeeping, reporting, and coordination of committee activities. If you have questions or concerns that you would like to discuss with the IACUC, please contact ORIC. ORIC staff can help address your questions directly or coordinate discussion with the committee as appropriate.
The project summary should be written in lay language so that all members of the IACUC can understand the purpose, objectives, and significance of the proposed research. Federal regulations require that the committee include at least one non-scientist member, and all committee members must be able to adequately evaluate the protocol. Using clear, non-technical language also helps ensure that reviewers from different scientific backgrounds can understand the proposed work. As a general guideline, the summary should be written at approximately a high school reading level.

In addition, research protocols may be subject to requests under the Freedom of Information Act (FOIA) or applicable state public records laws. A well-written lay summary promotes transparency and helps members of the public understand the purpose of the research, the role of animals in the study, and the measures taken to ensure animal welfare. Clear communication helps foster public trust in the university's research program and its commitment to the responsible conduct of research.

Death as an endpoint in an animal study must be scientifically justified by the investigator and approved by the IACUC. The justification must address the following:

  • Alternative endpoints that were considered and the rationale for selecting death as the endpoint.
  • If analgesics cannot be used, a scientific justification explaining why their use would interfere with the objectives of the study, when applicable.

Whenever possible, humane endpoints should be established and used in place of death as an endpoint. Animals should be euthanized at the earliest scientifically justified endpoint to prevent or minimize unnecessary pain, distress, or suffering.

In accordance with JMU SOP No. BIO-12-114 and SOP No. CHBS-12-114, animals must be observed at least once daily, including weekends and holidays, unless an alternative schedule has been specifically approved by the IACUC within the protocol. Individuals responsible for animal care are expected to monitor animals for signs of illness, injury, distress, or unexpected changes in condition and promptly report any concerns.

As outlined in JMU's PHS Assurance, animal care personnel are responsible for performing daily health checks and notifying the Principal Investigator (PI) of any health concerns. The PI is then responsible for consulting with the Attending Veterinarian and/or Vivarium and Lab Safety Manager to ensure that animals receive timely and appropriate care.

Questions regarding forms should be directed to ORIC. Questions directly related to research should be directed to the Vivarium and Lab Safety Manager and/or the Attending Veterinarian.

The review timeline depends on the complexity of the protocol, the completeness of the submission, and the need for revisions.

Once a new protocol is received by ORIC, it will be assigned for review. Protocols submitted by the posted submission deadline will be placed on the agenda for the next scheduled IACUC meeting.

Amendments involving significant changes to approved animal activities require Full Committee Review. Minor modifications may be reviewed through the Designated Member Review (DMR) process. Administrative changes, such as adding research personnel, may be approved by ORIC.

Committee members are provided time to evaluate new protocols and amendments. Reviewer comments are compiled and shared with the Principal Investigator (PI) before the meeting to allow time for review and response. If the PI would like to address reviewer comments in advance or is unable to attend the meeting, responses should be submitted in a Word document prior to the meeting.

During the convened meeting, the committee will discuss and vote on the protocol. If substantial concerns are identified, the committee may table the protocol pending additional information or revisions. Although attendance is not required, PIs are strongly encouraged to attend meetings to address committee questions and facilitate the review process.

Following the meeting, ORIC will provide the PI with the committee's decision, reviewer comments, and any requested modifications. The PI will then be asked to submit any required revisions.

Once revisions are received, they will be reviewed by ORIC and, when applicable, through the DMR process. Protocols that require additional Full Committee Review will be placed on the agenda for a subsequent IACUC meeting.

Before a protocol can receive final approval, the following requirements must be completed:

  • Protocol submitted through the electronic Research Administration (eRA) system
  • Occupational Health Risk Assessment Questionnaire completed for all study personnel, including students
  • Required CITI IACUC training completed
  • Required species-specific training completed, when applicable
  • Laboratory-specific, hands-on training provided by the PI or designee
  • Review and documentation of all applicable Standard Operating Procedures (SOPs)

Completing these requirements as early as possible will help avoid delays in protocol approval.

As outlined in JMU’s Public Health Service (PHS) Assurance, protocol approval is valid for a maximum of three years, with annual progress reports completed and reviewed as part of the post-approval monitoring process.

The annual progress report allows the IACUC to verify that approved animal activities remain accurate, current, and compliant with institutional, federal, and funding agency requirements. It also provides investigators with an opportunity to report changes, address concerns, and confirm that animal work continues as originally approved.

Maintaining an accurate and up-to-date protocol inventory is essential to preserving both researchers’ ability to conduct animal activities and JMU’s authority to maintain an animal care and use program. Compliance with annual review requirements helps ensure that JMU remains in good standing with its regulatory obligations and institutional assurance commitments.

Please complete an Animal Transfer Form.

If you have any additional questions that you would like included on this page, please contact researchintegrity@jmu.edu.

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