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Animal Research - IACUC

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Frequently Asked Questions


How are members appointed to the IACUC committee?

Why are there more than 5 members on the IACUC?
What qualifications do the IACUC members have?
Why is the IACUC always inspecting my lab?
Why does the IACUC nitpick my protocols and labs?
Who do I contact about IACUC questions?
Why does the project summary have to be written in lay language?
What are the general requirements for when death is used as an endpoint?
Why do we have to do daily checks?
Where can I get assistance writing a protocol?
How long will it take before my protocol is approved?
Why do we have to do annual reports?
How do I transfer animals to my protocol from another study?

How are members appointed to the IACUC committee? Members are appointed from the President’s Office. Recommendations may be sought from current and outgoing committee members as well as deans and department heads.

The Chief Executive Officer (CEO) is charged with appointing an IACUC (AWA § 2143,b,1; AWAR §2.31,a; PHS Policy IV,A,3,a). The CEO is defined in PHS Policy (IV,A,3,a, footnote 5) as the highest operating official of the organization, such as the President of a University. The Guide for the Care and Use of Laboratory Animals (8th Edition) (Guide) (p.12) requires institutions to comply with the AWAR and PHS Policy.

Why are there more than 5 members on the IACUC?
Per the Guide (pp. 24-25), PHS Policy IV,A,3,b, and JMU's Animal Welfare Assurance, the IACUC membership is comprised of at least:

  • A Doctor of Veterinary Medicine either certified (e.g., by ACLAM, ECLAM, JCLAM, KCLAM) or with training and experience in laboratory animal science and medicine or in the use of the species at the institution,
  • At least one practicing scientist experienced in research involving animals,
  • At least one member from a nonscientific background, drawn from inside or outside the institution, and
  • At least one public member to represent general community interests in the proper care and use of animals.

Please note the USDA discourages one person filling multiple positions. For additional membership on membership, please see: http://www.nal.usda.gov/awic/legislat/Policy15.pdf

Having an IACUC that is too small limits the range of expertise and can also make it more difficult to attain quorum. Furthermore, if a required member vacates their position on the committee, an IACUC is not properly constituted and therefore may conduct official business until that position is filled (National Institutes of Health, 2013).

According to Silverman, Suckow, & Murthy (2014), other institutional constituencies that have merit for serving on the IACUC include, “IACUC administrators, health and safety personnel, statisticians, librarians, legal counsel, and public relations personnel” (p. 49). IACUC administrators monitor regulatory changes as well as serve as liaison between the committee and researchers. Health and safety personnel can keep the committee up-to-date on health and safety regulations. Librarians can help researchers consider and search for alternatives to the use of live animals. Legal and public relations can assist with policy and perception of the public. Furthermore, senior animal management or supervisory personnel, research laboratory technicians involved with animals, grants and financial personnel, and student body representatives are also preferred institutional constituencies.

References:
National Institutes of Health, Office of Laboratory Animal Welfare. 2013. Frequently Asked Questions B.1, What are the IACUC membership criteria? http://grants.nih.gov/grants/olaw/faqs.htm#B.

Silverman, J., Suckow, M., & Murthy, S. (Eds.). (2014). The IACUC handbook (Third ed.). Boca Raton, FL: CRC Press.

What qualifications do the IACUC members have?
In addition to meeting the specific membership requirements, members are chosen to represent all areas of animal research being conducted on and off campus. Members are appointed from a variety of backgrounds. The experience, expertise, and diversity of the IACUC members should allow the IACUC to provide a complete and adequate review of the animal research activities conducted at the institution.

Members are required to complete the CITI Program course “Essentials for IACUC Members” and are also asked to complete species specific courses for all animals currently on campus. Members must also read and document all Standard Operating Procedures (SOPs) for CHBS and Biology. In-house training sessions conducted by the attending veterinarian are also provided at least annually and members are notified of offsite training as opportunities become available. Training is verified and documented by ORI.

Why is the IACUC always inspecting my lab?
Per the Guide, PHS Policy, and the JMU Assurance, the institution’s animal facilities, including animal study areas and satellite facilities, are to be inspected at least once every six months using the Animal Welfare Act and Animal Welfare Regulations and the Guide as a basis for evaluation. JMU follows the Semiannual Program Review and Facility Inspection Checklist provided on NIH’s website: http://grants.nih.gov/grants/olaw/sampledoc/cheklist.htm. Post-approval monitoring is also conducted to ensure that all findings during the inspections have been addressed.

In addition, SoBran, Inc. conducts QA Inspections as part of their contract with JMU.

Furthermore, inspectors from the USDA may visit any lab where USDA species are used. These are unannounced inspections. Additional outside regulatory or accrediting agencies may visit labs.     

Why does the IACUC nitpick my protocols and lab?
The IACUC oversees the responsible use of animals in University research and instructional activities. The IACUC reviews protocols, reviews the animal care and use program, and monitors University animal facilities to ensure compliance with standards and regulatory requirements. The protocol you submit is a standalone document and you cannot refer to procedures in other protocols or publications, or assume that they are so generally used that everyone will know what you will do.     

Who do I contact about IACUC questions?

Administrative and compliance questions should be directed to ORI. ORI provides compliance oversight for the IACUC and coordinates with compliance committees by providing administrative support, recordkeeping, and reporting. If you have questions that you want to address before the committee, please contact ORI and the support staff will coordinate a meeting. 

Why does the project summary have to be written in lay language?
The IACUC must have at least one non-scientist who must be able to adequately evaluate a protocol. If the overall intent and objectives of the study has terminology and concepts that are too scientific or technical, even others scientists may have difficulty in comprehending the project summary.  A common standard is to write the summary at a high-school reading level.

