What is a Contract Vivarium?
Institutional Animal Care and Use Committees (IACUCs) are internal committees at animal research facilities or other institutions that work with laboratory animals, that ensure the laws and regulations pertaining to ethical and humane animal research are being applied and adhered to by research teams.
Typically, an IACUC oversees, reviews and approves all research with animals and conducts semi-annual evaluations of the animal program and inspection of the animal facility. The federal requirement for an institution to have an IACUC in place is dependent upon the type of species used, funding source for the research, and state or local ordinances.
The Animal Welfare Act and Regulations (AWAR), enforced by the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA), is the only federal legislation to regulate the care and use of research animals across the U.S. and requires facilities to create internal IACUCs. However, mice of the genus Mus and rats of the genus Rattus are specifically excluded from coverage under the AWAR, despite the fact that at least 93-97% of research is conducted with these species.
Mice and rats are protected under the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, enforced by the National Institutes of Health’s (NIH) Office of Laboratory Animal Welfare (OLAW), as they cover all vertebrate animals used for research. Similar to the AWAR, the PHS policy also mandates institutions create internal IACUCs; however, this law applies only to those research facilities that receive federal funding (i.e., grants given by NIH, FDA, CDC, or any other PHS agency). This means institutions conducting research only with mice or rats without any federal funding support are not required to develop an IACUC.
So why should a vivarium facility voluntarily support an in-house IACUC to ensure compliance with federal animal welfare standards when it isn’t obligated to do so?
“Having an IACUC in place is an indicator of good scientific practice, and crucial to understanding the ethical obligation that comes with in vivo research,” says Claire Johnson, Manager of Quality Assurance & Compliance and IACUC Chairperson for Mispro Biotech Services.
“It’s not just the right thing to do for the animals, but it’s good for your science. Accurate animal studies happen when the animals are free from stress and well taken care of in a stable environment,” she adds.
“An IACUC acts as a guide for the care of research animals. Animal welfare is the top priority, but research teams at our facilities also benefit from the IACUC approval process. An IACUC is built-in expertise that supports your research. It creates flexibility and delivers feedback for conducting the best science. Plus, an IACUC provides additional veterinary support, which is one less component for research teams to worry about. An IACUC is a best-practice that’s just good for everybody,” she explains.
Johnson stresses that an IACUC does not act as the animal police, they’re not seeking non-compliance. Rather, an IACUC’s role is to help researchers into compliance before their in vivo trials begin, providing guidance for ethical scientific research involving animals and biomedical research. There are mandated procedures for non-compliance an IACUC must adhere to, but, Johnson says, their aim is to address potential issues before they become non-compliant. “Insight, not oversight,” she says.
There is a set of specific requirements for IACUC composition mandated by the AWAR & PHS Policy. An IACUC must have at minimum a Chairperson, a Doctor of Veterinary Medicine with training or experience working with laboratory animals, a non-scientific member not related in any scientific discipline, and a member with no affiliation with the institution.
“Mispro’s IACUC committee, for example, is composed of more than the five required roles,” explains Johnson. “We have scientists, a retired veterinary pathologist, an infectious disease researcher, and at least one non-affiliated member to represent community interests and concerns, to maximize integrity. So there’s this wealth of information and robust experience to review and approve protocols and offer comprehensive advice to our incoming research teams.”
A local IACUC reviews research protocols and conducts evaluations of the institution's animal care. For example, each research team conducting their preclinical research with Mispro must submit an animal use protocol to be reviewed by Mispro’s IACUC committee prior to beginning their preclinical trials.
The protocols cover points including the identification of the species and approximate number of animals to be used, the rationale for involving animals, and a complete description of the proposed use of the animals, including all procedures associated with conducting scientifically valuable research.
Before a client submits their protocol to Mispro’s IACUC office for review, they first meet with Johnson for a pre-review, where Johnson offers feedback and helps the team modify their submission to make it as ready as possible for IACUC approval.
Johnson says the pre-review process is an uncommon extra step, but it helps to reduce administrative burden. Clients who go through a pre-review with an industry expert before submitting to the IACUC committee are more likely to have their protocols approved in the first round, and less likely to have their submission returned for edits.
“We understand our clients are excited to get their preclinical studies underway. This high-touch, concierge-level customer experience helps us uncomplicate the IACUC process and offer a quick turnaround time. The approval time frame is dependent upon how quickly the client can adjust to feedback.”
Johnson has a few words of wisdom for researchers in the early stages of applying for IACUC approval.
“Researchers put a lot of regulatory burdens on themselves by putting too much information into their first round of the protocol. I understand the impulse, they’re trying to anticipate every experiment they can think of in case their research might need it.”
“Less is more,” says Johnson. “Focus on the immediate future for your research plans, amendments can be made later, and our amendment process is quick and easy.”
One of the benefits of an IACUC, Johnson explains, is that it helps you articulate specifically and succinctly how your research will progress. “It spells out the work in detail, from A to Z, for the research team who will be doing the day-to-day work.”
She also points out, “It’s okay to have multiple protocols if your research has different areas of focus. It’s not necessary to find a one-size-fits-all protocol for multifaceted research needs. Let your discovery guide your work. There are processes in place to amend protocols, so don’t be afraid to follow where your research takes you!”
All IACUCs do not operate the same way. They must meet different performance standards, but there’s also a measure of flexibility.
“Mispro’s IACUC does all it can to work with our clients to remove the administrative burden from the compliance process. We’re keenly aware of the precise regulations and standards that must be followed, where there is latitude, and where our client can afford to be flexible. But it takes a set of specialized skills and technical knowledge to navigate the intricacies of IACUC,” says Johnson. Ultimately, having a robust, experienced IACUC committee can help to improve research outcomes down the line.
“I’m very passionate about this,” explains Johnson. “I had no idea research animals were protected under the law until I started my graduate program at Tufts Cummings School of Veterinary Medicine. You always hear no one cares about them. But it’s the complete opposite. It’s a privilege to work with research animals; I feel like I make a difference every day and I think it’s really cool to have a job like that.”