In addition, research protocols are commonly requested under the Freedom of Information Act (FOIA) and State Open Records. Should the university receive a request under FOIA or the state open record law, the summary ought be written in such a way that the general public can understand. Animal rights activists submit requests in an effort to end the use of animals in research and use the information they receive to convince the public that researchers are abusing animals.

Sources:
Pinson, D. M. (2011). Writing clear animal activity proposals. Lab Animal, 40(6), 187-192.

http://primr.blogspot.com/2011/03/composition-of-lay-summary-for-iacuc.html

http://ori.hhs.gov/education/products/ncstate/iacuc.htm

http://www.niaid.nih.gov/researchfunding/sci/animal/pages/anitutorial.aspx#H1

Responding to FOIA Requests: Facts and Resources
FASEB, NABR, and the SfN co-developed a document providing best practices for responding to FOIA requests in the US.

What are the general requirements for when death is used as an endpoint?

Death as an endpoint in animal experiments must be appropriately justified by the investigator and approved by the IACUC. The justification must include the following:

  • Alternative endpoints that were considered and why death as an endpoint was selected.
  • If analgesics cannot be used, a justification for why they cannot be used whenever possible.

The earliest endpoint of an experiment must be chosen, and the animal should be euthanized to avoid a prolonged or painful death if possible.

Why do we have to do daily checks?
Per SOP No. BIO-12-114 and SOP No. CHBS-12-114, health checks are to be conducted daily on all species unless stated otherwise within an approved IACUC protocol.

In addition, it is a must that responsibilities for daily animal care and facility management are assigned to specific individual(s) when a full-time veterinarian is not available on site (Guide, p. 14).

Furthermore, the JMU PHS Assurance states, “Animal care personnel will be responsible for performing the daily health checks of the animals, and will notify the principal investigator who will inform the attending veterinarian of any health problems.” 

Where can I get assistance writing a protocol?
Questions regarding forms should be directed to ORI. Questions directly related to research should be directed to the Vivarium Facility Manager and/or the Attending Veterinarian.

How long will it take before my protocol is approved?

Once a new protocol is received in ORI, it will be posted for review. If the protocol was submitted by the posted submission deadline, it will be included on the next meeting agenda.

Amendments with significant changes require Full Committee review. Minor amendments to research will be sent for Designated-Member Review (DMR). Administrative amendments (adding personnel to a study) can be approved by ORI.

The committee is given (5) business days to evaluate a new protocol and amendments with changes to research. Reviewers’ comments will be compiled and sent back to the PI to allow sufficient time to prepare for the meeting once all evaluation forms have been received. If the PI would like to respond to the reviewers’ comments and/or is unable to attend the meeting, it is requested that they submit responses in a Word document one week prior to the convened meeting to allow the committee sufficient time to review. Please do not submit the revised protocol as additional revisions may be requested during the meeting.

After the protocol is discussed during the meeting, the committee will vote for approval. If a protocol has significant issues, the committee may vote to table until the next convened meeting. While is not required that a PI attend the meeting since there may be circumstances that prevent someone from being present, it is strongly recommended that they attend to address any questions or concerns the committee may have.

After the meeting, ORI will email the PI with the reviewers’ comments again and any additional comments brought up at the meeting. It is at this time that the PI will be requested to revise their protocol. The PI will be notified immediately following the meeting or the next business day.

Once revisions are received in ORI, they will be posted for review. Protocols that were approved pending modifications will be sent for DMR. Evaluation forms are due within (3) business days of being posted. Protocols that were not approved during the convened meeting will be included on the next month’s meeting agenda.

In order to process approval, the following items must be complete:

  • Animal Use Protocol (AUP) Form or Amendment Form (signed by PI(s), Department Head, and all students involved)
  • Occupational Health Risk Assessment Questionnaire (all students involved must have on file)
  • CITI Working with the IACUC Training
  • CITI (working w/species specific) Training
  • Hands-on Training (in the lab training of specific research and safety procedures conducted by the PI for all students listed on the protocol)
  • Read and document all applicable Standard Operating Procedures (required for all personnel involved in study)

Please complete all items as early on as possible to avoid any unnecessary delays. 

Why do we have to do annual reports?
Per NIH, “Monitoring of animal care and use is required by the PHS Policy. The Guide (p. 33) describes methods for continuing review to include ‘continuing protocol review; laboratory inspections (conducted either during regular facilities inspections or separately); veterinary or IACUC observation of selected procedures; observation of animals by animal care, veterinary, and IACUC staff and members; and external regulatory inspections and assessments.’

Continuing protocol review may consist of an annual update. ‘Some institutions use the annual review as an opportunity for the investigator to submit proposed amendments for future procedures, to provide a description of any adverse or unanticipated events, and to provide updates on work progress.’ (Guide, p. 34) The PHS Policy determines the maximum interval between IACUC review and approval as 3 years, i.e., a complete de novo review is required at least every 3 years. The review must encompass all of the criteria in the Policy at IV.C.1.a.-g. Animal work may not be administratively extended beyond the 3-year expiration date.’” http://grants.nih.gov/grants/olaw/tutorial/iacuc.htm#5c_2

The JMU PHS Assurance states: “Protocol approval will be valid for a maximum of three years with progress reports reviewed annually... All animal protocols must be re-approved by the IACUC annually if the protocol is to remain open. The purpose of this Progress/Continuing Review is to provide the IACUC with current information concerning the status of Protocols.”

The process of submitting an annual progress report also helps ensure that researchers can still have academic freedom and protects the university as this is stated in the Assurance.  All it takes is one event to have the university’s Assurance pulled.  If the Assurance is pulled ALL research at JMU will be temporarily stopped until the Assurance is re-approved. 

How do I transfer animals to my protocol from another study? 
Please state the name of the PI who you will be receiving the animals from within the protocol.  


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